In collaboration with the Tanzania National Institute for Medical Research (NIMR) and London School of Hygiene and Tropical Medicine (LSHTM)

A study to determine the feasibility of conducting a microbicide trial of daily vaginal gel and to inform the way adherence should be assessed (Top-Up study)

Principal Investigators: Saidi Kapiga, Richard Hayes

Project Coordinators: Joseph Masanja, Sheila Harvey, Grace Mtolela

Funding: DFID and MRC to the Microbicides Development Programme (MDP), a consortium of UK and African institutions

Staff meeting potential participants.

Study participants at the end of the study.

Summary: It is widely recognized that there is an urgent need to develop and introduce new methods to diminish HIV transmission across the world, and in particular among women in developing countries. The Microbicide Development Program (MDP) is a partnership set up to develop vaginal microbicide for prevention of HIV transmission among women. The goal of the Top-Up study is to determine the feasibility of conducting a microbicide trial of once-daily use of a vaginal gel and assess different methods for monitoring adherence in order to inform the design of a future trial. This is a multicentre open-label study, in which participants are randomized to one of the three methods for monitoring adherence to daily gel use. The study is being carried out in six MDP trial sites (Durban in South Africa, Mwanza in Tanzania, Masaka in Uganda and Mazabuka in Zambia, and Manhica and Maputo in Mozambique).

A minimum of 45 participants per site will be recruited to the study (approximately 15 per site per randomized group), will receive pre-filled vaginal applicators containing a placebo vaginal gel, Hydroxyethyl cellulose (HEC), and will be asked to insert one dose of gel intravaginally each day for 12 weeks. All participants will be provided with safe sex education, condoms and VCT for HIV will be offered to all. The primary outcome will be adherence to daily use of gel. Secondary outcomes include consistency of adherence measure, retention of participants at week 12 and reasons for non-adherence.