HIV Prevention Among Vulnerable Male Youth
Primary Purpose
Homosexuality, Male, HIV, Substance-related Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyPeeps Manualized Group Intervention
Standard Sexual Health Education
Sponsored by
About this trial
This is an interventional prevention trial for Homosexuality, Male focused on measuring HIV infection
Eligibility Criteria
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
Sites / Locations
- Ann and Robert H. Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MyPeeps Manualized Group Intervention
Standard Sexual Health Education
Arm Description
Highly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM.
Educational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01771237
First Posted
December 18, 2012
Last Updated
January 25, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Howard Brown Health Center
1. Study Identification
Unique Protocol Identification Number
NCT01771237
Brief Title
HIV Prevention Among Vulnerable Male Youth
Official Title
Feasibility and Acceptability Trial of Behavioral Group-based HIV Prevention Intervention for Young Men Who Have Sex With Men (YMSM).
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Howard Brown Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Homosexuality, Male, HIV, Substance-related Disorders, Sexual Dysfunctions, Psychological
Keywords
HIV infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MyPeeps Manualized Group Intervention
Arm Type
Experimental
Arm Description
Highly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM.
Arm Title
Standard Sexual Health Education
Arm Type
Active Comparator
Arm Description
Educational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM.
Intervention Type
Behavioral
Intervention Name(s)
MyPeeps Manualized Group Intervention
Other Intervention Name(s)
MyPeeps Intervention
Intervention Description
Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
Intervention Type
Behavioral
Intervention Name(s)
Standard Sexual Health Education
Other Intervention Name(s)
Sexual health education-as-usual
Intervention Description
Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
Primary Outcome Measure Information:
Title
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA)
Description
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).
Time Frame
Baseline, 6- and 12-week
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Garofalo, MD, MPH
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann and Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25135064
Citation
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.
Results Reference
result
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HIV Prevention Among Vulnerable Male Youth
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