Project Focus HIV/AIDS; STIs, HIV Prevention, female controlled methods
Project Location Yeoville, Johannesburg
Duration of Project 2006 - 2008
Project Partners International Partnership for Microbicides (IPM)
Project Donors IPM
Contact Dr Claire Von Mollendorf
Project Aims /Objectives While safety and efficacy are critical factors in the development of vaginal microbicides, in order for these products to have an impact on HIV transmission rates, they must also employ delivery methods that are acceptable to potential users.
The favorable response from postmenopausal women to a vaginal ring drug delivery method is promising. However, additional information is needed on the acceptability of the vaginal ring as a drug delivery method among pre-menopausal women, and also among women in geographical regions other than the U.S.
The primary objective of the IPM011 study is to assess the safety and acceptability of a silicone elastomer vaginal ring intended as a microbicide delivery method for the prevention of HIV infection when inserted in place for a 12 week period in healthy sexually active women.
The study will be an open-label cross-over study conducted at a number of sites, with 200 healthy sexually active women.
Project Activities The project is currently in the start up phase with site readiness activities being undertaken. The protocol has been finalized and submitted for ethical review at the University of the Witwatersrand Human Research Ethics Committee. Budgeting and resourcing are near completion.
Anticipated/Actual Results Established safety and acceptability of a silicone elastomer vaginal ring as a microbicide delivery method
Additional Outputs Contribution to protocol development
Future Plans
To enroll and follow up study participants between February 2007 – January 2008 and to conduct focus group discussions to provide additional information to be used in the interpretation of the study’s quantitative behavioural acceptability tool