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Nurse-Led PrEP Initiation Among Incarcerated Individuals (SWIFT)

2026年8月21日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

  • アメリカ
    • Rhode Island
      • Providence、Rhode Island、アメリカ、02903

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：コントロールアーム
行動：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.

行動：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.
実験的：実験アーム
行動：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.

行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Linkage to Community-Based PrEP Care assessed with medical record review
時間枠：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
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
PrEP Care Retention
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Alcohol Use assessed with the Timeline Followback
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Rhode Island Hospital

捜査官

  • 主任研究者：Susan Ramsey, PhD、Rhode Island Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2027年6月30日

研究の完了 (推定)

2028年4月30日

試験登録日

最初に提出

2026年8月18日

QC基準を満たした最初の提出物

2026年8月21日

最初の投稿 (実際)

2026年8月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月24日

QC基準を満たした最後の更新が送信されました

2026年8月21日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • R34DA061656 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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