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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hiv, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Project iSTRIVE
* Behavioral: incentivized Directly Observed Therapy (iDOT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |