Alcohol ConsumptionNCT02359487
Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
A study testing Alcohol-HIV Risk Reduction Counseling in people with Alcohol Consumption and Alcohol Abuse, run by Centers for Disease Control and Prevention.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Consumption, Alcohol Abuse, HIV
- What is being tested?
- Alcohol-HIV Risk Reduction Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 550 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Alcohol Consumption, Alcohol Abuse, HIV, Sexual Behavior
- Being tested
- Alcohol-HIV Risk Reduction Counseling, Placebo Intervention
- Keywords
- Namibia, Alcohol, HIV, Sexual risk
- Medical subject headings
- Alcohol Drinking, Alcoholism, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol-HIV Risk Reduction CounselingBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Alcohol-HIV Risk Reduction Counseling |
| Control | Placebo comparator | 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. Receives: Behavioral: Placebo Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months, 6 months after intervention
Secondary outcomes (4)
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
Measured: 3 months, 6 months after intervention
Change in number of sex partners
Number of sex partners in preceding 6 months
Measured: 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
Measured: 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
Measured: 3 months, 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startFeb 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Naomi Bock, MD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359487
- Sponsor's protocol ID
- 6031
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia
- ClinicalTrials.gov ID
- NCT02359487
- Acronym / sponsor ID
- 6031
- Conditions
- Alcohol Consumption, Alcohol Abuse, HIV, Sexual Behavior
- Keywords
- Namibia, Alcohol, HIV, Sexual risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Feb 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Alcohol-HIV Risk Reduction CounselingThe 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. |
| Control | Placebo comparator | Behavioral: Placebo InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol-HIV Risk Reduction CounselingThe 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. | Behavioural | Intervention |
| Placebo InterventionParticipants 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. | Behavioural | Control |
Primary outcome
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
4 secondary outcomes
Change in frequency of condom use (measured by count data and proportions)
Time frame: 3 months, 6 months after intervention
Change in number of sex partners
Time frame: 3 months, 6 months after intervention
Change in frequency of alcohol use (measured by AUDIT and CAGE screens)
Time frame: 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)
Time frame: 3 months, 6 months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Bock, MD principal investigator
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol-HIV Risk Reduction Counseling in people with Alcohol Consumption and Alcohol Abuse, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of sex after drinking (measured by count data and proportions) (time frame: 3 months, 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.