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

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ClinicalTrials.gov Identifier: NCT02704208
Recruitment Status : Active, not recruiting
First Posted : March 9, 2016
Last Update Posted : March 27, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Center for HIV Education Studies and Training (CHEST) Hunter College CUNY NY, NY
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
HIV Behavioral: Thrive With Me Control Behavioral: Thrive With Me Intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Actual Study Start Date : October 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Behavioral: Thrive With Me Intervention
Participants randomized to the TWM Intervention will gain access to a website for 150 days. The TWM website includes: peer-to-peer support through a private social network and optimized gaming features; daily SMS communication for medication reminders and mood tracking; medication adherence monitoring; and tailored HIV informational content.
Behavioral: Thrive With Me Intervention
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 Name: TWM Intervention

Placebo Comparator: Behavioral: Thrive With Me Control
Participants randomized to the TWM Control group will receive HIV related content through a weekly web link. The web links will be static pages (not interactive) with information aimed at improving overall wellbeing while living with HIV, but not focused on improving ART medication adherence.
Behavioral: Thrive With Me Control
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.
Other Name: TWM Control




Primary Outcome Measures :
  1. HIV Viral Load [ Time Frame: up to 18 months period ]
    Certified phlebotomists will conduct blood draws in a clinical setting to test HIV viral load. Specifically, blood draws will be taken to assess the effects of the TWM intervention on VL, the most important biological marker for adherence. Blood will be drawn by a certified phlebotomist at the CHEST in New York City, NY and analyzed by Quest Diagnostics. Plasma VL is considered undetectable at <20 copies/mm3 and we will provide test results to participants.


Secondary Outcome Measures :
  1. Self Reported Adherence Measures [ Time Frame: up to 18 months period ]
    A questionnaire that tests self-reported adherence information, motivation, and behavioral skills by completing the IMB-AAQ which is a 33-items measure that assess adherence-related information.

  2. Social Support Measures [ Time Frame: up to 18 months period ]
    We will administer a questionnaire which is a modified version of two social support questionnaires to assess social support.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704208


Locations
United States, New York
Center for HIV Education Studies and Training, Hunter College
New York, New York, United States, 10018
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Center for HIV Education Studies and Training (CHEST) Hunter College CUNY NY, NY

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02704208     History of Changes
Other Study ID Numbers: Horvath_TWM
1R01DA039950-01 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Antiretroviral Therapy
Medication Adherence
Technology-based Intervention

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action