A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults

The "Thrive with Me" (TWM) intervention is a technology-delivered peer-to-peer social support
intervention grounded in the Information, Motivation, and Behavioral Skills (IMB) model for
HIV positive men who have sex with men (MSM). In addition to asynchronous peer-to-peer
support capabilities, the TWM intervention provides participants with Antiretroviral Therapy
(ART) adherence self-monitoring tools, medication dose reminders, and HIV-related
informational content. Based on the encouraging findings of the TWM pilot study (completed in
2011) and the need for novel, evidence-based effective ART adherence interventions, we
propose the following study aims for this full-scale RCT. Primary aims (Aims 1 and 2) are to
examine the efficacy of the online and mobile-enabled TWM intervention in a full-scale
randomized controlled trial. HIVpositive adults (all men who have sex with men [MSM]) with
detectable HIV viral load (VL) residing in New York City will be randomized to receive the
TWM intervention or an information-only HIV/ART intervention for a 6-month period.
Recruitment will be stratified by recent drug use, such that half will report recent illicit
drug use. HIV VL, validated self-reported ART adherence, and intervention utilization
measures will be collected at baseline, post-intervention, and 6-, and 12- month follow up.
We hypothesize that participants in the TWM intervention will demonstrate significant
improvements in self-reported ART adherence and VL at each follow-up time point compared to
control participants, with greatest improvements among recent drug users. Aim 3 (a secondary
aim) is to examine the effects of the intervention on theory-based change processes (i.e.,
IMB factors and social support) for improving VL, ART adherence, and substance use outcomes.
We hypothesize that tailored adherence information, motivation for adherence, adherence
behavioral skills, and peer social support will be associated with VL suppression and
improved ART adherence and drug use outcomes. All study participants will reside in the New
York City metropolitan area. The Center for HIV Education Studies and Training at CUNY Hunter
College is overseeing the recruitment, enrollment, and retention of human subjects. The
primary outcome measure is biological viral load (VL) at each assessment period.
Specifically, blood draws will be taken at baseline, immediate post-intervention, 6- and
12-month post-intervention follow-up assessment points to assess the effects of the TWM
intervention on VL, the most important biological marker for adherence. Plasma VL is
considered undetectable at <20 copies/mm3 and we will provide test results to participants
after each visit. The University of Minnesota IRB is overseeing all human subjects protocols
for the study. Brief Summary The "Thrive with Me" (TWM) intervention is a
technology-delivered peer-to-peer social support intervention grounded in the Information,
Motivation, and Behavioral Skills (IMB) model for HIV positive men who have sex with men
(MSM). In addition to asynchronous peer-to-peer support capabilities, the TWM intervention
provides participants with Antiretroviral Therapy (ART) adherence self-monitoring tools,
medication dose reminders, and HIV-related informational content. This is a randomized
control efficacy trial of the TWM intervention. The primary outcome measure is biological
viral load (VL) at each assessment period. All study participants will reside in the New York
City metropolitan area. The Center for HIV Education Studies and Training at CUNY Hunter
College is overseeing the recruitment, enrollment, and retention of human subjects.

Inclusion Criteria:

1. 18+ years of age;

2. Male gender;

3. Sex with 1+ men in the prior year;

4. Diagnosis of HIV and currently prescribed ART;

5. Self-reported detectable VL in past 12 months OR self-reported problems with HIV
medication adherence;

6. Residing in the New York City metropolitan area and availability meet with project
staff at each assessment time point; and

7. English-speaking (since the intervention will be in English).

8. Self-reported recent drug use (the sample will be stratified by recent drug use and
non-recent drug use)

Exclusion Criteria:

1. 17 years of age or younger;

2. Not male gender;

3. 0 male sex partners in the prior year;

4. No diagnosis of HIV and/or not currently prescribed ART;

5. No self-reported detectable VL in past 12 months OR self- reported very good/excellent
HIV medication adherence;

6. Residing outside of the New York City metropolitan area and/or no availability meet
with project staff at each assessment time point; and

7. Non-English-speaking (since the intervention will be in English).