Browsing by Author "Balkus JE"

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Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women.
(2014-Feb) Balkus JE; Richardson BA; Rabe LK; Taha TE; Mgodi N; Kasaro MP; Ramjee G; Hoffman IF; Abdool Karim SS; From the *Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington;Departments of †Global Health and ‡Biostatistics, University of Washington, Seattle, Washington; §Magee-Womens Research Institute, Pittsburgh, Pennsylvania; ∥Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland; ¶Department of Obstetrics and Gynecology College of Health Science, University of Zimbabwe, Harare, Zimbabwe;**Center for Infectious Disease Research in Zambia, Lusaka, Zambia; ††HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa; ‡‡Division of Infectious Diseases, University of North Carolina, Chapel Hill, North Carolina; §§Centre for the AIDS Program of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; and ∥∥Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
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. T. vaginalis was detected by saline microscopy. Bacterial vaginosis (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, 2920 participants from Malawi, South Africa, United States, Zambia, and Zimbabwe contributed 16,259 follow-up visits. Bacterial vaginosis was detected at 5680 (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 higher than 3 were at an increased risk for acquiring TV. If this relationship is causal, interventions that improve the vaginal microbiota could contribute to reductions in TV incidence.
Corrigendum to "oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial" [Contraception 2016; 93 (1): 25-31].
(2016-Jul) Balkus JE; Brown ER; Hillier SL; Coletti A; Ramjee G; Mgodi N; Makanani B; Reid C; Martinson F; Soto-Torres L; Abdool Karim SS; Chirenje ZM; College of Medicine, University of Malawi, Blantyre, Malawi.; National Institutes of Health, Bethesda, MD, USA.; FHI360, Durham, NC, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Women's Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi.; Centre for the AIDS Program of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; University of Zimbabwe - University of California San Francisco Research Program, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: jbalkus@fhcrc.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Long-term follow-up of HIV seroconverters in microbicide trials - rationale, study design, and challenges in MTN-015.
(2016-Sep) Riddler SA; Husnik M; Gorbach PM; Levy L; Parikh U; Livant E; Pather A; Makanani B; Muhlanga F; Kasaro M; Martinson F; Elharrar V; Balkus JE; h UZ-UCSF Collaborative Research Programme , University of Zimbabwe , Harare , Zimbabwe.; b MTN Statistical and Data Management Center , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.; j UNC Project - Tidziwe Centre , Kamuzu Central Hospital , Lilongwe , Malawi.; g College of Medicine-John Hopkins University Research Project , Queen Elizabeth Central Hospital , Blantyre , Malawi.; k Division of AIDS , National Institutes of Health , Bethesda , MD , USA.; f HIV Prevention Research Unit , South African Medical Research Council , Durban , South Africa.; e Microbicide Trials Network , Magee-Womens Research Institute , Pittsburgh , PA , USA.; d FHI360 , Durham, NC , USA.; i Centre for Infectious Disease Research in Zambia , Lusaka , Zambia.; a Division of Infectious Diseases , University of Pittsburgh , Pittsburgh , PA , USA.; c Department of Epidemiology , University of California , Los Angeles , CA , USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. METHODS: Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. RESULTS: MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. CONCLUSIONS: Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.
Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial.
(2016-Jan) Balkus JE; Brown ER; Hillier SL; Coletti A; Ramjee G; Mgodi N; Makanani B; Reid C; Martinson F; Soto-Torres L; Abdool Karim SS; Chirenje ZM; College of Medicine, University of Malawi, Blantyre, Malawi.; National Institutes of Health, Bethesda, MD, USA.; FHI360, Durham, NC, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences and the Magee-Women's Research Institute, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.; University of North Carolina Project, Kamuzu Central Hospital, Lilongwe, Malawi.; Centre for the AIDS Program of Research in South Africa, Doris Duke Medical Research Institute, Nelson R. Mandela School of Medicine, University of KwaZulu-Natal, Congella, South Africa; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.; University of Zimbabwe - University of California San Francisco Research Program, Harare, Zimbabwe.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; HIV Prevention Research Unit, South Africa Medical Research Council, Durban, South Africa.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. Electronic address: jbalkus@fhcrc.org.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
OBJECTIVE: To assess the effect of oral and injectable contraceptive use compared to nonhormonal contraceptive use on HIV acquisition among Southern African women enrolled in a microbicide trial. STUDY DESIGN: This is a prospective cohort study using data from women enrolled in HIV Prevention Trials Network protocol 035. At each quarterly visit, participants were interviewed about self-reported contraceptive use and sexual behaviors and underwent HIV testing. Cox proportional hazards regression was used to assess the effect of injectable and oral hormonal contraceptive use on HIV acquisition. RESULTS: The analysis included 2830 participants, of whom 106 became HIV infected (4.07 per 100 person-years). At baseline, 1546 (51%) participants reported using injectable contraceptives and 595 (21%) reported using oral contraceptives. HIV incidence among injectable, oral and nonhormonal contraceptive method users was 4.72, 2.68 and 3.83 per 100 person-years, respectively. Injectable contraceptive use was associated with a nonstatistically significant increased risk of HIV acquisition [adjusted hazard ratio (aHR)=1.17; 95% confidence interval (CI) 0.70, 1.96], while oral contraceptive use was associated with a nonstatistically significant decreased risk of HIV acquisition (aHR=0.76; 95% CI 0.37,1.55). CONCLUSION: In this secondary analysis of randomized trial data, a marginal, but nonstatistically significant, increase in HIV risk among women using injectable hormonal contraceptives was observed. No increased HIV risk was observed among women using oral contraceptives. Our findings support the World Health Organization's recommendation that women at high risk for acquiring HIV, including those using progestogen-only injectable contraception, should be strongly advised to always use condoms and other HIV prevention measures. IMPLICATIONS: Among Southern African women participating in an HIV prevention trial, women using injectable hormonal contraceptives had a modest increased risk of HIV acquisition; however, this association was not statistically significant. Continued research on the relationship between widely used hormonal contraceptive methods and HIV acquisition is essential.