Study Results
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Basic Information
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COMPLETED
PHASE3
1211 participants
INTERVENTIONAL
2016-05-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
Soccer League/Vocational Training (SL-V)
The SL-V arm will include both the SL intervention as well as access to Vocational Training through either Silulo Ulutho Technologies, which offers computer courses, or Zenzele Training and Development programs, which provides training in woodwork and wielding. Both programs are located in Khayelitsha, which is close to participants' homes, thus avoiding transport-related barriers. Additionally, the training programs occur in a mentor-mentee context so that participants can develop the interpersonal skills required for employment.
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 Silulo or Zenzele programs based in Khayelitsha for a period of 6 months. These programs offer practical and market-related training in computer skills, woodwork, or welding. The SL-V intervention arm will last for one year; with six months dedicated to soccer and six months dedicated to vocational training.
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.
No interventions assigned to this group
Interventions
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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.
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 Silulo or Zenzele programs based in Khayelitsha for a period of 6 months. These programs offer practical and market-related training in computer skills, woodwork, or welding. The SL-V intervention arm will last for one year; with six months dedicated to soccer and six months dedicated to vocational training.
Eligibility Criteria
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Inclusion Criteria
* sleeps at least 4 nights per week in the two months prior to recruitment in a household in the target neighborhood boundaries
* speaks Xhosa or English
* provides voluntary informed consent and understands the consent process
* does not appear to be actively hallucinating or incapable of understanding the interviewer
Exclusion Criteria
18 Years
29 Years
MALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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Mary Jane Rotheram-Borus
Director, Global Center for Children and Families
Principal Investigators
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Mary Jane Rotheram, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
Locations
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Stellenbosch University
Stellenbosch, , South Africa
Countries
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References
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Parry, C. D. H., & Bennetts, A. L. (1998). Alcohol policy and public health in South Africa. Cape Town: Oxford University Press.
Simbayi, L. C., Kalichman, S. C., Cain, D., Cherry, C., Henda, N., & Cloete, A. (2006). Methamphetamine use and sexual risks for HIV infection in Cape Town, South Africa. Journal of Substance Use, 11(4), 291-300.
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Harwood JM, Weiss RE, Comulada WS. Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes. Prev Sci. 2017 Jul;18(5):526-533. doi: 10.1007/s11121-017-0788-y.
Rotheram-Borus MJ, Tomlinson M, Stewart J, Skiti Z, Rabie S, Wang J, Almirol E, Vogel L, Christodoulou J, Weiss RE. Soccer and Vocational Training are Ineffective Delivery Strategies to Prevent HIV and Substance Abuse by Young, South African Men: A Cluster Randomized Controlled Trial. AIDS Behav. 2024 Dec;28(12):3929-3943. doi: 10.1007/s10461-024-04458-0. Epub 2024 Sep 11.
Rabie S, Tomlinson M, Almirol E, Stewart J, Skiti Z, Weiss RE, Vogel L, Rotheram-Borus MJ. Utilizing Soccer for Delivery of HIV and Substance Use Prevention for Young South African Men: 6-Month Outcomes of a Cluster Randomized Controlled Trial. AIDS Behav. 2023 Mar;27(3):842-854. doi: 10.1007/s10461-022-03819-x. Epub 2022 Nov 15.
Rabie S, Bantjes J, Gordon S, Almirol E, Stewart J, Tomlinson M, Rotheram-Borus MJ. Who can we reach and who can we keep? Predictors of intervention engagement and adherence in a cluster randomized controlled trial in South Africa. BMC Public Health. 2020 Feb 27;20(1):275. doi: 10.1186/s12889-020-8357-x.
Christodoulou J, Stokes LR, Bantjes J, Tomlinson M, Stewart J, Rabie S, Gordon S, Mayekiso A, Rotheram-Borus MJ. Community context and individual factors associated with arrests among young men in a South African township. PLoS One. 2019 Jan 17;14(1):e0209073. doi: 10.1371/journal.pone.0209073. eCollection 2019.
Rotheram-Borus MJ, Tomlinson M, Mayekiso A, Bantjes J, Harris DM, Stewart J, Weiss RE. Gender-specific HIV and substance abuse prevention strategies for South African men: study protocol for a randomized controlled trial. Trials. 2018 Aug 3;19(1):417. doi: 10.1186/s13063-018-2804-3.
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