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Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia

Primary Purpose

Alcohol Consumption, Alcohol Abuse, HIV

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alcohol-HIV Risk Reduction Counseling
Placebo Intervention
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Consumption focused on measuring Namibia, Alcohol, HIV, Sexual risk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Self reported HIV negative status after testing at the Council of Churches Namibia (CCN) NewStart VCT center
  • More than 1 sexual partner in the past 6 months
  • AUDIT screen score 8 to 19
  • Able to provide informed consent
  • Access to a cell phone to retrieve private text messages and calls
  • Plans to stay in the local area for 6 months
  • Able to verbally communicate in English, Oshiwambo, or Afrikaans

Exclusion Criteria:

  • Self reported HIV positive status after testing at the CCN NewStart VCT center
  • Less than 1 sexual partner in the past 6 months
  • AUDIT screen score less than 8 or greater than 20
  • Unable to provide informed consent to participate to enroll in the study
  • Unable to retrieve private cell phone text messages and calls
  • Unable to verbally communicate in English, Oshiwambo, or Afrikaans

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    The intervention consists of a 1-hour individual counseling session relating to alcohol consumption and HIV sexual risk behaviors. Intervention counselors will assess alcohol-related sexual risk behaviors through the use of job aids that include a flip chart, guided scripts, activities, role plays, and a take home booklet. Counselors use motivational interviewing and interactive activities to discuss alcohol and HIV myths and facts, participants personal risk behaviors, and a decision-making activity that assists participants in weighing the pros and cons of engaging in risky behavior. Counselors also facilitate role plays to improve communication skills in risky situations, as well as a condom demonstration and skills session, and goal setting. In addition, men in the intervention arm will also receive two cell phone text messages 1-month and 4-months following enrollment to reiterate risk reduction messages.

    Participants assigned to the control arm will be given a general alcohol information booklet and an alcohol abuse support services brochure. The alcohol information booklet contains information about responsible drinking, signs and symptoms of alcohol abuse, advice and guidance to reduce alcohol intake, and resources for assistance. The alcohol support services brochure contains times, dates, and locations of peer support and counseling services in the Windhoek region.

    Outcomes

    Primary Outcome Measures

    Change in frequency of sex after drinking (measured by count data and proportions)
    Sex acts preceded by alcohol use, for up to 4 recent sex partners, measured by count data and proportions

    Secondary Outcome Measures

    Change in frequency of condom use (measured by count data and proportions)
    Sex acts protected by condoms, for up to 4 recent sex partners, measured by count data and proportions
    Change in number of sex partners
    Number of sex partners in preceding 6 months
    Change in frequency of alcohol use (measured by AUDIT and CAGE screens)
    Quantity and frequency of alcohol use, measured by AUDIT and CAGE screens
    Change in condom skills (measured by a condom use demonstration score, modified 9-item male condom use score (MCUS)
    Changes in condom skills, as measured by a condom use demonstration score

    Full Information

    First Posted
    January 28, 2015
    Last Updated
    February 6, 2015
    Sponsor
    Centers for Disease Control and Prevention
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02359487
    Brief Title
    Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
    Official Title
    Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centers for Disease Control and Prevention

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The overall purpose of this study is to evaluate an intervention that aims to reduce alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives of the study are to determine the effectiveness of an individual counseling intervention in reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and hazardous alcohol use among men.
    Detailed Description
    This study involves a randomized controlled trial of 550 HIV-negative adult men recruited from a single Voluntary Counseling and Testing (VCT) center for HIV in Windhoek, Namibia who report harmful or hazardous alcohol consumption and more than one sex partner in the previous three months. After receiving standard counseling at the VCT center, all men who test HIV-negative will be invited to be screened for eligibility for the study, and if eligible, to consent to enroll. Personnel hired for the study will then administer a baseline survey via Personal Digital Assistant to all enrolled men. Enrolled participants will then be randomized to either an intervention arm, and receive an additional one-hour counseling session and take-home materials plus general alcohol information materials or to a control arm, and receive general alcohol information materials alone. All men enrolled in the study will receive the general alcohol information materials, consisting of a booklet with alcohol health information and a brochure detailing alcohol abuse support services in the local community. Men in the intervention arm will also receive two cellphone text messages one month and four months following enrollment to boost the risk reduction counseling. Follow-up surveys of all participants will be conducted three months and six months after enrollment Outcomes measured include self-reported data at baseline, three months and six months post-enrollment regarding: 1) Number, proportion of sex acts preceded by alcohol use; 2) Number, proportion of sex acts protected by condoms; 3) Number of sex partners; and 4) Quantity and frequency of alcohol use; 5) Condom use demonstration scores.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alcohol Consumption, Alcohol Abuse, HIV, Sexual Behavior
    Keywords
    Namibia, Alcohol, HIV, Sexual risk

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The intervention consists of a 1-hour individual counseling session relating to alcohol consumption and HIV sexual risk behaviors. Intervention counselors will assess alcohol-related sexual risk behaviors through the use of job aids that include a flip chart, guided scripts, activities, role plays, and a take home booklet. Counselors use motivational interviewing and interactive activities to discuss alcohol and HIV myths and facts, participants personal risk behaviors, and a decision-making activity that assists participants in weighing the pros and cons of engaging in risky behavior. Counselors also facilitate role plays to improve communication skills in risky situations, as well as a condom demonstration and skills session, and goal setting. In addition, men in the intervention arm will also receive two cell phone text messages 1-month and 4-months following enrollment to reiterate risk reduction messages.
    Arm Title
    Control
    Arm Type
    Placebo Comparator
    Arm Description
    Participants assigned to the control arm will be given a general alcohol information booklet and an alcohol abuse support services brochure. The alcohol information booklet contains information about responsible drinking, signs and symptoms of alcohol abuse, advice and guidance to reduce alcohol intake, and resources for assistance. The alcohol support services brochure contains times, dates, and locations of peer support and counseling services in the Windhoek region.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Alcohol-HIV Risk Reduction Counseling
    Intervention Description
    The intervention consists of a 1-hour individual counseling session relating to alcohol consumption and HIV sexual risk behaviors. Intervention counselors will assess alcohol-related sexual risk behaviors through the use of job aids that include a flip chart, guided scripts, activities, role plays, and a take home booklet. Counselors use motivational interviewing and interactive activities to discuss alcohol and HIV myths and facts, participants personal risk behaviors, and a decision-making activity that assists participants in weighing the pros and cons of engaging in risky behavior. Counselors also facilitate role plays to improve communication skills in risky situations, as well as a condom demonstration and skills session, and goal setting. In addition, men in the intervention arm will also receive two cell phone text messages 1-month and 4-months following enrollment to reiterate risk reduction messages.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Placebo Intervention
    Intervention Description
    Participants assigned to the control arm will be given a general alcohol information booklet and an alcohol abuse support services brochure. The alcohol information booklet contains information about responsible drinking, signs and symptoms of alcohol abuse, advice and guidance to reduce alcohol intake, and resources for assistance. The alcohol support services brochure contains times, dates, and locations of peer support and counseling services in the Windhoek region.
    Primary Outcome Measure Information:
    Title
    Change in frequency of sex after drinking (measured by count data and proportions)
    Description
    Sex acts preceded by alcohol use, for up to 4 recent sex partners, measured by count data and proportions
    Time Frame
    3 months, 6 months after intervention
    Secondary Outcome Measure Information:
    Title
    Change in frequency of condom use (measured by count data and proportions)
    Description
    Sex acts protected by condoms, for up to 4 recent sex partners, measured by count data and proportions
    Time Frame
    3 months, 6 months after intervention
    Title
    Change in number of sex partners
    Description
    Number of sex partners in preceding 6 months
    Time Frame
    3 months, 6 months after intervention
    Title
    Change in frequency of alcohol use (measured by AUDIT and CAGE screens)
    Description
    Quantity and frequency of alcohol use, measured by AUDIT and CAGE screens
    Time Frame
    3 months, 6 months after intervention
    Title
    Change in condom skills (measured by a condom use demonstration score, modified 9-item male condom use score (MCUS)
    Description
    Changes in condom skills, as measured by a condom use demonstration score
    Time Frame
    3 months, 6 months after intervention

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Self reported HIV negative status after testing at the Council of Churches Namibia (CCN) NewStart VCT center More than 1 sexual partner in the past 6 months AUDIT screen score 8 to 19 Able to provide informed consent Access to a cell phone to retrieve private text messages and calls Plans to stay in the local area for 6 months Able to verbally communicate in English, Oshiwambo, or Afrikaans Exclusion Criteria: Self reported HIV positive status after testing at the CCN NewStart VCT center Less than 1 sexual partner in the past 6 months AUDIT screen score less than 8 or greater than 20 Unable to provide informed consent to participate to enroll in the study Unable to retrieve private cell phone text messages and calls Unable to verbally communicate in English, Oshiwambo, or Afrikaans
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Naomi Bock, MD
    Organizational Affiliation
    Centers for Disease Control and Prevention
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia

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