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HIV Prevention Among Vulnerable Male Youth

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ClinicalTrials.gov Identifier: NCT01771237
Recruitment Status : Completed
First Posted : January 18, 2013
Last Update Posted : February 1, 2018
Howard Brown Health Center
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago

December 18, 2012
January 18, 2013
February 1, 2018
July 2007
January 2011   (Final data collection date for primary outcome measure)
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA) [ Time Frame: Baseline, 6- and 12-week ]
The ARBA assesses changes in substance use (i.e, type of drugs, number of times, method), sexual behavior (e.g., frequency of condom use, frequency of sex with high-risk partners, frequency of sex while using drugs or alcohol, number of partners, frequency of vaginal, oral, and anal sex, and age of sexual debut) and lifetime needle use (e.g., any history of tattooing, sharing, and piercing) across three time periods (i.e., 2 weeks preintervention, 6 week postintervention, and 12 week postintervention).
Same as current
Complete list of historical versions of study NCT01771237 on ClinicalTrials.gov Archive Site
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HIV Prevention Among Vulnerable Male Youth
Feasibility and Acceptability Trial of Behavioral Group-based HIV Prevention Intervention for Young Men Who Have Sex With Men (YMSM).
This exploratory study aims to design and test an HIV prevention intervention for young men who have sex with men (MSM) between the ages of 16-20 as this group comprises the US adolescent population most at-risk for HIV infection through sexual contact. To help develop the content and format of our intervention we will first conduct in-depth interviews with twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact between ages 16-20 (i.e., the target age of our intended intervention). We will then design a group-based primary intervention for young MSM between ages 16-20, relying on the information we gathered from these interviews, as well as consultation from an advisory board of young MSM and HIV prevention experts. Last, we will use an experimental design to compare our intervention to a control condition. We hypothesize that, relative to a control condition of sexual health education and risk reduction, participants in our intervention will demonstrate lower rates of HIV risk behavior, find participation more feasible, and endorse greater acceptability of our intervention.
The purpose of this three year study is to develop and then test the feasibility and acceptability of a uniquely targeted HIV risk reduction intervention for young men who have sex with men (MSM), ages 16 to 20, at risk for HIV acquisition or transmission. In year one, the preliminary components of a primary prevention intervention for young MSM aged 16-20 will result from the findings of qualitative interviews conducted among a multiethnic sample of 21 young MSM (aged 18-24) who acquired HIV through male-to-male sexual contact between ages 16-20. In year two, a preliminary primary prevention intervention curriculum will be completed and subsequently refined through community advisory board review. In year three, the feasibility and acceptability of the intervention will be tested in a two-arm randomized controlled trial in a community-based agency with excellent access to and research experience with the population. We will enroll 100 at-risk young MSM ages 16-20; two-thirds of the sample (N=66)will be randomized to the intervention condition while one-third (N=34) will be randomized to the time-matched attention control condition and receive standard health promotion information in a group-based format. Sexual risk will be assessed at baseline, 6, and 12 weeks post-intervention. The specific aims of this exploratory study are: 1) to design an HIV and substance use primary prevention program for 16-20 year-old urban, ethnically-diverse YMSM; 2) to pilot test and refine study methods; 3) to test the revised multi-ethnic intervention with 100 young YMSM and examine preliminary effects on risky sexual behavior, alcohol/drug use, and psychosocial intermediate outcomes specified by our theoretical framework in preparation for a large-scale, efficacy study. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Homosexuality, Male
  • HIV
  • Substance-related Disorders
  • Sexual Dysfunctions, Psychological
  • Behavioral: MyPeeps Manualized Group Intervention
    Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
    Other Name: MyPeeps Intervention
  • Behavioral: Standard Sexual Health Education
    Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
    Other Name: Sexual health education-as-usual
  • Experimental: MyPeeps Manualized Group Intervention
    Highly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM.
    Intervention: Behavioral: MyPeeps Manualized Group Intervention
  • Active Comparator: Standard Sexual Health Education
    Educational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM.
    Intervention: Behavioral: Standard Sexual Health Education
Hidalgo MA, Kuhns LM, Hotton AL, Johnson AK, Mustanski B, Garofalo R. The MyPEEPS randomized controlled trial: a pilot of preliminary efficacy, feasibility, and acceptability of a group-level, HIV risk reduction intervention for young men who have sex with men. Arch Sex Behav. 2015 Feb;44(2):475-85. doi: 10.1007/s10508-014-0347-6. Epub 2014 Aug 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • able to speak and read English
  • age 16-20
  • biological/cisgender male
  • willing and able to provide assent/consent
  • HIV-negative or of an unknown HIV serostatus
  • sexually active with male partner in past 12 mos.
  • willing to provide locator information

Exclusion Criteria:

  • unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
  • active suicidal ideation at the time of baseline interview
Sexes Eligible for Study: Male
16 Years to 20 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R34MH079707( U.S. NIH Grant/Contract )
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Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
Howard Brown Health Center
Principal Investigator: Robert Garofalo, MD, MPH Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children's Hospital of Chicago
January 2018

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