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Increasing Condom Use in People at Risk for HIV Infection

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individual feedback and specially-tailored manuals
General HIV information feedback and the best-available information
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 Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention

Eligibility Criteria

18 Years - 44 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria HIV uninfected Sexually active At risk for HIV (as determined by study officials) Speaks English Seen at a participating clinic Exclusion Criteria Pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4

    Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

    Outcomes

    Primary Outcome Measures

    Frequency of condom use
    Number of occurances of unprotected sex
    Stage of change for condom use with main and nonmain partners, and men and women

    Secondary Outcome Measures

    Frequency of condom use with main and nonmain partners, and men and women
    Number and ratios of protected sex occasions with main and nonmain partners, and men and women
    Stage of change for condom use with main and nonmain partners, and men and women

    Full Information

    First Posted
    March 23, 2004
    Last Updated
    September 25, 2008
    Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00080093
    Brief Title
    Increasing Condom Use in People at Risk for HIV Infection
    Official Title
    Increasing Condom Use With a Stage-Matched Intervention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    October 2007 (Actual)
    Study Completion Date
    December 2008 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    Brief Summary
    This study will evaluate a new program designed to increase condom use in both women and men.
    Detailed Description
    As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk. Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual. Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Condom, HIV Seronegativity, HIV Prevention, Behavioral Intervention

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    534 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4
    Intervention Type
    Behavioral
    Intervention Name(s)
    Individual feedback and specially-tailored manuals
    Intervention Description
    Individual feedback and specially-tailored manuals
    Intervention Type
    Behavioral
    Intervention Name(s)
    General HIV information feedback and the best-available information
    Intervention Description
    General HIV information feedback and the best-available information
    Primary Outcome Measure Information:
    Title
    Frequency of condom use
    Time Frame
    At 30 days and 2 months before each assessment
    Title
    Number of occurances of unprotected sex
    Time Frame
    At 30 days before each assessment
    Title
    Stage of change for condom use with main and nonmain partners, and men and women
    Time Frame
    Throughout study
    Secondary Outcome Measure Information:
    Title
    Frequency of condom use with main and nonmain partners, and men and women
    Time Frame
    Throughout Study
    Title
    Number and ratios of protected sex occasions with main and nonmain partners, and men and women
    Time Frame
    Throughout study
    Title
    Stage of change for condom use with main and nonmain partners, and men and women
    Time Frame
    Throughout Study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    44 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria HIV uninfected Sexually active At risk for HIV (as determined by study officials) Speaks English Seen at a participating clinic Exclusion Criteria Pregnant
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Patricia Morokoff, PhD
    Organizational Affiliation
    University of Rhode Island
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    Citation
    Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.
    Results Reference
    result
    Citation
    Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.
    Results Reference
    result

    Learn more about this trial

    Increasing Condom Use in People at Risk for HIV Infection

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