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

NCT05819411 | Completed DMC

• 2 other identifiers: 2021P002094R34DA053686
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Hiv; Substance Use Disorders

Outcome Measures

Primary Outcomes (3)

• Feasibility of iSTRIVE intervention

  Percent of sessions completed (≥70% considered indicative of feasibility).

  change from baseline to 12 weeks after intervention completion

• Feasibility of iDOT intervention

  Percent of DOT video check ins completed by participants (≥50% considered indicative of feasibility).

  change from baseline to 12 weeks after intervention completion

• Acceptability of intervention

  A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.

  12 weeks after intervention completion

Secondary Outcomes (3)

• HIV Viral Load

  change from baseline to 12 weeks after intervention completion

• Substance Use

  change from baseline to 12 weeks after intervention completion

• Injection Drug Use Behaviors

  change from baseline to 12 weeks after intervention completion

Study Arms (2)

Intervention

EXPERIMENTAL

This intervention includes 6 face-to-face therapy sessions with a trained clinician plus an incentivized directly observed therapy (iDOT) intervention facilitated via a mobile application.

Behavioral: Project iSTRIVE; Behavioral: incentivized Directly Observed Therapy (iDOT)

incentivized Directly Observed Therapy (iDOT)

ACTIVE COMPARATOR

Participants in the iDOT condition will be provided a mobile application to facilitate video recording of their daily medication adherence in order to receive small, escalating monetary incentives for HIV medication adherence.

Behavioral: incentivized Directly Observed Therapy (iDOT)

Interventions

Project iSTRIVE BEHAVIORAL

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.

Intervention

incentivized Directly Observed Therapy (iDOT) BEHAVIORAL

Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.

Intervention; incentivized Directly Observed Therapy (iDOT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV positive
• HIV virally unsuppressed (\>20 copies/mL) in past year or no past-year HIV viral load result
• Opioid and/or stimulant use behavior endorsed in past 6 months
• Able to provide informed consent
• years or older
• English speaking

You may not qualify if:

• HIV negative
• Denying drug use in past 6 months

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Fenway Community Health: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Boston University: collaborator

Study Sites (1)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 19, 2023
• Study Start: September 1, 2021
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)