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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Group counseling intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Sexual Partners, Condoms, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    A

    Arm Description

    All study participants

    Outcomes

    Primary Outcome Measures

    Assess acceptability and participation
    Assess the potential for the intervention to result in increased condom use among stable sexual partners

    Secondary Outcome Measures

    Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate
    Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing
    Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership

    Full Information

    First Posted
    November 2, 1999
    Last Updated
    November 4, 2016
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000928
    Brief Title
    Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
    Official Title
    Phase I Trial of an Intervention to Increase Condom Use by HIV-Discordant Couples
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    July 1999 (Actual)
    Study Completion Date
    July 1999 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Sexual Partners, Condoms, Counseling

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    All study participants
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group counseling intervention
    Intervention Description
    Participants will engage in a multi-session group-based condom promotion program for approximately 12 months
    Primary Outcome Measure Information:
    Title
    Assess acceptability and participation
    Time Frame
    Throughout study
    Title
    Assess the potential for the intervention to result in increased condom use among stable sexual partners
    Time Frame
    Throughout study
    Secondary Outcome Measure Information:
    Title
    Assessment of willingness to disclose serostatus to a regular sexual partner and the willingness of that partner to participate
    Time Frame
    Throughout study
    Title
    Evaluation of adverse experiences (social, psychological, and physical harms) of individuals resulting from participation in counseling and testing
    Time Frame
    Throughout study
    Title
    Evaluation of attempts to initiate condom use within a stable HIV serodiscordant partnership
    Time Frame
    Throughout study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David D. Celentano
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Janet McGrath
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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