HIV & Drug Abuse Prevention for South African Men

Human Immunodeficiency Virus Clinical Trial

Official title:

HIV & Drug Abuse Prevention for South African Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358226
• Other study ID #: R01DA038675
• Secondary ID: 1R01DA038675-01A
• Status: Completed
• Phase: Phase 3
• Start date: May 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1211
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcoholism
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Substance-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
South Africa	Stellenbosch University	Stellenbosch

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

South Africa, 

References & Publications (24)

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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. Epub 2005 Jul 27. — View Citation

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Parry CD, Myers B, Morojele NK, Flisher AJ, Bhana A, Donson H, Plüddemann 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. — View Citation

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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.

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. — View Citation

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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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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	Among HIV+, uptake and adherence to ARV medications and medical regimens	Assessed via repeated self-reports over 18 months	Baseline to 18 months