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1.  Bacterial vaginosis and the risk of Trichomonas vaginalis acquisition among HIV-1 negative women 
Sexually transmitted diseases  2014;41(2):123-128.
Background
The vaginal microbiota may play a role in mediating susceptibility to sexually transmitted infections, including Trichomonas vaginalis (TV).
Methods
Data were analyzed from HIV-1 seronegative women participating in HIV Prevention Trials Network Protocol 035. At quarterly visits for up to 30 months, participants completed structured interviews and specimens were collected for genital tract infection testing. TV was detected by saline microscopy. BV was characterized by Gram stain using the Nugent score (BV=7-10; intermediate=4-6; normal=0-3 [reference group]). Cox proportional hazards models stratified by study site were used to assess the association between Nugent score category at the prior quarterly visit and TV acquisition.
Results
In this secondary analysis, 2,920 participants from Malawi, South Africa, USA, Zambia and Zimbabwe contributed 16,259 follow-up visits. BV was detected at 5,680 (35%) visits and TV was detected at 400 (2.5%) visits. Adjusting for age, marital status, hormonal contraceptive use, unprotected sex in the last week and TV at baseline, intermediate Nugent score and BV at the prior visit were associated with an increased risk of TV (intermediate score: adjusted hazard ratio [aHR]=1.73, 95% confidence interval [CI] 1.21-2.19; BV: aHR=2.40, 95% CI 1.92-3.00). Sensitivity analyses excluding 211 participants with TV at baseline were similar to those from the full study population (intermediate score: aHR=1.54, 95% CI 1.10-2.14; BV: aHR=2.23, 95% CI 1.75-2.84)
Conclusions
Women with a Nugent score >3 were at an increased risk of acquiring TV. If this relationship is causal, interventions that improve the vaginal microbiota could contribute to reductions in TV incidence.
doi:10.1097/OLQ.0000000000000075
PMCID: PMC4128240  PMID: 24413493
Bacterial vaginosis; Trichomonas vaginalis; vaginal microbiota; sexually transmitted disease acquisition; prospective cohort
2.  Cost-effectiveness of provider-based HIV partner notification in urban Malawi 
Health Policy and Planning  2013;29(1):115-126.
Provider-initiated partner notification for HIV effectively identifies new cases of HIV in sub-Saharan Africa, but is not widely implemented. Our objective was to determine whether provider-based HIV partner notification strategies are cost-effective for preventing HIV transmission compared with passive referral. We conducted a cost-effectiveness analysis using a decision-analytic model from the health system perspective during a 1-year period. Costs and outcomes of all strategies were estimated with a decision-tree model. The study setting was an urban sexually transmitted infection clinic in Lilongwe, Malawi, using a hypothetical cohort of 5000 sex partners of 3500 HIV-positive index cases. We evaluated three partner notification strategies: provider notification (provider attempts to notify indexes’ locatable partners), contract notification (index given 1 week to notify partners then provider attempts notification) and passive referral (index is encouraged to notify partners, standard of care). Our main outcomes included cost (US dollars) per transmission averted, cost per new case identified and cost per partner tested. Based on estimated transmissions in a 5000-person cohort, provider and contract notification averted 27.9 and 27.5 new infections, respectively, compared with passive referral. The incremental cost-effectiveness ratio (ICER) was $3560 per HIV transmission averted for contract notification compared with passive referral. Provider notification was more expensive and slightly more effective than contract notification, yielding an ICER of $51 421 per transmission averted. ICERs were sensitive to the proportion of partners not contacted, but likely HIV positive and the probability of transmission if not on antiretroviral therapy. The costs per new case identified were $36 (provider), $18 (contract) and $8 (passive). The costs per partner tested were $19 (provider), $9 (contract) and $4 (passive). We conclude that, in this population, provider-based notification strategies are potentially cost-effective for identifying new cases of HIV. These strategies offer a simple, effective and easily implementable opportunity to control HIV transmission.
doi:10.1093/heapol/czs140
PMCID: PMC3872371  PMID: 23325584
Cost-benefit analysis; contact tracing; HIV; sub-Saharan Africa
3.  A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia 
AIDS and behavior  2013;17(7):2510-2520.
We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs.
doi:10.1007/s10461-013-0563-4
PMCID: PMC3950300  PMID: 23881187
Injection drug users; Russia; HIV prevention; Network
5.  Placental Malaria and Mother-to-Child Transmission of Human Immunodeficiency Virus-1 
There are few studies of the association between placental malaria (PM) and mother-to-child transmission (MTCT) of human immunodeficiency virus-1 (HIV-1), and the results of published studies are inconsistent. To determine the association between PM and MTCT of HIV-1, we performed a secondary analysis of data from a clinical trial of antibiotics to reduce chorioamnionitis. Data regarding 1,662 HIV-1–infected women with live born singleton and first-born twin infants with information regarding PM and infant HIV-1 infection status at birth were analyzed. At the time of the study, women did not have access to antiretroviral drugs for treatment of acquired immunodeficiency syndrome but had received nevirapine prophylaxis to reduce the risk of MTCT of HIV-1. Placental malaria was not associated with the infant HIV-1 infection status at birth ( P = 0.67). Adjustment for maternal plasma viral load and CD4+ cell count did not change these results (odds ratio = 1.06, 95% confidence interval = 0.51–2.20, P = 0.87). Placental malaria was more likely to be related to HIV-1 infection at birth among women with low viral load at baseline (P for interaction = 0.08). In conclusion, PM was not associated with infant HIV-1 infection status at birth. The interaction of maternal plasma viral load, PM, and MTCT of HIV-1 warrants further studies.
PMCID: PMC3775571  PMID: 19346367
6.  The feasibility of an intensive case management program for injection drug users on antiretroviral therapy in St. Petersburg, Russia 
Background
The majority of HIV-infected individuals requiring antiretroviral therapy (ART) in Russia are Injection Drug Users (IDU). Substitution therapy used as part of a comprehensive harm reduction program is unavailable in Russia. Past data shows that only 16% of IDU receiving substance abuse treatment completed the course without relapse, and only 40% of IDU on ART remained on treatment at 6 months. Our goal was to determine if it was feasible to improve these historic outcomes by adding intensive case management (ICM) to the substance abuse and ART treatment programs for IDU.
Methods
IDU starting ART and able to involve a “supporter” who would assist in their treatment plan were enrolled. ICM included opiate detoxification, bi-monthly contact and counseling with the case, weekly group sessions, monthly contact with the “supporter” and home visits as needed. Full follow- up (FFU) was 8 months. Stata v10 (College Station, TX) was used for all analysis. Descriptive statistics were calculated for all baseline demographic variables, baseline and follow-up CD4 count, and viral load. Median baseline and follow-up CD4 counts and RNA levels were compared using the Kruskal-Wallis test. The proportion of participants with RNA < 1000 copies mL at baseline and follow-up was compared using Fisher’s Exact test. McNemar’s test for paired proportions was used to compare the change in proportion of participants with RNA < 1000 copies mL from baseline to follow-up.
Results
Between November 2007 and December 2008, 60 IDU were enrolled. 34 (56.7%) were male. 54/60 (90.0%) remained in FFU. Overall, 31/60 (52%) were active IDU at enrollment and 27 (45%) were active at their last follow-up visit. 40/60 (66.7%) attended all of their ART clinic visits, 13/60 (21.7%) missed one or more visit but remained on ART, and 7/60 (11.7%) stopped ART before the end of FFU. Overall, 39/53 (74%) had a final 6–8 month HIV RNA viral load (VL) < 1000 copies/mL.
Conclusions
Despite no substitution therapy to assist IDU in substance abuse and ART treatment programs, ICM was feasible, and the retention and adherence of IDU on ART in St. Petersburg could be greatly enhanced by adding ICM to the existing treatment programs.
doi:10.1186/1477-7517-10-15
PMCID: PMC3844607  PMID: 24006958
Injection drug users; Russia; HIV/AIDS; Antiretroviral therapy; Case management
7.  Early Experience after Developing a Pathology Laboratory in Malawi, with Emphasis on Cancer Diagnoses 
PLoS ONE  2013;8(8):e70361.
Background
Despite increasing cancer burden in Malawi, pathology services are limited. We describe operations during the first 20 months of a new pathology laboratory in Lilongwe, with emphasis on cancer diagnoses.
Methods and Findings
We performed a cross-sectional study of specimens from the Kamuzu Central Hospital pathology laboratory between July 1, 2011 and February 28, 2013. Patient and specimen characteristics, and final diagnoses are summarized. Diagnoses were categorized as malignant, premalignant, infectious, other pathology, normal or benign, or nondiagnostic. Patient characteristics associated with premalignancy and malignancy were assessed using logistic regression. Of 2772 specimens, 2758 (99%) with a recorded final diagnosis were included, drawn from 2639 unique patients. Mean age was 38 years and 63% were female. Of those with documented HIV status, 51% had unknown status, and 36% with known status were infected. Histologic specimens comprised 91% of cases, and cytologic specimens 9%. Malignant diagnoses were most common overall (n = 861, 31%). Among cancers, cervical cancer was most common (n = 117, 14%), followed by lymphoma (n = 91, 11%), esophageal cancer (n = 86, 10%), sarcoma excluding Kaposi sarcoma (n = 75, 9%), and breast cancer (n = 61, 7%). HIV status was known for 95 (11%) of malignancies, with HIV prevalence ranging from 9% for breast cancer to 81% for cervical cancer. Increasing age was consistently associated with malignancy [bivariable odds ratio 1.24 per decade increase (95% CI 1.19–1.29) among 2685 patients with known age; multivariable odds ratio 1.33 per decade increase (95% CI 1.14–1.56) among 317 patients with known age, gender, and HIV status], while HIV infection and gender were not.
