- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03594305
From Obstacles to Opportunities for Family Planning in Tanzania
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Mwanza, Tanzania
- St. Paul College
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
|
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.
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Uptake of family planning at village dispensaries
Tijdsspanne: 12 months
|
The investigators will measure the percent of the population seeking modern contraception.
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Pregnancy rates
Tijdsspanne: 12 months
|
The investigators will obtain pregnancy rates for the village stratified by age.
|
12 months
|
Reasons for seeking family planning
Tijdsspanne: 12 months
|
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.
|
12 months
|
Couple-years of protection
Tijdsspanne: 12 months
|
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)
|
12 months
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 1605017246
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Educational seminar
-
University of Witten/HerdeckeFH Münster University of Applied Sciences; The Witten Institute For Family BusinessWervingPsychologisch en systeemfunctionerenDuitsland
-
Assuta Hospital SystemsVoltooid
-
Technical University of MunichMoving - ab jetzt gesund GmbHVoltooidEndotheliale functie (reactieve hyperemie)Duitsland
-
Teesside UniversityConnect Health LtdVoltooid
-
Joel ThompsonVoltooidJuveniel primair fibromyalgiesyndroomVerenigde Staten
-
Université de MontréalOnbekendChirurgische opleiding | Geavanceerde hechtvaardigheden
-
Stanford UniversityActief, niet wervendVeerkracht, psychisch | Draagbare apparaten | Psychologische Welzijn | Persoonlijke en professionele vervulling | MultiomicsVerenigde Staten
-
University of AberdeenVoltooid
-
Happy Nation SocietyVoltooidVerbeter de geestelijke gezondheid
-
University of California, Los AngelesNational Institute on Aging (NIA)Voltooid