HIV & Drug Abuse Prevention for South African Men

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 3

Conditions: Alcoholism; Human Immunodeficiency Virus; Substance-Related Disorders

Treatments: Behavioral: Soccer League/Vocational Training (SL-V); Behavioral: Soccer League (SL)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02358226

R01DA038675

1R01DA038675-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,211 patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,211 participants in 3 patient groups

Soccer League (SL)

Experimental group

Description:

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.

Treatment:

Behavioral: Soccer League (SL)

Soccer League/Vocational Training (SL-V)

Experimental group

Description:

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.

Treatment:

Behavioral: Soccer League/Vocational Training (SL-V)

Control Condition (CC)

No Intervention group

Description:

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.