Hiv, Substance Use Disorders
Conditions
Brief summary
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.
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 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.
Interventions
BEHAVIORALProject 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.
BEHAVIORALincentivized Directly Observed Therapy (iDOT)
Both the intervention group and the active control group will receive a mobile app-based iDOT intervention.
Sponsors
Fenway Community Health
National Institute on Drug Abuse (NIDA)
Boston University
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of iSTRIVE intervention | change from baseline to 12 weeks after intervention completion | Percent of sessions completed (≥70% considered indicative of feasibility). |
| Feasibility of iDOT intervention | change from baseline to 12 weeks after intervention completion | Percent of DOT video check ins completed by participants (≥50% considered indicative of feasibility). |
| Acceptability of intervention | 12 weeks after intervention completion | A qualitative analysis of exit interviews conducted with iSTRIVE study intervention participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HIV Viral Load | 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. |
| Substance Use | 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. |
| Injection Drug Use Behaviors | 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). |
Countries
United States
Outcome results
None listed