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 : Completed
First Posted : March 9, 2016
Last Update Posted : June 8, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Thrive With Me Control Behavioral: Thrive With Me Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults|
|Actual Study Start Date :||October 1, 2016|
|Actual Primary Completion Date :||May 31, 2022|
|Actual Study Completion Date :||May 31, 2022|
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
- 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.
- 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.
- 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|
- 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)
- 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).
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
|United States, New York|
|Center for HIV Education Studies and Training, Hunter College|
|New York, New York, United States, 10018|
|Responsible Party:||University of Minnesota|
|Other Study ID Numbers:||
1R01DA039950-01 ( U.S. NIH Grant/Contract )
|First Posted:||March 9, 2016 Key Record Dates|
|Last Update Posted:||June 8, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Peripheral Nervous System Agents
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