HIV Prevention Among Vulnerable Male Youth

January 25, 2021 updated by: Ann & Robert H Lurie Children's Hospital of Chicago

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann and Robert H. Lurie Children's Hospital of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MyPeeps Manualized Group Intervention
Highly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM.
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 Names:
  • MyPeeps 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.
Behavioral: Standard Sexual Health Education
Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
Other Names:
  • Sexual health education-as-usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, 6- and 12-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborators

Howard Brown Health Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH079707 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sexual Dysfunctions, Psychological

Clinical Trials on MyPeeps Manualized Group Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe