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).
1 other identifier
interventional
121
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedJanuary 27, 2021
January 1, 2021
3.5 years
December 18, 2012
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA)
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).
Baseline, 6- and 12-week
Study Arms (2)
MyPeeps Manualized Group Intervention
EXPERIMENTALHighly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM.
Standard Sexual Health Education
ACTIVE COMPARATOREducational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM.
Interventions
Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Related Publications (1)
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.
PMID: 25135064RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Garofalo, MD, MPH
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2012
First Posted
January 18, 2013
Study Start
July 1, 2007
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 27, 2021
Record last verified: 2021-01