ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000928
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: Group counseling intervention Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Actual Primary Completion Date : July 1999
Actual Study Completion Date : July 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Assess acceptability and participation [ Time Frame: Throughout study ]
  2. Assess the potential for the intervention to result in increased condom use among stable sexual partners [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate [ Time Frame: Throughout study ]
  2. Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing [ Time Frame: Throughout study ]
  3. Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership [ Time Frame: Throughout study ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000928


Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: David D. Celentano
Study Chair: Janet McGrath

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000928     History of Changes
Other Study ID Numbers: HIVNET 013
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: October 2012

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Sexual Partners
Condoms
Counseling

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases