Overview

This trial has been completed.

Condition hiv infections
Treatment group counseling intervention
Phase phase 1
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
End date July 1999
Trial size 90 participants
Trial identifier NCT00000928, HIVNET 013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
All study participants
group counseling intervention
Participants will engage in a multi-session group-based condom promotion program for approximately 12 months

Primary Outcomes

Measure
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

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

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).