- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02491177
Mother and Infant Visit Adherence and Treatment Engagement Study (MOTIVATE!)
22 de abril de 2021 actualizado por: University of Colorado, Denver
Maximizing Adherence and Retention for Women and Infants in the Context of Option B+
This is a 2x2 factorial cluster randomized trial of two interventions to improve retention and adherence for women and infants on Option B+.
The overall goal is to determine which intervention (or combination of interventions) maximizes antiretroviral therapy (ART) adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.The proposed study will be conducted in rural Nyanza Province, Kenya at 20 low-resource primary health care facilities and associated communities supported by Family AIDS Care and Education Services (FACES), a President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV prevention care, and treatment program, ((AIDS) acquired immune deficiency syndrome, (HIV) human immunodeficiency virus) .
The investigators will assess both process and outcome indicators using a 2x2 factorial design, in which equal numbers of clusters will be randomized to one of the interventions (community-based mentor mothers or theory-based mobile text messages), both interventions, or standard of care.
The interventions will be added to fully integrated high quality HIV and antenatal, maternal, neonatal, and child health (ANC/MNCH) services already offered at these sites.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In order to eliminate new pediatric HIV infections, save maternal lives, and simplify antiretroviral therapy (ART) implementation in settings with generalized HIV epidemics, current World Health Organization (WHO) guidance recommends lifelong triple ART for all pregnant and breastfeeding women (Option B+).
However, despite the promise of Option B+ to remove logistical barriers and to promote maternal health through life-long ART, this strategy brings challenges.
Key amongst these challenges are adherence to ART and continuous retention in HIV care, especially for women who do not require ART for their own health.
Barriers to adherence and retention in care for prevention of mother-to-child transmission (PMTCT) have been identified at the individual, interpersonal, community, and health facility levels; yet specific barriers in the context of Option B+ are not well understood.
The investigators' study will be conducted at 20 health facilities and associated communities in Nyanza Province, Kenya where Mother to Child Transmission (MTCT) rates prior to Option B+ roll-out remained near 10%, despite the wide availability of PMTCT services.
As Option B+ is scaled up in Kenya, it is essential to identify effective methods to ensure long-term adherence and retention in care for mother-baby pairs, throughout pregnancy, breastfeeding, and beyond.
Building on the investigating team's prior research experience in this setting, the investigators propose to gain understanding of and address potential barriers at the individual, community, and health facility levels through formative research with HIV-positive pregnant and postpartum women, their male partners, and health care providers.
This information will be used to refine two proposed interventions that are highly likely to maximize ART adherence and retention in care among HIV-infected pregnant women and HIV-exposed infants.
These interventions will be rigorously tested in rural Kenya, using a cluster randomized 2x2 factorial design.
The evidence-based interventions to be tested will include 1) community Mentor Mothers (cMM) who will provide support for ART adherence and retention in care for HIV-positive women in the community and 2) individually tailored, theory based mobile phone text messages to help retain women and infants in HIV care.
The investigators' overall goal is to determine which intervention (or combination of interventions) maximizes ART adherence and retention in care in the context of Option B+ and thus improves maternal and infant health outcomes.
The investigators' primary outcomes will include ART adherence at 12 months postpartum and retention in care, measured by a documented HIV care visit within 90 days prior to 12 months postpartum.
Secondary outcomes will include MTCT at 6 weeks, 12 months and 18 months; as well as maternal viral loads and CD4 counts.
Results from this study will inform the scale-up of Option B+ in Kenya by identifying effective interventions and combinations of interventions that can reduce barriers and increase facilitators of optimal ART adherence and retention in care with the aims of reaching the elimination of mother to child transmission of HIV and significantly improving maternal health.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1338
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
-
-
-
Nairobi, Kenia
- Kenya Medical Research Institute
-
-
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:
- Age 18 years or older,
- HIV-infected pregnant women and their HIV-exposed infants pairs,
- attends the antenatal care (ANC) clinic at one of the study sites.
Exclusion Criteria:
- Less than 18 years of age,
- HIV-infected women not currently pregnant,
- not HIV-infected at the time of the first ANC visit.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Otro: cMM and Text Messaging
Participants randomized to this arm will receive both the community mentor mother and mobile phone text messaging intervention.
The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits.
The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language.
|
Home visits from community mentor mothers
Text messages received on mobile phone
|
Otro: cMM Only
Participants randomized to this arm will receive the community mentor mother intervention only.The community mentor mother intervention will consist of home visits conducted by the community mentor mother who will assist with safe disclosure, support safe infant feeding, promote safer sex and family planning, encourage early infant testing and follow up, and promote ART adherence and return for HIV care visits.
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Home visits from community mentor mothers
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Otro: Text Messaging Only
Participants randomized to this arm will receive the mobile phone text messaging intervention only.
The text messaging intervention will entail participants receiving tailored mobile phone text messages at their preferred frequency and in their preferred language.
