Effectiveness of the Diaphragm for HIV Prevention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Latex Diaphragm to Prevent HIV Acquisition Among Women: A Female-Controlled, Physical Barrier of the Cervix

Conditions
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HIV Infection

Intervention / Treatment
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* Device: Ortho All-Flex diaphragm and Replens lubricant gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 49 years old Sexually active (coital frequency at least four times per month on average) HIV negative based on testing within two weeks prior to enrollment Chlamydia trachomatis and Neisseria gonorrhoeae negative based on testing within 30 days prior to enrollment or if positive, completes treatment before enrollment Have a healthy cervix, as assessed by naked-eye speculum exam at enrollment Planning to live in the study area for the next 24 months Willing to be randomly assigned either to use or not use a latex diaphragm with lubricant gel during participation in the study, and to follow the protocol, including being tested for HIV and STIs Willing and able to give informed consent Exclusion Criteria: Known sensitivity or allergy to latex History of TSS (as suggested by current labeling for diaphragm use) Currently pregnant, or desiring to become pregnant in the next two years No cervix (total hysterectomy) Refuses treatment for diagnosed or suspected current STI and/or reproductive tract infection requiring treatment at enrollment Within six weeks of any pelvic surgery or last pregnancy outcome at the time of screening and enrollment Presence of clinically apparent lesion(s) with epithelial disruption at enrollment (may enroll after lesion(s) has healed, if otherwise eligible) Injected illicit drugs in the 12 months prior to screening and enrollment Blood transfusion or received blood products in 3 months prior to screening and enrollment Unable or unwilling to insert the diaphragm correctly Participation in any other clinical trial (including those of a vaginal product or barrier contraceptive). Verification by comparing participant lists to other concurrently running research studies may be conducted if necessary. Unable to speak English, Zulu, Shona, or Sotho Other conditions that, in the opinion of the investigator, would constitute contraindications to participation in the study or would compromise ability to comply with the study protocol, such as a major psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ortho All-Flex diaphragm and Replens lubricant gel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV incidence |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| STI incidence (CT, NG, syphilis, trichomoniasis, HSV2) |  |  | 
| acceptability |  |  | 
| feasibility and sustainability |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diaphragm, HIV prevention, Southern/South Africa, Zimbabwe, female-controlled methods, Replens, STI prevention, HIV Seronegativity