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Substance-Related DisordersPhase 3NCT02358226

HIV & Drug Abuse Prevention for South African Men

A Phase 3 study testing Soccer League (SL) and Soccer League/Vocational Training (SL-V) in people with Substance-Related Disorders and Human Immunodeficiency Virus, run by University of California, Los Angeles at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 29 years, men only
What is being tested?
Soccer League (SL) and Soccer League/Vocational Training (SL-V)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,211 participants
Where
1 siteSouth Africa
Study dates
May 2016to Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 29 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Stellenbosch University

    Stellenbosch

Other trials in South Africa

About this study

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.

Read the 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.

Being tested
Soccer League (SL), Soccer League/Vocational Training (SL-V)
Keywords
Substance-Related Disorders, Human Immunodeficiency Virus, Alcoholism, South Africa, Men, Soccer, Vocational Training
Medical subject headings
Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Alcoholism, Multiple Endocrine Neoplasia Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Soccer League (SL)Behavioural

    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)Behavioural

    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.

Study groups in NCT02358226
Study groupRoleWhat they receive
Soccer League (SL)ExperimentalIn 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.
Receives: Behavioral: Soccer League (SL)
Soccer League/Vocational Training (SL-V)ExperimentalThe 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.
Receives: Behavioral: Soccer League/Vocational Training (SL-V)
Control Condition (CC)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline to 18 months

Secondary outcomes (2)

  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.

    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).

    Measured: Baseline to 18 months

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

    Assessed via repeated self-reports over 18 months

    Measured: Baseline to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2015 (estimated)
  2. Study startMay 2016
  3. Primary completionJan 2020
  4. Study completionJan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02358226
Sponsor's protocol ID
R01DA038675
Other IDs
1R01DA038675-01A1
Status last verified
Feb 2020
First submitted
24 Nov 2014
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No

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.

  • Barnighausen T, Tanser F, Newell ML. Lack of a decline in HIV incidence in a rural community with high HIV prevalence in South Africa, 2003-2007. AIDS Res Hum Retroviruses. 2009 Apr;25(4):405-9. doi: 10.1089/aid.2008.0211.

    PubMed 19320571

  • Statistics South Africa. (2013). Quarterly Labour Force Survey: Quarter 2, 2013. Cape Town, South Africa: Statistics South Africa.

  • Aral SO, Peterman TA. Measuring outcomes of behavioural interventions for STD/HIV prevention. Int J STD AIDS. 1996;7 Suppl 2:30-8. doi: 10.1258/0956462961917753. No abstract available.

    PubMed 8799792

  • 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.

  • 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.

    PubMed 19709728

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

    PubMed 15784051

  • 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.

    PubMed 22273585

  • 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.

    PubMed 16054281

  • 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.

    PubMed 15288752

  • 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.

    PubMed 18264762

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Soccer League (SL) and Soccer League/Vocational Training (SL-V) in people with Substance-Related Disorders and Human Immunodeficiency Virus, run by University of California, Los Angeles at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02358226, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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