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Text messages received on mobile phone
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Sin intervención: Neither cMM nor Text Messaging
Participants randomized to this arm will receive standard of care with no interventions.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Self-reported adherence on antiretroviral therapy
Periodo de tiempo: 12 months post-partum
|
Self-report
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12 months post-partum
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Adherence on antiretroviral therapy
Periodo de tiempo: 12 months post-partum
|
Viral load<100 copies/ml based on medical records
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12 months post-partum
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Adherence on antiretroviral therapy (infant)
Periodo de tiempo: 12 months post-partum
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Use of ARVs for the infant
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12 months post-partum
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Retention in care
Periodo de tiempo: 12 months post-partum
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Proportion of women who have an HIV care visit within 90 days at 12 months after the birth
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12 months post-partum
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Adherence on antiretroviral therapy (dried blood spots)
Periodo de tiempo: 12 months post-partum
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Viral load<100 copies/ml based on dried blood spots
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12 months post-partum
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Maternal CD4 count change
Periodo de tiempo: 6 months after baseline
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Change in CD4 count baseline to 6 months after baseline
|
6 months after baseline
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Maternal viral load count change
Periodo de tiempo: 6 months after baseline
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Change in viral load from baseline to 6 months after baseline
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6 months after baseline
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Infant retention in care (feeding method)
Periodo de tiempo: 12 and 18 months
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Infant feeding method
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12 and 18 months
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Infant retention in care
Periodo de tiempo: 12 and 18 months
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Retention in care through 12 and 18 months
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12 and 18 months
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Infant retention in care (survival status)
Periodo de tiempo: 12 and 18 months
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Survival status of infant
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12 and 18 months
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Uptake of intervention services (Number/types of text messages sent)
Periodo de tiempo: 3 years
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Number/types of text messages sent
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3 years
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Uptake of intervention services (receipt of text messages)
Periodo de tiempo: 3 years
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Receipt of text messages
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3 years
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Uptake of intervention services (home visits)
Periodo de tiempo: 3 years
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Number of home visits received
|
3 years
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Uptake of intervention services (support groups attended)
Periodo de tiempo: 3 years
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Number of support groups attended.
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3 years
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Mother-to-Child-Transmission
Periodo de tiempo: 6 weeks, 9 months and 18 months
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Result of infant HIV test at 6 wks, 9,18 months
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6 weeks, 9 months and 18 months
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Infant testing
Periodo de tiempo: 6 weeks, 9 months and 18 months
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Uptake and date of infant testing
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6 weeks, 9 months and 18 months
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Infant enrollment in care
Periodo de tiempo: 6 weeks
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Infant enrollment in HIV care
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6 weeks
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Male partner involvement
Periodo de tiempo: 12 months post-partum
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Composite variable including Y/N response to indicate if male partner attended a health visit with his female partner, encouraged facility delivery, reminded to take HIV medication, reminded to go for HIV care, provided transport money to go to the clinic/dispensary, reminded to give the infant prophylaxis, helped giving the infant prophylaxis medication, collected medication for the woman or infant, encouraged specific infant feeding, and encouraged pediatric HIV testing.
These are assessed in the follow-up questionnaires completed at 12 months post-partum.
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12 months post-partum
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa Abuogi, MD, MSc, University of Colorado, Denver
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
- Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
- Abuogi LL, Onono M, Odeny TA, Owuor K, Helova A, Hampanda K, Odwar T, Onyango D, McClure LA, Bukusi EA, Turan JM. Effects of behavioural interventions on postpartum retention and adherence among women with HIV on lifelong ART: the results of a cluster randomized trial in Kenya (the MOTIVATE trial). J Int AIDS Soc. 2022 Jan;25(1):e25852. doi: 10.1002/jia2.25852.
- Helova A, Onono M, Abuogi LL, Hampanda K, Owuor K, Odwar T, Krishna S, Odhiambo G, Odeny T, Turan JM. Experiences, perceptions and potential impact of community-based mentor mothers supporting pregnant and postpartum women with HIV in Kenya: a mixed-methods study. J Int AIDS Soc. 2021 Nov;24(11):e25843. doi: 10.1002/jia2.25843.
- Onono M, Odwar T, Wahome S, Helova A, Bukusi EA, Hampanda K, Turan J, Abuogi L. Behavioral Interventions can Mitigate Adverse Pregnancy Outcomes Among Women Conceiving on ART and Those Initiated on ART During Pregnancy: Findings From the MOTIVATE Trial in Southwestern Kenya. J Acquir Immune Defic Syndr. 2021 Jan 1;86(1):46-55. doi: 10.1097/QAI.0000000000002521.
- Wanga I, Helova A, Abuogi LL, Bukusi EA, Nalwa W, Akama E, Odeny TA, Turan JM, Onono M. Acceptability of community-based mentor mothers to support HIV-positive pregnant women on antiretroviral treatment in western Kenya: a qualitative study. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):288. doi: 10.1186/s12884-019-2419-z.
- Odeny TA, Onono M, Owuor K, Helova A, Wanga I, Bukusi EA, Turan JM, Abuogi LL. Maximizing adherence and retention for women living with HIV and their infants in Kenya (MOTIVATE! study): study protocol for a randomized controlled trial. Trials. 2018 Jan 29;19(1):77. doi: 10.1186/s13063-018-2464-3.
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 mayo de 2014
Finalización primaria (Actual)
1 de abril de 2019
Finalización del estudio (Actual)
1 de marzo de 2021
Fechas de registro del estudio
Enviado por primera vez
11 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de julio de 2015
Publicado por primera vez (Estimar)
7 de julio de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de abril de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Palabras clave
- Retención en el cuidado
- Salud infantil
- Vinculación a la atención
- Transmisión vertical
- Diagnóstico infantil temprano
- Transmisión del VIH
- Adherencia a la terapia antirretroviral
- Prevención de la transmisión de madre a hijo
- Madres Mentoras de la Comunidad
- Mobile phone text messaging
- CD4/cargas virales maternas
- Aceptabilidad de las intervenciones
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones transmitidas por la sangre
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades del sistema inmunológico
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
Otros números de identificación del estudio
- 14-0331
- R01HD080477-01 (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
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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