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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

410

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline

Completed

Started Oct 2016

Longer than P75 for not_applicable hiv

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.7 years study duration

First Submitted

Initial submission to the registry

March 4, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed

7 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed

5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed

1 year until next milestone

Results Posted

Study results publicly available

June 7, 2023

Completed

Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

5.7 years

First QC Date

March 4, 2016

Results QC Date

April 11, 2023

Last Update Submit

June 5, 2023

Conditions

HIV

Keywords

Antiretroviral TherapyMedication AdherenceTechnology-based Intervention

Outcome Measures

Primary Outcomes (1)

Proportion of Participants With an Undetectable HIV Viral Load
Undetectable viral load (plasma viral load is considered undetectable at \<20 copies/mm3)
up to 17 months period

Study Arms (2)

Behavioral: Thrive With Me Intervention

EXPERIMENTAL

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

Behavioral: Thrive With Me Control

PLACEBO COMPARATOR

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

Interventions

Thrive With Me ControlBEHAVIORAL

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.

Also known as: TWM Control

Behavioral: Thrive With Me Control

Thrive With Me InterventionBEHAVIORAL

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.

Also known as: TWM Intervention

Behavioral: Thrive With Me Intervention

Eligibility Criteria

Age18 Years - 100 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

+ years of age;
Male gender;
Sex with 1+ men in the prior year;
Diagnosis of HIV and currently prescribed ART;
Self-reported detectable VL in past 12 months OR self-reported problems with HIV medication adherence;
Residing in the New York City metropolitan area and availability meet with project staff at each assessment time point; and
English-speaking (since the intervention will be in English).
Self-reported recent drug use (the sample will be stratified by recent drug use and non-recent drug use)

You may not qualify if:

years of age or younger;
Not male gender;
male sex partners in the prior year;
No diagnosis of HIV and/or not currently prescribed ART;
No self-reported detectable VL in past 12 months OR self- reported very good/excellent HIV medication adherence;
Residing outside of the New York City metropolitan area and/or no availability meet with project staff at each assessment time point; and
Non-English-speaking (since the intervention will be in English).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Minnesotalead
National Institute on Drug Abuse (NIDA)collaborator
Center for HIV Educational Studies & Trainingcollaborator

Study Sites (1)

Center for HIV Education Studies and Training, Hunter College

New York, New York, 10018, United States

Location

Related Publications (2)

Horvath KJ, Lammert S, Erickson D, Amico KR, Talan AJ, Shalhav O, Sun CJ, Rendina HJ. A Web-Based Antiretroviral Therapy Adherence Intervention (Thrive With Me) in a Community-Recruited Sample of Sexual Minority Men Living With HIV: Results of a Randomized Controlled Study. J Med Internet Res. 2024 Sep 30;26:e53819. doi: 10.2196/53819.
PMID: 39348677DERIVED
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.
PMID: 29853437DERIVED

MeSH Terms

Conditions

Medication Adherence

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title: Keith J. Horvath
Organization: San Diego State University

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 9, 2016

Study Start

October 1, 2016

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

June 7, 2023

Results First Posted

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing: Will not share

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Behavioral: Thrive With Me Intervention

Behavioral: Thrive With Me Control

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations