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OpenTrials
Completed

NCT Number: NCT00000928

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group counseling intervention

Behavioral

Participants will engage in a multi-session group-based condom promotion program for approximately 12 months

Primary outcomes

  1. Assess acceptability and participation

    Time frame: Throughout study

  2. Assess the potential for the intervention to result in increased condom use among stable sexual partners

    Time frame: Throughout study

Secondary outcomes

  1. Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate

    Time frame: Throughout study

  2. Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing

    Time frame: Throughout study

  3. Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership

    Time frame: Throughout study

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Registry information

Important dates

Primary completion
1999
Study completion
1999
First posted
Aug 31, 2001
Registry last updated
Nov 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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