Browsing by Author "Ramjee G"

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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)
HPTN 035 phase II/IIb randomised safety and effectiveness study of the vaginal microbicides BufferGel and 0.5% PRO 2000 for the prevention of sexually transmitted infections in women.
(2014-Aug) Guffey MB; Richardson B; Husnik M; Makanani B; Chilongozi D; Yu E; Ramjee G; Mgodi N; Gomez K; Hillier SL; Karim SA; Fred Hutchinson Cancer Research Center, Seattle, Washington, USA Department of Biostatistics, University of Washington, Seattle, Washington, USA.; University of North Carolina Project, Lilongwe, Malawi.; Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; Department of Obstetrics and Gynaecology, University of Malawi College of Medicine, Blantyre, Malawi.; Department of Psychiatry, University of Pennsylvania, Philadelphia, Pensylvania, USA.; University of KwaZulu-Natal, CAPRISA, Durban, KwaZulu-Natal, South Africa.; Department of Obstetrics and Gynaecology, University of Zimbabwe-University of California San Francisco Collaborative Research Programme, Belgravia, Harare, Zimbabwe.; FHI 360, Science Facilitation, Research Triangle Park, North Carolina, USA.; Department of Obstetrics, Gynecology and Reproductive Sciences, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.; HIV Prevention Research Unit, South African Medical Research Council, Durban, KwaZulu-Natal, South Africa.; Departments of Medicine and Pediatrics, University of Alabama at Birmingham, Birmingham, Alabama, USA Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
OBJECTIVES: To estimate the effectiveness of candidate microbicides BufferGel and 0.5% PRO 2000 Gel (P) (PRO 2000) for prevention of non-ulcerative sexually transmitted infections (STIs). METHODS: Between 2005 and 2007, 3099 women were enrolled in HIV Prevention Trials Network (HPTN) protocol 035, a phase II/IIb evaluation of the safety and effectiveness of BufferGel and PRO 2000 for prevention of STIs, including Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV). Incidences of STIs were determined by study arm, and HRs of BufferGel and PRO 2000 versus placebo gel or no gel control groups were computed using discrete time Andersen-Gill proportional hazards model. RESULTS: The overall incidence rates were 1.6/100 person-years at risk (PYAR) for NG, 3.9/100 PYAR for CT and 15.3/100 PYAR for TV. For BufferGel versus placebo gel, HRs were 0.99 (95% CI 0.49 to 2.00), 1.00 (95% CI 0.64 to 1.57) and 0.95 (95% CI 0.71 to 1.25) for prevention of NG, CT and TV, respectively. For PRO 2000, HRs were 1.66 (95% CI 0.90 to 3.06), 1.16 (95% CI 0.76 to 1.79) and 1.18 (95% CI 0.90 to 1.53) for prevention of NG, CT and TV, respectively. CONCLUSIONS: The incidence of STIs was high during HIV Prevention Trials Network 035 despite provision of free condoms and comprehensive risk-reduction counselling, highlighting the need for effective STI prevention programmes in this population. Unfortunately, candidate microbicides BufferGel and PRO2000 had no protective effect against gonorrhoea, chlamydia or trichomoniasis. TRIAL REGISTRATION NUMBER: NCT00074425.
Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study.
