From Obstacles to Opportunities for Family Planning in Tanzania

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03594305
Collaborator
Fuller Theological Seminary (Other), St. Paul College (Other)
24
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2
52.4
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Educational seminar
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.
Masking:
Single (Participant)
Primary Purpose:
Health Services Research
Official Title:
From Obstacles to Opportunities for Family Planning in Tanzania
Actual Study Start Date :
Aug 20, 2018
Actual Primary Completion Date :
Dec 12, 2021
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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.

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

  1. Uptake of family planning at village dispensaries [12 months]

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

Secondary Outcome Measures

  1. Pregnancy rates [12 months]

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

  2. Reasons for seeking family planning [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 [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Paul College Mwanza Tanzania

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • Fuller Theological Seminary
  • St. Paul College

Investigators

  • Principal Investigator: Jennifer A Downs, MD, PhD, Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT03594305
Other Study ID Numbers:
  • 1605017246
First Posted:
Jul 20, 2018
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 1, 2022