- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802304
Beyond Bias - Reducing Provider Bias Towards Adolescents to Increase Contraception Take-Up in Tanzania, Burkina Faso, and Pakistan
Beyond Bias will evaluate the impact of an intervention designed to reduce family planning provider bias towards young, unmarried, and nulliparous women in Tanzania, Burkina Faso, and Pakistan. The intervention has three components: 1) a summit that includes impactful stories told to and by family planning providers that highlight the consequences of provider bias, 2) a forum for continued communication between providers, and 3) a rewards program where clinics in which providers exhibit less biased client interactions or who have improved the most towards this end will be rewarded with social recognition and a ceremony.
Half of the eligible clinics in each country (233 in total) are randomly assigned to receive the intervention, while the remaining half serves as control. The objective of the evaluation is to estimate the impact of the intervention on a range of outcomes related to quality of family planning care among young, unmarried, and nulliparous women. The investigators hypothesize that the intervention will increase the share of young, unmarried, and nulliparous women who received counseling on a range of methods, counseling on long acting methods, and who received their preferred method.
The investigators will collect four types of data to evaluate the intervention: 1) provider surveys, 2) mystery clients' visits, 3) direct observations of client-provider interactions, and 4) qualitative interviews with clients, providers, and implementors.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Santa Monica, California, United States, 90401
- RAND
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria for Providers:
- All providers that are part of Pathfinder Internal's supported clinic network in Burkina Faso, Tanzania, and Pakistan.
Exclusion Criteria for Providers:
- None
Inclusion Criteria for Clients:
- All clients aged 24 or under that visit a clinic that is enrolled in the study
Exclusion Criteria for Providers:
- Clients over 24
- Clients who do not visit the clinic for family planning services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Experimental: Treatment
|
The intervention has three components: 1) a summit that includes impactful stories told to and by family planning providers that highlight the consequences of provider bias, 2) a forum for continued communication between providers, and 3) a rewards program where clinics in which providers exhibit less biased client interactions or who have improved the most towards this end will be rewarded with social recognition and a ceremony.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whether client was able to receive services
Time Frame: 12 months after the intervention starts
|
This is a measure of whether the client received family planning services on the day they came into the clinic.
This will be measured from real clients using client exit surveys and using mystery clients.
|
12 months after the intervention starts
|
Optimal Counseling
Time Frame: 12 months after the intervention starts
|
This is a measure of whether the client was counseled on all methods that were good options for the client given her background and preferences.
This will be coded as 1 if client was counseled on the full set of optimal family planning methods and zero if the client was not counseled on the full set of optimal family planning methods.
This will be collected in the client exit survey and in by mystery clients.
|
12 months after the intervention starts
|
Received modern method
Time Frame: 12 months after the intervention starts
|
This is a measure of whether the client received a modern family planning method during her visit.
This will be collected in the client exit survey only.
|
12 months after the intervention starts
|
Perceived patient centeredness
Time Frame: 12 months after the intervention starts
|
This is a composite scale (ranging from 0 to 1) that measures the extent to which the client perceived the her interaction with family provider as patient centered.
The questions included in the scale will be chosen based on data driven factor analysis methods.
Higher scores will indicate better patient centeredness.
This will be collected in the client exit survey and in by mystery clients.
|
12 months after the intervention starts
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Provider biased attitudes
Time Frame: 12 months after the intervention starts
|
This is a composite scale (ranging from 0 to 1) that measures the extent to which providers have biased attitudes towards young, unmarried, and adolescent women.
The questions included in the scale will be chosen based on data driven factor analysis methods.
Higher scores will indicate better patient centeredness.
This will be collected through a provider survey.
|
12 months after the intervention starts
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Zachary Wagner, Ph.D, RAND
- Principal Investigator: Corrina Moucheraud, Ph.D, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-0387 (Other Identifier: M D Anderson Cancer Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Family Planning Services
-
Saint-Joseph UniversityRecruitingFamily Planning ServicesLebanon
-
Assiut UniversityNot yet recruitingFamily Planning Services
-
Aga Khan UniversityUnited Nations; Global Affairs CanadaRecruitingReproductive Behavior, Family Planning ServicesPakistan
-
International Centre for Diarrhoeal Disease Research...RecruitingMaternal Health | Child Health | Vaccination | Family Planning ServicesBangladesh
-
RANDMakerere UniversityNot yet recruitingFamily Planning
-
Emory UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
University of California, San DiegoEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Boston UniversityUnited States Agency for International Development (USAID); Pharmaceutical...Completed
-
Addis Ababa UniversityUnknown
-
University of California, San FranciscoPopulation Services InternationalCompleted
Clinical Trials on Beyond Bias Treatment
-
Yair Bar-HaimGeha Mental Health CenterCompleted
-
Roseli ShavittCompleted
-
Tel Aviv UniversityCompletedAttention Bias Modification Treatment (ABMT) for Patients With Post Traumatic Stress Disorder (PTSD)Attention Bias Modification Treatment (ABMT)Israel
-
Florida State UniversityTerminatedEating Disorder Symptom | Negative Thoughts | Emotional MaladjustmentUnited States
-
Hospital de Clinicas de Porto AlegreUnknownGeneralized Anxiety Disorder | Social Anxiety Disorder | Separation Anxiety DisorderUnited States, Australia, Brazil, Israel
-
Humboldt-Universität zu BerlinCompletedObsessive-Compulsive DisorderGermany
-
Hospital de Clinicas de Porto AlegreUnknownGeneralized Anxiety Disorder | Social Anxiety Disorder | Panic DisorderBrazil
-
Ruhr University of BochumUniversity Hospital, EssenCompleted
-
Florida International UniversityYale UniversityRecruitingSocial Anxiety Disorder of ChildhoodUnited States
-
Tel Aviv UniversityCompleted