Clinical trial No longer in our active list Interventional Ages 18 and up

Improving HIV self-care for people who inject drugs

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

Run by Massachusetts General Hospital · NCT05819411 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing a new way to help people with HIV who inject drugs take better care of themselves by using a mobile app and therapy sessions to see if it makes a difference in their health.

More HIV trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorMassachusetts General Hospital
Academic / other
Locations1 site (Boston, Massachusetts)
Trial IDNCT05819411 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are HIV-positive individuals who inject drugs and have been sub-optimally engaged in HIV care.

Probably not a fit

Patients who are HIV-negative or who deny drug use in the past six months will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot randomized controlled trial aims to assess the feasibility and acceptability of an intervention designed to enhance HIV self-care among HIV-positive individuals who inject drugs and are not optimally engaged in HIV care. Participants will be randomly assigned to receive either a mobile application-facilitated directly observed therapy (iDOT) alone or iDOT combined with the iSTRIVE intervention, which includes therapy sessions focused on emotion regulation and communication skills. The study will take place at Fenway Health in Boston, MA, and participants will be compensated for their involvement and adherence to the protocol.

Why it matters

Potential benefit: If successful, this intervention could significantly improve HIV self-care and engagement in treatment for individuals who inject drugs.

How similar studies have gone: Other studies have shown promise in using behavioral interventions to improve health outcomes in similar populations, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Fenway Community Health
    Boston, Massachusetts, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.