HIV & Drug Abuse Prevention for South African Men

NCT02358226 | Completed Phase 3

• 2 other identifiers: R01DA0386751R01DA038675-01A1
• Study Type: interventional
• Target: 1,211
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders; Human Immunodeficiency Virus; Alcoholism

Keywords

Substance-Related Disorders; Human Immunodeficiency Virus; Alcoholism; South Africa; Men; Soccer; Vocational Training

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017)

  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 18 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 18 months only).

  Baseline to 18 months

Secondary Outcomes (2)

• 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.

  Baseline to 18 months

• Among HIV+, uptake and adherence to ARV medications and medical regimens

  Baseline to 18 months

Study Arms (3)

Soccer League (SL)

EXPERIMENTAL

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)

Soccer League/Vocational Training (SL-V)

EXPERIMENTAL

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)

Control Condition (CC)

NO INTERVENTION

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.

Interventions

Soccer League (SL) BEHAVIORAL

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 (SL)

Soccer League/Vocational Training (SL-V) BEHAVIORAL

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.

Soccer League/Vocational Training (SL-V)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Stellenbosch University

Stellenbosch, South Africa

Location

Related Publications (29)

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  BACKGROUND

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• Epstein, H. (2007). The invisible cure: Africa, the West, and the fight against AIDS. New York, NY: Farrar, Straus, and Giroux.

  BACKGROUND

• Bhana, D., & Pattman, R. (2009). Researching South African youth, gender and sexuality within the context of HIV/AIDS. Development, 52(1), 68-74.

  BACKGROUND

• 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.

  BACKGROUND

• South African Department of Health, Medical Research Council. (2007). South Africa Demographic and Health Survey 2003. Pretoria, South Africa: Department of Health.

  BACKGROUND

• Coovadia H, Jewkes R, Barron P, Sanders D, McIntyre D. The health and health system of South Africa: historical roots of current public health challenges. Lancet. 2009 Sep 5;374(9692):817-34. doi: 10.1016/S0140-6736(09)60951-X. Epub 2009 Aug 24.

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• Parry CD. South Africa: alcohol today. Addiction. 2005 Apr;100(4):426-9. doi: 10.1111/j.1360-0443.2005.01015.x.

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• Scott-Sheldon LA, Carey MP, Carey KB, Cain D, Harel O, Mehlomakulu V, Mwaba K, Simbayi LC, Kalichman SC. Patterns of alcohol use and sexual behaviors among current drinkers in Cape Town, South Africa. Addict Behav. 2012 Apr;37(4):492-7. doi: 10.1016/j.addbeh.2012.01.002. Epub 2012 Jan 11.

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• Morojele NK, Kachieng'a MA, Mokoko E, Nkoko MA, Parry CD, Nkowane AM, Moshia KM, Saxena S. Alcohol use and sexual behaviour among risky drinkers and bar and shebeen patrons in Gauteng province, South Africa. Soc Sci Med. 2006 Jan;62(1):217-27. doi: 10.1016/j.socscimed.2005.05.031. Epub 2005 Jul 27.

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• Parry CD, Myers B, Morojele NK, Flisher AJ, Bhana A, Donson H, Pluddemann A. Trends in adolescent alcohol and other drug use: findings from three sentinel sites in South Africa (1997-2001). J Adolesc. 2004 Aug;27(4):429-40. doi: 10.1016/j.adolescence.2003.11.013.

  PMID: 15288752 BACKGROUND

• Kalichman SC, Simbayi LC, Vermaak R, Jooste S, Cain D. HIV/AIDS risks among men and women who drink at informal alcohol serving establishments (Shebeens) in Cape Town, South Africa. Prev Sci. 2008 Mar;9(1):55-62. doi: 10.1007/s11121-008-0085-x. Epub 2008 Feb 9.

  PMID: 18264762 BACKGROUND

• Parry, C. D. H., & Bennetts, A. L. (1998). Alcohol policy and public health in South Africa. Cape Town: Oxford University Press.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Jewkes R. Intimate partner violence: causes and prevention. Lancet. 2002 Apr 20;359(9315):1423-9. doi: 10.1016/S0140-6736(02)08357-5.

  PMID: 11978358 BACKGROUND

• Jewkes RK, Dunkle K, Nduna M, Shai N. Intimate partner violence, relationship power inequity, and incidence of HIV infection in young women in South Africa: a cohort study. Lancet. 2010 Jul 3;376(9734):41-8. doi: 10.1016/S0140-6736(10)60548-X.

  PMID: 20557928 BACKGROUND

• Michielsen K, Chersich MF, Luchters S, De Koker P, Van Rossem R, Temmerman M. Effectiveness of HIV prevention for youth in sub-Saharan Africa: systematic review and meta-analysis of randomized and nonrandomized trials. AIDS. 2010 May 15;24(8):1193-202. doi: 10.1097/QAD.0b013e3283384791.

  PMID: 20375876 BACKGROUND

• UNAIDS. (2010). UNAIDS 2010 Report on the Global AIDS Epidemic. Retrieved from: http://www.unaids.org/globalreport/Global_report.htm

  BACKGROUND

• Gupta GR, Parkhurst JO, Ogden JA, Aggleton P, Mahal A. Structural approaches to HIV prevention. Lancet. 2008 Aug 30;372(9640):764-75. doi: 10.1016/S0140-6736(08)60887-9. Epub 2008 Aug 5.

  PMID: 18687460 BACKGROUND

• Dean HD, Fenton KA. Addressing social determinants of health in the prevention and control of HIV/AIDS, viral hepatitis, sexually transmitted infections, and tuberculosis. Public Health Rep. 2010 Jul-Aug;125 Suppl 4(Suppl 4):1-5. doi: 10.1177/00333549101250S401. No abstract available.

  PMID: 20629250 BACKGROUND

• 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.

  PMID: 28434056 BACKGROUND

• 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.

  PMID: 39259241 DERIVED

• 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.

  PMID: 36380117 DERIVED

• 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.

  PMID: 32106835 DERIVED

• 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.

  PMID: 30653530 DERIVED

• 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.

  PMID: 30075740 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders; Acquired Immunodeficiency Syndrome; Alcoholism; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Mary Jane Rotheram, PhD

  Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Global Center for Children and Families

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: February 6, 2015
• Study Start: May 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

ZA (1)