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

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

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 I

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

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 ] [ 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 ]

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 ] [ 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 ]

Estimated Enrollment:

90

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Additional Information:

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No publications provided

Responsible Party:	Rona Siskind, DAIDS
ClinicalTrials.gov Identifier:	NCT00000928 History of Changes
Other Study ID Numbers:	HIVNET 013
Study First Received:	November 2, 1999
Last Updated:	September 23, 2008
Health Authority:	United States: Federal Government

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

Sexual Partners
Condoms
Counseling

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012