Clinical trial NCT02358226: HIV & Drug Abuse Prevention for South African Men
Official title: HIV & Drug Abuse Prevention for South African Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance-Related Disorders
Human Immunodeficiency Virus
Alcoholism
Keywords: Substance-Related Disorders
Human Immunodeficiency Virus
Alcoholism
South Africa
Men
Soccer
Vocational Training
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2015-02-06
Enrollment: 1211
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017)
timeFrame: Baseline to 18 months
Secondary outcomes:
measure: 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.
timeFrame: Baseline to 18 months
measure: Among HIV+, uptake and adherence to ARV medications and medical regimens
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Stellenbosch
country: South Africa
facility: Stellenbosch University
Study officials:
affiliation: Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
name: Mary Jane Rotheram, PhD
role: PRINCIPAL_INVESTIGATOR
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