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Nurse-Led PrEP Initiation Among Incarcerated Individuals (SWIFT)

21 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

90

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Braço de controle
Comportamental: 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.

Comportamental: 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.
Experimental: Braço Experimental
Comportamental: 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.

Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Linkage to Community-Based PrEP Care assessed with medical record review
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
PrEP Care Retention
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Alcohol Use assessed with the Timeline Followback
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Rhode Island Hospital

Investigadores

  • Investigador principal: Susan Ramsey, PhD, Rhode Island Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

30 de junho de 2027

Conclusão do estudo (Estimado)

30 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de agosto de 2026

Primeira postagem (Real)

24 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

24 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

21 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R34DA061656 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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