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

NCT00000928 | Completed Phase 1

• 1 other identifier: HIVNET 013
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections

Keywords

Sexual Partners; Condoms; Counseling

Outcome Measures

Primary Outcomes (2)

• Assess acceptability and participation

  Throughout study

• Assess the potential for the intervention to result in increased condom use among stable sexual partners

  Throughout study

Secondary Outcomes (3)

• Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate

  Throughout study

• Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing

  Throughout study

• Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership

  Throughout study

Study Arms (1)

A

EXPERIMENTAL

All study participants

Behavioral: Group counseling intervention

Interventions

Group counseling intervention BEHAVIORAL

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

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Volunteers with the following are excluded:
• History of domestic violence.
• Current consistent condom use.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• David D. Celentano

  STUDY CHAIR

• Janet McGrath

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: July 1, 1999
• Study Completion: July 1, 1999
• Last Updated: November 7, 2016

Record last verified: 2012-10