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Completed

NCT Number: NCT03594305

From Obstacles to Opportunities for Family Planning in Tanzania

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.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Paul College

Mwanza, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational seminar

Behavioral

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.

Primary outcomes

  1. Uptake of family planning at village dispensaries

    Time frame: 12 months

    The investigators will measure the percent of the population seeking modern contraception.

Secondary outcomes

  1. Pregnancy rates

    Time frame: 12 months

    The investigators will obtain pregnancy rates for the village stratified by age.

  2. Reasons for seeking family planning

    Time frame: 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.

  3. Couple-years of protection

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Fuller Theological Seminary
  • St. Paul College

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Jul 20, 2018
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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