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A Safety & Acceptability Study of a Vaginal Ring Microbicide Delivery Method for the Prevention of HIV Infection in Women (IPM011)

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

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

Projects in the STI's & HIV Research Cluster:

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