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

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

This study will implement a pilot randomized controlled trial (RCT, N=70) to refine and assess the feasibility and acceptability of an emotion regulation and communication skills intervention designed to improve engagement in HIV-care among substance using HIV+ PWID sub-optimally engaged in HIV care.

Study Overview

• Status: Recruiting
• Conditions: Hiv; Substance Use Disorders
• Intervention / Treatment: Behavioral: Project iSTRIVE; Behavioral: incentivized Directly Observed Therapy (iDOT)

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 attend 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 texts 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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abigail W Batchelder, PhD, MPH; Phone Number: 6172670900; Email: abatchelder@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Fenway Community Health
      • Contact: Abigail Batchelder, PhD, MPH; Email: istrive@fenwayhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• HIV positive
• HIV virally unsuppressed (>200 copies/mL) in past year or no past-year HIV viral load result
• Injection drug use behavior endorsed in past 6 months
• Able to provide informed consent
• 18 years or older
• English speaking

Exclusion Criteria:

• HIV negative
• Denying injection drug use in past 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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; 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.
Active Comparator: incentivized Directly Observed Therapy (iDOT); 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); Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV Viral Load	Viral suppression (≤200 copies/mL) will be assessed via blood draw at the final follow up visit and will be the primary outcome variable in the planned subsequent efficacy trial.	change from baseline to 12 weeks after intervention completion
Substance Use	Addiction Severity Index-Lite will be used to assess self-reported substance use at each research visit and a subset of questions will be asked at all intervention visits. The primary metric will be number of days a participant reports experiencing drug problems in the past month (0-30), with a decrease in days (i.e., lower number) indicating a favorable outcome.	change from baseline to 12 weeks after intervention completion
Injection Drug Use Behaviors	We will assess injection behaviors associated with HIV risk by self-report by adapting items identified by Shahesmaeili et al. (Brief Scale to Measure HIV Transmission Risk Among Injecting Drug Users). These questions will include injection behaviors and related factors that differ by gender (e.g., needle borrowing, ancillary equipment sharing, being injected by someone else, and whether injection partners are also sexual partners). The total scale is scored from 0-36, with lower scores indicating favorable outcomes (i.e., reduction in HIV risk behavior).	change from baseline to 12 weeks after intervention completion

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Fenway Community Health; National Institute of Drug Abuse

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): February 29, 2024
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2021P002094; R34DA053686 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No