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Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000928
Enrollment
90
Registered
2001-08-31
Start date
Unknown
Completion date
1999-07-31
Last updated
2016-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Sexual Partners, Condoms, Counseling

Brief summary

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.

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.

Interventions

BEHAVIORALGroup counseling intervention

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

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Assess acceptability and participationThroughout study
Assess the potential for the intervention to result in increased condom use among stable sexual partnersThroughout study

Secondary

MeasureTime frame
Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participateThroughout study
Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testingThroughout study
Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnershipThroughout study

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026