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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05819411
Collaborator
Fenway Community Health (Other), National Institute of Drug Abuse (U.S. Fed)
70
1
2
46.9
1.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Project iSTRIVE
  • Behavioral: incentivized Directly Observed Therapy (iDOT)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pilot Randomized Controlled TrialPilot Randomized Controlled Trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Feb 29, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of iSTRIVE intervention [change from baseline to 12 weeks after intervention completion]

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

  2. Feasibility of iDOT intervention [change from baseline to 12 weeks after intervention completion]

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

  3. Acceptability of intervention [12 weeks after intervention completion]

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

Secondary Outcome Measures

  1. HIV Viral Load [change from baseline to 12 weeks after intervention completion]

    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.

  2. Substance Use [change from baseline to 12 weeks after intervention completion]

    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.

  3. Injection Drug Use Behaviors [change from baseline to 12 weeks after intervention completion]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fenway Community Health Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Fenway Community Health
  • National Institute of Drug Abuse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abigail Batchelder, Ph.D., M.P.H., Staff Psychologist and Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05819411
Other Study ID Numbers:
  • 2021P002094
  • R34DA053686
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 19, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 19, 2023