Trial Outcomes & Findings for A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults (NCT NCT02704208)
NCT ID: NCT02704208
Last Updated: 2023-06-07
Results Overview
Undetectable viral load (plasma viral load is considered undetectable at \<20 copies/mm3)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
410 participants
Primary outcome timeframe
up to 17 months period
Results posted on
2023-06-07
Participant Flow
Men residing in the New York City metro area were recruited by study staff using active (e.g., direct outreach) and passive (e.g., advertising in clinic settings, internet-based) recruitment approaches. Internet-recruitment efforts were using online venues that cater to the study population and field-based recruitment strategies include conduct on-site preliminary screening via tablets at local bars, clubs, and community events.
Participant milestones
| Measure |
Behavioral: Thrive With Me Intervention
Participants randomized to the TWM Intervention gained access to the TWM 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: Control Arm
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.
|
|---|---|---|
|
Overall Study
STARTED
|
202
|
199
|
|
Overall Study
COMPLETED
|
160
|
162
|
|
Overall Study
NOT COMPLETED
|
42
|
37
|
Reasons for withdrawal
| Measure |
Behavioral: Thrive With Me Intervention
Participants randomized to the TWM Intervention gained access to the TWM 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: Control Arm
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
42
|
37
|
Baseline Characteristics
A Technology-Delivered Peer-to-Peer Support ART Adherence Intervention for Substance-using HIV+ Adults
Baseline characteristics by cohort
| Measure |
Behavioral: Thrive With Me Intervention
n=202 Participants
Participants randomized to the TWM Intervention gained access to the TWM 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: Control Arm
n=199 Participants
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.
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
38.1 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
39.1 years
STANDARD_DEVIATION 10.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
202 Participants
n=99 Participants
|
199 Participants
n=107 Participants
|
401 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
62 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=99 Participants
|
153 Participants
n=107 Participants
|
293 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
123 Participants
n=99 Participants
|
107 Participants
n=107 Participants
|
230 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
12 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=99 Participants
|
199 participants
n=107 Participants
|
401 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 17 months periodUndetectable viral load (plasma viral load is considered undetectable at \<20 copies/mm3)
Outcome measures
| Measure |
Behavioral: Thrive With Me Intervention
n=202 Participants
Participants randomized to the TWM Intervention gained access to the TWM 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: Control Arm
n=199 Participants
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.
|
|---|---|---|
|
Proportion of Participants With an Undetectable HIV Viral Load
|
107 Participants
|
113 Participants
|
Adverse Events
Behavioral: Thrive With Me Intervention
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Behavioral: Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Behavioral: Thrive With Me Intervention
n=202 participants at risk
Participants randomized to the TWM Intervention gained access to the TWM 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: Control Arm
n=199 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Suicidal Ideation
|
0.99%
2/202 • Number of events 3 • Adverse event data were collected for 17 months (i.e., from baseline to the end of study participation).
|
0.00%
0/199 • Adverse event data were collected for 17 months (i.e., from baseline to the end of study participation).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place