HIV Prevention Among Vulnerable Male Youth

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.

• MyPeeps Manualized Group Intervention (Behavioral), also known as MyPeeps Intervention: Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
• Standard Sexual Health Education (Behavioral), also known as Sexual health education-as-usual: Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use

Primary outcomes

• Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA) [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).

Sex: Male, ages: 16 Years to 20 Years, accepts healthy volunteers

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

• Results publication: 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 25135064

• Robert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago