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

NCT05819411 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-08

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Fenway Community Health

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Boston University

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05819411 on ClinicalTrials.gov