공유 의사 결정을 통한 교정 인구의 HIV 치료 및 예방(STOP) (R33)
STOP (공유 의사 결정을 통한 치료 및 예방): 법률 관련 집단 내 HIV
This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP/ART and substance use/substance use disorder (SU/SUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.
연구 개요
상세 설명
This study will be done in two phases. Aim 1, the R61 portion of the project will be a Pilot Study, and Aim 2, the R33 portion of the project will be a Randomized Controlled Trail informed by the pilot.
The focus of this registration is Aim 2, the randomized controlled trial. The Aim 1 (R61) portion is registered with NCT06439329. In Aim 2 (R33), investigators will evaluate standard PN compared to PN+PC on participant outcomes, implementation outcomes and costs associated with implementing the study.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alysse Schultheis, MA
- 전화번호: 203-231-2454
- 이메일: alysse.schultheis@yale.edu
연구 연락처 백업
- 이름: Sandra Springer, MD
- 전화번호: 203-231-2454
- 이메일: Sandra.springer@yale.edu
연구 장소
-
-
Connecticut
-
New Haven, Connecticut, 미국, 06510
- 모병
- Yale School of Medicine
-
수석 연구원:
- Sandy Springer, MD
-
-
Kentucky
-
Lexington, Kentucky, 미국, 40506
- 모병
- College of Medicine at the University of Kentucky
-
수석 연구원:
- Michele Staton, PhD, MSW
-
-
Texas
-
Dallas, Texas, 미국, 75390
- 모병
- University of Texas Southwestern Medical Center (UTSW)
-
수석 연구원:
- Ank Nijhawan, MD, MPH
-
Fort Worth, Texas, 미국, 76109
- 모병
- Texas Christian University's (TCU) School of Medicine
-
수석 연구원:
- Kevin Knight,, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- able to provide written informed consent in English or Spanish;
- living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);
- Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);
- willing to have HIV testing to determine negative or positive status;
- persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and/or (ii) sharing IDU equipment with HIV positive or unknown status partner; and/or (iii) bacterial STI and;
- Having a history of opioid and/or stimulant use in the last 12 months within the community.
Exclusion Criteria:
- severe medical or psychiatric disability making participation unsafe;
- unable to provide consent.
- persons self-reporting pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Standard Patient Navigation (PN)
PNs are "near-peer" professionals who have shared lived experiences with participants and help them overcome barriers to accessing and engaging in quality care. PNs are trained and linked to PrEP/ART and SUD services. This manualized PN approach provides a complete assessment of participant needs, goal setting, and help with appointment scheduling. |
Standard of care |
|
실험적: PN + Patient Choice (PC) (PN+PC)
PNs working in the PN + PC arm will be trained to engage participants in selecting from a menu of service options in their community. This menu of SUD and HIV prevention and treatment service delivery options will be created through bolstering and working with our Community Advisory Boards (CAB). PNs will also be trained to discuss sexual and substance use history with participants in order to provide education and motivation towards starting PrEP/ART and SUD treatment. |
Standard of care Participants can select from a menu of options including brick and mortar services, Mobile Health Unit (MHU) or telehealth services. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants who initiate or re-initiate PrEP
기간: 6 months
|
Percentage of participants not living with HIV who initiate or re-initiate PrEP within the 6-month intervention period by self report |
6 months
|
|
Percentage of participants who initiate or re-initiate ART
기간: 6 months
|
Percentage of participants living with HIV who initiate or re-initiate ART within the 6-month intervention period by self report |
6 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of participants that adhere to PrEP
기간: 6 and 12 months
|
Percentage of participants that adhere to PrEP |
6 and 12 months
|
|
Percentage of participants retaining on PrEP
기간: 6 and 12 months
|
Percentage of participants retaining on PrEP |
6 and 12 months
|
|
HIV incidence
기간: 6 and 12 months
|
HIV incidence [binary] for those testing negative using rapid point of care (POC) test over time |
6 and 12 months
|
|
Percentage of participants that adhere to ART
기간: 6 and 12 months
|
Percentage of participants that adhere to ART |
6 and 12 months
|
|
ART retention
기간: 6 and 12 months
|
For persons living with HIV (PLH), ART retention [binary] |
6 and 12 months
|
|
Substance use treatment
기간: 6 and 12 months
|
Percentage of participants engaged in substance use disorder (SUD) treatment |
6 and 12 months
|
|
HIV viral suppression
기간: 6 months
|
For PLH, HIV viral suppression, for those with HIV at time of randomization: the percent who maintain or achieve HIV viral load < 200 copies/mL at 6 months |
6 months
|
|
Retention in HIV PrEP/ART
기간: 6 months
|
Retention in HIV PrEP/ART care [binary]: defined as attending 2 or more visits in 6-months |
6 months
|
|
Number of Participants Who Had Any Needle Sharing Activity to Assess HIV Risk Behavior
기간: 6 and 12 months
|
Number of Participants Who Had Any Needle Sharing Activity |
6 and 12 months
|
|
Number of Participants Who Had Sex Without a Condom to assess HIV Risk Behavior
기간: 6 and 12 months
|
Number of Participants Who Had Vaginal or Anal Sex Without a Condom |
6 and 12 months
|
|
Days of using opioids
기간: 6 and 12 months
|
Measured by Timeline Followback, which assesses self-reported alcohol and other drug use including opioid use |
6 and 12 months
|
|
Number of participants with with overdose events
기간: 6 and 12 months
|
Number of participants with non-fatal and fatal overdose events |
6 and 12 months
|
|
Percentage of participants with retention in SUD treatment
기간: 6 and 12 months
|
Retention in SUD treatment including but not exclusive to Medication for Opioid Use Disorder (MOUD) for Opioid Use Disorder (OUD) |
6 and 12 months
|
|
Quality of Life assessed using PROMIS-PROPr
기간: 6 and 12 months
|
PROMIS-PROPr assesses general societal health. Total summary score ranges from -0.022, worse than dead, to 1, perfect health. |
6 and 12 months
|
|
Change in Depression assessed using Patient Health Questionnaire-9 (PHQ-9)
기간: 6 and 12 months
|
Depression will be assessed using the PHQ-9. PHQ-9 is a 9-item validated questionnaire used to screen for depression with a range of scores from 0-45. A cumulative score of ≥10 is considered positive with lower scores indicating no or mild anxiety. |
6 and 12 months
|
|
Recidivism: Reasons
기간: 6 and 12 months
|
Number of participants per reason for arrest/ incarceration/return-to-custody |
6 and 12 months
|
|
Recidivism: Mean days in custody/incarcerated
기간: 6 and 12 months
|
Mean days in custody/incarcerated |
6 and 12 months
|
|
Recidivism: Mean days to return
기간: 6 and 12 months
|
Mean days to return to custody/incarcerated |
6 and 12 months
|
|
HIV and SU Stigma assessed using Substance Use Stigma Mechanisms Scale (SU-SMS)
기간: 6 and 12 months
|
Mean score for Enacted (6 items), Anticipated (6 items), and Internalized (6 items) scales. Each scale is scored 1-5, with higher scores indicating greater endorsement of substance use stigma |
6 and 12 months
|
|
Percentage of participants diagnosed with SUD
기간: Baseline and 12 months
|
Percentage of participants diagnosed with SUD using DSM-5 |
Baseline and 12 months
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Sandra Springer, MD, Yale University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2000037052_a
- 4R33DA060625-02 (미국 NIH 보조금/계약)
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
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