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

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.

Study Overview

• Status: Completed
• Conditions: HIV; Sexual Behavior; Alcohol Consumption; Alcohol Abuse
• Intervention / Treatment: Behavioral: Alcohol-HIV Risk Reduction Counseling; Behavioral: Placebo Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months, 6 months after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months, 6 months after intervention
Change in number of sex partners	Number of sex partners in preceding 6 months	3 months, 6 months after intervention
Change in frequency of alcohol use (measured by AUDIT and CAGE screens)	Quantity and frequency of alcohol use, measured by AUDIT and CAGE screens	3 months, 6 months after intervention
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	3 months, 6 months after intervention

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Naomi Bock, MD, Centers for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 28, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 10, 2015

Study Record Updates

• Last Update Posted (Estimate): February 10, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: HIV; Alcohol; Namibia; Sexual risk
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Alcohol Drinking; Alcoholism
• Other Study ID Numbers: 6031