Conclusions
Despite selection and referral bias inherent in these data, a new pathology laboratory in Lilongwe has created a robust platform for cancer care and research. Strategies to effectively capture clinical information for pathologically confirmed cancers can allow these data to complement population-based registration.
doi:10.1371/journal.pone.0070361
PMCID: PMC3737192  PMID: 23950924
8.  Predicting Partner HIV Testing and Counseling following a Partner Notification Intervention 
AIDS and behavior  2012;16(5):1148-1155.
Provider-assisted methods of partner notification increase testing and counseling among sexual partners of patients diagnosed with HIV, however they are resource-intensive. The sexual partners of individuals enrolled in a clinical trial comparing different methods of HIV partner notification were analyzed to identify who was unlikely to seek testing on their own. Unconditional logistic regression was used to identify partnership characteristics, which were assigned a score based on their coefficient in the final model, and a risk score was calculated for each participant. The risk score included male partner sex, relationship duration 6–24 months, and index education > primary. A risk score of ≥ 2 had a sensitivity of 68% and specificity of 78% in identifying partners unlikely to seek testing on their own. A risk score to target partner notification can reduce the resources required to locate all partners in the community while increasing the testing yield compared to patient-referral.
doi:10.1007/s10461-011-0094-9
PMCID: PMC3515685  PMID: 22120879
HIV/AIDS; Partner Notification; Contact Tracing; sub-Saharan Africa
9.  Prevalence of hepatitis C virus infection among human immunodeficiency virus-1-infected pregnant women in Malawi: The BAN study☆ 
Background
In Sub-Saharan Africa, prevalence estimates of hepatitis C virus (HCV) vary widely.
Objectives
To assess the prevalence of HCV infection among HIV-infected, pregnant women screened for a large clinical trial in Lilongwe, Malawi.
Study design
Plasma from 2041 HIV-infected, pregnant women was screened for anti-HCV IgG using a chemiluminiscent immunometric assay (CIA). Specimens with a signal-cut-off ratio ≥ 1.00 were considered reactive and those with S/Co ratio < 1.00 non-reactive. All CIA-reactive specimens were tested by a recombinant immunoblot assay (RIBA) for anti-HCV and by PCR for HCV RNA.
Results
Of 2041 specimens, 110 (5.3%, 95% CI: 4.5–6.5%) were CIA reactive. Of the 109 CIA reactive specimens available for RIBA testing, 2 (1.8%) were positive, 28 (25.7%) were indeterminate, and 79 (72.5%) were negative. All CIA-reactive specimens were HCV RNA negative (n = 110). The estimated HCV prevalence based on the screening assay alone was 5.3%; based on supplemental RIBA testing, the status of HCV infection remained indeterminate in 1.4% (28/2040, 95% CI: 0.1–2.0) and the prevalence of confirmed HCV infections was 0.1% (2/2040, 95% CI: 0–0.4%).
Conclusions
HCV seroprevalence among HIV-infected, pregnant women in Malawi confirmed by supplemental RIBA HCV 3.0 is low (0.1%); CIA showed a high false-reactivity rate in this population.
doi:10.1016/j.jcv.2012.05.003
PMCID: PMC3652577  PMID: 22658797
HIV; HCV; Pregnant women; Malawi
10.  Detection of Acute HIV Infection: A Field Evaluation of the Determine® HIV-1/2 Ag/Ab Combo Test 
The Journal of Infectious Diseases  2011;205(4):528-534.
(See the editorial commentary by Branson and Stekler, on pages 521–4.)
Background. Most human immunodeficiency virus (HIV) point-of-care tests detect antibodies (Ab) but not p24 antigen (Ag) or RNA. In the absence of antibodies, p24 antigen and RNA typically indicate acute HIV infection. We conducted a field evaluation of the Determine® HIV-1/2 Ag/Ab Combo rapid test (Combo RT).
Methods. The antigen portion of the Combo RT (for acute HIV infection) was compared with a Roche Monitor HIV RNA polymerase chain reaction assay. The antibody portion of Combo RT (for established HIV infection) was compared with rapid test algorithms. Participants were enrolled at a sexually transmitted infection clinic and HIV testing and counseling center in Lilongwe, Malawi. Rapid testing was conducted with parallel testing in the clinic and serial testing in the center. The Combo RT was performed in clinic participants with negative or discordant antibody results and in all center participants.
Results. Of the participants 838 were HIV negative, 163 had established HIV infection, and 8 had acute HIV infection. For detecting acute HIV infection, the antigen portion had a sensitivity of 0.000 and a specificity of 0.983. For detecting established HIV infection, the antibody portion had a sensitivity of 0.994 and a specificity of 0.992.
Conclusions. Combo RT displayed excellent performance for detecting established HIV infection and poor performance for detecting acute HIV infection. In this setting, Combo RT is no more useful than current algorithms.
doi:10.1093/infdis/jir789
PMCID: PMC3318673  PMID: 22207651
11.  Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission 
The New England journal of medicine  2010;362(24):2271-2281.
Background
We evaluated the efficacy of a maternal triple-drug antiretroviral regimen or infant nevirapine prophylaxis for 28 weeks during breast-feeding to reduce postnatal transmission of human immunodeficiency virus type 1 (HIV-1) in Malawi.
Methods
We randomly assigned 2369 HIV-1–positive, breast-feeding mothers with a CD4+ lymphocyte count of at least 250 cells per cubic millimeter and their infants to receive a maternal antiretroviral regimen, infant nevirapine, or no extended postnatal antiretroviral regimen (control group). All mothers and infants received perinatal prophylaxis with single-dose nevirapine and 1 week of zidovudine plus lamivudine. We used the Kaplan–Meier method to estimate the cumulative risk of HIV-1 transmission or death by 28 weeks among infants who were HIV-1–negative 2 weeks after birth. Rates were compared with the use of the log-rank test.
Results
Among mother–infant pairs, 5.0% of infants were HIV-1–positive at 2 weeks of life. The estimated risk of HIV-1 transmission between 2 and 28 weeks was higher in the control group (5.7%) than in either the maternal-regimen group (2.9%, P = 0.009) or the infant-regimen group (1.7%, P<0.001). The estimated risk of infant HIV-1 infection or death between 2 and 28 weeks was 7.0% in the control group, 4.1% in the maternal-regimen group (P = 0.02), and 2.6% in the infant-regimen group (P<0.001). The proportion of women with neutropenia was higher among those receiving the antiretroviral regimen (6.2%) than among those in either the nevirapine group (2.6%) or the control group (2.3%). Among infants receiving nevirapine, 1.9% had a hypersensitivity reaction.
Conclusions
The use of either a maternal antiretroviral regimen or infant nevirapine for 28 weeks was effective in reducing HIV-1 transmission during breast-feeding. (ClinicalTrials.gov number, NCT00164736.)
doi:10.1056/NEJMoa0911486
PMCID: PMC3440865  PMID: 20554982
12.  Sexual Partnership Patterns in Malawi: Implications for HIV/STI Transmission 
Sexually transmitted diseases  2011;38(7):657-666.
Background
Concurrent sexual partnerships are believed to play an important role in HIV transmission in sub-Saharan Africa, but the contributions of concurrency to HIV and STI spread depend on the details of infectious periods and relationship patterns. To contribute to the understanding of sexual partnership patterns in this region, we estimated partnership lengths, temporal gaps between partners, and periods of overlap across partners at an STI clinic in Lilongwe, Malawi.
Methods
Participants underwent physical examinations and HIV tests, and responded to questionnaires about demographics and risk behaviors, including detailed questions about a maximum of 3 sexual partners in the previous 2 months. We calculated partnership length as the time between the first and most recent sexual contact with a partner, and gap length as the time between the most recent contact with one partner and the first contact with the next. We defined concurrent and consecutive partnerships as gap length≤0 days and gap length>0 days, respectively.
Results
The study population (n=183) had a mean partnership length of 858 days (median=176 days). Eighty-six percent reported 0 or 1 partner, 5% reported multiple consecutive partnerships, and 9% reported concurrency. Gaps between consecutive partnerships were short (mean=21 days), and overlaps across concurrent partners tended to be long (mean=246 days).
Conclusions
Multiple sexual partnerships were uncommon, and partnerships were long on average. Among those reporting multiple recent partners, both long-term concurrency and narrowly spaced consecutive partnerships could present substantial risk for efficient transmission of HIV and classical STIs.
doi:10.1097/OLQ.0b013e31820cb223
PMCID: PMC3125407  PMID: 21301383
Transmission; concurrency; partnership length; gap length; overlap
13.  High HIV Incidence and Sexual Behavior Change among Pregnant Women in Lilongwe, Malawi: Implications for the Risk of HIV Acquisition 
PLoS ONE  2012;7(6):e39109.
Background
HIV incidence is higher among pregnant women than their non-pregnant counterparts in some sub-Saharan African settings. Our aims were (1) to estimate HIV incidence during pregnancy and (2) to compare sexual activity between pregnant, postpartum, and non-pregnant women.
Methods
We examined a retrospective cohort of 1087 women to identify seroconverters using antenatal and labor ward HIV test results. We also conducted a cross-sectional survey, including a quantitative questionnaire (n = 200) and in-depth interviews (n = 20) among women in early pregnancy, late pregnancy, postpartum, and non-pregnancy. Outcomes included measures of sexual activity, reported spouse’s risky behavior, and beliefs about abstinence.
Results
11 of 1087 women seroconverted during pregnancy yielding a 1% seroconversion risk and an incidence rate of 4.0/100 person years (95% CI 2.2–7.2). The reported sexual activity of the early pregnancy and non-pregnancy groups was similar, but significantly higher than the late pregnancy and postpartum groups (p<0.001). During pregnancy, sex acts decreased as gestation increased (p = 0.001). There was no reported difference in the spouse’s risky behavior. Most women believed that sex should cease between the 6th and 8th month of pregnancy and should not resume until 6 months postpartum. Some talked about conflict between their cultural obligation to abstain and fear of HIV infection if their spouses find other partners.
