Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +

Study Overview
=================
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).

Official Title
-----------------
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: the CHORUS+ Study

Conditions
-----------------
Opioid Use Disorder

Intervention / Treatment
-----------------
* Behavioral: CHORUS+
* Other: Standard of care


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: Individuals with HIV (self report) Express desire to harm themselves or others -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHORUS+<br>The baseline questionnaire for participants in this arm will be followed by a 30-minute motivational interviewing (MI) session with the peer recovery coach (PRC), and will assess readiness for change and provide information about PrEP. The PRC will also assess readiness for MOUD, and this will be further explored during subsequent visits. | Behavioral: CHORUS+<br>* 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.<br>|
| Active Comparator: Usual care- control<br>Participants in this arm will receive passive referral for care. there will be no PRC MI session and they will not be offered PrEP or MOUD. | Other: Standard of care<br>* Normal protocols for care of participants who inject opioids will be followed.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to HIV PrEP at 6 months Adherence to HIV PrEP | This outcome will be assessed by measured by the proportion of individuals who have dried blood spot tenofovir-diphosphate (TFV-DP) blood level 52.0 ng/ mL or greater at 6 months post-enrollment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to PrEP at 3 and 12 months | Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended. | 3 months. 12 months | 
| Receipt of medication for opioid use disorder (MOUD) | 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. | 3 months, 6 months, and 12 months | 
| Test results for gonorrhea | Results will be assessed as negative or positive. | Baseline, 3 months, 6 months, and 12 months | 
| Test results for chlamydia | Results will be assessed as negative or positive. | Baseline, 3 months, 6 months, and 12 months | 
| Test results for syphilis | Results will be assessed as negative or positive. | Baseline, 3 months, 6 months, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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)