Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 126 for:    "Viral Infectious Disease" | "Ethanol"

HIV & Drug Abuse Prevention for South African Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02358226
Recruitment Status : Active, not recruiting
First Posted : February 6, 2015
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mary Jane Rotheram-Borus, University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE February 6, 2015
Last Update Posted Date January 7, 2019
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Substance Abuse [ Time Frame: Baseline to 24 months ]
    Alcohol and drug use assessed repeatedly using point-of-contact, rapid diagnostic tests over 24 months; Hazardous alcohol use and dependence symptoms self-reported repeatedly over 24 months using the AUDIT-C (a three-item questionnaire)
  • Recent HIV testing [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports of HIV tests over 24 months
Change History Complete list of historical versions of study NCT02358226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2019)
  • 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. [ Time Frame: Baseline to 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).
  • Among HIV+, uptake and adherence to ARV medications and medical regimens [ Time Frame: Baseline to 18 months ]
    Assessed via repeated self-reports over 18 months
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Concurrent sexual partnerships [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
  • Employment [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports of employment over 24 months, validated by external documentation
  • Violence towards Women [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports of violence towards women over 24 months, validated by external documentation
  • Among HIV+, uptake and adherence to ARV medications and medical regimens [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 3, 2015)
  • Density and centrality of social networks [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
  • Community and personal norms regarding HIV stigma, alcohol use, healthy nutrition, and hopefulness for the future [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
  • Consistency of daily routines [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
  • Partner's behaviors, and involvement of female partners and father in the home life [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
  • Values, life goals, and goal for the next month [ Time Frame: Baseline to 24 months ]
    Assessed via repeated self-reports over 24 months
 
Descriptive Information
Brief Title  ICMJE HIV & Drug Abuse Prevention for South African Men
Official Title  ICMJE HIV & Drug Abuse Prevention for South African Men
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Substance-Related Disorders
  • Human Immunodeficiency Virus
  • Alcoholism
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Soccer League (SL)
    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.
    Intervention: Behavioral: Soccer League (SL)
  • Experimental: Soccer League/Vocational Training (SL-V)
    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.
    Intervention: Behavioral: Soccer League/Vocational Training (SL-V)
  • No Intervention: Control Condition (CC)
    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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2015)
1200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02358226
Other Study ID Numbers  ICMJE R01DA038675( U.S. NIH Grant/Contract )
1R01DA038675-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mary Jane Rotheram-Borus, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Mary Jane Rotheram, PhD Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA
PRS Account University of California, Los Angeles
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP