Clinical trial NCT05819411: Intervention to Improve HIV Self-care Among People Who Inject Drugs
Official title: Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People With HIV Who Inject Drugs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hiv
Substance Use Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Fenway Community Health
name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility of iSTRIVE intervention
timeFrame: change from baseline to 12 weeks after intervention completion
measure: Feasibility of iDOT intervention
timeFrame: change from baseline to 12 weeks after intervention completion
measure: Acceptability of intervention
timeFrame: 12 weeks after intervention completion
Secondary outcomes:
measure: HIV Viral Load
timeFrame: change from baseline to 12 weeks after intervention completion
measure: Substance Use
timeFrame: change from baseline to 12 weeks after intervention completion
measure: Injection Drug Use Behaviors
timeFrame: change from baseline to 12 weeks after intervention completion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
Study officials:
References: