Effectiveness of the Diaphragm for HIV Prevention

HIV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00121459
• Other study ID #: H6070-22217-03
• Secondary ID: 21082
• Status: Withdrawn
• Phase: Phase 3
• First received: July 12, 2005
• Last updated: March 3, 2015
• Start date: September 2003

Study information

• Verified date: March 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSouth Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infection

Intervention

Device:
• Ortho All-Flex diaphragm and Replens lubricant gel

Locations

Country	Name	City	State
South Africa	Medical Research Council of South Africa	Durban	KwaZulu Natal
South Africa	Perinatal HIV Research Unit	Soweto	Gauteng
Zimbabwe	UZ-UCSF	Harare

Sponsors (7)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Ibis Reproductive Health, Medical Research Council, South Africa, Perinatal HIV Research Unit of the University of the Witswatersrand, UZ-UCSF Collaborative Research Programme, Women's Health Global Imperative

Countries where clinical trial is conducted

South Africa,  Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV incidence
Secondary	STI incidence (CT, NG, syphilis, trichomoniasis, HSV2)
Secondary	acceptability
Secondary	feasibility and sustainability

External Links

•   Cervical Barrier Advancement Society web site
•   Ibis Reproductive Health web site
•   Medical Research Council
•   Perinatal HIV Research Unit of South Africa
•   University of Zimbabwe, UCSF
•   Women's Global Health Imperative