- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03594305
From Obstacles to Opportunities for Family Planning in Tanzania
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this community randomized trial, the investigators will randomize 12 rural villages to receive an educational seminar for their religious leaders about family planning. The investigators will compare these uptake of family planning in these 12 villages with 12 matched villages whose religious leaders do not attend an educational seminar about family planning. The investigators will also determine women's reasons for seeking family planning at the village dispensaries..
Prior to the start of the trial, the study team will ensure that dispensaries in all villages in the trial will have a reliable supply of contraceptive options. To mitigate the effect of economic barriers and medication shortages on access to contraception, a dedicated medication supply team will make certain that all dispensaries remain well-stocked with standard contraceptives that are free from the Tanzanian Ministry of Health. These include oral contraceptive pills, implants, injections, copper intrauterine devices, and condoms.
Villages will be paired by proximity (within 50 kilometers of one another). Within the pair, one village will be randomly assigned, using a computer-generated algorithm, to receive the intervention of religiously- and culturally-informed teaching intervention about family planning for religious leaders. The other village will be the control village. Each intervention village will be followed, and its religious leaders mentored in groups, for 12 months after the start of the intervention. Mentorship groups of 25 leaders, led by the study team, will meet for 1 hour per month. The investigators will also conduct focus groups in both intervention and control villages to understand community perceptions of family planning.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Mwanza, Tanzania
- St. Paul College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Rural villages in northwest Tanzania with populations between 8,000 and 20,000
- Village dispensaries present to measure uptake of family planning
- Located in close proximity (50 km or less) to another eligible village with which it can be paired
Exclusion Criteria:
- Private dispensaries at which family planning uptake would be missed
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Educational Intervention Arm
Villages randomized to this arm will receive a one-day educational seminar, which their religious leaders of all denominations will be invited to attend.
The seminar will address religious, cultural, and medical aspects of family planning.
Leaders who attend will also have the opportunity to participate in mentorship group discussions after the intervention.
In addition, both villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured.
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Religious leaders will be invited to participate in a one-day seminar led by Tanzanian religious leaders and physicians.
The religious, cultural, and medical aspects of family planning will be discussed and seminar attendees will be given ample time for group discussions.
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Sin intervención: Control arm
Villages randomized to this arm will not receive the educational seminar.
These villages will have standard teaching provided by nurses at dispensaries about family planning, and a continual supply of contraceptive options at dispensaries in all villages will be ensured.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Uptake of family planning at village dispensaries
Periodo de tiempo: 12 months
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The investigators will measure the percent of the population seeking modern contraception.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pregnancy rates
Periodo de tiempo: 12 months
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The investigators will obtain pregnancy rates for the village stratified by age.
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12 months
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Reasons for seeking family planning
Periodo de tiempo: 12 months
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Women seeking family planning will answer a short structured yes/no questionnaire to determine the sources from which they were encouraged to seek family planning.
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12 months
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Couple-years of protection
Periodo de tiempo: 12 months
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The investigators will use the types of family planning accessed to calculate couple-years of protection per given population number, according to conversion numbers provided by USAID (https://www.usaid.gov/what-we-do/global-health/family-planning/couple-years-protection-cyp)
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12 months
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1605017246
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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Ensayos clínicos sobre Educational seminar
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Terminado