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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000928
• Other study ID #: HIVNET 013
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: November 4, 2016
• Est. completion date: July 1999

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1999
• Est. primary completion date: July 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• Group counseling intervention
Participants will engage in a multi-session group-based condom promotion program for approximately 12 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess acceptability and participation		Throughout study	No
Primary	Assess the potential for the intervention to result in increased condom use among stable sexual partners		Throughout study	No
Secondary	Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate		Throughout study	No
Secondary	Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing		Throughout study	Yes
Secondary	Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership		Throughout study	No

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