Clinical trial NCT01771237: 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
Overall status: COMPLETED
Phase: NA
Conditions: Homosexuality, Male
HIV
Substance-related Disorders
Sexual Dysfunctions, Psychological
Keywords: HIV infection
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Howard Brown Health Center
First posted: 2013-01-18
Enrollment: 121
Sex: MALE
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA)
timeFrame: Baseline, 6- and 12-week
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann and Robert H. Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Robert Garofalo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.