Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)
17 de mayo de 2022 actualizado por: Professor Landon Myer, University of Cape Town
Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+").
There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period.
The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
Descripción general del estudio
Descripción detallada
South Africa is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities.
However, there are few well developed models of service delivery to support implementation.
There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally.
Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care.
ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART.
The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy.
Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
Tipo de estudio
Intervencionista
Inscripción (Actual)
412
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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Western Cape
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Cape Town, Western Cape, Sudáfrica, 7750
- Gugulethu Community Health Centre
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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
Femenino
Descripción
Inclusion Criteria:
- Documented HIV infection with ART initiation during the preceding antenatal period
- Within 70 days post-delivery
- Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
- Willingness to be randomised and return for study measurement visits
- Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
- Able to provide informed consent for research
Exclusion Criteria:
- Intention to relocate out of Cape Town permanently during the study period
- Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study including: refusal to take ART/antiretrovirals (ARVs) and/or denial of HIV status
- Loss of pregnancy/neonate at the time of eligibility determination
- Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Clinic-based Care
Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services.
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Experimental: Adherence Club Care
Adherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses.
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Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC).
AC visits occur 2-4 monthly at a community hall near the CHC.
At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART.
Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse.
A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit.
Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Viral suppression
Periodo de tiempo: 24 months
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Time to viral load >1000 copies per ml
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24 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Maternal retention in care
Periodo de tiempo: 24 months
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Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
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24 months
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Maternal death
Periodo de tiempo: 24 months
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Maternal deaths over the study period
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24 months
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Maternal mental health
Periodo de tiempo: 24 months
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Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
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24 months
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Maternal health care service use
Periodo de tiempo: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant death
Periodo de tiempo: 24 months
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Infant deaths over the study period
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24 months
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Infant health care service use
Periodo de tiempo: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant HIV testing
Periodo de tiempo: 24 months
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Uptake of routine infant HIV testing
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24 months
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Infant HIV infection
Periodo de tiempo: 24 months
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Mother-to-child transmission of HIV
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24 months
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Infant feeding
Periodo de tiempo: 24 months
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Breastfeeding practices
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24 months
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Cost and cost-effectiveness
Periodo de tiempo: 24 months
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Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
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24 months
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Acceptability of each ART service
Periodo de tiempo: 24 months
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Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
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24 months
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Viral suppression at other cutpoints (>400 copies/mL)
Periodo de tiempo: 24 months
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Time to VL >400 copies/mL
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24 months
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Viral suppression at other cutpoints (>50 copies/mL)
Periodo de tiempo: 24 months
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Time to VL >50 copies/mL
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24 months
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Virologic Failure
Periodo de tiempo: 24 months
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Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
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24 months
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Combined retention/VL outcome
Periodo de tiempo: 24 months
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Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
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24 months
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Viral suppression at each study visit
Periodo de tiempo: 24 months
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VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
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24 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Landon Myer, MBChB PhD, University of Cape Town
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13.
- Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f.
- Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee.
- Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. No abstract available.
- Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z.
- Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
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 (Actual)
1 de enero de 2016
Finalización primaria (Actual)
1 de enero de 2020
Finalización del estudio (Actual)
1 de noviembre de 2020
Fechas de registro del estudio
Enviado por primera vez
21 de marzo de 2017
Primero enviado que cumplió con los criterios de control de calidad
23 de junio de 2017
Publicado por primera vez (Actual)
27 de junio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
17 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
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. .
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