Trial reportSexually transmitted infections2014
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.
Trial report in Sexually transmitted infections, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00074425 (Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II/IIb Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women
Who cites it
17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- Topical microbicides for preventing sexually transmitted infections.The Cochrane database of systematic reviews · 2021Pooled it
- Reported oral and anal sex among adolescents and adults reporting heterosexual sex in sub-Saharan Africa: a systematic review.Reproductive health · 2019Pooled it
- How common and frequent is heterosexual anal intercourse among South Africans? A systematic review and meta-analysis.Journal of the International AIDS Society · 2017Pooled it
- Women for science and science for women: Gaps, challenges and opportunities towards optimizing pre-exposure prophylaxis for HIV-1 prevention.Frontiers in immunology · 2022Review
- Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.Journal of the International AIDS Society · 2021Article
- Identification of bile acid and fatty acid species as candidate rapidly bactericidal agents for topical treatment of gonorrhoea.The Journal of antimicrobial chemotherapy · 2021Article
- Incidence and risk factors of C. trachomatis and N. gonorrhoeae among young women from the Western Cape, South Africa: The EVRI study.PloS one · 2021Article
- Designing & Conducting Trials To Reliably Evaluate HIV Prevention Interventions.Statistical communications in infectious diseases · 2019Article
- The Etiology of Vaginal Discharge Syndrome in Zimbabwe: Results from the Zimbabwe STI Etiology Study.Sexually transmitted diseases · 2018Article
- Article
- [Lactic acid inhibits the formation of semen-derived amyloid fibrils].Nan fang yi ke da xue xue bao = Journal of Southern Medical University · 2017Article
- New Biomedical Technologies and Strategies for Prevention of HIV and Other Sexually Transmitted Infections.Journal of sexually transmitted diseases · 2016Review
- HIV Infection and AIDS in Sub-Saharan Africa: Current Status, Challenges and Opportunities.The open AIDS journal · 2016Article
- Multipurpose prevention technologies: the future of HIV and STI protection.Trends in microbiology · 2015Review
- Cognitive testing of an instrument to evaluate acceptability and use of pre-exposure prophylaxis products among women.Applied cognitive psychologyArticle
- Trial designs for evaluating combination HIV prevention approaches.HIV research & clinical practiceArticle
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 10 institutions in 5 countries.
Funding
Abstract
objectivesTo 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).
methodsBetween 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.
resultsThe 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.
conclusionsThe 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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.