About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
CHORUS+
BehavioralThe 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.
Standard of care
Other interventionNormal protocols for care of participants who inject opioids will be followed.
Treatment groups
Trial outcomes
Primary outcomes
Adherence 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.
Secondary outcomes
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.
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.
Test results for gonorrhea
Results will be assessed as negative or positive.
Test results for chlamydia
Results will be assessed as negative or positive.
Sponsors and contacts
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Boston Medical Center
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Victory Programs Mobile Prevention Services Van and Navigation Center
Collaborator