Improving HIV self-care for people who inject drugs
Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05819411 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive individuals who inject drugs and have been sub-optimally engaged in HIV care.
Not a fit: Patients who are HIV-negative or who deny drug use in the past six months will not benefit from this study.
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 performed: Other studies have shown promise in using behavioral interventions to improve health outcomes in similar populations, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Boston, Massachusetts
- Fenway Community Health — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Abigail W Batchelder, PhD, MPH
- Email: abigail.batchelder@bmc.org
- Phone: 6172670900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.