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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Group counseling intervention

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: David D. Celentano; Study Chair: Janet McGrath

Study record dates

Study Major Dates

• Primary Completion (Actual): July 1, 1999
• Study Completion (Actual): July 1, 1999

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Counseling; Sexual Partners; Condoms
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: HIVNET 013