이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Nurse-Led PrEP Initiation Among Incarcerated Individuals (SWIFT)

2026년 8월 21일 업데이트: Rhode Island Hospital

Nurse-Led Rapid Initiation of HIV Pre-Exposure Prophylaxis Care Among Incarcerated Individuals With Continuation of Care Services Post-Incarceration

PrEP is a medication that can help prevent the spread of HIV, but many who might benefit from PrEP do not take it. Individuals experiencing incarceration are interested in starting PrEP while incarcerated, but there are challenges that make it difficult for them to start this medication when they return to the community. This study will test to see if a nurse-led, same-day PrEP start program can help individuals experiencing incarceration start and stay on PrEP. To do this, N = 90 PrEP-eligible patients during their incarceration will test the nurse-led program. Everyone will receive access to a nurse-led behavioral intervention during incarceration and information about PrEP services available in the community. Then, N = 60 participants will receive patient navigation support to help them link with PrEP care in the community and N = 30 participants will receive a list of community resources. Research interviews will be conducted with participants while they are incarcerated and 1, 3, and 6 months after they re-enter the community. Participants are offered compensation for each of the research interviews.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

90

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • Rhode Island
      • Providence, Rhode Island, 미국, 02903

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Currently incarcerated at the Rhode Island Department of Corrections
  • At least 18 years of age
  • Not currently pregnant
  • Eligible for PrEP
  • No PrEP use in the 90 days prior to incarceration
  • Interested in starting PrEP
  • Report any criminalized drug use or at least one heavy drinking day in the 90 days prior to incarceration
  • Likely to be incarcerated for more than a week but less than 6 months
  • Able to understand and speak English and provide written and verbal informed consent

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 컨트롤 암
행동: Nurse-Led Intervention

All participants will receive the nurse-led intervention. The study nurse will meet with participants twice during incarceration and deliver behavioral sessions focused on motivational interviewing and psychoeducation related to PrEP. The aim of these sessions is to enhance motivation to start PrEP following community re-entry. Anyone expressing interest in starting PrEP will be provided information about how to access PrEP care in the community with our study nurse and other community-based providers.

The study nurse will deliver same-day PrEP care services at a outpatient clinic. In this setting, the nurse will perform all of the necessary activities required to initiate a patient on same-day PrEP. These activities include, HIV testing and any other remaining recommended testing that was not performed while the participant was at RIDOC and placing an order for a PrEP prescription. All clinical activities will be supervised by a physician or a nurse-practitioner.

행동: Standard-of-care (SoC)
SOC will consist of a brochure regarding how to receive PrEP care in the community after discharge from RIDOC, which SOC participants will receive from the study nurse prior to discharge.
실험적: 실험용 암
행동: Nurse-Led Intervention

All participants will receive the nurse-led intervention. The study nurse will meet with participants twice during incarceration and deliver behavioral sessions focused on motivational interviewing and psychoeducation related to PrEP. The aim of these sessions is to enhance motivation to start PrEP following community re-entry. Anyone expressing interest in starting PrEP will be provided information about how to access PrEP care in the community with our study nurse and other community-based providers.

The study nurse will deliver same-day PrEP care services at a outpatient clinic. In this setting, the nurse will perform all of the necessary activities required to initiate a patient on same-day PrEP. These activities include, HIV testing and any other remaining recommended testing that was not performed while the participant was at RIDOC and placing an order for a PrEP prescription. All clinical activities will be supervised by a physician or a nurse-practitioner.

행동: Patient Navigation Intervention
Participants randomly assigned to the experimental arm will receive a warm handoff from the study nurse to the patient navigator (PN), in which they will be introduced by the nurse to the PN prior to discharge. NAV participants will receive 6 monthly phone calls, or alternate means of contact (texts, emails, HIPAA compliant videoconferencing) if preferred by participant, from the PN and access to navigation services for 6 months. Navigation services include: assistance with health insurance issues, facilitating transfer of medical records, scheduling PrEP care appointments, and facilitating linkage to substance use treatment and mental health services as appropriate. In addition, the PN will remind participants of PrEP care appointments, arrange transportation to appointments as needed, and attend the first PrEP care appointment if desired by participant. The PN can also provide information regarding other community-based resources.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Linkage to Community-Based PrEP Care assessed with medical record review
기간: 1, 3, & 6-Month Follow-ups
Operationalized as receipt of prescription from a community-based provider within 6 months of release from incarceration. This will be verified through medical record review.
1, 3, & 6-Month Follow-ups
Intervention Feasibility assessed with Exit Interviews
기간: 6-Month Follow-up
Participant eligibility rate, enrollment rate, rate of recruitment, and follow-up completion rate will serve as indices of intervention feasibility and will be compiled at the conclusion of the study. In exit interviews with NAV participants, feedback will be solicited regarding the feasibility of the intervention.
6-Month Follow-up
Intervention Acceptability assessed with the Client Satisfaction Questionnaire-Revised
기간: 6-Month Follow-up
The 8-item Client Satisfaction Questionnaire-Revised will be administered to participants to assess intervention acceptability. Total scores range from 8 to 32, with higher scores representing greater intervention acceptability.
6-Month Follow-up

2차 결과 측정

결과 측정
측정값 설명
기간
PrEP Care Retention
기간: 3 & 6-Month Follow-up
Retention in care is defined as attending a clinical appointment 3 months (+/- 1 month) after an initial PrEP care appointment. These data will be captured via medial record review.
3 & 6-Month Follow-up
PrEP Adherence assessed with 3-item adherence measure
기간: 1, 3, & 6-Month Follow-up
PrEP adherence will be assessed via Wilson et al.'s 3-item adherence measure. This assessment is widely used and boasts favorable psychometric properties. Scores range from 0 to 30, with higher scores representing greater PrEP adherence.
1, 3, & 6-Month Follow-up

기타 결과 측정

결과 측정
측정값 설명
기간
Alcohol Use assessed with the Timeline Followback
기간: Baseline, 1, 3, & 6-Month Follow-up
The number of standard drinks consumed per day will be assessed with the Timeline Followback (TLFB) interview. The TLFB is a calendar-assisted structured interview which provides a way to cue memory and enhance recall. This data collection method has excellent reliability and validity.
Baseline, 1, 3, & 6-Month Follow-up
Drug Use assessed with the Timeline Followback
기간: Baseline, 1, 3, & 6-Month Follow-up
The class of drugs used each day will be assessed with the Timeline Followback (TLFB) interview. The TLFB is a calendar-assisted structured interview which provides a way to cue memory and enhance recall. This data collection method has excellent reliability and validity.
Baseline, 1, 3, & 6-Month Follow-up
HIV-Related Risk Behavior assessed with the HIV Risk Assessment Battery
기간: Baseline, 1, 3, & 6-Month Follow-up
The HIV Risk Assessment Battery (RAB) will be administered at each assessment period to capture participants' overall HIV acquisition risk. The RAB is a standardized measure with strong psychometric properties. Total scores range from 0 to 40, with higher scores representing greater HIV risk.
Baseline, 1, 3, & 6-Month Follow-up
Depressive Symptoms assessed with the Center for Epidemiologic Studies Depression Scale
기간: Baseline, 1, 3, & 6-Month Follow-up
The Center for Epidemiologic Studies Depression Scale (CES-D) will be used to assess depressive symptoms at baseline and follow-ups. This 20-item measure is widely used and has strong psychometric properties. Total scores range from 0 to 60, with higher scores representing greater depressive symptoms.
Baseline, 1, 3, & 6-Month Follow-up
Knowledge Regarding PrEP assessed with a PrEP Knowledge Questionnaire
기간: Baseline, 1, 3, & 6-Month Follow-up
PrEP knowledge will be assessed with a slightly-adapted 5-item measure that was developed to assess knowledge regarding PrEP. Scores range from 0 to 13, with higher scores representing greater PrEP knowledge.
Baseline, 1, 3, & 6-Month Follow-up
Attitudes and Beliefs Regarding PrEP Use assessed with PrEP Attitudes Survey
기간: Baseline, 1, 3, & 6-Month Follow-up
Attitudes and beliefs (norms, self-efficacy, and stigma) related to PrEP will be assessed with an adapted 9-item survey utilized in previous PrEP research. Scores range from 0 to 27, with higher scores representing greater stigmatizing attitudes related to PrEP.
Baseline, 1, 3, & 6-Month Follow-up
Treatment Received assessed with the Treatment Services Review
기간: Baseline, 1, 3, & 6-Month Follow-up
Receipt of case management, HIV/STI risk reduction counseling, mental health, substance use, and other treatment services will be assessed with the Treatment Services Review (TSR). This is a semi-structured method of assessing different types of treatment received. The number of times different types of treatment were utilized will be captured for each time period.
Baseline, 1, 3, & 6-Month Follow-up
Use of Medications assessed with semi-structured interview
기간: Baseline, 1, 3, & 6-Month Follow-up
Participants will be asked to provide information regarding their use of medications for medical, psychiatric, or substance use indications. The number of medications for each category (medical, psychiatric, and substance use indications) will be captured at each time point.
Baseline, 1, 3, & 6-Month Follow-up
Pregnancies assessed with semi-structured interview
기간: Baseline, 1, 3, & 6-Month Follow-up
Participants will also be asked about any pregnancies they have experienced.
Baseline, 1, 3, & 6-Month Follow-up
Reasons for PrEP Care Linkage/Non-Linkage assessed with qualitative exit interview
기간: 6-Month Follow-up
Brief qualitative exit interviews will be conducted with NAV participants (n = 60). These participants will be asked to reflect on factors that impacted their use or non-use of PrEP while incarcerated and after release and about other HIV risk reduction strategies used. Participants who linked with a community-based PrEP care provider will be asked about the decision process for their PrEP formulation choice (daily oral vs. long acting). Lastly, we will ask about perceived utility of the nurse-led and NAV intervention components and suggested changes.
6-Month Follow-up
Mistrust of Medial Organizations assessed with the Medical Mistrust Index
기간: Baseline, 1, 3, & 6-Month Follow-up
Mistrust of medical organizations will be assessed with the Medical Mistrust Index (MMI) The MMI is well suited for assessing medical mistrust of organizations and has been validated among various racial and ethnic groups. Scores range from 7 to 28, with higher scores representing greater mistrust of medical organizations.
Baseline, 1, 3, & 6-Month Follow-up
Mistrust of Medical Personnel assessed with the Group Based Medical Mistrust Scale
기간: Baseline, 1, 3, & 6-Month Follow-up
Mistrust of medical personnel will be assessed with the Group Based Medical Mistrust Scale (GBMMS). The GBMMS boasts strong psychometric properties and has been validated in various racial and ethnic groups. Scores range from 12 to 60, with higher scores representing greater mistrust of medical personnel.
Baseline, 1, 3, & 6-Month Follow-up

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Rhode Island Hospital

수사관

  • 수석 연구원: Susan Ramsey, PhD, Rhode Island Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 6월 30일

연구 완료 (추정된)

2028년 4월 30일

연구 등록 날짜

최초 제출

2026년 8월 18일

QC 기준을 충족하는 최초 제출

2026년 8월 21일

처음 게시됨 (실제)

2026년 8월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 21일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • R34DA061656 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다