Clinical Trials

MainTitle

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

This study has been completed
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)


Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier
NCT00000928

First received: November 2, 1999
Last updated: November 4, 2016
Last Verified: October 2012
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HIV Infections

Behavioral : Group counseling intervention
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures

  • Assess acceptability and participation [ Time Frame: Throughout study ]
  • Assess the potential for the intervention to result in increased condom use among stable sexual partners [ Time Frame: Throughout study ]
Secondary Outcome Measures:
  • Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate [ Time Frame: Throughout study ]
  • Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing [ Time Frame: Throughout study ]
  • Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership [ Time Frame: Throughout study ]

Enrollment: 90
Study Completion Date: July 1999
Primary Completion Date: July 1999 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: A
All study participants
Behavioral: Group counseling intervention

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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000928

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Study Chair: David D. Celentano
Study Chair: Janet McGrath
More Information

More Information


Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)  
ClinicalTrials.gov Identifier: NCT00000928   History of Changes  
Other Study ID Numbers: HIVNET 013  
Study First Received: November 2, 1999  
Last Updated: November 4, 2016  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Sexual Partners
Condoms
Counseling

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.