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Diaphragm Acceptability


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Diaphragm and Microbicide Safety Study

Overview

Location
Zimbabwe

Funders
Contractive Research and
Development (CONRAD)

Principal Investigator
Nancy Padian, PhD

In sub-Saharan Africa, female controlled methods against Human Immunodeficiency Virus (HIV) and Sexually Transmitted Infections (STIs) are desperately needed as many women are unable to negotiate male condom use. If proven effective against HIV/STIs, diaphragms may provide a viable women-controlled alternative to condoms. As a first step towards an effectiveness trial, we are implementing a phase I, two armed randomized trial, to determine the safety of using the diaphragm with a microbicide among reproductive age women in Harare, Zimbabwe. To date no formal safety studies of the diaphragm have been conducted which include colposcopic and microbiological evaluations. We will examine safety issues associated with prolonged use (by following women over a six month period) as well as extended use (by asking women to leave the device for 24 hours before the midpoint visit).

Primary Objectives

  1. Signs and symptoms of vaginal and cervical irritation at 6 months among diaphragm+microbicide vs. microbicide users

  2. Changes in vaginal flora and cervical inflammation at six months of use of the product(s)

  3. Presence of colposcopic findings after 24 hours of inserting/using the product(s)

Secondary Objectives

  1. To assess acceptability of and compliance with use of diaphragm and/or microbicide among participants.

 
Information: kciabattari@psg.ucsf.edu  Web site problems/comments: kciabattari@psg.ucsf.edu.
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