NCT03594305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3.3 years

First QC Date

June 5, 2018

Last Update Submit

January 30, 2023

Conditions

Contraception Behavior

Outcome Measures

Primary Outcomes (1)

  • Uptake of family planning at village dispensaries

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

    12 months

Secondary Outcomes (3)

  • Pregnancy rates

    12 months

  • Reasons for seeking family planning

    12 months

  • Couple-years of protection

    12 months

Study Arms (2)

Educational Intervention Arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

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.

Interventions

Educational seminarBEHAVIORAL

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.

Educational Intervention Arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Private dispensaries at which family planning uptake would be missed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Paul College

Mwanza, Tanzania

Location

Related Publications (1)

  • Mwakisole AH, Lambert VJ, Nzali A, Aristide C, Laizer E, Cordeiro AA, Gregory L, Mwakisole N, Nicol CEW, Paul N, Kalluvya SE, Kihunrwa A, Downs DJ, Wamoyi J, Downs JA, Lee MH. Partnerships with religious leaders to promote family planning in rural Tanzania: an open-label, cluster randomised trial. Lancet Glob Health. 2023 Dec;11(12):e1943-e1954. doi: 10.1016/S2214-109X(23)00453-9.

    PMID: 37973342DERIVED

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Jennifer A Downs, MD, PhD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized trial in which villages are randomized to receive or not to receive the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 20, 2018

Study Start

August 20, 2018

Primary Completion

December 12, 2021

Study Completion

June 2, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations

TA(1)