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Diaphragm Acceptability


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Methods for Improving Reproductive Health in Africa

Overview

Location
Zimbabwe and South Africa

Funders
• Bill and Melinda Gates Foundation

Principal Investigator
Nancy Padian, PhD

This multi-site randomized, controlled trial will measure the effectiveness of the diaphragm in preventing heterosexual acquisition of HIV infection among women.  The study is powered to detect effectiveness (biological efficacy combined with adherence) of 33 percent.  Women in South Africa and Zimbabwe (N=4,500) at risk of contracting HIV will be invited to participate and will be followed for up to 24 months, with a total study duration of 4 years.  All women will receive safer-sex counseling, free male condoms and diagnosis and treatment of sexually transmitted infections (STIs).  Half of the participants will be randomly selected to receive, in addition, an Ortho All-Flex® latex diaphragm and Replens® lubricant gel.  We will assess whether women using diaphragms and lubricant gel have lower rates of HIV or STI infection than do their counterparts.  Additionally, we will investigate the long-term acceptability of the diaphragm in this study population.

Primary Objective

To determine the effectiveness of the diaphragm with lubricant gel (Replens®) in preventing heterosexual transmission of HIV among at-risk women

Secondary Objectives

1.  To determine the effectiveness of the diaphragm with lubricant gel in preventing cervical infections with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) among women at risk for sexually transmitted infections  

2.  To assess the long-term acceptability of diaphragms with lubricant gel for use as an HIV prevention method

3.  To examine the effect of using the diaphragm and lubricant gel on Trichomonas vaginalis (TV) and herpes simplex virus type 2 (HSV-2) infection and to evaluate Treponema pallidum, TV, and HSV-2 as potential effect modifiers of a diaphragm-HIV relationship

4.  To examine the feasibility of the diaphragm and lubricant gel as a sustainable HIV prevention strategy, including logistical factors such as: access to product in a timely fashion, hygiene and diaphragm washing and reuse, problems associated with use, ability to use the diaphragm covertly when so desired, as well as other issues related to user feasibility.

Partners

The study is financed by a grant from the Bill and Melinda Gates Foundation.  Dr. Nancy Padian of UCSF is the trial’s principal investigator, and the collaborating institutions and co-investigators are Ibis Reproductive Health (Dr. Charlotte Ellertson), the University of Zimbabwe (Dr. Tsungai Chipato), the Medical Research Council of South Africa (Dr. Gita Ramjee), and the Perinatal HIV Research Unit of South Africa (Dr. Natalya Dinat).

 

 

 
Information: kciabattari@psg.ucsf.edu  Web site problems/comments: kciabattari@psg.ucsf.edu.
Copyright © 2001, Women's Global Health Imperative, a project of the
AIDS Research Institute at the University of California, San Francisco.
Web site by
Progressive Health Partners.
 
 
Information: kciabattari@psg.ucsf.edu  Web site problems/comments: kciabattari@psg.ucsf.edu.
Copyright © 2001, Women's Global Health Imperative, a project of the
AIDS Research Institute at the University of California, San Francisco.
Web site by
Progressive Health Partners.