Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
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, an...
Gender
ALL
Eligibility 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.
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
David D. Celentano
Study Chair
Janet McGrath
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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