An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R) in Nyanza, Kenya (AdaPT-R)
11 de marzo de 2021 actualizado por: University of California, San Francisco
An Adaptive Strategy for Preventing and Treating Lapses of Retention in Adult HIV Care (AdaPT-R)
Retaining HIV-infected patients in care is critical, but loss to follow-up after enrolment often reaches 20%-40% by two years, placing millions of patients at risk of poor outcomes.
A strategy to optimize retention within resource constraints is urgently needed.
Sequential adaptive strategies - a novel class of public health approaches - may offer a solution.
A candidate sequential adaptive strategy would start with a less expensive intervention (e.g., SMS) in all patients and then apply a more costly and intensive one (e.g., navigator) only to patients who show early signs of poor retention.
This study involves a sequential multiple assignment randomized trial to evaluate a family of such strategies.
the investigators will randomize 1,800 adults newly initiating antiretroviral treatment (ART) at 4 HIV clinics in the Nyanza region of Kenya to (1) standard of care routine education and counselling (REC), (2) SMS text messages, or (3) transport vouchers.
Patients with early signs of weakening retention (defined as the first time a patient is 14 days late for an appointment) will be re-randomized to (1) a single episode of outreach (standard of care), (2) SMS combined with vouchers, or (3) a peer navigator.
Patients not successfully contacted by 28 days after missed visit (and not verified to have left the area or transferred to another clinic) will also be rerandomized to of one the same three re-engagement interventions.
Individuals randomized at first stage to SMS or voucher that do not miss a visit by at least 14 days in the first 12 months of follow up will be re-randomized at 12 months to stop first stage intervention or continue with that same intervention to 24 months.
The investigators primary objective is to assess the comparative effectiveness of sequenced intervention strategies to prevent initial lapses in retention and to treat those that occur.
The investigators primary endpoint is fraction of time retained in care two years after enrolment.
In addition, the investigators will assess the comparative effectiveness of first-stage strategies (REC, SMS, voucher) to prevent lapses in retention, and the comparative effectiveness of second stage strategies (outreach, SMS + voucher, navigator) to re-engage patients after initial lapse.
This study will also compare outcomes among patients who continue versus discontinue the SMS and voucher interventions, including a small complementarity component utilizing qualitative methods to examine the voucher approach and the effects of discontinuing this approach after success among a subset of participants.
At study conclusion the investigators output will be a menu of adaptive strategies for retention, accompanied by estimates of cost and effectiveness, which policy makers in different settings can use to advance the impact of HIV care and treatment programs in Africa.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
- Conductual: REC; Outreach if Failure
- Conductual: REC; SMS + Voucher if Failure
- Conductual: REC; Navigator if Failure
- Conductual: SMS; Outreach if Failure
- Conductual: SMS; Outreach if Failure; Stop SMS if Success
- Conductual: SMS; SMS+Voucher if Failure
- Conductual: SMS; SMS+Voucher if Failure; Stop SMS if Success
- Conductual: SMS; Navigator if Failure
- Conductual: SMS; Navigator if Failure; Stop SMS if Success
- Conductual: Voucher; Outreach if Failure
- Conductual: Voucher; Outreach if Failure; Stop Voucher if Success
- Conductual: Voucher; SMS+Voucher if Failure
- Conductual: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
- Conductual: Voucher; Navigator if Failure
- Conductual: Voucher; Navigator if Failure; Stop Voucher if Success
Tipo de estudio
Intervencionista
Inscripción (Actual)
1816
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.
Ubicaciones de estudio
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Nyanza
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Kisumu, Nyanza, Kenia
- Kenya Medical Research Institute
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- HIV-infection
- 18 years old
- Planning to remain in the study area (Nyanza region) for the duration of the study, capable of informed consent
- Newly initiating ART (within past 90 days)
- Access to a cell phone
- Ability to read or be read SMS messages
- And willingness to be contacted by clinic upon missed appointment.
Exclusion Criteria:
- Plans to move out of Nyanza region or acutely ill and requiring hospitalization.
- Hospitalized patients who later recover will be eligible for enrolment at the first post-hospitalization clinic visit during which eligibility criteria are met.
- No access to a cell phone.
- Involvement in studies with the potential to influence retention behaviors.
