Clinical trial NCT02359487: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Alcohol Abuse
HIV
Sexual Behavior
Keywords: Namibia
Alcohol
HIV
Sexual risk
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2015-02-10
Enrollment: 550
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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.

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

Primary outcomes:
measure: Change in frequency of sex after drinking (measured by count data and proportions)
timeFrame: 3 months, 6 months after intervention
Secondary outcomes:
measure: Change in frequency of condom use (measured by count data and proportions)
timeFrame: 3 months, 6 months after intervention
measure: Change in number of sex partners
timeFrame: 3 months, 6 months after intervention
measure: Change in frequency of alcohol use (measured by AUDIT and CAGE screens)
timeFrame: 3 months, 6 months after intervention
measure: Change in condom skills (measured by a condom use demonstration score, modified 9-item male condom use score (MCUS)
timeFrame: 3 months, 6 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Naomi Bock, MD
role: PRINCIPAL_INVESTIGATOR
References: