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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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ClinicalTrials.gov Identifier: NCT02359487
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : February 10, 2015
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Alcohol Consumption Alcohol Abuse HIV Sexual Behavior Behavioral: Alcohol-HIV Risk Reduction Counseling Behavioral: Placebo Intervention Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
Study Start Date : February 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
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.
Behavioral: Alcohol-HIV Risk Reduction Counseling
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.

Placebo Comparator: Control
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.
Behavioral: Placebo Intervention
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 Measures :
  1. Change in frequency of sex after drinking (measured by count data and proportions) [ Time Frame: 3 months, 6 months after intervention ]
    Sex acts preceded by alcohol use, for up to 4 recent sex partners, measured by count data and proportions


Secondary Outcome Measures :
  1. Change in frequency of condom use (measured by count data and proportions) [ Time Frame: 3 months, 6 months after intervention ]
    Sex acts protected by condoms, for up to 4 recent sex partners, measured by count data and proportions

  2. Change in number of sex partners [ Time Frame: 3 months, 6 months after intervention ]
    Number of sex partners in preceding 6 months

  3. Change in frequency of alcohol use (measured by AUDIT and CAGE screens) [ Time Frame: 3 months, 6 months after intervention ]
    Quantity and frequency of alcohol use, measured by AUDIT and CAGE screens

  4. Change in condom skills (measured by a condom use demonstration score, modified 9-item male condom use score (MCUS) [ Time Frame: 3 months, 6 months after intervention ]
    Changes in condom skills, as measured by a condom use demonstration score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02359487


Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Naomi Bock, MD Centers for Disease Control and Prevention

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Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02359487     History of Changes
Other Study ID Numbers: 6031
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Centers for Disease Control and Prevention:
Namibia
Alcohol
HIV
Sexual risk

Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs