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1.  Improving Vaginal Health in Women at Risk for HIV-1: Results of a Randomized Trial 
The Journal of infectious diseases  2008;197(10):1361-1368.
Vaginal infections are common and have been associated with increased HIV-1 risk.
We conducted a randomized trial of monthly oral directly observed treatment for reducing vaginal infections in Kenyan women at risk for HIV-1. Trial interventions included metronidazole 2 grams plus fluconazole 150 milligrams versus identical metronidazole and fluconazole placebos. The primary endpoints were bacterial vaginosis (BV), vaginal candidiasis, trichomoniasis, and colonization with Lactobacillus (, NCT00170430).
Of 310 HIV-1-seronegative female sex workers enrolled (155 per arm), 303 were included in the primary endpoints analysis. Median follow-up was 12 visits in both study arms (p=0.8). Compared to controls, women receiving the intervention had fewer episodes of BV (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.49-0.63), and more frequent vaginal colonization with Lactobacillus species (HR 1.47, 95% CI 1.19-1.80) and hydrogen peroxide-producing Lactobacillus species (HR 1.63, 95% CI 1.16-2.27). Vaginal candidiasis (HR 0.84, 95% CI 0.67-1.04) and trichomoniasis (HR 0.55, 95% CI 0.27-1.12) were reduced in treated women compared to controls, although not significantly.
Periodic presumptive treatment reduced BV and promoted normal vaginal flora. Vaginal health interventions have the potential to provide simple, female-controlled approaches for reducing HIV-1 risk.
PMCID: PMC4122228  PMID: 18444793
Bacterial vaginosis; vaginal candidiasis; Trichomonas vaginalis; Lactobacillus; HIV-1; randomized trial; women; Africa
2.  A Prospective Study of Risk Factors for Bacterial Vaginosis in HIV-1-Seronegative African Women 
Sexually transmitted diseases  2008;35(6):617-623.
Bacterial vaginosis (BV) is common and has been associated with increased HIV-1 susceptibility. The objective of this study was to identify risk factors for BV in African women at high risk for acquiring HIV-1.
We conducted a prospective study among 151 HIV-1-seronegative Kenyan female sex workers. Non-pregnant women were eligible if they did not have symptoms of abnormal vaginal itching or discharge at the time of enrollment. At monthly follow-up, a vaginal examination and laboratory testing for genital tract infections were performed. Multivariate Andersen-Gill proportional hazards analysis was used to identify correlates of BV.
Participants completed a median of 378 (interquartile range 350–412) days of follow-up. Compared to women reporting no vaginal washing, those who reported vaginal washing 1–14 (adjusted hazard ratio [aHR] 1.29, 95% confidence interval [CI] 0.88–1.89), 15–28 (aHR 1.60, 95% CI 0.98–2.61), and >28 times/week (aHR 2.39, 95% CI 1.35–4.23) were at increased risk of BV. Higher BV incidence was also associated with the use of cloth for intravaginal cleansing (aHR 1.48, 95% CI 1.06–2.08) and with recent unprotected intercourse (aHR 1.75, 95% CI 1.47–2.08). Women using depot medroxyprogesterone acetate contraception were at lower risk for BV (aHR 0.59, 95% CI 0.48–0.73).
Vaginal washing and unprotected intercourse were associated with increased risk of BV. These findings could help to inform the development of novel vaginal health approaches for HIV-1 risk reduction in women.
PMCID: PMC3902781  PMID: 18418290
Bacterial vaginosis; vaginal washing; intravaginal practices; women; Africa
3.  Circumcision preference among women and uncircumcised men prior to scale-up of male circumcision for HIV prevention in Kisumu, Kenya 
AIDS care  2011;24(2):157-166.
Following the endorsement by the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) of male circumcision as an additional strategy to HIV prevention, initiatives to introduce safe, voluntary medical male circumcision (VMMC) services commenced in 2008 in several sub-Saharan African communities. Information regarding perceptions of circumcision as a method of HIV prevention, however, is largely limited to data collected before this important endorsement and the associated increase in the availability of VMMC services. To address this, we completed a community-based survey of male circumcision (MC) perceptions in the major non-circumcising community in Kenya, which is the current focus of VMMC programs in the country. Data was collected between November 2008 and April 2009, immediately before VMMC program scale-up commenced. Here we present results limited to women (n = 1088) and uncircumcised males (n = 460) to provide insight into factors contributing to the acceptability and preference for MC in those targeted by VMMC programs. Separate multivariable models examining preference for circumcision were defined for married men, unmarried men, and women. Belief in the protective effect of circumcision on HIV risk was strongly associated with preference for MC in all models. Other important factors included education, perceived improvement in sexual pleasure, and perceptions of impact on condom utilization. Identified barriers to circumcision were the belief that circumcision was not part of the local culture, the perception of a long healing period following the procedure, the lack of a specific impetus to seek out services, and the general fear of pain associated with becoming circumcised. A minority of participants expressed beliefs suggesting that behavioral risk compensation with increased MC prevalence and awareness is a possibility. This work describes the early impact of a large-scale VMMC program on beliefs and behaviors regarding MC and HIV risk. It is hoped that our findings may offer guidance into anticipating potential impacts that similar programs may observe in populations throughout Eastern Africa.
PMCID: PMC3682798  PMID: 21854351
HIV/AIDS; circumcision; sexual behavior; Africa
4.  Determinants of Consistent Condom Use Vary by Partner Type among Young Men in Kisumu, Kenya: A Multi-level Data Analysis 
AIDS and behavior  2008;14(4):949-959.
To evaluate whether determinants of consistent condom use vary by partner type among young sexually active Kenyan men, we conducted a cross-sectional assessment of lifetime sexual histories from a sub-sample of men enrolled in a clinical trial of male circumcision. 7913 partnerships of 1370 men were analyzed. 262 men (19%) reported never, 1018 (74%) sometimes and 92 (7%) always using a condom with their partners. Condoms were always used in 2672 (34%) of the total relationships—212 (70%) of the relationships with sex workers, 1643 (40%) of the casual and 817 (23%) of the regular/marital relationships. Factors influencing condom use varied significantly by partner type, suggesting that HIV prevention messages promoting condom use with higher-risk partners have achieved a moderate level of acceptance. However, in populations of young, single men in generalized epidemic settings, interventions should promote consistent condom use in all sexual encounters, independently of partner type and characteristics.
PMCID: PMC3673546  PMID: 18791819
Condom use; Partner type; Multiple partners; Concurrent partners; Kenya; Africa
5.  Loss to Follow-Up as a Competing Risk in an Observational Study of HIV-1 Incidence 
PLoS ONE  2013;8(3):e59480.
Conventional survival estimates may be biased if loss to follow-up (LTF) is associated with the outcome of interest. Our goal was to assess whether the association between sexual risk behavior and HIV-1 acquisition changed after accounting for LTF with competing risks regression.
HIV-1-seronegative women who enrolled in a Kenyan sex worker cohort from 1993–2007 were followed prospectively and tested for HIV at monthly clinic visits. Our primary predictor was self-reported sexual risk behavior in the past week, analyzed as a time-dependent covariate. Outcomes included HIV-1 acquisition and LTF. We analyzed the data using Cox proportional hazards regression and competing risks regression, in which LTF was treated as a competing event.
A total of 1,513 women contributed 4,150 person-years (py), during which 198 (13.1%) acquired HIV-1 infection (incidence, 4.5 per 100 py) and 969 (64.0%) were LTF (incidence, 23.4 per 100 py). After adjusting for potential confounders, women reporting unprotected sex with multiple partners were less likely to be lost to follow-up (adjusted sub-hazard ratio (aSHR) 0.50, 95% confidence interval (CI) 0.32–0.76, relative to no sexual activity). The risk of HIV-1 acquisition after reporting unprotected sex with multiple partners was similar with Cox regression (adjusted hazard ratio (aHR) 2.41, 95% CI 1.36–4.27) and competing risks regression (aSHR 2.47, 95% CI 1.33–4.58).
Unprotected sex with multiple partners was associated with higher HIV-1 acquisition risk, but lower attrition. This differential attrition did not substantially bias Cox regression estimates when compared to competing risks regression results.
PMCID: PMC3595247  PMID: 23555041
6.  Anal Sex, Vaginal Practices, and HIV Incidence in Female Sex Workers in Urban Kenya: Implications for the Development of Intravaginal HIV Prevention Methods 
AIDS Research and Human Retroviruses  2011;27(10):1067-1072.
Multiple intravaginal HIV prevention methods, including microbicide gels, barriers, and intravaginal rings, are in clinical development in Africa. Development of intravaginal HIV prevention products requires an understanding of sexual behavior, sexually transmitted infection (STI), and vaginitis prevalences, and sexual and vaginal practices in potential target populations. We assessed these factors in a cohort of Kenyan female sex workers (FSW). Women who reported exchanging sex for money/gifts at least three times in the past month and who were HIV uninfected were enrolled and followed for 6 months. STI prevalence and HIV incidence were analyzed by multivariate logistic regression analysis, controlling for demographic and behavioral factors. Thirty-seven percent (74/200) reported having had anal sex. Frequency of anal sex was higher with regular and casual partners than with primary partners. Women were less likely to use condoms for anal sex than for vaginal sex with regular or casual partners. Vaginal washing was universal (100%). HIV incidence was 5.6 per 100 person-years (95% CI 1.62, 11.67). HIV incidence was not associated with any demographic or risk behavior. The relatively high rate of anal sex and universal vaginal washing may complicate both safety and efficacy evaluation of intravaginal products and should be taken into account in trial design. This FSW population had significant HIV incidence and needs continued HIV prevention interventions.
PMCID: PMC3186689  PMID: 21406032
7.  Establishing and Sustaining a Healthy Vaginal Environment: Analysis of Data From a Randomized Trial of Periodic Presumptive Treatment for Vaginal Infections 
The Journal of Infectious Diseases  2011;204(2):323-326.
Data from a randomized trial of oral periodic presumptive treatment (PPT) to reduce vaginal infections were analyzed to assess the effect of the intervention on a healthy vaginal environment (normal flora confirmed by Gram stain with no candidiasis or trichomoniasis). The incidence of a healthy vaginal environment was 608 cases per 100 person-years in the intervention arm and 454 cases per 100 person-years in the placebo arm (hazard ratio [HR], 1.36; 95% confidence interval [CI], 1.17–1.58). Sustained vaginal health (healthy vaginal environment for ≥3 consecutive visits) was also more frequent in the intervention arm (HR, 1.69; 95% CI, 1.23–2.33). PPT is effective at establishing and sustaining a healthy vaginal environment.
PMCID: PMC3114467  PMID: 21673045
8.  Effect of breastfeeding on mortality among HIV-1 infected women: a randomised trial 
Lancet  2001;357(9269):1651-1655.
We have completed a randomised clinical trial of breastfeeding and formula feeding to identify the frequency of breastmilk transmission of HIV-1 to infants. However, we also analysed data from this trial to examine the effect of breastfeeding on maternal death rates during 2 years after delivery. We report our findings from this secondary analysis.
Pregnant women attending four Nairobi city council clinics were offered HIV tests. At about 32 weeks’ gestation, 425 HIV-1 seropositive women were randomly allocated to either breastfeed or formula feed their infants. After delivery, mother-infant pairs were followed up monthly during the first year and quarterly during the second year until death, or 2 years after delivery, or end of study.
Mortality among mothers was higher in the breastfeeding group than in the formula group (18 vs 6 deaths, log rank test, p=0·009). The cumulative probability of maternal death at 24 months after delivery was 10·5% in the breastfeeding group and 3·8% in the formula group (p=0·02). The relative risk of death for breastfeeding mothers versus formula feeding mothers was 3·2 (95% CI 1·3–8·1, p=0·01). The attributable risk of maternal death due to breastfeeding was 69%. There was an association between maternal death and subsequent infant death, even after infant HIV-1 infection status was controlled for (relative risk 7·9, 95% CI 3·3–18·6, p<0·001).
Our findings suggest that breastfeeding by HIV-1 infected women might result in adverse outcomes for both mother and infant.
PMCID: PMC3372408  PMID: 11425369
9.  Genital Shedding of Human Immunodeficiency Virus Type 1 DNA during Pregnancy: Association with Immunosuppression, Abnormal Cervical or Vaginal Discharge, and Severe Vitamin A Deficiency 
The presence of human immunodeficiency virus type 1 (HIV-1) in genital secretions may be a determinant of vertical HIV-1 transmission. Cervical and vaginal secretions from HIV-1–seropositive pregnant women were evaluated to determine prevalence and correlates of HIV-1–infected cells in the genital tract. HIV-1 DNA was detected by polymerase chain reaction in 32% of 212 cervical and 10% of 215 vaginal specimens. Presence of HIV-1 DNA in the cervix was associated with cervical mucopus and a significantly lower absolute CD4 cell count (354 vs. 469, P < .001). An absolute CD4 cell count <200 was associated with a 9.6-fold increased odds of cervical HIV-1 DNA detection compared with a count ≥500 (95% confidence interval, 2.8–34.2). Detection of vaginal HIV-1 DNA was associated with abnormal vaginal discharge, lower absolute CD4 cell count, and severe vitamin A deficiency. Presence of HIV-1–infected cells in genital secretions was associated with immunosuppression and abnormal cervical or vaginal discharge.
PMCID: PMC3372419  PMID: 8985196
10.  Cell-Free Human Immunodeficiency Virus Type 1 in Breast Milk 
Breast-feeding may be an important route of human immunodeficiency virus type 1 (HIV-1) vertical transmission in settings where it is routinely practiced. To define the prevalence and quantity of HIV-1 in cell-free breast milk, samples from HIV-1-seropositive women were analyzed by quantitative competitive reverse transcription-polymerase chain reaction (QC-RT-PCR). HIV-1 RNA was detected in 29 (39%) of 75 specimens tested. Of these 29 specimens, 16 (55%) had levels that were near the detection limit of the assay (240 copies/mL), while 6 (21%) had >900 copies/mL. The maximum concentration of HIV-1 RNA detected was 8100 copies/mL. The prevalence of cell-free HIV-1 was higher in mature milk (47%) than in colostrum (27%, P = 0.1). Because mature milk is consumed in large quantities, these data suggest that cell-free HIV-1 in breast milk may contribute to vertical transmission of HIV-1.
PMCID: PMC3358132  PMID: 9419167
11.  Morbidity and Mortality in Breastfed and Formula-Fed Infants of HIV-1–Infected Women A Randomized Clinical Trial 
Jama  2001;286(19):2413-2420.
Breastfeeding among women infected with human immunodeficiency virus type 1 (HIV-1) is associated with substantial risk of HIV-1 transmission, but little is known about the morbidity risks associated with formula feeding in infants of HIV-1–infected women in resource-poor settings.
To compare morbidity, nutritional status, mortality adjusted for HIV-1 status, and cause of death among formula-fed and breastfed infants of HIV-1–infected women.
Randomized clinical trial conducted between 1992 and 1998.
Four antenatal clinics in Nairobi, Kenya.
Of 401 live-born, singleton, or first-born twin infants of randomized HIV-1–seropositive mothers, 371 were included in the analysis of morbidity and mortality.
