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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Behavioral: Group counseling intervention

• Registration Number: NCT00000928
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Primary Completion: 1999-07
• Study Completion: 1999-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2012-10
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Group counseling intervention	All study participants

Primary Outcome Measures

Name	Time	Method
Assess acceptability and participation	Throughout study
Assess the potential for the intervention to result in increased condom use among stable sexual partners	Throughout study

Secondary Outcome Measures

Name	Time	Method
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