From Obstacles to Opportunities for Family Planning in Tanzania

Contraception Behavior Clinical Trial

Official title:

From Obstacles to Opportunities for Family Planning in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594305
• Other study ID #: 1605017246
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: June 2, 2022

Study information

• Verified date: January 2023
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2, 2022
• Est. primary completion date: December 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

Behavioral:
• Educational seminar
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.

Locations

Country	Name	City	State
Tanzania	St. Paul College	Mwanza

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Fuller Theological Seminary, St. Paul College

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of family planning at village dispensaries	The investigators will measure the percent of the population seeking modern contraception.	12 months
Secondary	Pregnancy rates	The investigators will obtain pregnancy rates for the village stratified by age.	12 months
Secondary	Reasons for seeking family planning	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
Secondary	Couple-years of protection	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