CClinicalTrials.gg
CompletedNCT05328648Updated May 23, 2025Results posted

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

An interventional study of Community Score Card and Citizen Report Card in Contraceptive Usage and Unintended Pregnancy, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Kenya. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
5,726
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Contraceptive Usage
  • Unintended Pregnancy
03

In context

Lead sponsor

University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.

Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,726 participants (actual)

Study arms

  • Experimental
    Community Score Card

    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

  • Experimental
    Citizen Report Card

    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

  • No intervention
    Control

    Communities in the control arm will not receive an intervention.

Interventions

  • BehavioralCommunity 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.

  • BehavioralCitizen 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 12 months

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

    Time frame: Baseline, 12 months

  8. 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.

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

  9. 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.

    Time frame: Baseline, 12 months

  10. 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.

    Time frame: Baseline, 12 months

  11. 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.

    Time frame: Baseline, 12 months

  12. 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.

    Time frame: Baseline, 12 months

  13. 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.

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

07

Results

Posted May 23, 2025

Participant flow

Two types of participants were enrolled at two time points. 2484 and 2501 women were enrolled in the individual-level survey at baseline and endline, respectively. 345 and 396 healthcare providers (staff) were enrolled in the facility-level survey at baseline and endline, respectively. The facility-level surveys were conducted across 137 public-sector facilities (i.e., the unit of randomization). 2484+345+2501+396 = 5,726. No facility facilitators were enrolled.

Baseline Women
Participant flow — Baseline Women
MilestoneCommunity Score CardCitizen Report CardControl
Started828835821
Completed828835821
Not completed000
Baseline Providers
Participant flow — Baseline Providers
MilestoneCommunity Score CardCitizen Report CardControl
Started106133106
Providers interviewed106133106
Providers not interviewed231828
Completed106133106
Not completed000
Endline Women
Participant flow — Endline Women
MilestoneCommunity Score CardCitizen Report CardControl
Started822850829
Completed822850829
Not completed000
Endline Providers
Participant flow — Endline Providers
MilestoneCommunity Score CardCitizen Report CardControl
Started148125123
Providers interviewed148125123
Providers not interviewed666
Completed148125123
Not completed000

Outcome measures

PrimaryPercentage 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.

Time frame:
Baseline, 12 months
Reported as:
Number · percentage of participants
Percentage Change in Current Modern Contraceptive Use
percentage of participantsCommunity Score CardCitizen Report CardControl
Percentage Change in Current Modern Contraceptive Use-1.11.41.5
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Knowledge of Patient Rights Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline18.1 ± 3.718.0 ± 3.618.0 ± 3.6
Endline18.0 ± 3.817.5 ± 3.617.8 ± 3.6
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Women's Agency Within Their Community Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline20.8 ± 6.521.1 ± 6.421.2 ± 6.1
Endline21.5 ± 6.721.2 ± 7.221.7 ± 7.1
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Women's Agency Within a Healthcare Facility
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline5.8 ± 2.16.0 ± 2.05.9 ± 2.2
Endline5.6 ± 2.15.7 ± 2.25.8 ± 2.0
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Women's Facility Satisfaction Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline23.6 ± 4.223.1 ± 4.023.2 ± 4.1
Endline22.4 ± 4.422.5 ± 4.723.0 ± 4.3
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Community Empowerment Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline9.9 ± 3.910.0 ± 3.810.4 ± 4.1
Endline9.8 ± 4.110.0 ± 4.510.0 ± 4.1
PrimaryMean 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.

Time frame:
Baseline, 12 months
Reported as:
Mean · score on a scale
Mean Community Involvement
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline1.3 ± 1.11.3 ± 1.11.3 ± 1.1
Endline1.4 ± 1.01.4 ± 1.01.4 ± 1.1
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Perceived Quality of Family Planning Service Delivery Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline17.3 ± 2.317.4 ± 2.217.3 ± 2.6
Endline17.0 ± 2.617.1 ± 2.517.1 ± 2.5
PrimaryPercent 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.

Time frame:
Baseline, 12 months
Reported as:
Number · percent change in providers absent
Percent Change in Provider Absenteeism
percent change in providers absentCommunity Score CardCitizen Report CardControl
Percent Change in Provider Absenteeism-5.915.2-8.3
PrimaryPercent 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.

Time frame:
Baseline, 12 months
Reported as:
Number · percent change
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+)
percent changeCommunity Score CardCitizen Report CardControl
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
PrimaryPercent 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.

Time frame:
Baseline, 12 months
Reported as:
Number · percent change
Percent Change in Mystery Client Observations With Informal Payment Solicitation
percent changeCommunity Score CardCitizen Report CardControl
Percent Change in Mystery Client Observations With Informal Payment Solicitation-34.0-20.6-25.2
PrimaryPercent 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.

Time frame:
Baseline, 12 months
Reported as:
Number · percent change mistreatment observations
Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment
percent change mistreatment observationsCommunity Score CardCitizen Report CardControl
Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment53.2161.9118.4
PrimaryMean 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.

Time frame:
Baseline, at the end of 12-month intervention (Endline)
Reported as:
Mean · score on a scale
Mean Close-to-Community (CTC) Provider Motivation Indicator Score
score on a scaleCommunity Score CardCitizen Report CardControl
Baseline17.9 ± 4.317.4 ± 4.318.3 ± 4.9
Endline18.4 ± 4.718.5 ± 4.617.8 ± 4.5

Adverse events

Collected over Adverse Events were not monitored/assessed for the study. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Community Score Card———
Citizen Report Card———
Control———

Baseline characteristics

Age, Continuous
Age, Continuous(years)Community Score CardCitizen Report CardControlTotal
Baseline Women30.43 ± 8.4430.99 ± 8.5730.22 ± 8.7230.55 ± 8.58
Baseline Providers36.25 ± 7.8237.52 ± 8.8337.96 ± 8.5437.26 ± 8.45
Endline Women30.66 ± 8.3631.31 ± 8.4931.11 ± 8.5231.03 ± 8.46
Endline Providers38.05 ± 7.7339.52 ± 8.2238.93 ± 8.5538.79 ± 8.15
Sex: Female, Male
Sex: Female, Male(Participants)Community Score CardCitizen Report CardControlTotal
Baseline Women — Female8288358212484
Baseline Women — Male0000
Baseline Providers — Female6910084253
Baseline Providers — Male37332292
Endline Women — Female8228508292501
Endline Women — Male0000
Endline Providers — Female1009099289
Endline Providers — Male483524107
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Community Score CardCitizen Report CardControlTotal
Count of participants———0
Region of Enrollment
Region of Enrollment(Participants)Community Score CardCitizen Report CardControlTotal
Kenya1904194318795726
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Study locations

1 site
  • Innovations for Poverty Action
    Kisumu, Kenya
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 7, 2024
  • Informed consent form · Oct 22, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The study will make available its data after it's been de-identified. These will be shared with researchers who provide a methodologically sound proposal to the study team. Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose will then receive the requested data. Proposals should be directed to Katherine Tumlinson, PhD at ktumlin@email.unc.edu. To gain access, data requestors will need to sign a data use agreement.

Supporting information: Study protocol

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05328648
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Safe Water and AIDS Project, Innovations for Poverty Action
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
May 25, 2022
Primary completion
May 15, 2024
Completion
May 15, 2024
Results posted
May 23, 2025
Last update
May 23, 2025

Study contacts

Katherine Tumlinson, PhD
principal investigator · University of North Carolina, Chapel Hill

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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