Clinical trial NCT03594305: From Obstacles to Opportunities for Family Planning in Tanzania
Official title: From Obstacles to Opportunities for Family Planning in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Fuller Theological Seminary
name: St. Paul College
First posted: 2018-07-20
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will conduct a cluster randomized trial to determine the effectiveness of an educational intervention for religious leaders in promoting uptake of family planning in Tanzania.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of family planning at village dispensaries
timeFrame: 12 months
Secondary outcomes:
measure: Pregnancy rates
timeFrame: 12 months
measure: Reasons for seeking family planning
timeFrame: 12 months
measure: Couple-years of protection
timeFrame: 12 months
Other outcomes:
Locations:
city: Mwanza
country: Tanzania
facility: St. Paul College
Study officials:
affiliation: Weill Medical College of Cornell University
name: Jennifer A Downs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: