Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
Task-shifting to lower-cadre providers at PMTCT sites
+ POC CD4+ cell count testing
+ integrated mother-infant care
Infecciones Transmitidas por la Sangre+12
+ Enfermedades Urogenitales
+ Enfermedades Genitales
Estudio de Prevención
Resumen
Fecha de inicio: 1 de marzo de 2013
Fecha en la que se inscribió al primer participante.The investigators propose a parallel cluster randomized trial to evaluate the effects of the intervention. Twelve primary and secondary level health care facilities in Niger State will be randomized to the control (standard-of-care) or intervention arms. The investigators will match clinics on patient volume and level of facility and randomize to intervention and standard-of-care/control arms - 6 clinics per arm. The investigators will make the proposed intervention available to all eligible women attending clinics that are randomized to the intervention arm. The drug regimens and general HIV care services provided as part of the package are standard of care, based on Nigerian national guidelines. Inclusion Criteria: (1) HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; (2) HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery. Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC. Home-based care (HBC) workers will track clients who miss appointments at control and intervention sites. The HBC workers will document clients as terminated care if they: (1) discontinued services due to death or personal decision; (2) transferred their care to another clinic; or (3) are lost to follow-up (defined as being 90 days late for a clinic appointment plus 5 failed attempts at tracking the client). Clients will not receive any remuneration for participating in the study. Clients will be allowed to discontinue participation and decide that their medical data cannot be used in the analysis.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 369 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery. Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Sin IntervenciónObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 12 ubicaciones
Rural Hospital
Auna, NigeriaMCH Chanchaga
Chanchaga, NigeriaNCWS Farin Doki
Farin Doki, Nigeria