Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings

NCT05328648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5726

Last updated 2025-05-23

Study results available
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Summary

This is a clinical trial investigating the impact of social accountability interventions on contraceptive use in Western Kenya. Social accountability interventions aim to improve the performance of healthcare providers via public monitoring of provider performance. This study aims to implement and evaluate two social accountability interventions: the community score card and the citizen report card. All public-sector healthcare facilities in Kisumu Country will be considered for enrollment; facility staff and residents of corresponding facility catchment areas will be randomized to one of the two treatments or the control arm.

Conditions

  • Contraceptive Usage
  • Unintended Pregnancy

Interventions

BEHAVIORAL

Community Score Card

In Community Score Card intervention, all communities associated with the targeted facilities will assess the primary barriers to quality family planning service delivery and develop indicators. The communities will then each complete the score card and generate ideas for quality improvement. Family planning providers in the target facilities will meet and determine the barriers to high quality family planning service delivery. Providers will decide on priority areas and make suggestions for improving service delivery. Study facilitators will bring these two groups together to share their respective score cards and jointly develop an action. Within the action plan, agreed upon responsibilities will be assigned and a timeline will be communicated.

BEHAVIORAL

Citizen Report Card

Citizen Report Card (CRC): The data from the CRC questionnaire will be analyzed and translated into a report card. Extensive dissemination activities will ensure the CRC is widely shared with members of the community. The goal is to create a public record of service quality.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH
  • Safe Water and AIDS Project

    collaborator OTHER
  • Innovations for Poverty Action

    collaborator OTHER
  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Katherine Tumlinson, PhD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2024-05-15
Completion
2024-05-15

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328648 on ClinicalTrials.gov