Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

National Institute of Allergy and Infectious Diseases (NIAID)0 sites90 target enrollmentAugust 31, 2001

Overview

Brief Summary

To assess the acceptability of and participation in a group counseling intervention, including an assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate. To evaluate the profile of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing and attempts to initiate condom use within a stable HIV serodiscordant partnership. To assess the potential for the intervention to result in increased condom use among stable sexual partners.

There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown.

Detailed Description

There is a significant risk of HIV transmission to HIV-uninfected partners in HIV-discordant couples. While condom use has been a major component of most AIDS prevention programs since the mid-1980s, there has been little emphasis on promoting condom use within stable partnerships. The most effective way to promote condom use among discordant couples remains largely unknown. A pilot study to assess the acceptability of intervention precedes the main study. The Phase I study recruits 15 HIV-infected men and 15 HIV-infected women and their partners at each of three sites (India, Thailand, and Uganda). Volunteers participate in a multi-session group-based condom promotion program for approximately 12 months. Couples are organized into small groups consisting of 4 to 6 couples per group. Each group meets for a total of 4 sessions within a 2- to 4-week period. Follow-up interviews are conducted at Months 1 and 3 following completion of the intervention.

Registry

clinicaltrials.gov

Start Date

August 31, 2001

End Date

July 1999

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Assess acceptability and participation

Time Frame: Throughout study

Assess the potential for the intervention to result in increased condom use among stable sexual partners

Time Frame: Throughout study

Secondary Outcomes

Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate(Throughout study)
Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing(Throughout study)
Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership(Throughout study)