(2017-Apr) Kasaro MP; Husnik MJ; Chi BH; Reid C; Magure T; Makanani B; Tembo T; Ramjee G; Maslankowski L; Rabe L; Brad Guffey M; 4 Department of Obstetrics and Gynecology, College of Health Science, University of Zimbabwe, Harare, Zimbabwe.; 9 Magee-Women's Research Institute, Pittsburgh, PA, USA.; 3 Fred Hutchinson Cancer Research Center, Statistical Center for HIV/AIDS Research & Prevention, Seattle, WA, USA.; 1 University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; 8 University of Pennsylvania, Philadelphia, PA, USA.; 5 College of Medicine-John Hopkins University Research Project, Queen Elizabeth Central Hospital, Blantyre, Malawi.; 7 HIV Prevention Research Unit 1, South African Medical Research Council, Durban, South Africa.; 2 Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; 1 0Family Legacy, Lusaka, Zambia.; 6 UNC Project-Malawi, Kamuzu Central Hospital, Lilongwe, Malawi.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
The objective of this study was to describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis. A secondary data analysis of the HIV Prevention Trials Network 035 study was undertaken, focusing on HIV-negative, nonpregnant women who were at least 18 years old, in seven African sites and one US site. At enrollment and during follow-up quarterly visits, vaginal hygiene practices were determined by face-to-face administration of a behavioral assessment questionnaire. Vaginal hygiene practices were categorized as insertion into the vagina of (1) nothing, (2) water only, and (3) other substances with or without water. Each practice was quantified by frequency and type/combination of inserted substances. At quarterly visits, diagnosis of bacterial vaginosis was made using the Nugent score. Trends for vaginal hygiene practices and bacterial vaginosis were evaluated using generalized estimating equation models. A total of 3087 participants from the HIV Prevention Trials Network 035 study were eligible for this analysis. At enrollment, 1859 (60%) reported recent vaginal hygiene practices. By one year, this figure had decreased to 1019 (33%) with counseling. However, bacterial vaginosis prevalence remained consistent across the study observation period, with 36%-38% of women testing positive for the condition ( p for trend = 0.27). Overall, those who reported douching with water only (AOR = 1.03, 95%CI: 0.94-1.13) and those who reported inserting other substances (AOR= 0.98, 95%CI: 0.88-1.09) in the past quarter were not more likely to have bacterial vaginosis compared to those who reported no insertions. However, in South Africa, an increase in bacterial vaginosis was seen among those who reported inserting other substances (AOR: 1.48, 95%CI: 1.17, 1.88). In conclusion, targeted counseling against vaginal hygiene practices resulted in change in self-reported behavior but did not have an impact on bacterial vaginosis diagnosis in all but one site.
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.
Phase 1 Human Immunodeficiency Virus (HIV) Vaccine Trial to Evaluate the Safety and Immunogenicity of HIV Subtype C DNA and MF59-Adjuvanted Subtype C Envelope Protein.
(2021-Jan-23) Hosseinipour MC; Innes C; Naidoo S; Mann P; Hutter J; Ramjee G; Sebe M; Maganga L; Herce ME; deCamp AC; Marshall K; Dintwe O; Andersen-Nissen E; Tomaras GD; Mkhize N; Morris L; Jensen R; Miner MD; Pantaleo G; Ding S; Van Der Meeren O; Barnett SW; McElrath MJ; Corey L; Kublin JG; National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa.; NIMR-Mbeya Medical Research Center, Mbeya, Tanzania.; Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.; Aurum Institute, Klerksdorp, South Africa.; GSK Vaccines, Rixensart, Belgium.; Cape Town HVTN Immunology Laboratory, Cape Town, South Africa.; EuroVacc Foundation, Lausanne, Switzerland.; UNC Project-Malawi, Lilongwe, Malawi.; University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.; Aurum Institute, Tembisa, South Africa.; HIV Prevention Research Unit, South African Medical Research Council, Durban, South Africa.; GSK Vaccines, Cambridge, Massachusetts, USA.; Division of Immunology and Allergy, Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.; Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
BACKGROUND: The Pox-Protein Public-Private Partnership is performing a suite of trials to evaluate the bivalent subtype C envelope protein (TV1.C and 1086.C glycoprotein 120) vaccine in the context of different adjuvants and priming agents for human immunodeficiency virus (HIV) type 1 (HIV-1) prevention. METHODS: In the HIV Vaccine Trials Network 111 trial, we compared the safety and immunogenicity of DNA prime followed by DNA/protein boost with DNA/protein coadministration injected intramuscularly via either needle/syringe or a needle-free injection device (Biojector). One hundred thirty-two healthy, HIV-1-uninfected adults were enrolled from Zambia, South Africa, and Tanzania and were randomized to 1 of 6 arms: DNA prime, protein boost by needle/syringe; DNA and protein coadministration by needle/syringe; placebo by needle/syringe; DNA prime, protein boost with DNA given by Biojector; DNA and protein coadministration with DNA given by Biojector; and placebo by Biojector. RESULTS: All vaccinations were safe and well tolerated. DNA and protein coadministration was associated with increased HIV-1 V1/V2 antibody response rate, a known correlate of decreased HIV-1 infection risk. DNA administration by Biojector elicited significantly higher CD4+ T-cell response rates to HIV envelope protein than administration by needle/syringe in the prime/boost regimen (85.7% vs 55.6%; P = .02), but not in the coadministration regimen (43.3% vs 48.3%; P = .61). CONCLUSIONS: Both the prime/boost and coadministration regimens are safe and may be promising for advancement into efficacy trials depending on whether cellular or humoral responses are desired. CLINICAL TRIALS REGISTRATION: South African National Clinical Trials Registry (application 3947; Department of Health [DoH] no. DOH-27-0715-4917) and ClinicalTrials.gov (NCT02997969).