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

NCT05328648 | Completed Results

• 2 other identifiers: 21-22171R01HD101453-01A1
• Study Type: interventional
• Target: 5,726
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (13)

• Percentage Change in Current Modern Contraceptive Use

  The measure of current modern contraceptive use is a binary variable (0=non-use; 1=use), attained by first asking participants, "Are you (or your partner) currently doing something or using any method to delay or avoid getting pregnant?" Those with an affirmative response are then asked, "What method are you using?" Modern contraceptive methods will be defined to include female or male sterilization, intrauterine device, implant, injectable contraception, oral contraceptive pill, male or female condom, and any other modern methods. The percent of women using modern contraceptives at baseline was subtracted from the percent using modern contraceptives at endline, and that difference is reported.

  Baseline, 12 months

• Mean Knowledge of Patient Rights Score

  The measure of women's knowledge of patient rights is a 7 item scale with answers on a 5 point Likert scale. Possible scores range from 7 to 35. Higher scores reflect greater knowledge of patient rights. The measure of women's knowledge of patient rights is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys. The percent change in the mean score across all women is presented, using the formula (endline-baseline)/baseline.

  Baseline, at the end of 12-month intervention (Endline)

• Mean Women's Agency Within Their Community Score

  The measure of women's agency within their community is an 8 item scale. Answers are on a 5 point scale with options "Completely sure" "Sure" "Neither sure or unsure" "Not sure" or "Not sure at all." Possible scores range from 8 to 40. Higher scores reflect greater agency for women within their community. The measure of women's agency within their community is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

• Mean Women's Agency Within a Healthcare Facility

  The measure of women's agency within a healthcare facility is a 2 item scale. Answers are on a 5 point scale with options "Completely sure" "Sure" "Neither sure or unsure" "Not sure" or "Not sure at all." Possible scores range from 2 to 10. Higher scores reflect greater agency for women within a healthcare facility. The measure of women's agency within a healthcare facility is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

• Mean Women's Facility Satisfaction Score

  The measure of women's facility satisfaction is an 11 item scale with answers on a 5 point Likert scale. Possible scores range from 11 to 55. Higher scores reflect greater facility satisfaction. The measure of women's facility satisfaction is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

• Mean Community Empowerment Score

  The measure of community empowerment is a 4 item scale with answers on a 5 point Likert scale. Possible scores range from 4 to 20. Higher scores reflect greater community empowerment. The measure of community empowerment is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

• Mean Community Involvement

  There are three indicators measuring community involvement: In the last 12 months, have you 1. been an active member in any organized group in your community, for example a women's group, a religious group, or other community group? 2. received help from any organized group in your community, for example a women's group, a religious group, or other community group? Help could include emotional support, economic assistance, or helping you to learn or do things. 3. joined together with other people in your community to improve health services for women or children? All indicators have a binary response option (Yes/No). A value of 1 was assigned to all affirmative responses and created a scale (0-3). Higher scores reflect more community involvement.

  Baseline, 12 months

• Mean Perceived Quality of Family Planning Service Delivery Score

  Perceived quality of family planning service delivery is measured via 20 survey questions with different answer options, ranging from binary to four response options. All but two of the 20 variables were binary yes/no (0/1) response options; the remaining two variables were initially variables with four response options that were collapsed to binary response options (0/1). Possible scores range from 0 to 20. Higher scores reflect greater perceived quality of family planning service delivery. The measure of perceived quality is implemented in the women's individual-level questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

• Percent Change in Provider Absenteeism

  The measure of absenteeism is a binary variable obtained using a roster of healthcare providers to assess provider absence. Response options for each provider include Yes and No and up to 10 providers at each facility will be assessed for absence. The percent of providers absent will be measured by taking the number of providers absent and dividing by the total number of providers listed on the roster. The percent change in absenteeism is calculated by subtracting the baseline from the endline and dividing by the baseline. The measure of provider absenteeism is implemented in the facility-level unannounced visitor questionnaire in the pre- and post-intervention surveys. Enumerators took attendance, using a pre-obtained roster of all scheduled healthcare providers, on the day of data collection. Not all healthcare providers were enrolled/interviewed. No non-provider staff were enrolled.

  Baseline, 12 months

• 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+)

  The Method Information Index Plus (MII+) consists of four indicators: "Were you informed about other methods?" "Were you informed about side effects?" "Were you told what to do if you experienced side effects?" "Were you told about the possibility of switching to another method if the method you selected was not suitable?" The reported value is the percentage of mystery client (MC) observations in which the mystery client answered in the affirmative for all four indicators in the index. The percent change in affirmative observations is calculated by subtracting the baseline from the endline and dividing by the baseline. MII+ is measured in the mystery client observation guide in the pre- and post-intervention surveys. Highly experienced, well-trained data collectors served as mystery clients. These enumerators were part of the study team and not participants who signed informed consent.

  Baseline, 12 months

• Percent Change in Mystery Client Observations With Informal Payment Solicitation

  The measure of informal payment solicitation is a binary variable obtained by asking mystery clients whether they were asked by facility staff to pay when seeking family planning services at a public-sector healthcare facility. Response options include Yes and No. The percent of mystery client visits in which an informal payment is solicited will be measured by taking the number of mystery client visits for which an informal fee is solicited and dividing by the total number of mystery client visits. The percent change in mystery client observations with informal payment solicitation is calculated by subtracting the baseline from the endline and dividing by the baseline.The measure of informal payments is implemented in the mystery client questionnaire in the pre- and post-intervention surveys. Highly experienced, well-trained data collectors served as mystery clients. These enumerators were part of the study team and not participants who signed informed consent.

  Baseline, 12 months

• Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment

  The measure of patient mistreatment is a binary variable obtained by asking mystery clients "Did your provider do any of the following?" Response options include Shouted at me; Scolded me or treated me with scorn; Threatened to withhold services; Called me by an insulting name; Laughed at me; Other type of disrespect, please explain. If the mystery client selects any of the response options, patient mistreatment is identified. The percent of mystery client visits in which patient mistreatment occurs will be measured by taking the number of mystery client visits for which mistreatment occurs and dividing by the total number of mystery client visits. The measure of patient mistreatment is implemented in the mystery client questionnaire in the pre- and post-intervention surveys. Highly experienced, well-trained data collectors served as mystery clients. These enumerators were part of the study team and not participants who signed informed consent.

  Baseline, 12 months

• Mean Close-to-Community (CTC) Provider Motivation Indicator Score

  The CTC provider motivation indicator scale is a 12 item scale. Answers are on a 5 point Likert scale. Possible scores range from 12 to 60. Higher scores reflect greater provider motivation. The measure of provider motivation is implemented in the facility-level provider's questionnaire in the pre- and post-intervention surveys.

  Baseline, at the end of 12-month intervention (Endline)

Study Arms (3)

Community Score Card

EXPERIMENTAL

In the Community Score Card approach, community members come together to document challenges they encounter when seeking services and develop a corresponding set of indicators that can be used to produce a validated facility score. The score is shared with the community and a collaborative process between key community members and facility staff takes place to develop feasible solutions and a strategic action plan.

Behavioral: Community Score Card

Citizen Report Card

EXPERIMENTAL

In the Citizen Report Card approach, individual-level feedback is collected from actual clients of target facilities, via a structured questionnaire, to assess facility performance and generate a public record of service quality. In addition to sharing the final report card with communities, engaged policymakers are invited to use the citizen feedback to improve service delivery.

Behavioral: Citizen Report Card

Control

NO INTERVENTION

Communities in the control arm will not receive an intervention.

Interventions

Community Score Card BEHAVIORAL

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.

Community Score Card

Citizen Report Card BEHAVIORAL

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.

Citizen Report Card

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Participants are eligible if they self-identify as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Safe Water and AIDS Project: collaborator
• Innovations for Poverty Action: collaborator

Study Sites (1)

Innovations for Poverty Action

Kisumu, Kenya

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Results Point of Contact

• Title: Emilia Goland, MMSc
• Organization: University of North Carolina at Chapel Hill

emilia_goland@unc.edu

919-966-2017

Study Officials

• Katherine Tumlinson, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 25, 2022
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be made available beginning 9 months and ending 36 months after article publication.
• Access Criteria: Ethics approval and executed data use agreement.

Locations

KE (1)