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

Mass General Brigham

Status: Completed

Conditions: Substance Use Disorders; Hiv

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05819411

2021P002094

R34DA053686 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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 be offered 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 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 18 years or older
• English speaking

Exclusion criteria

• HIV negative
• Denying drug use in past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Project iSTRIVE

Behavioral: incentivized Directly Observed Therapy (iDOT)

incentivized Directly Observed Therapy (iDOT)

Active Comparator group

Description:

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.

Treatment:

Behavioral: incentivized Directly Observed Therapy (iDOT)