Clinical trial NCT02704208: A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Official title: A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Antiretroviral Therapy
Medication Adherence
Technology-based Intervention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Center for HIV Educational Studies & Training
First posted: 2016-03-09
Enrollment: 410
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The "Thrive With Me" (TWM) trial is testing the efficacy of a mobile enhanced website aimed at improving Antiretroviral Therapy (ART) adherence for HIV-positive men who have sex with men (MSM). TWM is a technology-delivered peer-to-peer social support intervention with social networking and gaming components. In addition to real-time 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Proportion of Participants With an Undetectable HIV Viral Load
timeFrame: up to 17 months period
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Center for HIV Education Studies and Training, Hunter College
state: New York
Study officials:
References:
citation: Horvath KJ, Amico KR, Erickson D, Ecklund AM, Martinka A, DeWitt J, McLaughlin J, Parsons JT. Thrive With Me: Protocol for a Randomized Controlled Trial to Test a Peer Support Intervention to Improve Antiretroviral Therapy Adherence Among Men Who Have Sex With Men. JMIR Res Protoc. 2018 May 31;7(5):e10182. doi: 10.2196/10182.