Clinical trial NCT05328648: Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings
Official title: Randomized Controlled Trial to Address Unintended Pregnancy Rates in Low Resource Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Usage
Unintended Pregnancy
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Safe Water and AIDS Project
name: Innovations for Poverty Action
First posted: 2022-04-14
Enrollment: 5726
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: Purpose: The primary objective is to examine the health impact of implementing social accountability interventions in communities served by public-sector healthcare facilities in Western Kenya. The first aim is to assess the impact of two social accountability approaches on contraceptive use. The second aim is to assess the impact of these approaches on community empowerment, agency, and quality of care. Third third aim is to assess the scalability of these approaches to additional settings. The study will be carried out in Kisumu county, Kenya. This study design is a three-arm cluster-randomized controlled experiment in which all public healthcare facilities in the county will be randomized to one of three study arms: 1. Community Score Card treatment, 2. Citizen Report Card treatment or 3. control.

Before and after implementing the two treatments, individual- and facility-level pre- and postintervention surveys will be conducted.

The individual-level surveys will be conducted within a representative sample of women of reproductive age (ages 18 to 49), stratified by study arm and cluster, and will be used to establish the primary outcome, modern contraceptive use, in all three study arms, pre- and post-treatment. The individual-level surveys will also measure multiple linking constructs such as community empowerment and quality of care.

The facility-level surveys will be conducted in a census of all public-sector facilities located in Kisumu county and will be used to measure quality of family planning service delivery and negative provider behaviors such as informal payments, provider absenteeism, and client mistreatment. For the facility-level surveys, family planning service quality and negative provider behaviors will be measured via interviews with one to ten providers, depending on total staff at each of the facilities. This will result in approximately 385 provider interviews, with approximately 128 in each study arm. Unannounced visitors and mystery clients will also be deployed to secure less biased estimates of provider absenteeism, informal fee solicitation, and disrespectful/biased treatment of clients; mystery clients will also collect data on traditional measures of family planning service quality such as choice of methods and information on side effects. All facilities in Kisumu will receive two unannounced visits and three mystery client visits.

Post-treatment, the individual-level survey will be repeated, within a newly sampled cross-section of the population. All facility-level data collection in all public facilities in the county will also be repeated. The changes in contraceptive use, quality of care, and community engagement resulting from the Community Score Card and the Citizen Report Card interventions will be evaluated via data collected in these pre- and post-intervention surveys.

Following the interventions, four focus groups (two/arm) will be conducted with key facilitators in the two intervention approaches to better understand implementation challenges and potential barriers to scaling up these interventions to other regions or countries. In-depth interviews will be undertaken with health care providers and community members to assess the potential for scale-up of these interventions. Interviews with 30 providers and community members will be completed in each of the two intervention arms (15/arm). Respondents will be asked to reflect on their experiences with the intervention and provide feedback for areas for improvement and scalability.

The Interventions

The Community Score Card Approach (CSC) CSC Summary: 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.

CSC Procedures:

Step 1: Preparation. The communities and facility staff will be engaged and sensitized to the community score card via a meeting that discusses the community score card purpose and approach; a date, location, and general process for conducting the CSCs will be selected/designed.

Step 2: Conducting the CSC with target communities. During this phase, all communities associated with the targeted facilities will assess the primary barriers to quality family planning service delivery and develop corresponding indicators, assisted by an experienced facilitator. The communities will then each complete the score card and generate ideas for quality improvement.

Step 3: Conducting the CSC with family planning providers. 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. Providers may derive a similar list of issues/indicators as the community.

Step 4: Connecting the patients and providers and determining an action plan. Family planning patients and providers - as well as community leaders and process facilitators - will come together to present their findings and to jointly determine the priority areas and develop an action plan. Within the action plan, agreed upon responsibilities will be assigned and a timeline will be communicated.

Step 5: Implementing the action plan and continuous monitoring. In this final stage, the action plan will be carried out over a period of approximately six months, with community members and service providers in charge of monitoring implementation and progress. After a period of six months, the patient and provider score cards will be repeated.

The Citizen Report Card Approach (CRC) CRC Summary: In this 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.

Step 1: Preparing for data collection and dissemination. The PI will consult with the Kisumu County Health Director to confirm the geographic coverage of the citizen report card. The PI will also collaborate with staff in the county health office to develop a post-survey publicity strategy. The strategy could include community dialogues, radio call-in shows, television, and newspaper coverage.

Step 2: Designing the CRC survey. As part of the intervention, three focus groups will be conducted (two with family planning clients stratified into younger versus older women and one with service providers). This will help to identify key service challenges and inform the content of the CRC questionnaire by allowing citizens to articulate and prioritize relevant indicators for monitoring and reporting on service provider performance. Focus groups with service providers may elicit suggestions for the type of feedback they would find most useful for improving their service delivery. In general, both providers and clients will be asked about the problem areas related to family planning service delivery. Once focus group discussions are completed and the data are analyzed, investigators will identify the prominent themes related to family planning service delivery that emerge from the focus group data. In turn, these themes will inform the main content of the CRC questionnaire.

Step 4: Analyze the data. Data from the CRC questionnaire will be analyzed and results will be translated into a report card. The report card will also be translated into the local languages (Kiswahili and Dholuo) so that it is accessible to a broad range of stakeholders.

Step 5: Disseminate results to the community. Extensive dissemination activities will ensure the Citizen Report Card is widely shared with members of the community. Report card findings will be presented at a high-profile press conference and press kit materials with short, readable stories will be distributed to members of the print, radio, and television media. The goal is to create a public record of service quality.

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.

Primary outcomes:
measure: Percentage Change in Current Modern Contraceptive Use
timeFrame: Baseline, 12 months
measure: Mean Knowledge of Patient Rights Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Mean Women's Agency Within Their Community Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Mean Women's Agency Within a Healthcare Facility
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Mean Women's Facility Satisfaction Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Mean Community Empowerment Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Mean Community Involvement
timeFrame: Baseline, 12 months
measure: Mean Perceived Quality of Family Planning Service Delivery Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
measure: Percent Change in Provider Absenteeism
timeFrame: Baseline, 12 months
measure: 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+)
timeFrame: Baseline, 12 months
measure: Percent Change in Mystery Client Observations With Informal Payment Solicitation
timeFrame: Baseline, 12 months
measure: Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment
timeFrame: Baseline, 12 months
measure: Mean Close-to-Community (CTC) Provider Motivation Indicator Score
timeFrame: Baseline, at the end of 12-month intervention (Endline)
Secondary outcomes:
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Innovations for Poverty Action
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Katherine Tumlinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: