N/A
N=2,484
Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings
Contraceptive Usage · Unintended Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT05328648 ↗Enrolled (actual)
2,484
Serious AEs
—
Results posted
May 2025
Primary outcome: Primary: Percentage Change in Current Modern Contraceptive Use — -1.1; 1.4; 1.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Community Score Card (Behavioral); Citizen Report Card (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Current Modern Contraceptive Use |
-1.1; 1.4; 1.5 | — |
| PRIMARY Mean Knowledge of Patient Rights Score |
18.1; 18.0; 18.0; 18.0; 17.5; 17.8 | — |
| PRIMARY Mean Women's Agency Within Their Community Score |
20.8; 21.1; 21.2; 21.5; 21.2; 21.7 | — |
| PRIMARY Mean Women's Agency Within a Healthcare Facility |
5.8; 6.0; 5.9; 5.6; 5.7; 5.8 | — |
| PRIMARY Mean Women's Facility Satisfaction Score |
23.6; 23.1; 23.2; 22.4; 22.5; 23.0 | — |
| PRIMARY Mean Community Empowerment Score |
9.9; 10.0; 10.4; 9.8; 10.0; 10.0 | — |
| PRIMARY Mean Community Involvement |
1.3; 1.3; 1.3; 1.4; 1.4; 1.4 | — |
| PRIMARY Mean Perceived Quality of Family Planning Service Delivery Score |
17.3; 17.4; 17.3; 17.0; 17.1; 17.1 | — |
| PRIMARY Percent Change in Provider Absenteeism |
-5.9; 15.2; -8.3 | — |
| PRIMARY Percent Change in the Number of Mystery Client Observations of Providers in Which the Mystery Client Answered in the Affirmative to the Full Method Information Index Plus (MII+) |
-22.8; -67.0; -64.1 | — |
| PRIMARY Percent Change in Mystery Client Observations With Informal Payment Solicitation |
-34.0; -20.6; -25.2 | — |
| PRIMARY Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment |
53.2; 161.9; 118.4 | — |
| PRIMARY Mean Close-to-Community (CTC) Provider Motivation Indicator Score |
17.9; 17.4; 18.3; 18.4; 18.5; 17.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
Women's level survey:
- Women aged 18-49 years;
- Reside in randomly selected households.
Provider Survey:
- Healthcare service provider;
- Provides family planning or reproductive health services;
- Works in a public-sector healthcare facility located in Kisumu County.
Focus Group Discussions:
- Key intervention facilitators;
- Over the age of 18 years
Qualitative In-Depth Interviews:
- Community members in Kisumu County who participated in intervention activities;
- Family planning service providers who work within a public-sector healthcare facility in Kisumu County;
- Over 18 years of age.
Data sourced from ClinicalTrials.gov (NCT05328648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.