Nurse-Led PrEP Initiation Among Incarcerated Individuals (SWIFT)
21 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
90
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Susan Ramsey, PhD
- Número de teléfono: 401-444-7831
- Correo electrónico: sramsey@brownhealth.org
Copia de seguridad de contactos de estudio
- Nombre: Evan Ames
- Número de teléfono: 401-444-2474
- Correo electrónico: evan.ames@brownhealth.org
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02903
- Rhode Island Hospital
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Contacto:
- Evan Ames
- Número de teléfono: 401-444-2474
- Correo electrónico: evan.ames@brownhealth.org
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Brazo de control
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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.
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.
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Experimental: Brazo Experimental
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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.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Linkage to Community-Based PrEP Care assessed with medical record review
Periodo de tiempo: 1, 3, & 6-Month Follow-ups
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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.
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1, 3, & 6-Month Follow-ups
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Intervention Feasibility assessed with Exit Interviews
Periodo de tiempo: 6-Month Follow-up
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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.
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6-Month Follow-up
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Intervention Acceptability assessed with the Client Satisfaction Questionnaire-Revised
Periodo de tiempo: 6-Month Follow-up
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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.
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6-Month Follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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PrEP Care Retention
Periodo de tiempo: 3 & 6-Month Follow-up
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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.
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3 & 6-Month Follow-up
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PrEP Adherence assessed with 3-item adherence measure
Periodo de tiempo: 1, 3, & 6-Month Follow-up
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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.
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1, 3, & 6-Month Follow-up
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Alcohol Use assessed with the Timeline Followback
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Drug Use assessed with the Timeline Followback
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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HIV-Related Risk Behavior assessed with the HIV Risk Assessment Battery
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Depressive Symptoms assessed with the Center for Epidemiologic Studies Depression Scale
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Knowledge Regarding PrEP assessed with a PrEP Knowledge Questionnaire
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Attitudes and Beliefs Regarding PrEP Use assessed with PrEP Attitudes Survey
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Treatment Received assessed with the Treatment Services Review
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Use of Medications assessed with semi-structured interview
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Pregnancies assessed with semi-structured interview
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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Participants will also be asked about any pregnancies they have experienced.
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Baseline, 1, 3, & 6-Month Follow-up
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Reasons for PrEP Care Linkage/Non-Linkage assessed with qualitative exit interview
Periodo de tiempo: 6-Month Follow-up
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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.
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6-Month Follow-up
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Mistrust of Medial Organizations assessed with the Medical Mistrust Index
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Mistrust of Medical Personnel assessed with the Group Based Medical Mistrust Scale
Periodo de tiempo: Baseline, 1, 3, & 6-Month Follow-up
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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.
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Baseline, 1, 3, & 6-Month Follow-up
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Susan Ramsey, PhD, Rhode Island Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
30 de junio de 2027
Finalización del estudio (Estimado)
30 de abril de 2028
Fechas de registro del estudio
Enviado por primera vez
18 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de agosto de 2026
Publicado por primera vez (Actual)
24 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R34DA061656 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .