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

Hiv Clinical Trial

— iSTRIVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05819411
• Other study ID #: 2021P002094
• Secondary ID: R34DA053686
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: July 31, 2025

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: Abigail W Batchelder, PhD, MPH
• Phone: 6172670900
• Email: abatchelder[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 31, 2025
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.
• incentivized Directly Observed Therapy (iDOT)
Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Fenway Community Health, National Institute of Drug Abuse

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of iSTRIVE intervention	Percent of sessions completed (=70% considered indicative of feasibility).	change from baseline to 12 weeks after intervention completion
Primary	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
Primary	Acceptability of intervention	A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants.	12 weeks after intervention completion
Secondary	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
Secondary	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
Secondary	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