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Sponsors and Collaborators: |
University of California, San Francisco Bill and Melinda Gates Foundation Ibis Reproductive Health Medical Research Council, South Africa Women's Health Global Imperative UZ-UCSF Research Collaborative Programme in Women's Health Perinatal HIV Research Unit of the University of the Witswatersrand |
Information provided by: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT00121459 |
The purpose of this trial is to determine whether using the diaphragm and a lubricant get can reduce women's risk of acquiring an HIV infection.
Condition | Intervention | Phase |
HIV Infection |
Device: Ortho All-Flex diaphragm and Replens lubricant gel |
Phase III |
MedlinePlus related topics: | AIDS |
Drug Information available for: | Calcium polycarbophil Psyllium |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix |
Estimated Enrollment: | 5000 |
Study Start Date: | September 2003 |
This multi-site randomized, controlled trial will measure the effectiveness of the diaphragm in preventing heterosexual acquisition of HIV infection among women. This Phase III 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 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 non-diaphragm and gel counterparts. Additionally, we will investigate the long-term acceptability of the diaphragm in this study population.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
South Africa, Gauteng | |||||
Perinatal HIV Research Unit | |||||
Soweto, Gauteng, South Africa | |||||
South Africa, KwaZulu Natal | |||||
Medical Research Council of South Africa | |||||
Durban, KwaZulu Natal, South Africa | |||||
Zimbabwe | |||||
UZ-UCSF | |||||
Harare, Zimbabwe |
University of California, San Francisco |
Bill and Melinda Gates Foundation |
Ibis Reproductive Health |
Medical Research Council, South Africa |
Women's Health Global Imperative |
UZ-UCSF Research Collaborative Programme in Women's Health |
Perinatal HIV Research Unit of the University of the Witswatersrand |
Principal Investigator: | Nancy Padian, PhD | University of California, San Francisco |
Ibis Reproductive Health web site 
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Cervical Barrier Advancement Society web site 
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Women's Global Health Imperative 
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University of Zimbabwe, UCSF 
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Medical Research Council 
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Perinatal HIV Research Unit of South Africa 
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Study ID Numbers: | H6070-22217-03, 21082 |
First Received: | July 12, 2005 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00121459 |
Health Authority: | United States: Institutional Review Board; South Africa: Medicines Control Council |
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