Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men

First, the protocol team will finalize the development and manualization of Health 4 Life
(H4L) a comparison intervention, which will serve as the basis of comparison for Mobilizing
Our Voices for Empowerment (MOVE), the treatment intervention. H4L will be a health
promotion and life skills intervention to account for time and attention. Following this the
protocol team will then implement Trial 1. In this trial, the intervention specialist and a
"peer buddy" (intervention co-facilitator) from one AMTU will conduct one wave of both MOVE
and H4L. The team will then conduct an analysis of the process data and revise the two
interventions (MOVE and H4L). Upon revising the interventions, the protocol team will
implement Trial 2. In this trial, the protocol co-chairs and the interventionist from Trial
1 will train interventionists and peer buddies from four new AMTUs; these interventionists
and peer buddies will run the revised MOVE and H4L interventions. Each site will be
designated as either a treatment or comparison site, and they will conduct two waves of
their assigned intervention. The team at that time will conduct data analyses and then
modify and manualize the final version of MOVE and H4L.

To be considered eligible for enrollment into Trial 1 and Trial 2, an individual must meet
the criteria listed below:

- Receives services at one of the selected AMTU sites or one of their community
partners;

- Biological male at birth and self identifies as male gender at the time of consent;

- Self identifies as "Black" (including Black/African-American, Black Latino,
Black/Afro-Caribbean, Black/African immigrant, or any self-identified member of the
African Diaspora);

- HIV-infected as documented by medical record review or verification with referring
medical professional;

- Between the ages of 16-24 years, inclusive, at the time of consent;

- HIV-infected through sexual behavior;

- At least one sexual encounter involving oral or anal sex with a male partner in the
past year;

- Ability to understand both written and spoken English;

- Willingness to participate in a group-based intervention with other HIV-positive
B-YMSM and agree to respect the privacy of other group members;

- Willingness and ability to attend the first group session on any of the date chosen
by the site staff and;

- Willingness to provide signed informed consent or assent with parental/legal guardian
permission as applicable.

To be considered eligible for enrollment, an individual must not meet any of the criteria
listed below.

- Active psychiatric condition that in the opinion of the site personnel would
interfere with the ability to give true informed consent and to adhere to the study
requirements;

- Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal,
homicidal, or violent behavior);

- Active drug or alcohol use or dependence that, in the opinion of the site personnel,
would interfere with the ability to give true informed consent and to adhere to the
study requirements;

- Acute illness that, in the opinion of the treating clinician, would interfere with
the participant's ability to adhere to the protocol requirements and/or interfere
with the protocol objectives.

- Previous participation in ATN 090, "Development of a Secondary Prevention
Intervention Targeting HIV-Positive Black Young Men Who have Sex with Men." (NOTE:
YAB members from ATN090 cannot participate in ATN 104)

- Previous participation in Trial 1 of ATN104 and;

- Current enrollment in any other behavioral intervention study or program. Any cases
that are uncertain require Protocol Team approval.