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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 : February 28, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles

Brief Summary:
The purpose of this study is to test the efficacy of randomizing all young men in a neighborhood to receive: 1) soccer training; 2) soccer and vocational training; or 3) a control condition, as a means to engage young men in HIV prevention. The investigators hypothesize that the intervention will reduce young men's substance use and increase HIV testing.

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arm Intervention/treatment
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 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.
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 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.
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.



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • not employed
  • 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:

  • if the interviewer reports that the young man demonstrates delusional talk or cannot comprehend the voluntary informed consent forms

Information from the National Library of Medicine

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


Contacts
Contact: Mary Jane Rotheram, PhD (310) 794-8278 mrotheram@mednet.ucla.edu
Contact: Mark Tomlinson, PhD +27 (21) 808-3446 markt@sun.ac.za

Locations
South Africa
Stellenbosch University Recruiting
Stellenbosch, South Africa
Contact: Mark Tomlinson, PhD    +27-21-8083461      
Principal Investigator: Mark Tomlinson, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mary Jane Rotheram, PhD Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

Publications:
UNAIDS, WHO, & UNICEF. (2011). Global HIV/AIDS response: epidemic update and health sector progress towards universal access (progress report 2011). Geneva, Switzerland: UNAIDS, WHO, & UNICEF.
Statistics South Africa. (2013). Quarterly Labour Force Survey: Quarter 2, 2013. Cape Town, South Africa: Statistics South Africa.
Epstein, H. (2007). The invisible cure: Africa, the West, and the fight against AIDS. New York, NY: Farrar, Straus, and Giroux.
Bhana, D., & Pattman, R. (2009). Researching South African youth, gender and sexuality within the context of HIV/AIDS. Development, 52(1), 68-74.
Reddy, S. P., Panday, S., Swart, D., Jinabhai, C. C., Amosun, S. L., James, S., Monyeki, K. D., Stevens, G., Morejele, N., Kambaran, N. S., Omardien, R. G., & Van den Borne, H.W. (2003). Umthenthe Uhlaba Usamila - The South African Youth Risk Behaviour Survey 2002. Cape Town, South Africa: South African Medical Research Council.
South African Department of Health, Medical Research Council. (2007). South Africa Demographic and Health Survey 2003. Pretoria, South Africa: Department of Health.
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.
MRC Crime, Violence and Injury Lead Programme. (2003). A Profile of Fatal Injuries in South Africa. Fourth Annual Report of the National Injury Mortality Surveillance System. Pretoria: MRC.
UNAIDS. (2010). UNAIDS 2010 Report on the Global AIDS Epidemic. Retrieved from: http://www.unaids.org/globalreport/Global_report.htm

Responsible Party: Mary Jane Rotheram-Borus, Director, Global Center for Children and Families, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02358226     History of Changes
Other Study ID Numbers: R01DA038675 ( U.S. NIH Grant/Contract )
1R01DA038675-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by Mary Jane Rotheram-Borus, University of California, Los Angeles:
Substance-Related Disorders
Human Immunodeficiency Virus
Alcoholism
South Africa
Men
Soccer
Vocational Training

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Alcoholism
Substance-Related Disorders
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders