Counseling |
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Clinical Trial: Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
This study is no longer recruiting patients.
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Purpose
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-negative 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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| HIV Infections | Behavior: Group counseling intervention | Phase I |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Prevention
Expected Total Enrollment: 90
There is a significant risk of HIV transmission to HIV-negative 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-positive men and 15 HIV-positive 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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Accepts Healthy Volunteers
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.
Location Information
David D. Celentano, Study Chair
Janet McGrath, Study Chair
More Information
Record last reviewed: March 2004
Last Updated: October 13, 2004
Record first received: November 2, 1999
ClinicalTrials.gov Identifier: NCT00000928
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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