NCT05819411

Intervention to Improve HIV Self-care Among People Who Inject Drugs

Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will implement a pilot randomized controlled trial (RCT, N=50) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among HIV+ people who report opioid and/or stimulant use and are sub-optimally engaged in HIV care.

Detailed description

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). All participants will receive substance use treatment referral information if interested. Participants will be randomized to one of two treatment arms. Participants in both arms will receive a mobile application-facilitated incentivized directly observed therapy (iDOT) intervention. Participants in the control arm will receive iDOT alone. Participants in the intervention arm will receive iDOT in combination with the iSTRIVE intervention. After randomization, participants in the iSTRIVE intervention group will be offered 6 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, cognitive restructuring, and assertive communication skills. Participants in the iSTRIVE intervention arm will also receive messages containing customized compassionate self-statements to enhance HIV-related self-care. All participants will be compensated for every research visit and adherence to the iDOT protocol.

Conditions

• Hiv
• Substance Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Project iSTRIVE	This intervention includes 6 face-to-face therapy sessions with a trained clinician to develop skills to counter internalized stigma and shame as barriers to HIV self-care. Both the intervention group and the active control group will also receive a mobile app-based iDOT intervention.
BEHAVIORAL	incentivized Directly Observed Therapy (iDOT)	Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.

Timeline

• Start date: 2021-09-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-04-19
• Last updated: 2025-12-08

Locations

1 site across 1 country: United States