Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
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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-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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Behavioral: Group counseling intervention |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples |
- Assess acceptability and participation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Assess the potential for the intervention to result in increased condom use among stable sexual partners [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
- Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000928 History of Changes |
| Other Study ID Numbers: | HIVNET 013 |
| Study First Received: | November 2, 1999 |
| Last Updated: | October 29, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Sexual Partners Condoms Counseling |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013