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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Behavioral: Group counseling intervention

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000928

HIVNET 013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

90 participants in 1 patient group

A

Experimental group

Description:

All study participants

Treatment:

Behavioral: Group counseling intervention