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临床试验/NCT05769218
NCT05769218招募中不适用

PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study

Boston Medical Center4 个研究点 分布在 1 个国家目标入组 284 人开始时间: 2024年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
284
试验地点
4
主要终点
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

CHORUS+

Experimental

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.

干预措施: CHORUS+ (Behavioral)

Usual care- control

Active Comparator

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.

干预措施: Standard of care (Other)

结局指标

主要结局

Adherence to HIV PrEP at 6 months Adherence to HIV PrEP

时间窗: 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.

次要结局

  • Adherence to PrEP at 3 and 12 months(3 months. 12 months)
  • Receipt of medication for opioid use disorder (MOUD)(3 months, 6 months, and 12 months)
  • Test results for gonorrhea(Baseline, 3 months, 6 months, and 12 months)
  • Test results for chlamydia(Baseline, 3 months, 6 months, and 12 months)
  • Test results for syphilis(Baseline, 3 months, 6 months, and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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