구조적 인종차별과 차별을 해결하고 고위험 약물 사용 인구의 HIV 결과를 개선하기 위한 동료 행동 활성화 활용 (PUSH)
This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to:
Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory)
Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.
Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives.
This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Background. Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence, treatment interruption, and inability to achieve or maintain viral suppression. Use of PrEP, a key tool for HIV prevention, is disproportionately lower in racial/ethnic minorities, as well as people who inject drugs. Factors related to structural racism and discrimination (SRD) may contribute to low rates of adherence in these populations. New long-acting injectable (LAI) formulations of PrEP/ART provide a potential biomedical intervention to overcome adherence challenges, however, due to the prolonged subtherapeutic period after LAI discontinuation, ensuring adherence is crucial.
A peer-delivered reinforcement-based intervention may be a promising solution for improving LAI adherence. Our team has developed through several rounds of stakeholder feedback a peer-delivered behavioral activation and problem-solving intervention, Peer Activate. Peer Activate focuses on problem-solving skills to improve adherence to ART and/or PrEP both at the individual level and social/structural barriers to care (i.e., transportation, housing) and includes behavioral activation to promote engagement in rewarding, substance-free activities in one's environment and structured daily activities to promote treatment adherence. Delivery by a peer with formal training and shared lived experiences enhances the impact of the intervention on SRD-related factors. However, Peer Activate has not been evaluated in the context of LAI PrEP/ART.
Preliminary Studies. This proposal builds upon our team's prior studies demonstrating 1) our ability to engage patients with and at risk for HIV, facing multiple barriers due to SRD, and provide LAI PrEP/ART in community-based settings; 2) the feasibility and acceptability of Peer Activate and promise in improving HIV treatment adherence for people who use substances.; and 3) promise for cost-effectiveness.
Approach. We propose a randomized Type 1 hybrid effectiveness-implementation trial (N=186) to test the effectiveness and implementation of Peer Activate for LAI PrEP/ART ("Peer Activate-LAI") vs. enhanced treatment as usual for a predominantly Black substance using population living with or at high risk for HIV, evaluating the following over 12 months:
- effectiveness: a) LAI PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); b) substance use (secondary; urine toxicology, self-report); c) SRD as moderators of effectiveness (exploratory);
- Implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,9,10 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation; and
- Economic viability of Peer Activate-LAI, including cost of implementation and sustainment and cost-effectiveness from multiple stakeholder perspectives. Implications.
This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of ART/PrEP within Black, substance using populations who to date have had limited support for improving LAI adherence for HIV ART/PrEP.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Elana Rosenthal, MD
- 전화번호: 240-367-4157
- 이메일: erosenthal@ihv.umaryland.edu
연구 연락처 백업
- 이름: Emade Ebah Edongole, RN
- 전화번호: 202-655-6229
- 이메일: eebah@ihv.umaryland.edu
연구 장소
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-
District of Columbia
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Washington D.C., District of Columbia, 미국, 20002
- 모병
- HIPS (Harm reduction drop-in center)
-
수석 연구원:
- Elana Rosenthal, MD
-
연락하다:
- Phyllis Bijole Clinic Manager
- 전화번호: 202.834.3289
- 이메일: phyllis@hips.org
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부수사관:
- Meredith Zoltick, NP
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부수사관:
- Ashley Davis, NP
-
-
Maryland
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Baltimore, Maryland, 미국, 21218
- 모병
- Baltimore Safe Haven
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연락하다:
- Onyinyechi Ogbumbadiugha, MPH
- 전화번호: (443)-635-4943
- 이메일: oogbumbadiugha@ihv.umaryland.edu
-
연락하다:
- Claire Tindula, NP
- 전화번호: 443-897-3435
- 이메일: claire.tindula@ihv.umaryland.edu
-
부수사관:
- Claire Tindula, NP
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 years or older
- Able and willing to sign informed consent
- HIV status:
HIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test
- Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information
- Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol
Exclusion Criteria:
- Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation
- Pregnant or breastfeeding
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Peer Activate-LAI
Peer Activate-LAI, is a peer recovery specialist-delivered (PRS) behavioral activation (BA) and problem solving intervention aimed at improving adherence to LAI-PrEP/ART. BA was originally developed as an efficacious treatment for depression, with accumulating empirical support for SUD outcomes, including SUD treatment retention and HIV medication adherence, particularly when integrated with problem solving strategies. BA offers important advantages compared to other psychosocial interventions by being feasible and potentially sustainable for PRS delivery, appropriate for low-income individuals with OUD and other non-opioid SUD, and focused on building positive reinforcement in the current environment through engagement in adaptive, valued behaviors. |
Peer Activate-LAI is a Peer Recovery Specialist-delivered behavioral activation and problem solving intervention, based on our team's formative work. The intervention focuses on problem-solving skills to improve adherence to ART and/or PrEP both at the individual level and environmental barriers to care (i.e., transportation, housing). Standard of care HIV treatment or prevention with LAI-PrEP/ART |
|
활성 비교기: Enhanced Treatment As Usual
Participants in the Enhanced Treatment As Usual (ETAU) arm receive access to standard clinical care, including access to a clinician with expertise in HIV and PrEP, opportunity for co-located treatment of OUD, and STI testing and treatment, and general peer support. Enhanced treatment includes reminder phone calls and facilitated referrals to psychosocial, housing, financial benefits and legal services. |
Standard of care HIV treatment or prevention with LAI-PrEP/ART |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
LAI-PrEP/ART Complete Adherence
기간: 12 months
|
Defined as receiving all 6 LAI maintenance doses within the +/-7 day window. Unit of Measure: Binary (Yes/No) |
12 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- HP-00110311
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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