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: REC; Outreach if Failure
|
Routine education and counseling (REC) services, delivered per Kenya Ministry of Health Guidelines; followed by standard of care (SOC) outreach to encourage return to clinic for patients 14 days late for a scheduled visit in year 1.
|
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Comparador activo: REC; SMS + Voucher if Failure
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Routine education and counseling services, delivered per Kenya Ministry of Health (MOH) Guidelines; followed by SMS text messages for patients and reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
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Comparador activo: REC; Navigator if Failure
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REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
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|
Comparador activo: SMS; Outreach if Failure
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SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
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Comparador activo: SMS; Outreach if Failure; Stop SMS if Success
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SMS text messages for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
|
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Comparador activo: SMS; SMS+Voucher if Failure
|
SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
|
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Comparador activo: SMS; SMS+Voucher if Failure; Stop SMS if Success
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SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1, and discontinuation of SMS text messages if never 14 days late
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Comparador activo: SMS; Navigator if Failure
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SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
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Comparador activo: SMS; Navigator if Failure; Stop SMS if Success
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SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
|
|
Comparador activo: Voucher; Outreach if Failure
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit
|
|
Comparador activo: Voucher; Outreach if Failure; Stop Voucher if Success
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
|
|
Comparador activo: Voucher; SMS+Voucher if Failure
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit
|
|
Comparador activo: Voucher; SMS+Voucher if Failure; Stop Voucher if Success
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
|
|
Comparador activo: Voucher; Navigator if Failure
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
|
|
Comparador activo: Voucher; Navigator if Failure; Stop Voucher if Success
|
Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Retention
Periodo de tiempo: Up to two years after enrollment
|
Fraction of time in care
|
Up to two years after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Alive with suppressed HIV RNA level (<400 copies/ml)
Periodo de tiempo: Two years after study enrollment
|
Number of subjects alive with suppressed HIV RNA levels (<400 copies/ml)
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Two years after study enrollment
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Time from second randomization to return to clinic after initial retention lapse
Periodo de tiempo: Up to two years after enrollment
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Time from second randomization to re-engagement; re-engagement is defined as first visit back to clinic
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Up to two years after enrollment
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Mean visit adherence (% visits made)
Periodo de tiempo: Two years after study enrollment
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Proportion of kept scheduled appointments (range=0-100%), with kept visits being those attended by the patient and with the denominator excluding canceled visits
|
Two years after study enrollment
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Retention
Periodo de tiempo: Two years after enrollment
|
Fraction of time in care
|
Two years after enrollment
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Fraction on-time pharmacy pick-ups for antiretroviral drugs
Periodo de tiempo: Two years after enrollment
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Proportion of prescriptions filled and picked up by participants to prescriptions written
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Two years after enrollment
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Cost effectiveness
Periodo de tiempo: After two years of enrollment
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Cost per failure (virological failure (HIV RNA>=400 copies/ml) or death averted
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After two years of enrollment
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Patient-reported barriers to engagement
Periodo de tiempo: At years one and two after study enrollment
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Self-reported by questionnaire
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At years one and two after study enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elvin Geng, MD, University of California, San Francisco
- Investigador principal: Maya Petersen, MD, PhD, University of California, Berkeley
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
1 de marzo de 2015
Finalización primaria (Actual)
1 de noviembre de 2020
Finalización del estudio (Actual)
1 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
11 de diciembre de 2014
Primero enviado que cumplió con los criterios de control de calidad
9 de enero de 2015
Publicado por primera vez (Estimar)
14 de enero de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
11 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1R01MH104123-01 (Subvención/contrato del NIH de EE. UU.)
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
producto fabricado y exportado desde los 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. .
Ensayos clínicos sobre VIH
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Icahn School of Medicine at Mount SinaiIRRASReclutamientoHemorragia Intraventricular (HIV)Estados Unidos
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Yale UniversityTerminadoPrecocidad | Recién nacidos de muy bajo peso al nacer | Hemorragia Intraventricular (HIV) | Sangrado en el cerebroEstados Unidos
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China Medical University HospitalDesconocidoDisplasia broncopulmonar | Bebés extremadamente prematuros | TLP grave que las terapias convencionales han fallado | Sin anomalías congénitas graves | no Hiv Severa Ni FPV QuísticaTaiwán
Ensayos clínicos sobre REC; Outreach if Failure
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Washington University School of MedicineUniversity of Colorado, Denver; University of California, Berkeley; University... y otros colaboradoresActivo, no reclutando