Conclusions
HIV incidence is high among pregnant women in Malawi, and sexual activity decreases during pregnancy and postpartum. Pregnant women need to be informed of their increased risk for HIV and the importance of using condoms throughout pregnancy and the postpartum period.
doi:10.1371/journal.pone.0039109
PMCID: PMC3387180  PMID: 22768063
14.  Safety and Effectiveness of BufferGel and 0.5% PRO2000 Gel for the Prevention of HIV Infection in Women 
AIDS (London, England)  2011;25(7):957-966.
Objective
To determine the safety and effectiveness of BufferGel and 0.5% PRO2000 microbicide gels for the prevention of male to female HIV transmission
Design
Phase II/IIb, randomized, placebo-controlled trial with three double-blinded gel arms and an open label no gel arm.
Methods
Study participants from Malawi, South Africa, Zambia, Zimbabwe and USA were instructed to apply study gel ≤1 hour before each sex act and safety, sexual behavior, pregnancy, gel adherence, acceptability, and HIV serostatus were assessed during follow-up.
Results
The 3101 enrolled women were followed for an average of 20.4 months with 93.6% retention and 81.1% self-reported gel adherence. Adverse event rates were similar in all study arms. HIV incidence rates in the 0.5% PRO2000 Gel, BufferGel, Placebo Gel and No Gel arms were 2.70, 4.14, 3.91 and 4.02 per 100 women-years, respectively. HIV incidence in the 0.5% PRO2000 Gel arm was lower than the Placebo Gel arm (Hazard Ratio (HR)=0.7; p=0.10) and the No Gel arm (HR=0.67; p=0.06). HIV incidence rates were similar in the BufferGel and both Placebo Gel (HR=1.10; p=0.63) and No Gel control arms (HR=1.05; p=0.78). HIV incidence was similar in the Placebo Gel and No Gel arms (HR=0.97; p=0.89).
Conclusions
0.5% PRO2000 Gel demonstrated a modest 30% reduction in HIV acquisition in women. However, these results were not statistically significant and subsequent findings from the MDP 301 trial have confirmed that 0.5% PRO2000 has little or no protective effect. BufferGel did not alter the risk of HIV infection. Both products were safe.
doi:10.1097/QAD.0b013e32834541d9
PMCID: PMC3083640  PMID: 21330907
Microbicide; PRO 2000 Gel; BufferGel; HIV Prevention; Women
15.  HIV partner notification is effective and feasible in sub-Saharan Africa: Opportunities for HIV treatment and prevention 
Background
Sexual partners of persons with newly diagnosed HIV infection require HIV counseling, testing and, if necessary, evaluation for therapy. However, many African countries do not have a standardized protocol for partner notification and the effectiveness of partner notification has not been evaluated in developing countries.
Methods
Individuals with newly diagnosed HIV infection presenting to STI clinics in Lilongwe, Malawi were randomized to one of three methods of partner notification: passive referral, contract referral, or provider referral. The passive referral group was responsible for notifying their partners themselves. The contract referral group was given seven days to notify their partners, after which a health care provider contacted partners who had not reported for counseling and testing. In the provider referral group, a health care provider notified partners directly.
Results
240 index patients named 302 sexual partners and provided locator information for 252. Among locatable partners, 107 returned for HIV counseling and testing; 20/82 (24%; 95% CI 15 – 34%) partners returned in the passive referral arm, 45/88 (51%; 95% CI 41 – 62%) in the contract referral arm, and 42/82 (51%; 95% CI 40 – 62%) in the provider referral arm (p<0·001). Among returning partners (n=107), 67 (64%) of were HIV-infected with 54 (81%) newly diagnosed.
Discussion
This study provides the first evidence of the effectiveness of partner notification in sub-Saharan Africa. Active partner notification was feasible, acceptable, and effective among STI clinic patients. Partner notification will increase early referral to care and facilitate risk reduction among high-risk uninfected partners.
PMCID: PMC3207356  PMID: 22046601
Partner notification; HIV counseling and testing; sub-Saharan Africa
16.  Bacterial infections in Lilongwe, Malawi: aetiology and antibiotic resistance 
Background
Life-threatening infections present major challenges for health systems in Malawi and the developing world because routine microbiologic culture and sensitivity testing are not performed due to lack of capacity. Use of empirical antimicrobial therapy without regular microbiologic surveillance is unable to provide adequate treatment in the face of emerging antimicrobial resistance. This study was conducted to determine antimicrobial susceptibility patterns in order to inform treatment choices and generate hospital-wide baseline data.
Methods
Culture and susceptibility testing was performed on various specimens from patients presenting with possible infectious diseases at Kamuzu Central Hospital, Lilongwe, Malawi.
Results
Between July 2006 and December 2007 3104 specimens from 2458 patients were evaluated, with 60.1% from the adult medical service. Common presentations were sepsis, meningitis, pneumonia and abscess. An etiologic agent was detected in 13% of patients. The most common organisms detected from blood cultures were Staphylococcus aureus, Escherichia coli, Salmonella species and Streptococcus pneumoniae, whereas Streptococcus pneumoniae and Cryptococcus neoformans were most frequently detected from cerebrospinal fluid. Haemophilus influenzae was rarely isolated. Resistance to commonly used antibiotics was observed in up to 80% of the isolates while antibiotics that were not commonly in use maintained susceptibility.
Conclusions
There is widespread resistance to almost all of the antibiotics that are empirically used in Malawi. Antibiotics that have not been widely introduced in Malawi show better laboratory performance. Choices for empirical therapy in Malawi should be revised accordingly. A microbiologic surveillance system should be established and prudent use of antimicrobials promoted to improve patient care.
doi:10.1186/1471-2334-12-67
PMCID: PMC3342226  PMID: 22436174
17.  Epidemiology of Injuries at a Tertiary Care Center in Malawi 
World Journal of Surgery  2009;33(9):1836-1841.
Background
Injury surveillance is an ongoing process required for primary, secondary, and tertiary injury prevention. In Malawi, hospital-based injury data are not available.
Methods
From February to June 2008 we collected data on injured patients presenting to Kamuzu Central Hospital in Lilongwe, Malawi. The sample (n = 1,474) was predominantly male (75.7%), and age distribution was bimodal (peak age groups <5 years and 26–30 years). Road-traffic injury (RTI) was the most common reason for treatment (43.4%), followed by assault (24.0%), which was more common than expected. The most common injuries were lacerations, contusions, and abrasions. We observed both gender- and age-specific patterns in injury mechanism: Injured females were more likely than injured males to have suffered an injury as a passenger in a car or on a bicycle, or to have suffered from falls, foreign bodies, and burns; injured males were more likely than injured females to have suffered an injury as an automobile driver or bicyclist, or from an assault. Falls, burns, and foreign bodies affected younger victims, whereas bicyclists, automobile drivers, and motorcycle operators were generally older persons.
Results
The hospital admission rate was 26.8%. Most patients arrived by private vehicle (43.8%), which was also the fastest means of transportation. There were 25 mass casualties leading to 102 admissions; all but one were due to RTIs, and seven were associated with at least one fatality.
Conclusions
This study elucidated injury epidemiology in Malawi and identified questions for future research. Other developing countries should conduct such prospective data collection to identify region-specific injury patterns and to promote injury prevention.
doi:10.1007/s00268-009-0113-4
PMCID: PMC3290404  PMID: 19597877
18.  Hospital-based injury data in Malawi: strategies for data collection and feasibility of trauma scoring tools 
Tropical Doctor  2010;40(2):98-99.
SUMMARY
Injury is a major cause of morbidity and mortality in developing countries. Utilizing a partnership between Kamuzu Central Hospital (KCH) and the University of North Carolina Departments of Surgery, we describe an approach to injury surveillance, examine the utility of trauma scoring systems, and outline steps necessary before such scoring systems can be reliably instituted in a resource-constrained setting.
doi:10.1258/td.2009.090009
PMCID: PMC3290406  PMID: 20305105
19.  Prevention of HIV-1 Infection with Early Antiretroviral Therapy 
The New England journal of medicine  2011;365(6):493-505.
Background
Antiretroviral therapy that reduces viral replication could limit the transmission of human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples.
Methods
In nine countries, we enrolled 1763 couples in which one partner was HIV-1–positive and the other was HIV-1–negative; 54% of the subjects were from Africa, and 50% of infected partners were men. HIV-1–infected subjects with CD4 counts between 350 and 550 cells per cubic millimeter were randomly assigned in a 1:1 ratio to receive antiretroviral therapy either immediately (early therapy) or after a decline in the CD4 count or the onset of HIV-1–related symptoms (delayed therapy). The primary prevention end point was linked HIV-1 transmission in HIV-1–negative partners. The primary clinical end point was the earliest occurrence of pulmonary tuberculosis, severe bacterial infection, a World Health Organization stage 4 event, or death.
Results
As of February 21, 2011, a total of 39 HIV-1 transmissions were observed (incidence rate, 1.2 per 100 person-years; 95% confidence interval [CI], 0.9 to 1.7); of these, 28 were virologically linked to the infected partner (incidence rate, 0.9 per 100 person-years, 95% CI, 0.6 to 1.3). Of the 28 linked transmissions, only 1 occurred in the early-therapy group (hazard ratio, 0.04; 95% CI, 0.01 to 0.27; P<0.001). Subjects receiving early therapy had fewer treatment end points (hazard ratio, 0.59; 95% CI, 0.40 to 0.88; P = 0.01).
Conclusions
The early initiation of antiretroviral therapy reduced rates of sexual transmission of HIV-1 and clinical events, indicating both personal and public health benefits from such therapy.
doi:10.1056/NEJMoa1105243
PMCID: PMC3200068  PMID: 21767103
20.  The Role of Acute and Early HIV Infection in the Spread of HIV-1 in Lilongwe, Malawi: Implications for “Test and Treat” and Other Transmission Prevention Strategies 
Lancet  2011;378(9787):256-268.
Background
HIV transmission risk during acute and early HIV infection (EHI) is sharply elevated, but the contribution of EHI to ongoing HIV transmission is controversial. However, in settings where EHI contributes substantially to secondary transmissions, early diagnosis and intervention may be critical for HIV prevention. We estimated the contribution of EHI to HIV incidence in Lilongwe, Malawi and predicted the future impact of hypothetical prevention interventions affecting EHI only, chronic HIV infection (CHI) only, or both stages.
Methods
We developed a deterministic mathematical model describing heterosexual HIV transmission, informed by detailed behavioural and viral load data collected in Lilongwe. We included sexual contact within and outside steady pairs and divided the infectious period into multiple intervals to allow for changes in transmissibility by infection stage. We used a Bayesian melding approach to fit the model to HIV prevalence data collected over time at Lilongwe antenatal clinics. We evaluated interventions that reduced the per-contact transmission probability to 0·00003 in those receiving them and varied the proportion of individuals receiving the intervention in each stage.
Findings
We estimated that 38·4% (95% credible interval: 18·6%-52·3%) of ongoing HIV transmissions in Lilongwe are attributable to sexual contact with EHI index cases. Interventions acting only during EHI substantially reduced HIV prevalence, but did not lead to elimination, even with 100% coverage. Interventions acting only during CHI also reduced HIV prevalence, but coverage levels of 95%-99% were required to move the epidemic toward elimination. In scenarios with <95% CHI coverage, additional interventions reaching 25%-75% of EHI cases reduced HIV prevalence substantially.
Interpretation
Our results suggest that EHI plays an important role in HIV transmission in this sub-Saharan African setting. Without near-perfect coverage, interventions during CHI will likely have incomplete effectiveness unless complemented by strategies targeting the heightened transmission risk of EHI.
doi:10.1016/S0140-6736(11)60842-8
PMCID: PMC3274419  PMID: 21684591
21.  Episodic Therapy for Genital Herpes in Sub-Saharan Africa: A Pooled Analysis from Three Randomized Controlled Trials 
PLoS ONE  2011;6(7):e22601.
Background
A randomized controlled trial in South Africa found a beneficial effect of acyclovir on genital ulcer healing, but no effect was seen in trials in Ghana, Central African Republic and Malawi. The aim of this paper is to assess whether the variation in impact of acyclovir on ulcer healing in these trials can be explained by differences in the characteristics of the study populations.
Methodology/Principal Findings
Pooled data were analysed to estimate the impact of acyclovir on the proportion of ulcers healed seven days after randomisation by HIV/CD4 status, ulcer aetiology, size and duration before presentation; and impact on lesional HIV-1. Risk ratios (RR) were estimated using Poisson regression with robust standard errors. Of 1478 patients with genital ulcer, most (63%) had herpetic ulcers (16% first episode HSV-2 ulcers), and a further 3% chancroid, 2% syphilis, 0.7% lymphogranuloma venereum and 31% undetermined aetiology. Over half (58%) of patients were HIV-1 seropositive. The median duration of symptoms before presentation was 6 days. Patients on acyclovir were more likely to have a healed ulcer on day 7 (63% vs 57%, RR = 1.08, 95% CI 0.98–1.18), shorter time to healing (p = 0.04) and less lesional HIV-1 RNA (p = 0.03). Small ulcers (<50 mm2), HSV-2 ulcers, first episode HSV-2 ulcers, and ulcers in HIV-1 seropositive individuals responded best but the better effectiveness in South Africa was not explained by differences in these factors.
Conclusions/Significance
There may be slight benefit in adding acyclovir to syndromic management in settings where most ulcers are genital herpes. The stronger effect among HIV-1 infected individuals suggests that acyclovir may be beneficial for GUD/HIV-1 co-infected patients. The high prevalence in this population highlights that genital ulceration in patients with unknown HIV status provides a potential entry point for provider-initiated HIV testing.
doi:10.1371/journal.pone.0022601
PMCID: PMC3143155  PMID: 21799914
22.  Population Attributable Fractions for Late Postnatal Mother-to-Child Transmission of HIV-1 in Sub-Saharan Africa 
Objectives
Assess population attributable fractions (PAFs) for late postnatal transmission (LPT) of human immunodeficiency virus-1 (HIV-1) in a cohort of HIV-1-exposed infants.
Methods
We used data established from a risk factor analysis of LPT (negative HIV-1 results through the 4-6 week visit, but positive assays thereafter through the 12-month visit) from a perinatal clinical trial conducted in three sub-Saharan countries. PAFs were calculated as the proportions of excess LPTs attributed to identified risk factors.
Results
For the cohort of 1317 infants, 206 (15.6%) had only low maternal CD4+ counts (< 200 cells/mm3), 332 (25.2%) had only high maternal plasma viral loads (VLs) (> 50 000 copies/mL), and 81 (6.2%) had both low CD4+ counts and high VLs. Their PAFs were 26.0% [95% confidence interval (CI), 12.0%-36.0%], 37.0% (95% CI, 22.0%-51.0%) and 16.0% (95% CI, 6.0%-25.0%), respectively.
Conclusions
Our PAF analysis illustrates the public health impact of the substantial proportion of LPTs accounted for by high-risk women with both low CD4+ counts and high VLs. In light of these results, access to and use of antiretroviral therapy (ART) by high-risk HIV-1-infected pregnant women is essential. Additional strategies to reduce LPT for those not meeting criteria for ART should be implemented.
doi:10.1097/QAI.0b013e3181d61c2e
PMCID: PMC3086731  PMID: 20224418
Breast feeding; late postnatal transmission; prevention of mother to child transmission/vertical transmission; risk factors; viral load
23.  Unprotected sex in heterosexual partnerships of injecting drug users in St Petersburg, Russia 
AIDS and behavior  2011;15(1):58-64.
We examined the association of individual demographic and behavioral attributes, partnership (dyad) and social network characteristics with unprotected sex in the heterosexual dyads of IDUs in St Petersburg, Russia. Of the individual-level characteristics female gender and younger age; and of the dyad-level characteristics sharing injecting equipment, social exposure to the sex partner (“hanging out with” or seeing each other daily), and both partners self-reporting being HIV infected were associated with unprotected sex. Although self-reported HIV discordant couples were less likely to engage in unprotected sex, it was reported in over half of self-reported HIV discordant relationships. This study highlights the intertwining of sexual risk and injecting risk, and the importance of sero-sorting based on perceived HIV status among IDU sexual partnerships in St Petersburg, Russia. A combination of social network and dyad interventions may be appropriate for this population of IDUs, especially for IDUs who are both injecting and sex partners, supported by free and confidential rapid HIV testing and counseling services to provide a comprehensive response to the wide-spread HIV epidemic among IDUs in St Petersburg.
doi:10.1007/s10461-010-9721-0
PMCID: PMC3048022  PMID: 20532604
Injecting drug users; Risk networks; Sexual risk; HIV infection risk; Dyad analysis; Russia
24.  Injecting Equipment Sharing in Russian Drug Injecting Dyads 
AIDS and behavior  2009;14(1):141-151.
In this study, we investigated how individual attributes, dyad characteristics and social network characteristics may influence engaging in receptive syringe sharing, distributive syringe sharing and sharing cookers in injecting partnerships of IDUs in St Petersburg, Russia. We found that all three levels were associated with injecting equipment sharing, and that dyad characteristics were modified by characteristics of the social network. Self-reported HIV discordance and male gender concordance played a role in the risk of equipment sharing. Dyad interventions may not be sufficient to reduce injecting risk in IDU partnerships, but a combination of dyad and network interventions that target both IDU partnerships and the entire IDU population may be more appropriate to address injecting risk among IDUs.
doi:10.1007/s10461-008-9518-6
PMCID: PMC2818991  PMID: 19214731
Injecting drug users; Risk networks; Injecting risk; Dyad analysis; Russia
25.  Correlates of unsafe injecting among injecting drug users in St Petersburg, Russia 
European addiction research  2009;15(3):163-170.
Aims
To assess among injecting drug users (IDUs) in St Petersburg, Russia, the urban environmental, social norms, and individual correlates of unsafe injecting.
Methods
Between December 2004 and January 2007 IDUs (N=446) were interviewed in St. Petersburg, Russia.
Results
Prevalence of HCV was 96% and HIV 44%; 17% reported receptive syringe sharing after an HIV infected IDU (RSS); 49% distributive syringe sharing (DSS); 76% sharing cookers, 73% sharing filters and 71% syringe mediated drug sharing (SMS) when not all syringes were new. Urban environmental characteristics correlated with sharing cookers and SMS; and social norms correlated with RSS, DSS and sharing cookers. Individual correlates included cleaning used syringes (all five dependent variables) and self-report of HIV infection (RSS and DSS).
Conclusion
HIV status disclosure is an unreliable but frequently used HIV prevention method among IDUs in St. Petersburg, who reported alarmingly high levels of injecting equipment sharing. Voluntary counseling and testing should be widely available for this population. Ethnography is needed to assess the effectiveness of the syringe cleaning process. Prevention interventions need to be ongoing among IDUs in St. Petersburg, and should incorporate urban environmental factors and social norms, which may involve peer education and social network interventions.
doi:10.1159/000220344
PMCID: PMC2794890  PMID: 19506377
Russia; Injecting drug users; Injecting equipment sharing; HIV infection; Hepatitis infections

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