Mothers were randomly assigned either to use formula (n=186) or to breastfeed (n=185) their infants.
Main Outcome Measures
Mortality rates, adjusted for HIV-1 infection status; morbidity; and nutritional status during the first 2 years of life.
Two-year estimated mortality rates among infants were similar in the formula-feeding and breastfeeding arms (20.0% vs 24.4%; hazard ratio [HR], 0.8; 95% confidence interval [CI], 0.5–1.3), even after adjusting for HIV-1 infection status (HR, 1.1; 95% CI, 0.7–1.7). Infection with HIV-1 was associated with a 9.0-fold increased mortality risk (95% CI, 5.3–15.3). The incidence of diarrhea during the 2 years of follow-up was similar in formula and breastfeeding arms (155 vs 149 per 100 person-years, respectively). The incidence of pneumonia was identical in the 2 groups (62 per 100 person-years), and there were no significant differences in incidence of other recorded illnesses. Infants in the breastfeeding arm tended to have better nutritional status, significantly so during the first 6 months of life.
In this randomized clinical trial, infants assigned to be formula fed or breastfed had similar mortality rates and incidence of diarrhea and pneumonia during the first 2 years of life. However, HIV-1–free survival at 2 years was significantly higher in the formula arm. With appropriate education and access to clean water, formula feeding can be a safe alternative to breastfeeding for infants of HIV-1–infected mothers in a resource-poor setting.
PMCID: PMC3358136  PMID: 11712936
12.  Genital Ulceration Does Not Increase HIV-1 Shedding in Cervical or Vaginal Secretions of Women Taking Antiretroviral Therapy 
Sexually transmitted infections  2010;87(2):114-117.
Genital ulcer disease (GUD) is associated with increased HIV-1 RNA shedding in antiretroviral therapy (ART)-naïve women. The effect of GUD on HIV-1 shedding among ART-treated women is not known. Our objective was to test the hypothesis that genital ulcerations increase genital HIV-1 RNA shedding in women receiving ART.
Eligible women initiated ART and attended monthly visits with inspection for genital lesions and collection of genital swabs. GUD cases diagnosed after ≥2 months on ART were included for analysis and served as their own controls. HIV-1 RNA was quantitated in specimens collected before, during, and after GUD for all cases. The lower limit of quantitation was 100 HIV-1 RNA copies/swab. Using the pre-GUD visit as the reference, we compared detection of genital HIV-1 RNA before versus during and after GUD episodes.
Thirty-six women had GUD episodes after ART initiation. HIV-1 RNA was detected before, during, and after GUD in cervical secretions from 4 (11%), 1 (3%), and 6 (17%) women respectively, and in vaginal secretions from 3 (8%), 4 (11%) and 4 (11%) women respectively. After adjustment for time on ART, there was no difference in detection of cervical HIV-1 RNA before versus during GUD (aOR 0.22, 95% CI 0.04–1.23). Likewise, GUD did not increase HIV-1 detection in vaginal secretions (adjusted odds ratio [aOR] 1.32, 95% CI 0.29–5.92).
GUD did not significantly increase cervical or vaginal HIV-1 shedding. Our results suggest that ART maintains its effectiveness for genital HIV-1 suppression despite GUD episodes.
PMCID: PMC3081651  PMID: 20980464
genital ulcer; antiretroviral therapy; HIV infection; women
13.  Emergence of Quinolone Resistance and Cephalosporin MIC Creep in Neisseria gonorrhoeae Isolates from a Cohort of Young Men in Kisumu, Kenya, 2002 to 2009▿ 
We evaluated antimicrobial resistance in Neisseria gonorrhoeae isolated from men enrolled in a randomized trial of male circumcision to prevent HIV. Urethral specimens from men with discharge were cultured for N. gonorrhoeae. MICs were determined by agar dilution. Clinical and Laboratory Standards Institute (CLSI) criteria defined resistance: penicillin, tetracycline, and azithromycin MICs of ≥2.0 μg/ml; a ciprofloxacin MIC of ≥1.0 μg/ml; and a spectinomycin MIC of ≥128.0 μg/ml. Susceptibility to ceftriaxone and cefixime was shown by an MIC of ≤0.25 μg/ml. Additionally, PCR amplification identified mutations in parC and gyrA genes in selected isolates. From 2002 to 2009, 168 N. gonorrhoeae isolates were obtained from 142 men. Plasmid-mediated penicillin resistance was found in 65%, plasmid-mediated tetracycline resistance in 97%, and 11% were ciprofloxacin resistant (quinolone-resistant N. gonorrhoeae [QRNG]). QRNG appeared in November 2007, increasing from 9.5% in 2007 to 50% in 2009. Resistance was not detected for spectinomycin, cefixime, ceftriaxone, or azithromycin, but MICs of cefixime (P = 0.018), ceftriaxone (P < 0.001), and azithromycin (P = 0.097) increased over time. In a random sample of 51 men, gentamicin MICs were as follows: 4 μg/ml (n = 1), 8 μg/ml (n = 49), and 16 μg/ml (n = 1). QRNG increased rapidly and alternative regimens are required for N. gonorrhoeae treatment in this area. Amid emerging multidrug-resistant N. gonorrhoeae, antimicrobial resistance surveillance is essential for effective drug choice. High levels of plasmid-mediated resistance and increasing MICs for cephalosporins suggest that selective pressure from antibiotic use is a strong driver of resistance emergence.
PMCID: PMC3147659  PMID: 21606224
14.  Antiretroviral Adherence and Development of Drug Resistance Are the Strongest Predictors of Genital HIV-1 Shedding among Women Initiating Treatment 
The Journal of infectious diseases  2010;202(10):1538-1542.
Persistent genital HIV-1 shedding among women taking antiretroviral therapy (ART) may present a transmission risk. We investigated associations between genital HIV-1 suppression after ART initiation and adherence, resistance, pre-treatment CD4 count, and hormonal contraceptive use. First-line ART was initiated in 102 women. Plasma and genital HIV-1 RNA were measured at months 0, 3, and 6. Adherence was a strong and consistent predictor of genital HIV-1 suppression (p<0.001), while genotypic resistance was associated with higher vaginal HIV-1 RNA at 6 months (p=0.04). These results emphasize the importance of adherence to optimize the potential benefits of ART for reducing HIV-1 transmission risk.
PMCID: PMC2957525  PMID: 20923373
antiretroviral therapy; HIV infection; women; genital HIV-1 shedding
15.  Effect of Acquisition and Treatment of Cervical Infections on HIV-1 Shedding in Women on Antiretroviral Therapy 
AIDS (London, England)  2010;24(17):2733-2737.
Cervicitis increases the quantity of HIV-1 RNA in cervical secretions when women are not taking antiretroviral therapy (ART), and successful treatment of cervicitis reduces HIV-1 shedding in this setting.
To determine the effect of acquisition and treatment of cervical infections on genital HIV-1 shedding in women receiving ART.
Prospective cohort study.
We followed 147 women on ART monthly for incident non-specific cervicitis, gonorrhea, and chlamydia. Cervical swabs for HIV-1 RNA quantitation were collected at every visit. The lower limit for linear quantitation was 100 copies/swab. We compared the prevalence of HIV-1 RNA detection before (baseline) versus during and after treatment of cervical infections.
Thirty women contributed a total of 31 successfully treated episodes of non-specific cervicitis (N=13), gonorrhea (N=17), and chlamydia (N=1). HIV-1 RNA was detected in cervical secretions before, during, and after cervicitis at 1 (3.2%), 5 (16.1%), and 3 (9.7%) visits respectively. Compared to baseline, detection of HIV-1 RNA was increased when cervical infections were present (adjusted odds ratio 5.7, 95% confidence interval 1.0–30.3, P=0.04). However, even in the subset of women with cervical HIV-1 RNA levels above the threshold for quantitation, most had low concentrations during cervical infections (median 115, range 100–820 copies/swab).
While these data show a statistically significant increase in cervical HIV-1 RNA detection when cervical infections are present, most cervical HIV-1 RNA concentrations were near the threshold for detection, suggesting that infectivity remains low. Antiretroviral therapy appears to limit increases in genital HIV-1 shedding caused by cervical infections.
PMCID: PMC2978313  PMID: 20871388
Cervical infection; HIV-1 Shedding; Antiretroviral therapy; Women; Africa
16.  A prospective study of vaginal trichomoniasis and HIV-1 shedding in women on antiretroviral therapy 
BMC Infectious Diseases  2011;11:307.
Trichomonas vaginalis has been associated with increased vaginal HIV-1 RNA shedding in antiretroviral therapy (ART)-naïve women. The effect of trichomoniasis on vaginal HIV-1 shedding in ART-treated women has not been characterized. We tested the hypothesis that T. vaginalis infection would increase vaginal HIV-1 RNA shedding in women on ART, and that successful treatment would reduce vaginal HIV-1 RNA levels.
We conducted a prospective cohort study including monthly follow-up of 147 women receiving ART in Mombasa, Kenya. Those with T. vaginalis infection, defined by the presence of motile trichomonads on vaginal saline wet mount, received treatment with single dose metronidazole (2 g). Test of cure was performed at the next monthly visit. Using the pre-infection visit as the reference category, we compared detection of vaginal HIV-1 RNA before versus during and after infection using generalized estimating equations. A cut-off of 100 HIV-1 RNA copies/swab was used as the lower limit for linear quantitation.
Among 31 women treated for trichomoniasis, the concentration of vaginal HIV-1 RNA was above the limit for quantitation before, during, and after T. vaginalis infection in 4 (13% [95% CI 4% - 30%]), 4 (13% [95% CI 4% - 30%]), and 5 (16% [95% confidence interval {CI} 5% - 34%]) women respectively. After adjusting for potential confounding factors, we could detect no difference in the likelihood of detecting vaginal HIV-1 RNA before versus during infection (odds ratio [OR] 1.41, 95% CI 0.23 - 8.79, p = 0.7). In addition, detection of HIV-1 RNA was similar before infection versus after successful treatment (OR 0.68, 95% CI (0.13 - 3.45), p = 0.6).
Detection of vaginal HIV-1 RNA during ART was uncommon at visits before, during and after T. vaginalis infection.
PMCID: PMC3231993  PMID: 22047086
Trichomonas vaginalis; vaginal infection; antiretroviral therapy; HIV-1; women; Africa
17.  Increased risk of HIV acquisition among Kenyan men with human papillomavirus infection 
The Journal of infectious diseases  2010;201(11):1677-1685.
Few data are available concerning the effect of human papillomavirus (HPV) infection on HIV acquisition.
HIV-seronegative, sexually active 18-24 year-old Kenyan men within a randomized trial of male circumcision provided penile exfoliated cells from two anatomical sites (glans/coronal sulcus, and shaft) at baseline. The GP5+/6+ PCR assay ascertained a wide range of HPV DNA types at the baseline visit. Risk of HIV infection [95% confidence interval (CI)] was estimated using Kaplan-Meier methods, and hazard ratios (HR)[95% CI] from proportional hazards models.
Among 2,168 uncircumcised men with baseline HPV data, 1,089 (50%) were HPV DNA positive. Cumulative incidence of HIV infection by 42-months was 5.8% [95% CI 3.6, 7.9] in men with HPV-positive glans specimens versus 3.7% [1.8, 5.6] in men with HPV-negative glans specimens (p=0.01). Controlling for subsequent circumcision status, baseline HSV-2 serostatus, and sexual and sociodemographic risk factors, the HR of HIV infection in men with HPV-positive glans specimens was 1.8 [1.1, 2.9] compared to men with HPV-negative glans specimens.
Results suggest an independent, increased risk of HIV seroconversion among HPV positive men. If confirmed in other studies, HPV prevention could be another tool for HIV prevention.
PMCID: PMC2873838  PMID: 20415595
Human immunodeficiency virus (HIV); human papillomavirus (HPV); circumcision; Kenya; men; acquisition; risk factors
18.  Acceptability of Medical Male Circumcision Among Uncircumcised Men in Kenya One Year After the Launch of the National Male Circumcision Program 
PLoS ONE  2011;6(5):e19814.
Numerous studies have demonstrated that male circumcision (MC) reduces the incidence of the Type-1 human immunodeficiency virus (HIV) among heterosexual men by at least half.
One year after the launch of a national Voluntary Medical Male Circumcision program in Kenya, this study conducted 12 focus group discussions among uncircumcised men in Nyanza Province to assess the revealed, non-hypothetical, facilitators and barriers to the uptake of MC.
The primary barriers to MC uptake included time away from work; culture and religion; possible adverse events; and the post-surgical abstinence period. The primary facilitators of MC uptake included hygiene; social pressure; protection against HIV and other sexually transmitted infections; and improved sexual performance and satisfaction.
Some activities which might increase MC uptake include dispelling MC misconceptions; increasing involvement of religious leaders, women's groups, and peer mobilizers for MC promotion; and increasing the relevance of MC among men who are already practicing an HIV prevention method.
PMCID: PMC3095626  PMID: 21603622
19.  Circumcision and Reduced Risk of Self-Reported Penile Coital Injuries: Results from a Randomized Controlled Trial in Kisumu, Kenya 
The Journal of urology  2010;184(1):203-209.
Injuries to the penis during intercourse represent one hypothesized mechanism by which uncircumcised men are at increased risk for HIV. There are no published, systematically collected data regarding mild penile coital trauma. We identified risks for self-reported penile coital injuries in men aged 18–24 in our randomized trial of circumcision to prevent HIV in Kisumu, Kenya.
Materials and Methods
Each participant underwent standardized interview, medical history, and physical examination, at baseline and 6, 12, 18, and 24 months after enrollment. Self-reported penile coital injuries were assessed at each visit: penis feels sore during sex; penis gets scratches, cuts or abrasions during sex; skin of the penis bleeds after sex. Generalized estimating equation analysis estimated odds ratios (OR) for penile coital injuries.
February 2002–September 2005, 2,784 participants were randomized. At baseline, 1,775 (64.4%) men reported any coital injury: 1,313 (47.6%) soreness; 1,328 (48.2%) scratches, abrasions, or cuts; 461 (16.7%) bleeding. In multivariable analysis, coital injury risk was lower for circumcised than uncircumcised men: soreness [OR=0.71, 95% CI 0.64–0.80], scratches/abrasions/cuts [OR=0.52, 95% CI 0.46–0.59], bleeding [OR=0.62, 95% CI 0.51–0.75], any coital injury [OR=0.61, 95% CI 0.54–0.68]. Other significant risks (p<0.05) included: increasing age, multiple recent sex partners, HSV-2 seropositivity, and genital ulcers. Condom use, cleaning the penis soon after intercourse, and being married/cohabiting were protective (p<0.05, each).
Self-reported penile coital injuries were common in these healthy young men. Circumcised men were at lower risk for coital injuries. Verifying penile coital injuries, mechanism of acquisition, and association with HIV risk is needed.
PMCID: PMC3090633  PMID: 20483156
20.  Herpes Simplex Virus Type 2 Infection Among Young Uncircumcised Men in Kisumu, Kenya 
This analysis sought to identify factors associated with herpes simplex virus type 2 (HSV-2) infection among men aged 18–24 in Kisumu, Kenya.
We analyzed baseline data from a randomized trial of male circumcision. Participants were interviewed for socio-demographic and behavioral risks. The outcome was HSV-2 by antibody status. Risk factors were considered singly and in combination through logistic regression models.
Among 2,771 uncircumcised men, 766 (27.6%; 95% confidence interval [CI]: 26.0 – 29.3%) tested antibody positive for HSV-2. The median age at first sex was 16 years, and the median number of lifetime sexual partners was 4. HSV-2 seroprevalence increased from 19% among 18 year-olds to 43% among 24 year-olds (p<0.001). In multivariable analysis, statistically significant risks for infection were: increasing age (adjusted odds ratio [AOR] ranged from 1.22–2.58), being married or having a live-in female partner (AOR=1.80; 95% CI: 1.28 – 2.53), preferring “dry” sex (AOR=1.39; 95% CI: 1.14–1.69), reported penile cuts or abrasions during sex (AOR=1.58; 95% CI: 1.32 – 1.91), increasing lifetime sex partners (multiple response categories; AORs ranging 1.65–1.97), and non-student occupation (multiple response categories; AORs ranging 1.44–1.93). Risk decreased with reported condom used at last sex (AOR=0.82; 95% CI: 0.68–0.99).
Primary prevention efforts should be initiated at an early age. The same behavioral interventions used currently for HIV prevention – abstinence, reducing number of sex partners, and increasing condom use – should be effective for HSV-2 prevention.
PMCID: PMC3081652  PMID: 17855489
HSV-2; behavioral risk; epidemiology; Kenya; male circumcision
21.  Adult Male Circumcision Does Not Reduce Risk of Incident Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis: Results from a Randomized Controlled Trial in Kenya 
The Journal of infectious diseases  2009;200(3):370-378.
We examined the effect of male circumcision on the acquisition of three non-ulcerative sexually transmitted infections (STIs).
We evaluated STI incidence among men aged 18–24 enrolled in a randomized trial of circumcision to prevent HIV infection in Kisumu, Kenya. The outcome was first incident non-ulcerative STI over two years follow-up. STIs examined were laboratory-detected Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV).
There were 342 incident infections among 2,655 men followed. Incidences of infection per 100 person-years (PYs) were: 3.48 for NG; 4.55 for CT; and 1.32 for TV. The combined incidence of NG or CT infection was 7.26 per 100 PYs (95% CI: 6.49 – 8.13). The incidence of these STIs, individually or combined, did not differ by circumcision status as a time-dependent variable, or fixed variable based on assignment. Risks for incident STIs in multivariable analysis included: STI at enrollment, multiple sex partners < 30 days, and sex during menses in the past 6 months; condom use was protective.
Circumcision of men in this population did not reduce their risk of acquiring these non-ulcerative STIs. Improved STI control will require more effective STI management, including partner treatment, and behavioral risk reduction counseling.
PMCID: PMC3081655  PMID: 19545209
circumcision; gonorrhea; chlamydia; trichomonas; Africa; Kenya
22.  Implementing Voluntary Medical Male Circumcision for HIV Prevention in Nyanza Province, Kenya: Lessons Learned during the First Year 
PLoS ONE  2011;6(4):e18299.
In 2007, the World Health Organization endorsed male circumcision as an effective HIV prevention strategy. In 2008, the Government of Kenya (GoK) launched the national voluntary medical male circumcision (VMMC) program in Nyanza Province, the geographic home to the Luo, the largest non-circumcising ethnic group in Kenya. Currently, several other African countries are in the early stages of implementing this intervention.
Methods and Results
This paper uses data from a health facility needs assessment (n = 81 facilities) and a study to evaluate the implementation of VMMC services in 16 GoK facilities (n = 2,675 VMMC clients) to describe Kenya's experience in implementing the national program. The needs assessment revealed that no health facility was prepared to offer the minimum package of services as outlined by the national guidelines, and partner organizations were called upon to fill this gap. The findings concerning human resource shortages facilitated the GoK's decision to endorse trained nurses to provide VMMCs, enabling more facilities to offer the service. Findings from the evaluation study resulted in replacing voluntary counseling and testing (VCT) with provider-initiated testing and counseling (PITC) and subsequently doubling the proportion of VMMC clients tested for HIV.
This paper outlines how certain challenges, like human resource shortages and low HIV test rates, were addressed through national policy changes, while other challenges, like large fluctuations in demand, were addressed locally. Currently, the program requires significant support from partner organizations, but a strategic plan is under development to continue to build capacity in GoK staff and facilities. Coordination between all parties was essential and was facilitated through the formation of national, provincial, and district VMMC task forces. The lessons learned from Kenya's VMMC implementation experience are likely generalizable to other African countries.
PMCID: PMC3070734  PMID: 21483697
23.  Adult Male Circumcision: Effects on Sexual Function and Sexual Satisfaction in Kisumu, Kenya 
The journal of sexual medicine  2008;5(11):2610-2622.
Male circumcision is being promoted for HIV prevention in high-risk heterosexual populations. However, there is a concern that circumcision may impair sexual function.
To assess adult male circumcision’s effect on men’s sexual function and pleasure.
Participants in a controlled trial of circumcision to reduce HIV incidence in Kisumu, Kenya were uncircumcised, HIV negative, sexually active men, aged 18–24 years, with a hemoglobin ≥9.0 mmol/L. Exclusion criteria included foreskin covering less than half the glans, a condition that might unduly increase surgical risks, or a medical indication for circumcision. Participants were randomized 1:1 to either immediate circumcision or delayed circumcision after 2 years (control group). Detailed evaluations occurred at 1, 3, 6, 12, 18, and 24 months.
Main Outcome Measures
(i) Sexual function between circumcised and uncircumcised men; and (ii) sexual satisfaction and pleasure over time following circumcision.
Between February 2002 and September 2005, 2,784 participants were randomized, including the 100 excluded from this analysis because they crossed over, were not circumcised within 30 days of randomization, did not complete baseline interviews, or were outside the age range. For the circumcision and control groups, respectively, rates of any reported sexual dysfunction decreased from 23.6% and 25.9% at baseline to 6.2% and 5.8% at month 24. Changes over time were not associated with circumcision status. Compared to before they were circumcised, 64.0% of circumcised men reported their penis was “much more sensitive,” and 54.5% rated their ease of reaching orgasm as “much more” at month 24.
Adult male circumcision was not associated with sexual dysfunction. Circumcised men reported increased penile sensitivity and enhanced ease of reaching orgasm. These data indicate that integration of male circumcision into programs to reduce HIV risk is unlikely to adversely effect male sexual function.
PMCID: PMC3042320  PMID: 18761593
Male Circumcision; HIV Infection; Sexual Dysfunction; Sexual Satisfaction; Erectile Dysfunction; Ejaculatory Dysfunction; Balanitis
24.  Reasons for Ineligibility in Phase 1 and 2A HIV Vaccine Clinical Trials at Kenya Aids Vaccine Initiative (KAVI), Kenya 
PLoS ONE  2011;6(1):e14580.
With the persistent challenges towards controlling the HIV epidemic, there is an ongoing need for research into HIV vaccines and drugs. Sub-Saharan African countries - worst affected by the HIV pandemic - have participated in the conduct of clinical trials for HIV vaccines. In Kenya, the Kenya AIDS Vaccine Initiative (KAVI) at the University of Nairobi has conducted HIV vaccine clinical trials since 2001.
Participants were recruited after an extensive informed consent process followed by screening to determine eligibility. Screening included an assessment of risk behavior, medical history and physical examination, and if clinically healthy, laboratory testing. In the absence of locally derived laboratory reference ranges, the ranges used in these trials were derived from populations in the West.
Principal findings
Two hundred eighty-one participants were screened between 2003 and 2006 for two clinical trials. Of these, 167 (59.4%) met the inclusion/exclusion criteria. Overall, laboratory abnormalities based on the non-indigenous laboratory references used were the most frequent reasons (61.4%) for ineligibility. Medical abnormalities contributed 30.7% of the total reasons for ineligibility. Based on the laboratory reference intervals now developed from East and Southern Africa, those ineligible due to laboratory abnormalities would have been 46.3%. Of the eligible participants, 18.6% declined enrolment.
Participant recruitment for HIV vaccine clinical trials is a rigorous and time-consuming exercise. Over 61% of the screening exclusions in clinically healthy people were due to laboratory abnormalities. It is essential that laboratory reference ranges generated from local populations for laboratory values be used in the conduct of clinical trials to avoid unnecessary exclusion of willing participants and to avoid over-reporting of adverse events for enrolled participants.
Trial registration
Protocol IAVI VRC V001 [1]. NCT00124007 Protocol IAVI 010 [2] (registration with is in progress)
Protocols IAVI 002 and IAVI 004 are Phase 1 trials only mentioned in introductory paragraphs; details will not be reported. Registration was not required when they were conducted.
PMCID: PMC3024980  PMID: 21283743
25.  Increased risk of genital ulcer disease in women during the first month after initiating antiretroviral therapy 
Genital ulcer disease (GUD) is common in HIV-1-infected women, and a small number of studies have suggested increased GUD risk after antiretroviral therapy (ART) initiation. To better define this risk, we monitored 134 women at ART initiation and monthly thereafter.
Women were evaluated monthly for genital ulcers. Syphilis serology was tested quarterly, and chancroid culture performed on ulcers that were felt to be clinically consistent with a diagnosis of chancroid. A logistic model with generalized estimating equations was used to analyze predictors of GUD from baseline until 6 months after ART initiation.
During the study period, GUD occurred in 54 women (40.3%) at 85 visits (10.0%). GUD prevalence was 9.7% at baseline, increased to 16.7% at month 1 (adjusted odds ratio [aOR] 1.9 [1.0 – 3.6], p = 0.04), then decreased to 6.4% by month 6. History of GUD (aOR 3.8 [1.9 – 7.7], p < 0.001) and CD4 count <100 (aOR 1.8 [1.0 – 3.4, p = 0.06) were associated with increased risk of GUD after ART initiation.
Women experience increased risk of GUD in the first month after ART initiation, particularly if they have low CD4 counts or a history of GUD.
PMCID: PMC2787852  PMID: 19648822
genital ulcer; HIV; antiretroviral therapy; immune reconstitution

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