A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Condition: HIV
Study type: Interventional

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.
    

Intervention name(s): Thrive With Me Control; Thrive With Me Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those assigned to the TWM control group will receive a weekly email with static HIV informational content. Information will be focused more on quality of life and general wellbeing issues and will not be specific to medication adherence.; Those assigned to the TWM intervention will have 150 days to access tailored content on a mobile-enhanced website. They will also have social support through a network of other HIV-positive men. Finally they will track their daily ART medication adherence and mood through SMS and website use.
Other intervention name(s): TWM Control; TWM Intervention
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antiretroviral Therapy; Medication Adherence; Technology-based Intervention