HIVTWMNCT02704208
A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
A study testing Thrive With Me Intervention in people with HIV, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- HIV
- What is being tested?
- Thrive With Me Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2016to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+ 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)
Who cannot join
- 17 years of age or younger;
- Not male gender;
- 0 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV Education Studies and Training, Hunter College
New York, New York, 10018
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Thrive With Me Control, Thrive With Me Intervention
- Keywords
- Antiretroviral Therapy, Medication Adherence, Technology-based Intervention
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrive With Me ControlBehavioural
Also called TWM 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.
Thrive With Me InterventionBehavioural
Also called TWM 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Thrive With Me Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With an Undetectable HIV Viral Load
Undetectable viral load (plasma viral load is considered undetectable at <20 copies/mm3)
Measured: up to 17 months period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start1 Oct 2016
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Center for HIV Educational Studies & Training
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704208
- Sponsor's protocol ID
- 1504S69721
- Other IDs
- 1R01DA039950-01
- Acronym
- TWM
- Status last verified
- Jun 2023
- First submitted
- 4 Mar 2016
- Last updated
- 7 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39348677Horvath 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.
PubMed 29853437
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
- ClinicalTrials.gov ID
- NCT02704208
- Acronym / sponsor ID
- TWM / 1504S69721
- Conditions
- HIV
- Keywords
- Antiretroviral Therapy, Medication Adherence, Technology-based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Center for HIV Educational Studies & Training
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 7 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Thrive With Me Intervention | Experimental | Behavioral: Thrive With Me InterventionParticipants 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 Control | Placebo comparator | Behavioral: Thrive With Me ControlParticipants 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18+ 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;
Key exclusion criteria (7 listed)
- 17 years of age or younger;
- Not male gender;
- 0 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thrive With Me ControlAlso: TWM ControlThose 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. | Behavioural | Behavioral: Thrive With Me Control |
| Thrive With Me InterventionAlso: TWM InterventionThose 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. | Behavioural | Behavioral: Thrive With Me Intervention |
Primary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39348677Horvath 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.
- Derived from this study: PubMed 29853437Horvath 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrive With Me Intervention in people with HIV, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With an Undetectable HIV Viral Load (time frame: up to 17 months period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02704208, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.