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

June 5, 2023 updated by: University of Minnesota
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
410

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10018
        • Center for HIV Education Studies and Training, Hunter College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • TWM Control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With an Undetectable HIV Viral Load
Time Frame: up to 17 months period
Undetectable viral load (plasma viral load is considered undetectable at <20 copies/mm3)
up to 17 months period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
up to 18 months period
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.
up to 18 months period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
Center for HIV Education Studies and Training (CHEST) Hunter College CUNY NY, NY

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1504S69721
  • 1R01DA039950-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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