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Clinical Trials/NCT02358226
NCT02358226
Completed
Phase 3

HIV & Drug Abuse Prevention for South African Men

University of California, Los Angeles1 site in 1 country1,211 target enrollmentMay 2016

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
University of California, Los Angeles
Enrollment
1211
Locations
1
Primary Endpoint
The primary outcome is the number of outcomes out of 15 outcomes significantly favoring the intervention over the control (Harwood, Weiss & Comulada, 2017)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
January 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mary Jane Rotheram-Borus

Director, Global Center for Children and Families

University of California, Los Angeles

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

Outcomes

Primary Outcomes

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

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).

Secondary Outcomes

  • Among HIV+, uptake and adherence to ARV medications and medical regimens(Baseline to 18 months)
  • 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)

Study Sites (1)

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