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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Group counseling intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Volunteers must be: HIV-positive through HIVNET testing or HIV-seronegative by EIA. Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study. Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus. Willing to receive counseling and HIV testing (HIV-seronegative partners only). Willing to agree to be interviewed with their partner and individually. Willing to continue engaging in sex with their partner. Willing to participate in a couples-based condom promotion intervention. Willing and able to attend each scheduled intervention/follow-up study visit. Exclusion Criteria Volunteers with the following are excluded: History of domestic violence. Current consistent condom use.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>All study participants | Behavioral: Group counseling intervention<br>* Participants will engage in a multi-session group-based condom promotion program for approximately 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual Partners, Condoms, Counseling