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Completed

NCT Number: NCT05819411

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

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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance Use Disorders Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fenway Community Health

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Project iSTRIVE

Behavioral

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)

Behavioral

Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.

Primary outcomes

  1. Feasibility of iSTRIVE intervention

    Time frame: change from baseline to 12 weeks after intervention completion

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

  2. Feasibility of iDOT intervention

    Time frame: 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

    Time frame: 12 weeks after intervention completion

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

Secondary outcomes

  1. HIV Viral Load

    Time frame: 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.

  2. Substance Use

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Boston University
  • Fenway Community Health
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: iSTRIVE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 19, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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