Completed
Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2016-11-07
90
Participants Needed
N/A
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Site Locations not provided
Location information for this trial is currently unavailable.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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