Opioid Use Disorder
Conditions
Keywords
Medication for opioid use disorder, Human immunodeficiency (HIV), Pre-exposure prophylaxis (PrEP), Peer recovery coaching (PRC), Motivational interviewing (MI), HIV self testing, People who inject opioids (PWIO)
Brief summary
The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. HIV pre-exposure prophylaxis (PrEP) is an FDA approved medication taken daily orally by individuals who are HIV negative, but who are at increased risk for HIV. In order to obtain PrEP, a prescription is needed. Before being prescribed HIV PrEP, it is recommended by the Centers for Disease Control and Prevention (CDC) to obtain an HIV test first. Although home HIV self-test kits are recommended by the CDC and are locally available, uptake remains low. CHORUS+ (Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and continuation of MOUD (secondary outcome) among persons who inject opioids. At recruitment, the intervention will include HIV self-testing, rapid initiation of PrEP and MOUD, and 6-month peer recovery coaching (PRC) to support adherence to these medications. This research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder. The efficacy of this multi-site, two-arm randomized control trial of CHORUS+ and usual care \[passive referral\]. This study is not testing the efficacy of PrEP or HIV home testing which is already known. In addition the investigators will determine the influence of HIV self-testing on PrEP uptake and adherence. In the CHORUS+/ intervention arm, there will be a baseline in-person session with the participant to encourage uptake of PrEP and MOUD using motivational interviewing (MI).
Interventions
BEHAVIORALCHORUS+
The CHORUS+ intervention will include a baseline interview with a peer recovery coach to encourage uptake of HIV PrEP (pre-exposure prophylaxis) and medications for opioid use disorder (MOUD) through motivational interviewing (MI). Participants will also be offered HIV self-testing on the day of recruitment, HIV PrEP (if they are HIV negative) and MOUD. Participants will then receive peer coaching for 6 months to increase adherence to PrEP and or MOUD.
OTHERStandard of care
Normal protocols for care of participants who inject opioids will be followed.
Sponsors
Boston Medical Center
National Institute on Drug Abuse (NIDA)
Victory Programs Mobile Prevention Services Van and Navigation Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Injected opioids within the past 6 months (by self-report) * Willingness to provide contact information for two family members or friends * Willingness to sign medical records release forms * Ability to speak English * Plans to reside in Boston area for the next 6 months * Are medically cleared to take PrEP and MOUD (normal renal and PrEP-related labs)
Exclusion criteria
* Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result) * Express desire to harm themselves or others * Individuals who are pregnant at baseline * Individuals who are already enrolled in an interventional study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to HIV PrEP at 6 months Adherence to HIV PrEP | 6 months | This outcome will be assessed by the proportion of individuals who have dried blood spot tenofovir-diphosphate (TFV-DP) blood level 700 fmol/punch or greater at 6 months post-enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to PrEP at 3 and 12 months | 3 months. 12 months | Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended. |
| Receipt of medication for opioid use disorder (MOUD) | 3 months, 6 months, and 12 months | Receipts will be assessed by any of the following: (1) chart review of active medication refills for MOUD, (2) self-report, (3) urine toxicology results checked during study visit, and (4) chart review for appointments attended. |
| Test results for gonorrhea | Baseline, 3 months, 6 months, and 12 months | Results will be assessed as negative or positive. |
| Test results for chlamydia | Baseline, 3 months, 6 months, and 12 months | Results will be assessed as negative or positive. |
| Test results for syphilis | Baseline, 3 months, 6 months, and 12 months | Results will be assessed as negative or positive. |
Countries
United States
Contacts
CONTACTSabrina A Assoumou, MD MPH
CONTACTSarah Miller
PRINCIPAL_INVESTIGATORSabrina A Assoumou, MD MPH
Boston Medical Center, Infectious Diseases
Outcome results
None listed