HIV & Drug Abuse Prevention for South African Men
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|ClinicalTrials.gov Identifier: NCT02358226|
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : January 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders Human Immunodeficiency Virus Alcoholism||Behavioral: Soccer League (SL) Behavioral: Soccer League/Vocational Training (SL-V)||Phase 3|
South Africa has the highest number of HIV-infected persons of any nation, including 2.4 million men, and from 2002-2011 young men have had a 3% incidence HIV rate that has remained stable. New infections occur later in men than in women, making men in their 20s a target for intervention. Decreasing sexual risk and concurrent partnerships is a key outcome in interventions to reduce HIV incidence. Most men (68%) report unprotected sex, typically with three partners in the last three months,and more than half of young men do not use condoms with casual partners.
In South Africa, the amount of alcohol consumed per adult is among the highest in the world. 'Heavy episodic drinking', which most strongly correlates with risky sexual behaviors and HIV infection, is reported by 60% of men. Alcohol, tik (methamphetamine) and marijuana are common among young men in South Africa. Among alcohol abusers, men are highly likely to be poly substance users. Among HIV seropositive young men, drug use is common. Drug and alcohol use is associated with risky sexual behaviors and an increase in the number of sexual partners.
In townships, alcohol is involved in or responsible for 60% of automobile accidents, 75% of homicides, 50% of non-natural deaths, 67% of domestic violence, 30% of hospital admissions, and costs South Africa about R9 billion annually. Violence also characterizes the lives of young men in the Xhosa townships. Intimate partner violence is frequent in alcohol-using partnerships and is correlated with increased HIV incidence. Substance use and unemployment often lead to violence in a township. Jobs, by contrast, provide income and create a strong and respected community role.
HIV prevention efforts for young people in Sub-Saharan Africa have largely been unsuccessful: novel, structural, community level programs that address the social determinants of HIV are needed. Unemployment and a culture of alcohol and violence are major social determinants of HIV among young men. Yet, men are often excluded from economic development programs. Young, South African men need new pathways for prosocial roles and behaviors and our interventions need to be attractive and consistent with men's styles. The social determinants of HIV (unemployment, alcohol, and violence) are critical to creating opportunities for prosocial roles for young men. One of the most common comments by both the men and their families in our previous pilot qualitative study on soccer and vocational training was men's lack of "things to do." Given these needs, the investigators focus on soccer and vocational training in this randomized controlled trial as opportunities for young men to acquire the habits of daily living that are most likely to result in jobs, health, and positive relationships.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||HIV & Drug Abuse Prevention for South African Men|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: Soccer League (SL)
In the SL arm, participants will be invited to participate in a Soccer League, led by coaches who meet the criteria of: 1) soccer skills, 2) being a role model, and 3) social competence. Coaches will undergo intensive training in ethics; role-playing the delivery of health messages; conducting brief interventions for alcohol; how to acquire information on HIV, TB, alcohol use and employment; linkages to local clinics, data collection; and Street Smart, an evidence-based intervention for high-risk youth. Coaches will provide pre- and post-game talks, incorporating the topics of alcohol and drugs; interacting positively with health care providers, partners and family members; HIV, diabetes; daily routines; healthy social networks; making and saving money; loyalty and national success.
Behavioral: Soccer League (SL)
Participants will be invited to attend soccer practice in the late afternoons, roughly 2-3 times per week. Competitive games will be held on Saturdays so that friends and family may attend. Using a mobile phone application, coaches will regularly record information on participants' arrival and departure times, sportsmanship, volunteering in the community, the results of saliva tests for drugs and alcohol. The SL intervention arm will last for one year.
Experimental: Soccer League/Vocational Training (SL-V)
The SL-V arm will include both the SL intervention as well as access to Vocational Training through the Learn to Earn program based in Khayelitsha. This program offers practical and market-related training in life skills, business skills and mentorship.
Behavioral: Soccer League/Vocational Training (SL-V)
In addition to the SL intervention, participants will gain access to vocational training. The Vocational Training will take place through the Learn to Earn program based in Khayelitsha for a period of 6 months. This program offers practical and market-related training in life skills, business skills and mentorship. The SL-V intervention arm will last for one year; with six months dedicated to soccer and six months dedicated to vocational training.
No Intervention: Control Condition (CC)
Participants in the CC arm will routinely receive flyers with picture stories regarding HIV prevention strategies and how to access these strategies: HIV testing, circumcision, HIV treatment, including ARV, condoms and sexually transmitted diseases.
- The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017) [ Time Frame: Baseline to 24 months ]The primary outcome is the number of 15 outcomes (listed shortly) in which the intervention groups are better at the end of the study at 24 months. The outcomes are documented by biomarkers or self-report and except where otherwise noted, are in reference to the last three months. The outcomes are - (1) no concurrent partnerships; (2) no sex without condoms; (3) employment (part/full-time); (4) income above 1200 ZAR/month; (5) no violent acts toward women; (6) no arrests by police; (7) engaged in a community activity; (8) CES-D score < 16 (i.e., caseness); (9) AUDIT score < 3 (i.e., problematic alcohol use); (10) no alcohol usage in last 24 hours; (11) HIV testing; (12) no marijuana (dagga) usage in the last 10 days; (13) no quaalude (mandrax) usage in the last 2-3 days; (14) no methamphetamine (tik) usage in the last 1-2 days; and, (15) PEth Alcohol Test (excessive alcohol use in prior 3 weeks, at 24 months only).
- If a significant number of the 15 outcomes have intervention groups better than control at the end of the study, we will analyze and report on each outcome separately. [ Time Frame: Baseline to 24 months ]The outcomes are documented by biomarkers or self-report and except where otherwise noted, are in reference to the last three months. The outcomes are - (1) no concurrent partnerships; (2) no sex without condoms; (3) employment (part/full-time); (4) income above 1200 ZAR/month; (5) no violent acts toward women; (6) no arrests by police; (7) engaged in a community activity; (8) CES-D score < 16 (i.e., caseness); (9) AUDIT score < 3 (i.e., problematic alcohol use); (10) no alcohol usage in last 24 hours; (11) HIV testing; (12) no marijuana (dagga) usage in the last 10 days; (13) no quaalude (mandrax) usage in the last 2-3 days; (14) no methamphetamine (tik) usage in the last 1-2 days; and, (15) PEth Alcohol Test (excessive alcohol use in prior 3 weeks, at 24 months only).
- Among HIV+, uptake and adherence to ARV medications and medical regimens [ Time Frame: Baseline to 24 months ]Assessed via repeated self-reports over 24 months
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): NCT02358226
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358226
|Contact: Mary Jane Rotheram, PhD||(310) firstname.lastname@example.org|
|Contact: Mark Tomlinson, PhD||+27 (21) email@example.com|
|Stellenbosch, South Africa|
|Contact: Mark Tomlinson, PhD +27-21-8083461|
|Principal Investigator: Mark Tomlinson, PhD|
|Principal Investigator:||Mary Jane Rotheram, PhD||Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA|