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

Not Applicable

Recruiting

• Conditions: Hiv; Substance Use Disorders
• Interventions: Behavioral: Project iSTRIVE; Behavioral: incentivized Directly Observed Therapy (iDOT)

• Registration Number: NCT05819411
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

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

Exclusion Criteria

• HIV negative
• Denying drug use in past 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Project iSTRIVE	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.
incentivized Directly Observed Therapy (iDOT)	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.
Intervention	incentivized Directly Observed Therapy (iDOT)	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.

Primary Outcome Measures

Name	Time	Method
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).
Feasibility of iSTRIVE intervention	change from baseline to 12 weeks after intervention completion	Percent of sessions completed (≥70% considered indicative of feasibility).
Acceptability of intervention	12 weeks after intervention completion	A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.

Secondary Outcome Measures

Name	Time	Method
HIV Viral Load	change from baseline to 12 weeks after intervention completion	Viral suppression (≤20 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.
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.
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).

Trial Locations

Locations (1)

Fenway Community Health; 🇺🇸 Boston, Massachusetts, United States