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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000928
First received: November 2, 1999
Last updated: October 29, 2012
Last verified: October 2012

November 2, 1999
October 29, 2012
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  • Assess acceptability and participation [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Assess the potential for the intervention to result in increased condom use among stable sexual partners [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00000928 on ClinicalTrials.gov Archive Site
  • Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
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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

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
Behavioral: Group counseling intervention
Participants will engage in a multi-session group-based condom promotion program for approximately 12 months
Experimental: A
All study participants
Intervention: Behavioral: Group counseling intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
Not Provided
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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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00000928
HIVNET 013
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: David D. Celentano
Study Chair: Janet McGrath
National Institute of Allergy and Infectious Diseases (NIAID)
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP