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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
284
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.
Normal protocols for care of participants who inject opioids will be followed.
Boston Medical Center Faster Paths Bridge Clinic
Boston, Massachusetts, United States
RECRUITINGVictory Programs Mobile Prevention Services Van and Navigation Center
Boston, Massachusetts, United States
RECRUITINGAdherence to HIV PrEP at 6 months Adherence to HIV PrEP
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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 3 months, 6 months, and 12 months
Test results for gonorrhea
Results will be assessed as negative or positive.
Time frame: Baseline, 3 months, 6 months, and 12 months
Test results for chlamydia
Results will be assessed as negative or positive.
Time frame: Baseline, 3 months, 6 months, and 12 months
Test results for syphilis
Results will be assessed as negative or positive.
Time frame: Baseline, 3 months, 6 months, and 12 months
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