An international multi-centre, randomised, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 0.5% and 2% PRO 2000/5 gels for the prevention of vaginally acquired HIV infectionProject Focus
HIV/AIDS; STIs, HIV Prevention, Female Controlled Methods
Soweto and Orange Farm , Johannesburg
Duration of Project
2005 – 2009
British Medical Research Council Clinical Trials Unit, Microbicide Development Programme (MDP), Indevus Pharmaceuticals Inc
DfID via MDP
Dr Sibongile Walaza
Project Aims /Objectives
To determine the efficacy and safety of 0.5% and 2% PRO 2000/5 Gel (P) compared to placebo in preventing vaginally acquired HIV infection.
In addition to the clinical objectives of the trial, there is a significant social science research programme providing contextual information and insight into community and trial participant experiences and perceptions.
The objectives of the social science MDP programme are to provide insight into:
- The validity of reported sexual behaviours (partnerships, condom and gel use, types of sex act, frequency of sex, vaginal cleansing and product use).
- The experience and perceptions of women participating in the microbicide studies, with particular attention on their comprehension of the study and informed consent.
- The role of the community advisory group in increasing awareness and contributing towards our understanding of the community response to the trial.
9673 women will be recruited worldwide, 3000 by RHRU. This will enable 7875 woman years to be accumulated by 12 months, 6166 woman years by 9 months, the time of the primary endpoint.
This will provide 82% power to demonstrate a 40% reduction in an HIV incidence of 4 per 100 woman years at the 5% level and 89% power to demonstrate a 40% reduction in an HIV incidence of 5 per 100 woman years. This assumes that 15% woman years of observation are lost by 9 months because of women dropping out of the trial.
Participants that are eligible and have provided informed consent will receive pre-filled vaginal applicators containing an inert gel (the placebo gel), 0.5% or 2% PRO 2000/5 Gel (P). Participants will be asked to insert one dose of gel intra-vaginally within 1 hour before each act of vaginal sexual intercourse during the follow-up period.
Additional areas of social science activities include:
- Mapping the research context using a ‘cognitive mapping’ methodology that reports on the folk or community view of their community, and how the geographical and social boundaries are defined;
- The role of men and their participation in microbicide research. Although microbicides are designed specifically for women and may be used clandestinely, our research recognises the importance of male partner’s participation in the setting of a clinical trial.
- Understanding of anal sex and vaginal cleansing practices
- The social science team provides technical assistance to the awareness and recruitment process.
Establish that PRO 2000/5 is effective and safe in preventing HIV transmission compared to placebo gel; and secondarily establish that it can prevent HSV2, gonorrhea and chlamydia. In addition the social science outcome will establish if the microbicide is acceptable in this population.
- Contribution to protocol development
- Co-Chair of Project Management Board Executive Committee
- Arjun J, Walaza S, Moyes J et al. An assessment of participant acceptability of a placebo gel; and its implications for use of a vaginal PRO 2000/5 gel. SAAIDS, Durban 2005.
- Walaza S, Moyes J, Arjun J, et al. Does participant disclosure of microbicide gel use to partner affect gel use? A pilot study in preparation for a randomized placebo controlled trial of a vaginal microbicide. SAAIDS, Durban 2005.
- Moyes J, Delany S, Rees H. Testing for HIV: Field performance of two rapid tests in a South African population. SAAIDS, Durban 2005
To complete enrollment of study participants and complete social science elements.
Continue to work with project partners to research viable combination Pro 2000 and other candidate microbicides to increase efficacy.
Projects in the STI's & HIV Research Cluster:
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