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NCT05328648

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

Completed NA Results posted Last updated 23 May 2025
What this trial tests

NA trial testing Community Score Card in Contraceptive Usage in 5,726 participants. Completed in 15 May 2024.

Timeline
25 May 2022
Primary endpoint
15 May 2024
15 May 2024

Quick facts

Lead sponsorUniversity of North Carolina, Chapel Hill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment5,726
Start date25 May 2022
Primary completion15 May 2024
Estimated completion15 May 2024
Sites1 location across Kenya

Drugs / interventions tested

Conditions studied

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 18 to 49, female only, with Contraceptive Usage or Unintended Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage Change in Current Modern Contraceptive Use Primary · Baseline, 12 months

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 w

GroupValue95% CI
Community Score Card-1.1
Citizen Report Card1.4
Control1.5
Mean Knowledge of Patient Rights Score Primary · Baseline, at the end of 12-month intervention (Endline)

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
GroupValue95% CI
Community Score Card18.1± 3.7
Citizen Report Card18.0± 3.6
Control18.0± 3.6
Endline
GroupValue95% CI
Community Score Card18.0± 3.8
Citizen Report Card17.5± 3.6
Control17.8± 3.6
Mean Women's Agency Within Their Community Score Primary · Baseline, at the end of 12-month intervention (Endline)

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
GroupValue95% CI
Community Score Card20.8± 6.5
Citizen Report Card21.1± 6.4
Control21.2± 6.1
Endline
GroupValue95% CI
Community Score Card21.5± 6.7
Citizen Report Card21.2± 7.2
Control21.7± 7.1
Mean Women's Agency Within a Healthcare Facility Primary · Baseline, at the end of 12-month intervention (Endline)

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
GroupValue95% CI
Community Score Card5.8± 2.1
Citizen Report Card6.0± 2.0
Control5.9± 2.2
Endline
GroupValue95% CI
Community Score Card5.6± 2.1
Citizen Report Card5.7± 2.2
Control5.8± 2.0
Mean Women's Facility Satisfaction Score Primary · Baseline, at the end of 12-month intervention (Endline)

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
GroupValue95% CI
Community Score Card23.6± 4.2
Citizen Report Card23.1± 4.0
Control23.2± 4.1
Endline
GroupValue95% CI
Community Score Card22.4± 4.4
Citizen Report Card22.5± 4.7
Control23.0± 4.3
Mean Community Empowerment Score Primary · Baseline, at the end of 12-month intervention (Endline)

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
GroupValue95% CI
Community Score Card9.9± 3.9
Citizen Report Card10.0± 3.8
Control10.4± 4.1
Endline
GroupValue95% CI
Community Score Card9.8± 4.1
Citizen Report Card10.0± 4.5
Control10.0± 4.1
Mean Community Involvement Primary · Baseline, 12 months

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

Baseline
GroupValue95% CI
Community Score Card1.3± 1.1
Citizen Report Card1.3± 1.1
Control1.3± 1.1
Endline
GroupValue95% CI
Community Score Card1.4± 1.0
Citizen Report Card1.4± 1.0
Control1.4± 1.1
Mean Perceived Quality of Family Planning Service Delivery Score Primary · Baseline, at the end of 12-month intervention (Endline)

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 pr

Baseline
GroupValue95% CI
Community Score Card17.3± 2.3
Citizen Report Card17.4± 2.2
Control17.3± 2.6
Endline
GroupValue95% CI
Community Score Card17.0± 2.6
Citizen Report Card17.1± 2.5
Control17.1± 2.5
Percent Change in Provider Absenteeism Primary · Baseline, 12 months

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-leve

GroupValue95% CI
Community Score Card-5.9
Citizen Report Card15.2
Control-8.3
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+) Primary · Baseline, 12 months

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 an

GroupValue95% CI
Community Score Card-22.8
Citizen Report Card-67.0
Control-64.1
Percent Change in Mystery Client Observations With Informal Payment Solicitation Primary · Baseline, 12 months

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 calcula

GroupValue95% CI
Community Score Card-34.0
Citizen Report Card-20.6
Control-25.2
Percent Change in the Number of Mystery Client Observations Identifying Patient Mistreatment Primary · Baseline, 12 months

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 an

GroupValue95% CI
Community Score Card53.2
Citizen Report Card161.9
Control118.4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Contraceptive Usage

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05328648.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing