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1.  Bacterial Vaginosis Associated with Increased Risk of Female-to-Male HIV-1 Transmission: A Prospective Cohort Analysis among African Couples 
PLoS Medicine  2012;9(6):e1001251.
In a prospective study, Craig Cohen and colleagues investigate the association between bacterial vaginosis and the risk of female-to-male HIV-1 transmission.
Background
Bacterial vaginosis (BV), a disruption of the normal vaginal flora, has been associated with a 60% increased risk of HIV-1 acquisition in women and higher concentration of HIV-1 RNA in the genital tract of HIV-1–infected women. However, whether BV, which is present in up to half of African HIV-1–infected women, is associated with an increase in HIV-1 transmission to male partners has not been assessed in previous studies.
Methods and Findings
We assessed the association between BV on female-to-male HIV-1 transmission risk in a prospective study of 2,236 HIV-1–seropositive women and their HIV-1 uninfected male partners from seven African countries from a randomized placebo-controlled trial that enrolled heterosexual African adults who were seropositive for both HIV-1 and herpes simplex virus (HSV)-2, and their HIV-1–seronegative partners. Participants were followed for up to 24 months; every three months, vaginal swabs were obtained from female partners for Gram stain and male partners were tested for HIV-1. BV and normal vaginal flora were defined as a Nugent score of 7–10 and 0–3, respectively. To reduce misclassification, HIV-1 sequence analysis of viruses from seroconverters and their partners was performed to determine linkage of HIV-1 transmissions. Overall, 50 incident HIV-1 infections occurred in men in which the HIV-1–infected female partner had an evaluable vaginal Gram stain. HIV-1 incidence in men whose HIV-1–infected female partners had BV was 2.91 versus 0.76 per 100 person-years in men whose female partners had normal vaginal flora (hazard ratio 3.62, 95% CI 1.74–7.52). After controlling for sociodemographic factors, sexual behavior, male circumcision, sexually transmitted infections, pregnancy, and plasma HIV-1 RNA levels in female partners, BV was associated with a greater than 3-fold increased risk of female-to-male HIV-1 transmission (adjusted hazard ratio 3.17, 95% CI 1.37–7.33).
Conclusions
This study identified an association between BV and increased risk of HIV-1 transmission to male partners. Several limitations may affect the generalizability of our results including: all participants underwent couples HIV counseling and testing and enrolled in an HIV-1 prevention trial, and index participants had a baseline CD4 count ≥250 cells/mm3 and were HSV-2 seropositive. Given the high prevalence of BV and the association of BV with increased risk of both female HIV-1 acquisition and transmission found in our study, if this association proves to be causal, BV could be responsible for a substantial proportion of new HIV-1 infections in Africa. Normalization of vaginal flora in HIV-1–infected women could mitigate female-to-male HIV-1 transmission.
Trial Registration: ClinicalTrials.com NCT00194519
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Since the first reported case of AIDS in 1981, the number of people infected with HIV, the virus that causes AIDS, has risen steadily. By the end of 2010, 34 million people were living with HIV/AIDS. At the beginning of the epidemic more men than women were infected with HIV. Now, however, 50% of all adults infected with HIV are women and in sub-Saharan Africa, where two-thirds of HIV-positive people live, women account for 59% of people living with HIV. Moreover, among 15–24 year-olds, women are eight times more likely than men to be HIV-positive. This pattern of infection has developed because most people in sub-Saharan Africa contract HIV through unprotected heterosexual sex. The risk of HIV transmission for both men and women in Africa and elsewhere can be reduced by abstaining from sex, by only having one or a few partners, by always using condoms, and by male circumcision. In addition, several studies suggest that antiretroviral therapy (ART) greatly reduces HIV transmission.
Why Was This Study Done?
Unfortunately, in sub-Saharan Africa, only about a fifth of HIV-positive people are currently receiving ART, which means that there is an urgent need to find other effective ways to reduce HIV transmission in this region. In this prospective cohort study (a type of study that follows a group of people for some time to see which personal characteristics are associated with disease development), the researchers investigate whether bacterial vaginosis—a condition in which harmful bacteria disrupt the normal vaginal flora—increases the risk of female-to-male HIV transmission among African couples. Bacterial vaginosis, which is extremely common in sub-Saharan Africa, has been associated with an increased risk of HIV acquisition in women and induces viral replication and shedding in the vagina in HIV-positive women, which may mean that HIV-positive women with bacterial vaginosis are more likely to transmit HIV to their male partners than women without this condition. If this is the case, then interventions that reduce the incidence of bacterial vaginosis might be valuable HIV prevention strategies.
What Did the Researchers Do and Find?
The researchers analyzed data collected from 2,236 heterosexual African couples enrolled in a clinical trial (the Partners in Prevention HSV/HIV Transmission Study) whose primary aim was to investigate whether suppression of herpes simplex virus infection could prevent HIV transmission. In all the couples, the woman was HIV-positive and the man was initially HIV-negative. The female partners were examined every three months for the presence of bacterial vaginosis and the male partners were tested regularly for HIV infection. The researchers also determined whether the men who became HIV-positive were infected with the same HIV strain as their partner to check that their infection had been acquired from this partner. The HIV incidence in men whose partners had bacterial vaginosis was 2.9 per 100 person-years (that is, 2.9 out of every 100 men became HIV-positive per year) whereas the HIV incidence in men whose partners had a normal vaginal flora was 0.76 per 100 person-years. After controlling for factors that might affect the risk of HIV transmission such as male circumcision and viral levels in female partner's blood, the researchers estimated that bacterial vaginosis was associated with a 3.17-fold increased risk of female-to-male HIV transmission in their study population.
What Do These Findings Mean?
These findings suggest that HIV-positive African women with bacterial vaginosis are more than three times as likely to transmit HIV to their male partners as those with a normal vaginal flora. It is possible that some unknown characteristic of the men in this study might have increased both their own risk of HIV infection and their partner's risk of bacterial vaginosis. Nevertheless, because bacterial vaginosis is so common in Africa (half of the women in this study had bacterial vaginosis at least once during follow-up) and because this condition is associated with both female HIV acquisition and transmission, these findings suggest that bacterial vaginosis could be responsible for a substantial proportion of new HIV infections in Africa. Normalization of vaginal flora in HIV-infected women by frequent presumptive treatment with antimicrobials (treatment with a curative dose of antibiotics without testing for bacterial vaginosis) or possibly by treatment with probiotics (live “good” bacteria) might, therefore, reduce female-to-male HIV transmission in sub-Saharan Africa.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001251.
Information is available from the US National Institute of Allergy and infectious diseases on all aspects of HIV infection and AIDS and on bacterial vaginosis
The US Centers for Disease Control and Prevention has information on all aspects of HIV/AIDS, including specific information about HIV/AIDS and women; it also has information on bacterial vaginosis (in English and Spanish)
NAM/aidsmap provides basic information about HIV/AIDS, and summaries of recent research findings on HIV care and treatment, and information on bacterial vaginosis and HIV transmission (in several languages)
Information is available from Avert, an international AIDS nonprofit group on many aspects of HIV/AIDS, including detailed information on HIV and AIDS prevention, on women, HIV and AIDS and on HIV/AIDS in Africa (in English and Spanish); personal stories of women living with HIV are available; the website Healthtalkonline also provides personal stories about living with HIV
More information about the Partners in Prevention HSV/HIV Transmission Study is available
doi:10.1371/journal.pmed.1001251
PMCID: PMC3383741  PMID: 22745608
2.  Intermittent Intravaginal Antibiotic Treatment of Bacterial Vaginosis in HIV-Uninfected and -Infected Women: A Randomized Clinical Trial 
PLoS Clinical Trials  2007;2(2):e10.
Objective:
Assess efficacy of intermittent intravaginal metronidazole gel treatment in reducing frequency of bacterial vaginosis (BV).
Design:
Randomized, double-masked, placebo-controlled phase 3 trial.
Setting:
Postnatal and family planning clinics of the Queen Elizabeth Central Hospital and two health centers in Blantyre, Malawi.
Participants:
Nonpregnant HIV-uninfected and -infected women.
Intervention:
Intravaginal metronidazole treatment and placebo gels provided at baseline and every 3 mo for 1 y.
Outcome measures:
Primary: Cross-sectional and longitudinal comparisons of BV frequency at baseline, 1 mo after product dispensation (post-treatment evaluation [PTE]), and every quarterly visit. Secondary: Effect of treatment on BV clearance and recurrence.
Results:
Baseline: 842 HIV-uninfected and 844 HIV-infected women were enrolled. The frequency of BV at baseline in treatment and placebo arms, respectively, was 45.9% and 46.8% among HIV-uninfected women, and 60.5% and 56.9% among HIV-infected women. Primary outcomes: At the PTEs the prevalence of BV was consistently lower in treatment than placebo arms irrespective of HIV status. The differences were statistically significant mainly in HIV-uninfected women. Prevalence of BV was also reduced over time in both treatment and placebo arms. In a multivariable analysis that controlled for other covariates, the effect of intravaginal metronidazole treatment gel compared with placebo was not substantial: adjusted relative risk (RR) 0.90, 95% confidence interval (CI) 0.83–0.97 in HIV-uninfected women and adjusted RR 0.95, 95% CI 0.89–1.01 in HIV-infected women. Secondary outcomes: Intravaginal metronidazole treatment gel significantly increased BV clearance (adjusted hazard ratio [HR] 1.34, 95% CI 1.07–1.67 among HIV-uninfected women and adjusted HR 1.29, 95% CI 1.06–1.58 among HIV-infected women) but was not associated with decreased BV recurrence. Safety: No serious adverse events were related to use of intravaginal gels.
Conclusion:
Intermittent microbicide treatment with intravaginal gels is an innovative approach that can reduce the frequency of vaginal infections such as BV.
Editorial Commentary
Background: Bacterial vaginosis (BV) results from a change in the normal balance of bacteria in the vaginal tract, and is very common. In pregnant women, it is associated with poorer outcomes in pregnancy, and is also linked with HIV transmission (although it is not certain that BV actually increases the chance of getting HIV—just because these two occur together it does not necessarily follow that one causes the other). BV can be treated with metronidazole tablets, although these can cause gut symptoms and should not be taken repeatedly. The researchers wanted to carry out a multiclinic–based trial to find out whether a metronidazole gel applied intermittently to the vagina (for five nights every three months) would reduce the frequency of BV among women in Malawi. HIV-infected and HIV-uninfected women, recruited from postnatal and family planning clinics, were randomized to receive either metronidazole gels, or equivalent placebo gels, every three months and were then followed up for 12 months. The primary outcome for the trial was the proportion of women with BV at each quarterly follow-up visit, and the researchers intended to compare this outcome between treatment arms at each visit and also to look at the overall changes over time among women receiving either metronidazole or placebo, looking separately at HIV-infected and HIV-uninfected women.
What this trial shows: In total 1,686 women took part in the trial (842 not infected with HIV, and 844 infected with HIV). The proportion of HIV-uninfected women with BV dropped by around 20% over the course of the trial, both in women using metronidazole and in those using placebo. However, when comparing the proportion of HIV-uninfected women with BV between the two arms of the trial, there did not seem to be a consistent effect: differences were statistically significant at some time points and not others. Among HIV-infected women, there was also a drop over the course of the trial in the proportion of women with BV, irrespective of whether they used metronidazole or placebo. Again, when comparing the rate of BV among HIV-infected women between study arms (metronidazole versus placebo), the researchers did not see a consistent trend; differences were statistically significant at some time points but not others. Overall, when comparing metronidazole and placebo in an analysis that controlled for other factors, the metronidazole gel seemed to show a small effect in reduction of BV among HIV-uninfected women, but no obvious effect among HIV-infected women.
Strengths and limitations: Strengths in the design of this trial include the sample size, which was appropriate to detect an important effect of the metronidazole gel (versus placebo) had one existed, and the randomization and blinding procedures, which were designed to minimize the chance that the trialists or women being enrolled could anticipate to which arm of the trial they might be assigned. A key limitation of this study, as the researchers acknowledge, is the absence of a “no treatment” study arm. The frequency of BV dropped over the course of the trial in women using the placebo gel, raising the possibility that the placebo actually has some effect on bacteria in the vagina. However, a trial with a “no treatment” arm would pose its own problems, since trialists and participants would then not be fully blinded as to their treatment status.
Contribution to the evidence: This trial adds data on the efficacy of metronidazole gel when used intermittently, and among women in the community who may or may not actually have BV. Previous studies have evaluated treatment with metronidazole among women who already have symptoms or a diagnosis of BV. The findings of this trial rule out a substantial effect of metronidazole gel, as compared to placebo gel, in reducing the frequency of BV in this setting.
doi:10.1371/journal.pctr.0020010
PMCID: PMC1851729  PMID: 17318258
3.  The Diaphragm and Lubricant Gel for Prevention of Cervical Sexually Transmitted Infections: Results of a Randomized Controlled Trial 
PLoS ONE  2008;3(10):e3488.
Background
We evaluated the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens®) and condoms compared to condoms alone on the incidence of chlamydial and gonococcal infections in an open-label randomized controlled trial among women at risk of HIV/STI infections.
Methods
We randomized 5045 sexually-active women at three sites in Southern Africa. Participants who tested positive for curable STIs were treated prior to enrollment as per local guidelines. Women were followed quarterly and tested for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (GC) infection by nucleic-acid amplification testing (Roche Amplicor®) using first-catch urine specimens. STIs detected at follow-up visits were treated. We compared the incidence of first infection after randomization between study arms in both intent-to-treat (ITT) and per-protocol populations.
Findings
Baseline demographic, behavioral and clinical characteristics were balanced across study arms. Nearly 80% of participants were under 35 years of age. Median follow-up time was 21 months and the retention rate was over 93%. There were 471 first chlamydia infections, 247 in the intervention arm and 224 in the control arm with an overall incidence of 6.2/100 woman-years (wy) (relative hazard (RH) 1.11, 95% Confidence Interval (CI): 0.93–1.33; p = 0.25) and 192 first gonococcal infections, 95 in the intervention arm and 97 in the control arm with an overall incidence of 2.4/100wy (RH 0.98, 95%CI: 0.74–1.30; p = 0.90). Per protocol results indicated that when diaphragm adherence was defined as “always use” since the last visit, there was a significant reduction in the incidence of GC infection among women randomized to the intervention arm (RH 0.61, 95%CI: 0.41–0.91, P = 0.02).
Interpretation
There was no difference by study arm in the rate of acquisition of CT or GC. However, our per-protocol results suggest that consistent use of the diaphragm may reduce acquisition of GC.
Trial Registration
ClinicalTrials.gov NCT00121459 [NCT00121459]
doi:10.1371/journal.pone.0003488
PMCID: PMC2567030  PMID: 18941533
4.  Intravaginal Practices, Bacterial Vaginosis, and HIV Infection in Women: Individual Participant Data Meta-analysis 
PLoS Medicine  2011;8(2):e1000416.
Pooling of data from 14,874 women in an individual participant data meta-analysis by Nicola Low and colleagues reveals that some intravaginal practices increase the risk of HIV acquisition.
Background
Identifying modifiable factors that increase women's vulnerability to HIV is a critical step in developing effective female-initiated prevention interventions. The primary objective of this study was to pool individual participant data from prospective longitudinal studies to investigate the association between intravaginal practices and acquisition of HIV infection among women in sub-Saharan Africa. Secondary objectives were to investigate associations between intravaginal practices and disrupted vaginal flora; and between disrupted vaginal flora and HIV acquisition.
Methods and Findings
We conducted a meta-analysis of individual participant data from 13 prospective cohort studies involving 14,874 women, of whom 791 acquired HIV infection during 21,218 woman years of follow-up. Data were pooled using random-effects meta-analysis. The level of between-study heterogeneity was low in all analyses (I2 values 0.0%–16.1%). Intravaginal use of cloth or paper (pooled adjusted hazard ratio [aHR] 1.47, 95% confidence interval [CI] 1.18–1.83), insertion of products to dry or tighten the vagina (aHR 1.31, 95% CI 1.00–1.71), and intravaginal cleaning with soap (aHR 1.24, 95% CI 1.01–1.53) remained associated with HIV acquisition after controlling for age, marital status, and number of sex partners in the past 3 months. Intravaginal cleaning with soap was also associated with the development of intermediate vaginal flora and bacterial vaginosis in women with normal vaginal flora at baseline (pooled adjusted odds ratio [OR] 1.24, 95% CI 1.04–1.47). Use of cloth or paper was not associated with the development of disrupted vaginal flora. Intermediate vaginal flora and bacterial vaginosis were each associated with HIV acquisition in multivariable models when measured at baseline (aHR 1.54 and 1.69, p<0.001) or at the visit before the estimated date of HIV infection (aHR 1.41 and 1.53, p<0.001), respectively.
Conclusions
This study provides evidence to suggest that some intravaginal practices increase the risk of HIV acquisition but a direct causal pathway linking intravaginal cleaning with soap, disruption of vaginal flora, and HIV acquisition has not yet been demonstrated. More consistency in the definition and measurement of specific intravaginal practices is warranted so that the effects of specific intravaginal practices and products can be further elucidated.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Since the first reported case of acquired immunodeficiency syndrome (AIDS) in 1981, the number of people infected with the human immunodeficiency virus (HIV), which causes AIDS, has risen steadily. By the end of 2009, an estimated 33.3 million people were living with HIV/AIDS. At the beginning of the epidemic, more men than women were infected with HIV but now, globally, more than half of all adults living with HIV/AIDS are women, and HIV/AIDS is the leading cause of death among women of child-bearing age. In sub-Saharan Africa, where more than two-thirds of HIV-positive people live, the situation for women is particularly bad. About 12 million women live with HIV/AIDS in this region compared with about 8 million men; among 15–24 year-olds, women are eight times more likely than men to be HIV-positive. This pattern of infection has developed because in sub-Saharan Africa most people contract HIV through heterosexual sex.
Why Was This Study Done?
If modifiable factors that increase women's vulnerability to HIV infection could be identified, it might be possible to develop effective female-initiated prevention interventions. Some experts think that intravaginal practices such as cleaning the vagina with soap or a cloth increase the risk of HIV infection by damaging the vagina's lining or by increasing bacterial vaginosis (a condition in which harmful bacteria disrupt the healthy vaginal flora) but the evidence for such an association is inconclusive. In this meta-analysis, the researchers pool individual participant data from several prospective longitudinal cohort studies to assess the association between intravaginal practices and HIV acquisition among women in sub-Saharan Africa. Meta-analysis is a statistical method that combines data from several studies to get a clearer view of the factors associated with of a disease than is possible from individual studies. In a prospective longitudinal cohort study, groups of participants with different baseline characteristics (here, women who did or did not use intravaginal practices), who do not have the outcome of interest at the start of the study (here, HIV infection) are followed to see whether these characteristics affect disease development.
What Did the Researchers Do and Find?
The researchers pooled individual participant data from 13 prospective cohort studies in sub-Saharan Africa involving nearly 15,000 women, 791 of whom acquired HIV, and asked whether HIV infection within 2 years of study enrollment was associated with self-reported intravaginal practices. That is, were women who used specific intravaginal practices more likely to become infected with HIV than women who did not use these practices? After controlling for age, marital status, and the number of recent sex partners, women who used cloth or paper to clean their vagina were nearly one and half times more likely to have acquired HIV infection as women who did not use this practice (a pooled adjusted hazard ratio [aHR] of 1.47). The insertion of products to dry or tighten the vagina and intravaginal cleaning with soap also increased women's chances of acquiring HIV (aHRs of 1.31 and 1.24, respectively). Moreover, intravaginal cleaning with soap was associated with the development of bacterial vaginosis, and disrupted vaginal flora and bacterial vaginosis were both associated with an increased risk of HIV acquisition.
What Do These Findings Mean?
These findings suggest that some intravaginal practices increase the risk of HIV acquisition but they do not prove that there is a causal link between any intravaginal practice, disruption of vaginal flora, and HIV acquisition. It could be that the women who use intravaginal practices share other unknown characteristics that affect their vulnerability to HIV infection. The accuracy of these findings is also likely to be affected by the use of self-reported data and inconsistent definitions of intravaginal practices. Nevertheless, given the widespread use of intravaginal practices in some sub-Saharan countries (95% of female sex workers in Kenya use such practices, for example), these findings suggest that encouraging women to use less harmful intravaginal practices (for example, washing with water alone) should be included in female-initiated HIV prevention research strategies in sub-Saharan Africa and other regions where intravaginal practices are common.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000416
The US National Institute of Allergy and Infectious Diseases provides information on HIV infection and AIDS and on bacterial vaginosis
The US Centers for Disease Control and Prevention has information on all aspects of HIV/AIDS, including specific information about HIV/AIDS and women; it also has information on bacterial vaginosis (in English and Spanish)
HIV InSite has information on all aspects of HIV/AIDS
Information is available from Avert, an international AIDS nonprofit on all aspects of HIV/AIDS, including HIV/AIDS and women and HIV/AIDS in Africa (in English and Spanish)
A full description of the researchers' study protocol is available
Several Web sites provide information on microbicides Global Campaign for Microbicides, Microbicides Development Programme, Microbicides Trials Network, and International Partnership for Microbicides
doi:10.1371/journal.pmed.1000416
PMCID: PMC3039685  PMID: 21358808
5.  Diaphragm and lubricant gel for prevention of HIV acquisition in southern African women: a randomised controlled trial 
Lancet  2007;370(9583):251-261.
Summary
Background
Female-controlled methods of HIV prevention are urgently needed. We assessed the effect of provision of latex diaphragm, lubricant gel, and condoms (intervention), compared with condoms alone (control) on HIV seroincidence in women in South Africa and Zimbabwe.
Methods
We did an open-label, randomised controlled trial in HIV-negative, sexually active women recruited from clinics and community-based organisations, who were followed up quarterly for 12–24 months (median 21 months). All participants received an HIV prevention package consisting of pre-test and post-test counselling about HIV and sexually transmitted infections, testing, treatment of curable sexually transmitted infections, and intensive risk-reduction counselling. The primary outcome was incident HIV infection. This study is registered with ClinicalTrials.gov, number NCT00121459.
Findings
Overall HIV incidence was 4.0% per 100 woman-years: 4.1% in the intervention group (n=2472) and 3.9% in the control group (n=2476), corresponding to a relative hazard of 1.05 (95% CI 0.84–1.32, intention-to-treat analysis). The proportion of women using condoms was significantly lower in the intervention than in the control group (54% vs 85% of visits, p<0.0001). The proportions of participants who reported adverse events (60% [1523] vs 61% [1529]) and serious adverse events (5% [130] vs 4% [101]) were similar between the two groups.
Interpretation
We observed no added protective benefit against HIV infection when the diaphragm and lubricant gel were provided in addition to condoms and a comprehensive HIV prevention package. Our observation that lower condom use in women provided with diaphragms did not result in increased infection merits further research. Although the intervention seemed safe, our findings do not support addition of the diaphragm to current HIV prevention strategies.
doi:10.1016/S0140-6736(07)60950-7
PMCID: PMC2442038  PMID: 17631387
6.  Change in condom and other barrier method use during and after an HIV prevention trial in Zimbabwe 
Background
We examined the use of male condoms and the diaphragm following completion of a clinical trial of the diaphragm's HIV prevention effectiveness. In the trial, called Methods for Improving Reproductive Health in Africa (MIRA), women were randomized to a diaphragm group (diaphragm, gel and condoms) or a condom-only control group. At trial exit, all women were offered the diaphragm and condoms.
Methods
Our sample consisted of 801 Zimbabwean MIRA participants who completed one post-trial visit (median lapse: nine months; range two to 20 months). We assessed condom, diaphragm and any barrier method use at last sex act at enrolment, final MIRA and post-trial visits. We used multivariable random effects logistic regression to examine changes in method use between these three time points.
Results and discussion
In the condom group, condom use decreased from 86% at the final trial visit to 67% post trial (AOR = 0.20; 95% CI: 0.12 to 0.33). In the diaphragm group, condom use was 61% at the final trial visit, and did not decrease significantly post trial (AOR = 0.77; 95% CI: 0.55 to 1.09), while diaphragm use decreased from 79% to 50% post trial (AOR = 0.18; 95% CI: 0.12 to 0.28). Condom use significantly decreased between the enrolment and post-trial visits in both groups. Use of any barrier method was similar in both groups: it significantly decreased between the final trial and the post-trial visits, but did not change between enrolment and the post-trial visits.
Conclusions
High condom use levels achieved during the trial were not sustained post trial in the condom group. Post-trial diaphragm use remained relatively high in the diaphragm group (given its unknown effectiveness), but was very low in the condom group. Introducing "new" methods for HIV prevention may require time and user skills before they get adopted. Our findings underscore the potential benefit of providing a mix of methods to women as it may encourage more protected acts.
doi:10.1186/1758-2652-13-39
PMCID: PMC2984577  PMID: 20955629
7.  Consistent Condom Use Increases the Colonization of Lactobacillus crispatus in the Vagina 
PLoS ONE  2013;8(7):e70716.
Background
Non-hormonal contraception methods have been widely used, but their effects on colonization by vaginal lactobacilli remain unclear.
Objective
To determine the association between non-hormonal contraception methods and vaginal lactobacilli on women’s reproductive health.
Methods
The cross-sectional study included 164 healthy women between 18–45 years of age. The subjects were divided into different groups on the basis of the different non-hormonal contraception methods used by them. At the postmenstrual visit (day 21 or 22 of the menstrual cycle), vaginal swabs were collected for determination of Nugent score, quantitative culture and real-time polymerase chain reaction (PCR) of vaginal lactobacilli. The prevalence, colony counts and 16S rRNA gene expression of the Lactobacillus strains were compared between the different groups by Chi-square and ANOVA statistical analysis methods.
Results
A Nugent score of 0–3 was more common in the condom group (93.1%) than in the group that used an interuterine device(IUD) (75.4%), (p = 0.005). The prevalence of H2O2-producing Lactobacillus was significantly higher in the condom group (82.3%) than in the IUD group (68.2%), (p = 0.016). There was a significant difference in colony count (mean ± standard error (SE), log10colony forming unit (CFU)/ml) of H2O2-producing Lactobacillus between condom users (7.81±0.14) and IUD users (6.54±0.14), (p = 0.000). The 16S rRNA gene expression (mean ± SE, log10copies/ml) of Lactobacillus crispatus was significantly higher in the condom group (8.09±0.16) than in the IUD group (6.03±0.18), (p = 0.000).
Conclusion
Consistent condom use increases the colonization of Lactobacillus crispatus in the vagina and may protect against both bacterial vaginosis (BV) and human immunodeficiency virus (HIV).
doi:10.1371/journal.pone.0070716
PMCID: PMC3720897  PMID: 23894682
8.  Bacterial vaginosis in female facility workers in north-western Tanzania: prevalence and risk factors 
Sexually Transmitted Infections  2009;85(5):370-375.
Objectives:
To determine prevalence of, and risk factors for, bacterial vaginosis (BV) among herpes simplex virus (HSV) 2 seropositive Tanzanian women at enrolment into a randomised, placebo-controlled trial of HSV suppressive treatment.
Methods:
1305 HSV-2 seropositive women aged 16–35 years working in bars, guesthouses and similar facilities were interviewed, examined and tested for HIV, syphilis, Neisseria gonorrhoeae, Chlamydia trachomatis, BV, candidiasis and trichomoniasis. Factors associated with BV were analysed using logistic regression to estimate odds ratios and 95% confidence intervals.
Results:
BV prevalence was 62.9%; prevalence of Nugent score 9–10 was 16.1%. Independent risk factors for BV were work facility type, fewer dependents, increasing alcohol consumption, sex in the last week (adjusted OR 2.03; 95% CI 1.57 to 2.62), using cloths or cotton wool for menstrual hygiene, HIV (adjusted OR 1.41; 95% CI 1.09 to 1.83) and Trichomonas vaginalis infection. There was no association between BV and the frequency or method of vaginal cleansing. However, BV was less prevalent among women who reported inserting substances to dry the vagina for sex (adjusted OR 0.44; 95% CI 0.25 to 0.75).
Conclusion:
BV was extremely prevalent among our study population of HSV-2 positive female facility workers in North-western Tanzania. Although recent sex was associated with increased BV prevalence, vaginal drying was associated with lower BV prevalence. Further studies of the effects of specific practices on vaginal flora are warranted.
doi:10.1136/sti.2008.035543
PMCID: PMC2709714  PMID: 19473997
9.  Topical Penile Microbicide Use by Men to Prevent Recurrent Bacterial Vaginosis in Sex Partners: A Randomized Clinical Trial 
Sexually transmitted diseases  2011;38(6):483-489.
Background
Bacterial vaginosis (BV) recurs frequently after metronidazole treatment. This randomized, single-blinded clinical trial (RCT) evaluated the efficacy of topical application of 62% ethyl alcohol in emollient gel (gel) to the penis by male partners of women diagnosed with BV for preventing post-treatment BV recurrence.
Methods
Among 587 Kenyan women presenting with vulvovaginal symptoms, 236 had BV (vaginal Gram stain Nugent score ≥ 7), of whom 223 (94.3%) agreed, along with their partners, to be randomized: 115 to the intervention and 108 to the control arm. In the intervention arm, male partners agreed to apply gel each morning, and before and after sexual intercourse. All couples received counseling, condoms, and syndromic treatment of STI symptoms. Follow-up visits were scheduled 1 week, 1 month, and 2 months post-enrollment, with vaginal Gram stains at every visit and culture for H2O2-producing lactobacilli at the 2 month visit. The primary outcome was time to diagnosis of BV during follow-up.
Results
In the primary intent-to-treat analysis, diagnosis of BV was significantly more frequent in the intervention arm (Hazard ratio 1.44, 95% CI 1.01-2.04). After adjustment for baseline covariates, the hazard ratio was 1.39 (95% CI 0.98-1.99). At the 2 month visit, prevalences of any vaginal lactobacilli or of H2O2-producing lactobacilli did not differ appreciably in the two study arms (p=0.81, and 0.32 respectively).
Conclusion
Daily use of the 62% ethyl alcohol gel by men before and after sex significantly increased persistence or early recurrence of BV in their partners through two months after metronidazole treatment. However, no difference was observed in prevalences of vaginal lactobacilli within this same period.
PMCID: PMC3548328  PMID: 22256334
Bacterial vaginosis; recurrence; male factor; Kenya; microbicide
10.  The Bali STD/AIDS study: association between vaginal hygiene practices and STDs among sex workers 
Objectives: To assess the association between genital cleansing practices and the prevalence of sexually transmitted diseases and of sexual health knowledge among female sex workers in Bali, Indonesia.
Methods: Low priced commercial sex workers (CSWs) participated in the Bali STD/AIDS Study, a 3 year educational project evaluating the effect of education on the subsequent use of condoms and the prevalence of STDs and AIDS. Structured interviews, genital evaluation, laboratory evaluation for STDs, and treatment were performed. Vaginal cleansing characteristics including frequency, type, and reasons for use, were evaluated. Associations between these characteristics and the presence of bacterial and viral genital infections were assessed.
Results: Of 625 female sex workers evaluated between May and July 1998, 99.1% used substances, such as soap and toothpaste, to clean the vagina at least daily, with 69.3% performing this after each intercourse. The women using such cleansers after each client did not differ from those using them once or less daily in education, AIDS and condom use knowledge, time working as a CSW, or number of clients in the previous day. However, they were younger than those using vaginal cleansers daily or less, and reported lower condom usage in the past week. Several genital symptoms, such as discoloured discharge and odour, were reported less by women with the highest frequency of vaginal cleanser use. Prevalence of genital infections in this population of women was substantial, with bacterial infections more prevalent than viral infections. Infections were not associated with the type of cleanser used, using a genital cleanser on the day of examination, or using a cleanser after each client versus daily or less, except for candida colonisation, which was more prevalent in women cleansing after each client (OR=1.87, 95% CI 1.21, 2.90). However, symptomatic candida vulvovaginitis (positive culture plus presence of symptoms) was not associated with the prevalence of genital cleansing. Women using genital cleansing in part for "infection avoidance" (39.7%) were more likely to have heard of STDs and AIDS, but were less knowledgeable about these infections, compared with women not citing this reason for genital cleansing.
Conclusion: Commercial sex workers in low priced brothels in Bali have a high rate of genital infections, with lower rates of viral compared with bacterial infections. Genital cleansers, on a daily or after each intercourse schedule, are used routinely. Although genital cleansing after each intercourse was associated with fewer genital symptoms, the prevalence of STDs did not differ significantly based on this frequency, and the women's knowledge of STDs and AIDS was less than that of women cleansing less often. The effect of genital cleansing in general on STD and AIDS prevalence could not be assessed in this population owing to the lack of a non-cleansing cohort. Further study to elucidate the effect of vaginal cleansing practices on STD prevalence and resistance is needed.
Key Words: genital cleansing; sexually transmitted diseases; douching; Bali
doi:10.1136/sti.77.1.46
PMCID: PMC1758301  PMID: 11158691
11.  Performance of BVBlue Rapid Test in Detecting Bacterial Vaginosis among Women in Mysore, India 
Bacterial vaginosis (BV) is the most common cause of abnormal vaginal discharge in reproductive age women. It is associated with increased susceptibility to HIV/STI and adverse birth outcomes. Diagnosis of BV in resource-poor settings like India is challenging. With little laboratory infrastructure there is a need for objective point-of-care diagnostic tests. Vaginal swabs were collected from women 18 years and older, with a vaginal pH > 4.5 attending a reproductive health clinic. BV was diagnosed with Amsel's criteria, Nugent scores, and the OSOM BVBlue test. Study personnel were blinded to test results. There were 347 participants enrolled between August 2009 and January 2010. BV prevalence was 45.1% (95% confidence interval (CI): 41.5%–52.8%) according to Nugent score. When compared with Nugent score, the sensitivity, specificity, positive predictive value, negative predictive value for Amsel's criteria and BVBlue were 61.9%, 88.3%, 81.5%, 73.7% and 38.1%, 92.7%, 82.1%, 63.9%, respectively. Combined with a “whiff” test, the performance of BVBlue increased sensitivity to 64.4% and negative predictive value to 73.8%. Despite the good specificity, poor sensitivity limits the usefulness of the BVBlue as a screening test in this population. There is a need to examine the usefulness of this test in other Indian populations.
doi:10.1155/2014/908313
PMCID: PMC3913452  PMID: 24526829
12.  RACE OF MALE SEX PARTNERS AND OCCURRENCE OF BACTERIAL VAGINOSIS 
Sexually transmitted diseases  2010;37(3):184-190.
BACKGROUND
Whether bacterial vaginosis (BV) is sexually transmitted is uncertain. Also it is unknown why BV is approximately twice as prevalent among African-American as among white women. An association of BV with a characteristic of the male sex partner, such as race, might support sexual transmission as well as account for the observed ethnic disparity in BV.
METHODS
3620 non-pregnant women 15–44 years of age were followed quarterly for 1 year. At each visit, extensive questionnaire data and vaginal swabs for Gram’s staining were obtained. The outcome was transition from BV-negative to positive (Nugent’s score ≥7) in an interval of 2 consecutive visits.
RESULTS
BV occurred in 12.8% of 906 sexually active intervals to white women- 24.8% of intervals when the woman reported an African-American partner and 10.7% when all partners were white. Among white women, there was a two-fold increased risk for BV incidence with an African-American, compared with a white partner (risk ratio (RR) 2.3, 95% confidence interval (CI) 1.6–3.4; adjusted RR 2.2, 95% CI 1.5–3.4), but differed according to condom use. In the presence of consistent condom use, the adjusted RR was 0.7 (0.3–2.4); it was 2.4 (1.0–6.2) in the presence of inconsistent use; and 2.7 (1.7–4.2) in the absence of condom use. African-American women could not be studied, as there were insufficient numbers who reported only white male sex partners.
CONCLUSION
The association of BV occurrence with partner’s race, and its blunting by condom use, suggests that BV may have a core group component and may be sexually transmitted.
doi:10.1097/OLQ.0b013e3181c04865
PMCID: PMC2828507  PMID: 19959972
bacterial vaginosis; sexual transmission; health disparities
13.  Prevalence and Correlates of Bacterial Vaginosis in Different Sub-Populations of Women in Sub-Saharan Africa: A Cross-Sectional Study 
PLoS ONE  2014;9(10):e109670.
Background
Clinical development of vaginally applied products aimed at reducing the transmission of HIV and other sexually transmitted infections, has highlighted the need for a better characterisation of the vaginal environment. We set out to characterise the vaginal environment in women in different settings in sub-Saharan Africa.
Methods
A longitudinal study was conducted in Kenya, Rwanda and South-Africa. Women were recruited into pre-defined study groups including adult, non-pregnant, HIV-negative women; pregnant women; adolescent girls; HIV-negative women engaging in vaginal practices; female sex workers; and HIV-positive women. Consenting women were interviewed and underwent a pelvic exam. Samples of vaginal fluid and a blood sample were taken and tested for bacterial vaginosis (BV), HIV and other reproductive tract infections (RTIs). This paper presents the cross-sectional analyses of BV Nugent scores and RTI prevalence and correlates at the screening and the enrolment visit.
Results
At the screening visit 38% of women had BV defined as a Nugent score of 7–10, and 64% had more than one RTI (N. gonorrhoea, C. trachomatis, T. vaginalis, syphilis) and/or Candida. At screening the likelihood of BV was lower in women using progestin-only contraception and higher in women with more than one RTI. At enrolment, BV scores were significantly associated with the presence of prostate specific antigen (PSA) in the vaginal fluid and with being a self-acknowledged sex worker. Further, sex workers were more likely to have incident BV by Nugent score at enrolment.
Conclusions
Our study confirmed some of the correlates of BV that have been previously reported but the most salient finding was the association between BV and the presence of PSA in the vaginal fluid which is suggestive of recent unprotected sexual intercourse.
doi:10.1371/journal.pone.0109670
PMCID: PMC4188821  PMID: 25289640
14.  Is Food Insecurity Associated with HIV Risk? Cross-Sectional Evidence from Sexually Active Women in Brazil 
PLoS Medicine  2012;9(4):e1001203.
Alexander Tsai and colleagues show that in sexually active women in Brazil severe food insecurity with hunger was positively associated with symptoms potentially indicative of sexually transmitted infection and with reduced odds of condom use.
Background
Understanding how food insecurity among women gives rise to differential patterning in HIV risks is critical for policy and programming in resource-limited settings. This is particularly the case in Brazil, which has undergone successive changes in the gender and socio-geographic composition of its complex epidemic over the past three decades. We used data from a national survey of Brazilian women to estimate the relationship between food insecurity and HIV risk.
Methods and Findings
We used data on 12,684 sexually active women from a national survey conducted in Brazil in 2006–2007. Self-reported outcomes were (a) consistent condom use, defined as using a condom at each occasion of sexual intercourse in the previous 12 mo; (b) recent condom use, less stringently defined as using a condom with the most recent sexual partner; and (c) itchy vaginal discharge in the previous 30 d, possibly indicating presence of a sexually transmitted infection. The primary explanatory variable of interest was food insecurity, measured using the culturally adapted and validated Escala Brasiliera de Segurança Alimentar. In multivariable logistic regression models, severe food insecurity with hunger was associated with a reduced odds of consistent condom use in the past 12 mo (adjusted odds ratio [AOR] = 0.67; 95% CI, 0.48–0.92) and condom use at last sexual intercourse (AOR = 0.75; 95% CI, 0.57–0.98). Self-reported itchy vaginal discharge was associated with all categories of food insecurity (with AORs ranging from 1.46 to 1.94). In absolute terms, the effect sizes were large in magnitude across all outcomes. Underweight and/or lack of control in sexual relations did not appear to mediate the observed associations.
Conclusions
Severe food insecurity with hunger was associated with reduced odds of condom use and increased odds of itchy vaginal discharge, which is potentially indicative of sexually transmitted infection, among sexually active women in Brazil. Interventions targeting food insecurity may have beneficial implications for HIV prevention in resource-limited settings.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
At the beginning of the AIDS epidemic, more men than women were infected with HIV, the virus that causes AIDS, but currently half of all HIV-positive adults are women. Most women become infected with HIV through unprotected sexual intercourse with an infected male partner. Biologically, women are twice as likely to become infected through unprotected heterosexual intercourse as men. Moreover, women are often unable to negotiate condom use because of unequal gender relations—men can insist on unprotected sexual intercourse in many relationships. Another factor often related to unequal gender relations that may shape women's risk of exposure to HIV is food insecurity—limited or uncertain access to enough nutritionally adequate and safe food for an active, healthy life. Recent studies done in sub-Saharan Africa suggest that food insecurity can affect women's engagement in risky sexual behaviors such as unprotected sex, transactional sex (sexual relationships that involve the giving of goods or services such as free lodgings), and commercial sex work.
Why Was This Study Done?
Policymakers planning HIV prevention strategies in resource-limited settings need to know whether food insecurity affects sexual risk taking among women. If it increases risk taking, then interventions that target food insecurity should improve the effectiveness of HIV prevention strategies. However, little is known about food insecurity and sexual risk taking outside sub-Saharan Africa. In this cross-sectional study (a study that characterizes a population at a single point in time), the researchers investigate whether food insecurity is associated with risky sexual behavior among sexually active women in Brazil, a country where the number of new heterosexually transmitted HIV infections among women is increasing. Condom promotion is the mainstay of Brazil's HIV prevention strategy, but less than half of the population reports the use of a condom whenever sexual intercourse occurs (consistent condom use) or at last sexual intercourse (recent condom use), and a greater proportion of men than women report condom use, possibly because of unequal power relations between men and women.
What Did the Researchers Do and Find?
The researchers obtained data on consistent condom use, recent condom use, and self-reported itchy vaginal discharge in the previous 30 days (used here as an indication that a woman may have a sexually transmitted infection) for 12,684 sexually active women from a national survey conducted in Brazil in 2006–2007. They then used multivariable logistic regression (a statistical method) to investigate the association between these outcomes and food insecurity, which was measured using the Escala Brasiliera de Insegurança Alimentar, an 18-item questionnaire that asks people to recall information about the quantity and quality of food available to them over the previous three months. Severe food insecurity with hunger (the most extreme category of food insecurity) was associated with an adjusted odds ratio (AOR) for consistent condom use of 0.67. That is, women who reported severe food insecurity were two-thirds as likely to use a condom whenever they had sexual intercourse as women who were food secure, after adjustment for other factors that might have affected condom use. The probability of consistent condom use was 15% among women who were food secure but only 10.5% among women who had the worst food security. Severe food insecurity with hunger was also associated with a reduced odds of recent condom use (AOR = 0.75), whereas all categories of food insecurity increased the odds of a recent itchy vaginal discharge.
What Do These Findings Mean?
These findings indicate that severe food insecurity with hunger is associated with reduced condom use and with increased occurrence of symptoms that may indicate sexually transmitted disease among sexually active women in Brazil. Because the study looked at women at only a single time point, these findings do not show that food insecurity causes risky sexual behavior. Moreover, these findings may not be generalizable to other settings, and they do not distinguish between regular condom use with a regular partner and regular condom use with casual partners. Also, although the researchers investigated two hypothesized explanations—lack of control in sexual relations and chronic energy deficiency—neither of these factors could explain why food insecurity is associated with risky sexual behavior. Nevertheless, these findings suggest that interventions that target sexual risk reduction behaviors are unlikely to be optimally effective if food insecurity is not taken into account, and, thus, the researchers conclude, HIV prevention strategies in Brazil should include interventions that target food insecurity.
Additional Information
Please access these web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001203.
Information is available from the US National Institute of Allergy and Infectious Diseases on all aspects of HIV infection and AIDS
NAM/aidsmap provides basic information about HIV/AIDS, and summaries of recent research findings on HIV care and treatment (in several languages)
Information is available from Avert, an international AIDS charity on many aspects of HIV/AIDS, including detailed information on HIV and AIDS prevention, women, HIV, and AIDS, and HIV and AIDS in Brazil (in English and Spanish); personal stories of women living with HIV are available
HIV InSite provides comprehensive and up-to-date information on all aspects of HIV/AIDS from the University of California at San Francisco
Additional patient stories about living with HIV/AIDS are available through the charity website Healthtalkonline
A primer on food security from the Food and Agriculture Organization of the United Nations is available
Information about the 2006–2007 Brazilian national survey on health in women and children is available in Portuguese; a profile of food security in Brazil is also available (some information in English but mainly in Portuguese)
doi:10.1371/journal.pmed.1001203
PMCID: PMC3323512  PMID: 22505852
15.  The Safety of Adult Male Circumcision in HIV-Infected and Uninfected Men in Rakai, Uganda 
PLoS Medicine  2008;5(6):e116.
Background
The objective of the study was to compare rates of adverse events (AEs) related to male circumcision (MC) in HIV-positive and HIV-negative men in order to provide guidance for MC programs that may provide services to HIV-infected and uninfected men.
Methods and Findings
A total of 2,326 HIV-negative and 420 HIV-positive men (World Health Organization [WHO] stage I or II and CD4 counts > 350 cells/mm3) were circumcised in two separate but procedurally identical trials of MC for HIV and/or sexually transmitted infection prevention in rural Rakai, Uganda. Participants were followed at 1–2 d and 5–9 d, and at 4–6 wk, to assess surgery-related AEs, wound healing, and resumption of intercourse. AE risks and wound healing were compared in HIV-positive and HIV-negative men. Adjusted odds ratios (AdjORs) were estimated by multiple logistic regression, adjusting for baseline characteristics and postoperative resumption of sex. At enrollment, HIV-positive men were older, more likely to be married, reported more sexual partners, less condom use, and higher rates of sexually transmitted disease symptoms than HIV-negative men. Risks of moderate or severe AEs were 3.1/100 and 3.5/100 in HIV-positive and HIV-negative participants, respectively (AdjOR 0.91, 95% confidence interval [CI] 0.47–1.74). Infections were the most common AEs (2.6/100 in HIV-positive versus 3.0/100 in HIV-negative men). Risks of other complications were similar in the two groups. The proportion with completed healing by 6 wk postsurgery was 92.7% in HIV-positive men and 95.8% in HIV-negative men (p = 0.007). AEs were more common in men who resumed intercourse before wound healing compared to those who waited (AdjOR 1.56, 95% CI 1.05–2.33).
Conclusions
Overall, the safety of MC was comparable in asymptomatic HIV-positive and HIV-negative men, although healing was somewhat slower among the HIV infected. All men should be strongly counseled to refrain from intercourse until full wound healing is achieved.
Trial registration: http://www.ClinicalTrials.gov; for HIV-negative men, #NCT00047073 and for HIV-positive men, #NCT00047073.
Ron Gray and colleagues report on complications of circumcision in HIV-infected and HIV-uninfected men from two related trials in Uganda, finding increased risk with intercourse before wound healing.
Editors' Summary
Background
Worldwide over 33 million people are thought to be living with HIV, and in the absence of a vaccine, preventing its spread is a major health issue. The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimate that 68% of 2.5 million new infections worldwide in 2007 took place in sub-Saharan Africa, where 76% of 2.1 million AIDS-related deaths also took place.
One of the principal means of person-to-person transmission of HIV is through sex without the protection of a condom. In parts of Africa, male circumcision is performed in infancy or childhood for religious or cultural reasons or is a traditional rite of passage that marks the transition from child to man. Three trials, in South Africa, Kenya, and Uganda, each found that circumcised men were around half as likely as uncircumcised men to contract HIV from HIV-positive female partners. After reviewing the results, WHO and UNAIDS issued joint advice that male circumcision should be promoted for preventing HIV infection in heterosexual men. As male circumcision does not provide complete protection against HIV infection, they advised that it should be promoted in addition to existing strategies of promoting condom use, abstinence, and a reduction in the number of sexual partners.
Why Was This Study Done?
Although earlier studies had shown that adult male circumcision, when performed in Africa under optimal conditions, is a safe procedure for HIV-negative men, it was not known whether it would also be a safe procedure for HIV-positive men. WHO guidelines recommend that HIV-positive men who request the procedure or have a medical need and no contraindications for it should be circumcised. Also, exclusion of HIV-positive men from circumcision programs may result in stigmatization of these men, and discourage participation by men who do not wish to be tested for HIV. Therefore, it is important to know whether the procedure is safe for HIV-positive men.
What Did the Researchers Do and Find?
The authors compared results from two separate clinical trials carried out with identical procedures in rural Rakai, Uganda. The first, which compared the effect of circumcision with no circumcision in HIV-negative men, was one of the three trials that persuaded the WHO and UNAIDS to promote male circumcision as an HIV prevention strategy. The second Rakai trial did the same comparison but in men who were HIV positive and without symptoms. In this present study, the authors used data from both trials to compare the likelihood of surgery-related complications following circumcision for HIV-negative and HIV-positive men.
The trials recruited men aged 15–49, who were randomly assigned to be circumcised either on enrollment or two years later and were followed up to monitor complications related to the procedure, such as infections, as well as wound healing and when the participant first had sex after the operation. Condom use was recorded at enrollment and six months after enrollment.
The researchers found that most complications were infrequent, mild, and comparable in both groups, with moderate-to-severe complications occurring in only 3%–4% of men in each group. However, delayed wound healing was more frequent in HIV-positive men. Complications were more likely among men who had sex before healing was complete; such men were more likely to be HIV-positive and/or married. Similarly, moderate or severe complications were more likely where men had symptoms of sexually transmitted disease at enrollment, although these were treated before surgery, and these men were more likely to be HIV-positive. Six months after enrollment, similar proportions of HIV-positive and HIV-negative men used condoms consistently, but HIV-positive men were more likely to report using condoms inconsistently than HIV-negative men. However, consistent use of a condom increased among the HIV-positive men compared to when they enrolled.
What Do these Findings Mean?
Circumcision in HIV-positive men without symptoms of AIDS has a low rate of complications, although healing is slower than in HIV-negative men. Because of the greater risk of complications if sex is resumed before full healing, both men and their women partners should be advised to have no sex for at least six weeks after the operation. A separately reported analysis from one of these studies found that women partners are more likely to become HIV infected by HIV-positive men who resume sex prior to complete wound healing. Therefore, for protection of both men and their female partners, it is essential to refrain from intercourse after circumcision until the wound has completely healed.
Because the study found no increased risk of surgical complications in HIV-positive men who undergo circumcision, it should not be necessary to screen men with no symptoms of HIV in future circumcision programs. This should reduce the complexity of implementing such programs and reduce any stigma resulting from exclusion, making it likely that more men will be willing to be circumcised. The rise in consistent condom use among HIV-positive men suggests that messages of safe sex are reaching an important target group and changing their behavior, and that circumcision does not make men less likely to use a condom.
The authors also noted that the rates of complications they observed were low compared with those following traditional circumcision procedures. Others have found that circumcision carried out under unsafe conditions has a high rate of complications. The authors of this study comment that the resources and standards of surgery during the trial represented best practice and that to attain similarly low rates of complications—and the confidence of men in the safety of the procedure—there is a need to ensure sufficient resources and high standards of training.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050116.
WHO and the UNAIDS issued a joint report recommending male circumcision for HIV prevention and another on the HIV epidemic worldwide in December 2007
An information pack here on male circumcision and HIV prevention has also been developed jointly by WHO/UNAIDS, the United Nations International Children's Emergency Fund (UNICEF), the United Nations Population Fund (UNFPA), and the World Bank
The University of California San Francisco's HIV InSite provides information on HIV prevention, treatment, and policy
AEGIS is the world's largest searchable database on HIV and AIDS
The National AIDS Trust provides information on HIV prevention
doi:10.1371/journal.pmed.0050116
PMCID: PMC2408615  PMID: 18532873
16.  Quantification of bacterial species of the vaginal microbiome in different groups of women, using nucleic acid amplification tests 
BMC Microbiology  2012;12:83.
Background
The vaginal microbiome plays an important role in urogenital health. Quantitative real time Polymerase Chain Reaction (qPCR) assays for the most prevalent vaginal Lactobacillus species and bacterial vaginosis species G. vaginalis and A. vaginae exist, but qPCR information regarding variation over time is still very limited. We set up qPCR assays for a selection of seven species and defined the temporal variation over three menstrual cycles in a healthy Caucasian population with a normal Nugent score. We also explored differences in qPCR data between these healthy women and an ‘at risk’ clinic population of Caucasian, African and Asian women with and without bacterial vaginosis (BV), as defined by the Nugent score.
Results
Temporal stability of the Lactobacillus species counts was high with L. crispatus counts of 108 copies/mL and L. vaginalis counts of 106 copies/mL. We identified 2 types of ‘normal flora’ and one ‘BV type flora’ with latent class analysis on the combined data of all women. The first group was particularly common in women with a normal Nugent score and was characterized by a high frequency of L. crispatus, L. iners, L. jensenii, and L. vaginalis and a correspondingly low frequency of L. gasseri and A. vaginae. The second group was characterized by the predominance of L. gasseri and L. vaginalis and was found most commonly in healthy Caucasian women. The third group was commonest in women with a high Nugent score but was also seen in a subset of African and Asian women with a low Nugent score and was characterized by the absence of Lactobacillus species (except for L. iners) but the presence of G. vaginalis and A. vaginae.
Conclusions
We have shown that the quantification of specific bacteria by qPCR contributes to a better description of the non-BV vaginal microbiome, but we also demonstrated that differences in populations such as risk and ethnicity also have to be taken into account. We believe that our selection of indicator organisms represents a feasible strategy for the assessment of the vaginal microbiome and could be useful for monitoring the microbiome in safety trials of vaginal products.
doi:10.1186/1471-2180-12-83
PMCID: PMC3418157  PMID: 22647069
17.  Long-Term Biological and Behavioural Impact of an Adolescent Sexual Health Intervention in Tanzania: Follow-up Survey of the Community-Based MEMA kwa Vijana Trial 
PLoS Medicine  2010;7(6):e1000287.
David Ross and colleagues conduct a follow-up survey of the community-based MEMA kwa Vijana (“Good things for young people”) trial in rural Tanzania to assess the long-term behavioral and biological impact of an adolescent sexual health intervention.
Background
The ability of specific behaviour-change interventions to reduce HIV infection in young people remains questionable. Since January 1999, an adolescent sexual and reproductive health (SRH) intervention has been implemented in ten randomly chosen intervention communities in rural Tanzania, within a community randomised trial (see below; NCT00248469). The intervention consisted of teacher-led, peer-assisted in-school education, youth-friendly health services, community activities, and youth condom promotion and distribution. Process evaluation in 1999–2002 showed high intervention quality and coverage. A 2001/2 intervention impact evaluation showed no impact on the primary outcomes of HIV seroincidence and herpes simplex virus type 2 (HSV-2) seroprevalence but found substantial improvements in SRH knowledge, reported attitudes, and some reported sexual behaviours. It was postulated that the impact on “upstream” knowledge, attitude, and reported behaviour outcomes seen at the 3-year follow-up would, in the longer term, lead to a reduction in HIV and HSV-2 infection rates and other biological outcomes. A further impact evaluation survey in 2007/8 (∼9 years post-intervention) tested this hypothesis.
Methods and Findings
This is a cross-sectional survey (June 2007 through July 2008) of 13,814 young people aged 15–30 y who had attended trial schools during the first phase of the MEMA kwa Vijana intervention trial (1999–2002). Prevalences of the primary outcomes HIV and HSV-2 were 1.8% and 25.9% in males and 4.0% and 41.4% in females, respectively. The intervention did not significantly reduce risk of HIV (males adjusted prevalence ratio [aPR] 0.91, 95%CI 0.50–1.65; females aPR 1.07, 95%CI 0.68–1.67) or HSV-2 (males aPR 0.94, 95%CI 0.77–1.15; females aPR 0.96, 95%CI 0.87–1.06). The intervention was associated with a reduction in the proportion of males reporting more than four sexual partners in their lifetime (aPR 0.87, 95%CI 0.78–0.97) and an increase in reported condom use at last sex with a non-regular partner among females (aPR 1.34, 95%CI 1.07–1.69). There was a clear and consistent beneficial impact on knowledge, but no significant impact on reported attitudes to sexual risk, reported pregnancies, or other reported sexual behaviours. The study population was likely to have been, on average, at lower risk of HIV and other sexually transmitted infections compared to other rural populations, as only youth who had reached year five of primary school were eligible.
Conclusions
SRH knowledge can be improved and retained long-term, but this intervention had only a limited effect on reported behaviour and no significant effect on HIV/STI prevalence. Youth interventions integrated within intensive, community-wide risk reduction programmes may be more successful and should be evaluated.
Trial Registration
ClinicalTrials.gov NCT00248469
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 2.5 million people become infected with the human immunodeficiency virus (HIV), the virus that causes AIDS. HIV is most often spread through unprotected sex with an infected partner, so individuals can reduce their risk of HIV infection by abstaining from sex, by delaying first sex, by having few partners, and by always using a condom. And, because nearly half of new HIV infections occur among youths (15- to 24-year-olds), programs targeted at adolescents that encourage these protective behaviors could have a substantial impact on the HIV epidemic. One such program is the MEMA kwa Vijana (“Good things for young people”) program in rural Tanzania. This program includes in-school sexual and reproductive health (SRH) education for pupils in their last three years of primary education (12- to 15-year-olds) that provides them with the knowledge and skills needed to delay sexual debut and to reduce sexual risk taking. Between 1999 and 2002, the program was trialed in ten randomly chosen rural communities in the Mwanza Region of Tanzania; ten similar communities that did not receive the intervention acted as controls. Since 2004, the program has been scaled up to cover more communities.
Why Was This Study Done?
Although the quality and coverage of the MEMA kwa Vijana program was good, a 2001/2002 evaluation found no evidence that the intervention had reduced the incidence of HIV (the proportion of the young people in the trial who became HIV positive during the follow-up period) or the prevalence (the proportion of the young people in the trial who were HIV positive at the end of the follow-up period) of herpes simplex virus 2 (HSV-2, another sexually transmitted virus). However, the evaluation found improvements in SRH knowledge, in reported sexual attitudes, and in some reported sexual behaviors. Evaluations of other HIV prevention programs in other developing countries have also failed to provide strong evidence that such programs decrease the risk of HIV infection or other biological outcomes such as the frequency of other sexually transmitted infections or pregnancies, even when SRH knowledge improves. One possibility is that it takes some time for improved SRH knowledge to be reflected in true changes in sexual behavior and in HIV prevalence. In this follow-up study, therefore, researchers investigate the long-term impact of the MEMA kwa Vijana program on HIV and HSV-2 prevalence and ask whether the improvement in knowledge, reported attitudes and sexual risk behaviours seen at the 3-year follow up has persisted.
What Did the Researchers Do and Find?
In 2007/8, the researchers surveyed nearly 14,000 young people who had attended the trial schools between 1999 and 2002. Each participant had their HIV and HSV-2 status determined and answered questions (for example, “can HIV be caught by sexual intercourse (making love) with someone,” and “if a girl accepts a gift from a boy, must she agree to have sexual intercourse (make love) with him?”) to provide three composite sexual knowledge scores and one composite attitude score. 1.8% of the male and 4.0% of the female participants were HIV positive; 25.9% and 41.4% of the male and female participants, respectively, were HSV-2 positive. The prevalences were similar among the young people whose trial communities had been randomly allocated to receive the MEMA kwa Vijana Program and those whose communities had not received it, indicating that the MEMA kwa Vijana intervention program had not reduced the risk of HIV or HSV-2. The intervention program was associated, however, with a reduction in the proportion of men reporting more than four sexual partners in their lifetime and with an increase in reported condom use at last sex with a non-regular partner among women. Finally, although the intervention had still increased SRH knowledge, it now had had no impact on reported attitudes to sexual risk, reported pregnancies, or other reported risky sexual behaviors beyond what might have happened due to chance.
What Do These Findings Mean?
These findings indicate that, in the MEMA kwa Vijana trial, SRH knowledge improved and that this improved knowledge was retained for many years. Disappointingly, however, this intervention program had only a limited effect on reported sexual behaviors and no effect on HIV and HSV-2 prevalence at the 9-year follow-up. Although these findings may not be generalizable to other adolescent populations, they suggest that intervention programs that target only adolescents might not be particularly effective. Young people might find it hard to put their improved skills and knowledge into action when challenged, for example, by widespread community attitudes such as acceptance of older male–younger female relationships. Thus, the researchers suggest that the integration of youth HIV prevention programs within risk reduction programs that tackle sexual norms and expectations in all age groups might be a more successful approach and should be evaluated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000287.
This study is further discussed in a PLoS Medicine Perspective by Rachel Jewkes
More information about the MEMA kwa Vijana program is available at their Web site
Information is available from the Programme for Research and Capacity Building in Sexual and Reproductive Health and HIV in Developing Countries on recent and ongoing research on HIV infection and other STIs
Information is available from the World Health Organization on HIV and on the health of young people
Information on HIV is available from UNAIDS
Information on HIV in children and adolescents is available from UNICEF
Information on HIV prevention interventions in the education sector is available from UNESCO
Information on HIV infection and AIDS is available from the US National Institute of Allergy and Infectious Diseases
The US Centers for Disease Control and Prevention provide information on HIV/AIDS and on HIV/AIDS among youth (in English and Spanish)
HIV InSitehas comprehensive information on all aspects of HIV/AIDS, including links to information on the prevention of HIV/AIDS
Information is available from Avert, an international AIDS charity, on many aspects of HIV/AIDS, including information on HIV and AIDS prevention and AIDS and sex education (in English and Spanish)
doi:10.1371/journal.pmed.1000287
PMCID: PMC2882431  PMID: 20543994
18.  Prevalence of Bacterial Vaginosis and Vaginal Flora Changes in Peri- and Postmenopausal Women 
Journal of Clinical Microbiology  2002;40(6):2147-2152.
Our aim was to evaluate the prevalence of bacterial vaginosis and decrease in lactobacillus colonization in women 40 years old or older in relation to menopausal status by evaluation of Gram-stained smears. A total of 1,486 smears from Italian Caucasian women aged 40 to 79 years were examined. Women were classified as follows: fertile (regular cycles) (n = 328), perimenopausal (irregular cycles) (n = 237), and postmenopausal (n = 921), including 331 women on estroprogestinic hormone replacement therapy (HRT). The prevalences of bacterial vaginosis (assessed as a Nugent score of ≥7) in fertile (9.8%) and perimenopausal (11.0%) women were not statistically different, whereas the prevalence was significantly lower overall in postmenopausal women (6.0%) (P = 0.02). Specifically, 6.3% of postmenopausal women without HRT and 5.4% of postmenopausal women with HRT were positive for bacterial vaginosis. The Nugent score system was not adequate for evaluating the normal and intermediate vaginal flora in women over the age of 40 years. High numbers of peri- and postmenopausal women had no lactobacilli and no bacterial-vaginosis-associated microorganisms. This nonpathological absence of lactobacilli in women with a Nugent score of 4 was scored as 4∗, and this group was considered separately from the intermediate flora group. A score of 4∗ was obtained for 2.1% of fertile women, 11.4% of perimenopausal women, 44.1% of postmenopausal women without HRT, and 6.9% of postmenopausal women with HRT. The physiological reduction in lactobacillus colonization of the vagina in postmenopausal women does not cause an increase in bacterial-vaginosis prevalence. Reversion of lactobacillus flora to premenopausal levels due to HRT does not increase the prevalence of bacterial vaginosis in postmenopausal women.
doi:10.1128/JCM.40.6.2147-2152.2002
PMCID: PMC130764  PMID: 12037079
19.  Midpregnancy Vaginal Fluid Defensins, Bacterial Vaginosis, and Risk of Preterm Delivery 
Obstetrics and gynecology  2008;112(3):524-531.
Objective
To assess relations between midpregnancy vaginal defensin levels, a component of the host innate immune response, bacterial vaginosis and risk of preterm delivery. These relations are compared across race groups because previous studies have repeatedly shown that the prevalence of bacterial vaginosis and the risk of preterm delivery are greater in African-American women compared to that in White women.
Methods
Data are from a prospective study that enrolled pregnant women from 52 clinics in five Michigan communities. In the study subcohort, defensins (human neutrophil peptides 1, 2 and 3) and bacterial vaginosis (Nugent criteria) were measured in vaginal fluid collected at enrollment (15th -27th week of pregnancy) from 1,031 non-Hispanic White and African-American women (787 term, 244 preterm). Preterm deliveries were categorized by clinical circumstances; ie, spontaneous and medically indicated.
Results
Among African Americans, vaginal human neutrophil peptides 1-3 levels greater than or equal to the median were associated with bacterial vaginosis and specifically with spontaneous preterm delivery only (adjusted odds ratio = 2.3, 95% CI 1.2, 4.3). Once African-American women were stratified by human neutrophil peptide 1-3 levels, bacterial vaginosis added nothing to the prediction of spontaneous preterm delivery risk. None of the above associations were observed in non-Hispanic Whites.
Conclusions
The relations between human neutrophil peptide 1-3 levels, bacterial vaginosis, and preterm delivery vary by race group. In African Americans, midpregnancy human neutrophil peptide 1-3 levels were more informative to preterm delivery risk than was bacterial vaginosis, suggesting an important role for host response. In addition, elevated human neutrophil peptide 1-3 levels may be a marker for particular high-risk vaginal milieus that are not distinguished by the current bacterial vaginosis Nugent scoring system.
doi:10.1097/AOG.0b013e318184209b
PMCID: PMC2852105  PMID: 18757648
20.  Bacterial vaginosis, vaginal flora patterns and vaginal hygiene practices in patients presenting with vaginal discharge syndrome in The Gambia, West Africa 
Background
Bacterial vaginosis (BV) – a syndrome characterised by a shift in vaginal flora – appears to be particularly common in sub-Saharan Africa, but little is known of the pattern of vaginal flora associated with BV in Africa. We conducted a study aimed at determining the prevalence of BV and patterns of BV-associated vaginal micro-flora among women with vaginal discharge syndrome (VDS) in The Gambia, West Africa.
Methods
We enrolled 227 women with VDS from a large genito-urinary medicine clinic in Fajara, The Gambia. BV was diagnosed by the Nugent's score and Amsel's clinical criteria. Vaginal swabs were collected for T vaginalis and vaginal flora microscopy, and for Lactobacillus spp, aerobic organisms, Candida spp and BV-associated bacteria (Gardnerella vaginalis, anaerobic bacteria, and Mycoplasma spp) cultures; and cervical swabs were collected for N gonorrhoeae culture and C trachomatis PCR. Sera were tested for HIV-1 and HIV-2 antibodies. Sexual health history including details on sexual hygiene were obtained by standardised questionnaire.
Results
BV prevalence was 47.6% by Nugent's score and 30.8% by Amsel's clinical criteria. Lactobacillus spp were isolated in 37.8% of women, and 70% of the isolates were hydrogen-peroxide (H202)-producing strains. Prevalence of BV-associated bacteria were: G vaginalis 44.4%; Bacteroides 16.7%; Prevotella 15.2%; Peptostretococcus 1.5%; Mobiluncus 0%; other anaerobes 3.1%; and Mycoplasma hominis 21.4%. BV was positively associated with isolation of G vaginalis (odds-ratio [OR] 19.42, 95%CI 7.91 – 47.6) and anaerobes (P = 0.001 [OR] could not be calculated), but not with M hominis. BV was negatively associated with presence of Lactobacillus (OR 0.07, 95%CI 0.03 – 0.15), and H2O2-producing lactobacilli (OR 0.12, 95% CI 0.05 – 0.28). Presence of H2O2-producing lactobacilli was associated with significantly lower prevalence of G vaginalis, anaerobes and C trachomatis. HIV prevalence was 12.8%. Overall, there was no association between BV and HIV, and among micro-organisms associated with BV, only Bacteroides spp. and Prevotella spp. were associated with HIV. BV or vaginal flora patterns were not associated with any of the factors relating to sexual hygiene practices (vaginal douching, menstrual hygiene, female genital cutting).
Conclusion
In this population, BV prevalence was higher than in corresponding populations in industrialised countries, but the pattern of vaginal micro-flora associated with BV was similar. BV or vaginal flora patterns were not associated with HIV nor with any of the vaginal hygiene characteristics.
doi:10.1186/1471-2334-5-12
PMCID: PMC1083415  PMID: 15757510
21.  A Longitudinal Study of Vaginal Douching and Bacterial Vaginosis—A Marginal Structural Modeling Analysis 
American Journal of Epidemiology  2008;168(2):188-196.
The etiology of bacterial vaginosis is unknown, and there are no long-term therapies for preventing this frequently recurring condition. Vaginal douching has been reported to be associated with bacterial vaginosis in observational studies. However, this association may be due to confounding by indication—that is, confounding by women douching in response to vaginal symptoms associated with bacterial vaginosis. The authors used marginal structural modeling to estimate the causal effect of douching on bacterial vaginosis risk while controlling for this confounding effect. In 1999–2002, nonpregnant women (n = 3,620) were recruited into a prospective study when they visited one of 12 public health clinics in Birmingham, Alabama, for routine care. Participants were assessed quarterly for 1 year. Bacterial vaginosis was based on a Nugent's Gram stain score of 7 or higher. Thirty-two percent of participants douched in every study interval, and 43.0% never douched. Of the 12,349 study visits, 40.2% were classified as involving bacterial vaginosis. The relative risk for regular douching as compared with no douching was 1.21 (95% confidence interval: 1.08, 1.38). These findings indicate that douching confers increased risk of disruption of vaginal flora. In the absence of a large randomized trial, these findings provide the best evidence to date for a risk of bacterial vaginosis associated with douching.
doi:10.1093/aje/kwn103
PMCID: PMC2574994  PMID: 18503038
confounding factors (epidemiology); epidemiologic methods; longitudinal studies; models, structural; vaginal douching; vaginosis, bacterial
22.  The effect of Replens® on vaginal cytology in the treatment of postmenopausal atrophy: cytomorphology versus computerised cytometry 
Journal of Clinical Pathology  2002;55(6):446-451.
Background: After the menopause decreased concentrations of oestrogen may result in insufficient maturation of the vaginal epithelium, which can lead to a range of vaginal discomforts. This state of vaginal atrophy may be treated with oestrogen replacement treatment. Replens™, a non-hormonal alternative to oestrogen replacement treatment has been shown to be effective in relieving symptoms related to vaginal atrophy in previous studies.
Aims: To study the effect of Replens on the maturation of the vaginal epithelium and morphology of the vaginal cells and to compare the results of a recently developed cytomorphometric method with manual assessment of the degree of maturation in vaginal smears.
Methods: Vaginal smears from 38 postmenopausal women suffering from symptoms related to vaginal atrophy were analysed manually and by cytomorphometry. The maturation value (MV) and the percentages of (para)basal, intermediate, and superficial cells (maturation index; MI) were measured by both methods before and after treatment with Replens. Cytomorphometry also measured mean cellular area, mean nuclear area, and mean area ratio.
Results: A correlation was shown between the two methods in the assessment of percentages of (para) basal and intermediate cells and MV. Cytomorphometric data showed a significant increase in mean cellular area, indicating a positive effect of Replens on the maturation of the vaginal epithelium. Changes in nuclear area and ratio between nuclear and cellular areas were not significant. Treatment with Replens did not influence MI or MV, as assessed by the two methods.
Conclusions: Replens did have an effect on vaginal morphology. The automated procedure may be useful for the assessment of maturation in vaginal smears and is more sensitive to small (subvisual) changes.
PMCID: PMC1769660  PMID: 12037029
postmenopausal atrophy; vaginal maturation; maturation index; automated image analysis
23.  Behavioural and medical predictors of bacterial vaginosis recurrence among female sex workers: longitudinal analysis from a randomized controlled trial 
BMC Infectious Diseases  2013;13:208.
Background
Data on risk factors of recurrent bacterial vaginosis (RBV) are still scarce. We used data from female sex workers (FSW) participating in a randomized controlled microbicide trial to examine predictors of BV recurrence.
Methods
Trial’s participants with at least an episode of BV which was treated and/or followed by a negative BV result and at least one subsequent visit offering BV testing were included in the analysis. Behavioural and medical data were collected monthly while laboratory testing for STI and genital tract infections were performed quarterly. The Andersen-Gill proportional hazards model was used to determine predictors of BV recurrence both in bivariate and multivariate analyses.
Results
440 women were included and the incidence rate for RBV was 20.8 recurrences/100 person-months (95% confidence interval (CI) =18.1–23.4). In the multivariate analysis controlling for the study site, recent vaginal cleansing as reported at baseline with adjusted hazard-ratio (aHR)=1.30, 95% CI = 1.02-1.64 increased the risk of BV recurrence, whereas consistent condom use (CCU) with the primary partner (aHR=0.68, 95% CI=0.49-0.93) and vaginal candidiasis (aHR=0.70, 95% CI=0.53-0.93), both treated as time-dependent variables, were associated with decreased risk of RBV.
Conclusion
This study confirms the importance of counselling high-risk women with RBV about the adverse effects of vaginal cleansing and the protective effects of condom use with all types of partners for the prevention of sexually transmitted infections, including BV. More prospective studies on risk factors of BV recurrence are warranted.
Trial registration
Trial registration: NCT00153777
doi:10.1186/1471-2334-13-208
PMCID: PMC3655069  PMID: 23657072
Bacterial vaginosis; Recurrence; Predictors; Female sex workers; Microbicide trial
24.  Effect of Antibiotic Exposure on Nugent Score Among Pregnant Women With and Without Bacterial Vaginosis 
Obstetrics and gynecology  2011;117(4):844-849.
Objective
To evaluate whether vaginal flora is altered by antibiotic exposure and associated with a risk of preterm birth, particularly among women with initially normal vaginal flora.
Methods
This was a secondary analysis of a randomized trial of metronidazole and erythromycin for the prevention of preterm birth among women with a positive fetal fibronectin test. Vaginal swabs for Nugent Gram stain score were collected for classification of bacterial vaginosis before and after antibiotic exposure and read at a central laboratory. Change in Nugent score was assessed for women with (score 7 or higher) or without (score lower than 7) bacterial vaginosis. Linear regression analysis evaluated whether change in Nugent score was associated with preterm birth.
Results
Two-hundred women without and 69 women with bacterial vaginosis had Gram stain performed before and after antibiotic therapy. Median Nugent score for all women declined from 4.0 to 2.0 after antibiotic therapy, p<0.001. Nugent score declined both for those without (from 2.0 to 1.5, p=0.11) and more dramatically, those with bacterial vaginosis (from 8.0 to 3.0, p<0.01). The components of the Nugent score that were affected by antibiotic exposure were similar among women with and without bacterial vaginosis. Antibiotic exposure and the change in Nugent score were unrelated to preterm birth among bacterial vaginosis-negative women.
Conclusion
Antibiotic exposure is not associated with preterm birth and does not worsen Nugent score among women with normal vaginal flora and positive fetal fibronectin.
doi:10.1097/AOG.0b013e318209dd57
PMCID: PMC3889116  PMID: 21422854
25.  A behavioural intervention to reduce persistence of bacterial vaginosis among women who report sex with women: results of a randomised trial 
Sexually Transmitted Infections  2011;87(5):399-405.
Objectives
Bacterial vaginosis (BV) is common in lesbians, and treatment fails in up to 28%. Risks include sexual behaviours that transmit vaginal fluid. The authors measured efficacy of a behavioural intervention to reduce sexual transfer of vaginal fluid between female sex partners in reducing BV persistence.
Methods
Women aged 16–35 years with BV who reported sex with women (prior year) were eligible. Participants were randomised to intervention (motivational interviewing designed to reduce sharing of vaginal fluid on hands or sex toys post-treatment, by provision of condoms, gloves and water-based lubricant) or control (general STI education) arms. All were treated with vaginal metronidazole and underwent computer-assisted self-interview to ascertain sexual behaviours, with test-of-cure at 30 days.
Results
Of 129 women with BV, 108 (84%) were eligible; 89 (69%) agreed to enrol. 43 were randomised to control and 46 to intervention; 81 (91%) returned for test-of-cure. BV persisted in 12 (27.9%) of 43 women in intervention and 8 (21.1%) of 38 women in control arms (p1/40.6). Digital-vaginal sex was common post-treatment (50% intervention and 68% control); women randomised to the intervention were less likely to report receptive digital-vaginal sex without gloves than control (31% vs 61%; p1/40.01), without reported lower frequency of other sexual practices. Shared vaginal use of sex toys was infrequent.
Conclusions
Although the intervention effected a significant increase in glove use during digital-vaginal sex post-BV treatment, this was not associated with reduction in BV persistence. Shared use of vaginal sex toys was infrequent, suggesting that other mechanisms promote BV in lesbians.
doi:10.1136/sti.2011.049213
PMCID: PMC3291171  PMID: 21653935

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