Healthy Beginning Initiative (HBI)
30 de noviembre de 2015 actualizado por: University of Nevada, Reno
Comparative Effectiveness of Congregation and Clinic Based Approaches to Prevention of Mother to Child Transmission of HIV
The purpose of this study is to determine if providing free laboratory test to pregnant women and their spouses at churches, in addition to laboratories or hospitals, will increase the number of pregnant women and their spouses who get screened for HIV, malaria, sickle cell trait, hemoglobin levels, syphilis, and hepatitis B. These tests are necessary to keep mothers healthy during pregnancy and lead to healthy babies.
This research is taking place in 40 churches in Nigeria.
Descripción general del estudio
Estado
Desconocido
Condiciones
Descripción detallada
We are conducting a randomized trial to evaluate the comparative effectiveness of a congregation-based Healthy Beginning Initiative (HBI) delivered by lay health advisors (Intervention Group; IG), versus a Facility Based Approach (Control Group; CG) on the HIV testing rate and PMTCT completion among 2,700 pregnant women.
Four dioceses with forty churches nested in the dioceses, will be randomly assigned to either the IG (N=2; n=20) or the CG (N=2; n=20).
The HBI combines a family educational game show and an integrated on-site laboratory testing in the context of a baby shower.
Monthly prayer sessions for pregnant women will be used for recruitment and a baby reception following infant baptisms will be used for follow up after delivery.
The primary outcome is difference in testing rate among pregnant women in IG compared to CG.
The secondary outcomes are HIV testing rate among male partners and PMTCT completion among HIV-infected pregnant women.
Pregnant women will complete an investigator-administered questionnaire at the baby reception to collect information on HIV testing and PMTCT completion.
Data will be confirmed with Health Facilities and on-site testing data.
This proposal is a collaboration among Partners for Prevention, education, Training, Treatment and Research (PeTR-Global Solutions)/AIDSRelief (our PEPFAR-funded partner in Nigeria responsible for training, HIV testing, linkage to treatment and local oversight of the project); New York University School of Medicine (program evaluation and shares oversight with PI), Board of Regents, NSHE, obo University of Nevada, Reno (provide overall oversight, data management and evaluation of program effectiveness).
Tipo de estudio
De observación
Inscripción (Anticipado)
5400
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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Maitama
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Abuja, Maitama, Nigeria
- PeTR Global Solutions
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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 a 40 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Pregnant women and their male partners who are 18 years and older and attend one of the 40 churches in the Enugu state of Nigeria will be eligible to participate in the study.
All participation is voluntary.
Descripción
Inclusion Criteria:
- Pregnant females 18 years and older;
- Male partners of pregnant females 18 years and older;
- Subjects must attend church at one of the participating diocese
Exclusion Criteria:
- Subjects will be excluded if they are not pregnant women or their male partners or are younger than 18 years old.
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Lifestyle counseling
Prevention of mother to child transmission of HIV
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Lifestyle counseling Male
male partners and PMTCT completion rate among HIV-infected pregnant women.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Analysis of HIV testing rates in pregnant women and their male partners in a congregation based approach compared to a health facility based approach.
Periodo de tiempo: One year
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We need to have 1,313 pregnant women in each arm of the study and follow them through pregnancy and up to 6 weeks post-delivery.
Since pregnant women will be recruited at different stages of pregnancy, we will need to end recruitment 5 months after the study is open to recruitment and allow time to follow last recruited pregnant women through 9 months of pregnancy and up to 6 weeks post-delivery (approximately 11 months).
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One year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Associations between HIV Test and Interventions and other covariates (risk factors) at individual- and community (church)-level will also be analyzed.
Periodo de tiempo: one year
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Variables include age, household income, education level, previous HIV testing, last menstrual period, marital status, and employment status.
HIV testing and PMTCT completion: will be assessed using a one-page investigator-administered questionnaire completed by pregnant women during the baby reception.
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one year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Echezona Ezeanolue, MD, University of Nevada, Reno
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
- Turan JM, Bukusi EA, Onono M, Holzemer WL, Miller S, Cohen CR. HIV/AIDS stigma and refusal of HIV testing among pregnant women in rural Kenya: results from the MAMAS Study. AIDS Behav. 2011 Aug;15(6):1111-20. doi: 10.1007/s10461-010-9798-5.
- Tubiana R, Le Chenadec J, Rouzioux C, Mandelbrot L, Hamrene K, Dollfus C, Faye A, Delaugerre C, Blanche S, Warszawski J. Factors associated with mother-to-child transmission of HIV-1 despite a maternal viral load <500 copies/ml at delivery: a case-control study nested in the French perinatal cohort (EPF-ANRS CO1). Clin Infect Dis. 2010 Feb 15;50(4):585-96. doi: 10.1086/650005.
- European Collaborative Study. Mother-to-child transmission of HIV infection in the era of highly active antiretroviral therapy. Clin Infect Dis. 2005 Feb 1;40(3):458-65. doi: 10.1086/427287. Epub 2005 Jan 7.
- Centers for Disease Control and Prevention (CDC). Achievements in public health. Reduction in perinatal transmission of HIV infection--United States, 1985-2005. MMWR Morb Mortal Wkly Rep. 2006 Jun 2;55(21):592-7.
- Nunn A, Zaller N, Cornwall A, Mayer KH, Moore E, Dickman S, Beckwith C, Kwakwa H. Low perceived risk and high HIV prevalence among a predominantly African American population participating in Philadelphia's Rapid HIV testing program. AIDS Patient Care STDS. 2011 Apr;25(4):229-35. doi: 10.1089/apc.2010.0313. Epub 2011 Mar 15.
- Monjok E, Smesny A, Essien EJ. HIV/AIDS-related stigma and discrimination in Nigeria: review of research studies and future directions for prevention strategies. Afr J Reprod Health. 2009 Sep;13(3):21-35.
- Hardon A, Vernooij E, Bongololo-Mbera G, Cherutich P, Desclaux A, Kyaddondo D, Ky-Zerbo O, Neuman M, Wanyenze R, Obermeyer C. Women's views on consent, counseling and confidentiality in PMTCT: a mixed-methods study in four African countries. BMC Public Health. 2012 Jan 11;12:26. doi: 10.1186/1471-2458-12-26.
- Franca-Martins AM, Graubard Z, Holloway GA, Van der Merwe FJ. Placental haemangioma associated with acute fetal anemia in labour. Acta Med Port. 1990 May-Jun;3(3):187-9.
- Youngleson MS, Nkurunziza P, Jennings K, Arendse J, Mate KS, Barker P. Improving a mother to child HIV transmission programme through health system redesign: quality improvement, protocol adjustment and resource addition. PLoS One. 2010 Nov 9;5(11):e13891. doi: 10.1371/journal.pone.0013891.
- Ekouevi DK, Stringer E, Coetzee D, Tih P, Creek T, Stinson K, Westfall AO, Welty T, Chintu N, Chi BH, Wilfert C, Shaffer N, Stringer J, Dabis F. Health facility characteristics and their relationship to coverage of PMTCT of HIV services across four African countries: the PEARL study. PLoS One. 2012;7(1):e29823. doi: 10.1371/journal.pone.0029823. Epub 2012 Jan 20.
- Okunlola MA, Ayinde OA, Owonikoko KM, Omigbodun AO. Factors influencing gestational age at antenatal booking at the University College Hospital, Ibadan, Nigeria. J Obstet Gynaecol. 2006 Apr;26(3):195-7. doi: 10.1080/01443610500508220.
- Adegbola O. Gestational age at antenatal booking in Lagos University Teaching Hospital (LUTH). Nig Q J Hosp Med. 2009 Jul-Sep;19(3):162-4.
- Jivegard L, Holm J, Bergqvist D, Bjorck CG, Bjorkman H, Brunius U, Claes G, Hammarsten J, Jernby B, Konrad P, et al. Acute lower limb ischemia: failure of anticoagulant treatment to improve one-month results of arterial thromboembolectomy. A prospective randomized multi-center study. Surgery. 1991 May;109(5):610-6.
- Johnson LF, Stinson K, Newell ML, Bland RM, Moultrie H, Davies MA, Rehle TM, Dorrington RE, Sherman GG. The contribution of maternal HIV seroconversion during late pregnancy and breastfeeding to mother-to-child transmission of HIV. J Acquir Immune Defic Syndr. 2012 Apr 1;59(4):417-25. doi: 10.1097/QAI.0b013e3182432f27.
- Ezeanolue EE, Obiefune MC, Ezeanolue CO, Ehiri JE, Osuji A, Ogidi AG, Hunt AT, Patel D, Yang W, Pharr J, Ogedegbe G. Effect of a congregation-based intervention on uptake of HIV testing and linkage to care in pregnant women in Nigeria (Baby Shower): a cluster randomised trial. Lancet Glob Health. 2015 Nov;3(11):e692-700. doi: 10.1016/S2214-109X(15)00195-3.
- Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
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 septiembre de 2012
Finalización primaria (Anticipado)
1 de septiembre de 2016
Finalización del estudio (Anticipado)
1 de septiembre de 2016
Fechas de registro del estudio
Enviado por primera vez
15 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
19 de febrero de 2013
Publicado por primera vez (Estimar)
20 de febrero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
2 de diciembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2015
Última verificación
1 de noviembre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1R01HD075050-01 (Subvención/contrato del NIH de EE. UU.)
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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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