- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03594305
From Obstacles to Opportunities for Family Planning in Tanzania
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Mwanza, Tanzania
- St. Paul College
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Uptake of family planning at village dispensaries
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Pregnancy rates
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- 1605017246
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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