Family Planning ServicesNCT04802304
Beyond Bias - Reducing Provider Bias Towards Adolescents to Increase Contraception Take-Up in Tanzania, Burkina Faso, and Pakistan
A study testing Beyond Bias Treatment in people with Family Planning Services, run by RAND at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Family Planning Services
- What is being tested?
- Beyond Bias Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 14 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All providers that are part of Pathfinder Internal's supported clinic network in Burkina Faso, Tanzania, and Pakistan.
- All clients aged 24 or under that visit a clinic that is enrolled in the study
Who cannot join
- None
- Clients over 24
- Clients who do not visit the clinic for family planning services
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Family Planning Services
- Being tested
- Beyond Bias Treatment
- Keywords
- Human-centered design, Health provider bias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beyond Bias TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Other: Beyond Bias Treatment |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether client was able to receive services
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.
Measured: 12 months after the intervention starts
Optimal Counseling
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.
Measured: 12 months after the intervention starts
Received modern method
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.
Measured: 12 months after the intervention starts
Perceived patient centeredness
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.
Measured: 12 months after the intervention starts
Secondary outcomes (1)
Provider biased attitudes
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.
Measured: 12 months after the intervention starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion14 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family Planning ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, Bill and Melinda Gates Foundation, Pathfinder International
- Responsible party
- Principal investigator, Zachary Wagner, RAND
- Investigators
- Zachary Wagner, Ph.D, Principal investigator, RANDCorrina Moucheraud, Ph.D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802304
- Sponsor's protocol ID
- 2019-0387
- Status last verified
- Oct 2022
- First submitted
- 29 Jan 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected as part of the study and underlying results in publications will be de-identified and made public, with the exception of the content of in-depth interviews. IPD to be made available include data collected through provider surveys, mystery client visit debrief forms, and direct observations of client-provider interactions.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Bias - Reducing Provider Bias Towards Adolescents to Increase Contraception Take-Up in Tanzania, Burkina Faso, and Pakistan
- ClinicalTrials.gov ID
- NCT04802304
- Acronym / sponsor ID
- 2019-0387
- Conditions
- Family Planning Services
- Keywords
- Human-centered design, Health provider bias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, Bill and Melinda Gates Foundation, Pathfinder International
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Other: Beyond Bias Treatment |
| Control | No intervention | – |
Who may qualify
- Ages
- Up to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- All providers that are part of Pathfinder Internal's supported clinic network in Burkina Faso, Tanzania, and Pakistan.
- All clients aged 24 or under that visit a clinic that is enrolled in the study
Key exclusion criteria (3 listed)
- None
- Clients over 24
- Clients who do not visit the clinic for family planning services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beyond Bias TreatmentThe 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. | Other | Treatment |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Provider biased attitudes
Time frame: 12 months after the intervention starts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: Yes. All IPD collected as part of the study and underlying results in publications will be de-identified and made public, with the exception of the content of in-depth interviews. IPD to be made available include data collected through provider surveys, mystery client visit debrief forms, and direct observations of client-provider interactions.
Related trials for Family Planning Services
Recruiting
Estimating the Impact of Sexuality Education and Mobile Health Services on Reproductive Health and Empowerment Among Adolescents in Sierra Leone for the Family Planning Impact Lab
Reproductive Health, Sexual Health
Not yet recruiting
Impact of Gender-Transformative Interventions on Contraceptive Use and Reproductive Autonomy in Somalia
Contraceptive Behavior, Social Norms
Recruiting
Impact of Self-Care Family Planning Services on Health and Development in South Sudan (Family Planning Impact Lab)
Contraceptive Behavior, Self Administration
Recruiting
Improving Women's Fertility Awareness and Reducing Anxiety Through Ovarian Reserve Screening and AI Counseling
Fertility Awareness, Ovarian Reserve
Enrolling by invitation
The Use of Virtual Simulations in Family Planning Counseling Training
Family Planning Counseling, Nursing Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zachary Wagner, Ph.D principal investigator
RAND
Corrina Moucheraud, Ph.D principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beyond Bias Treatment in people with Family Planning Services, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether client was able to receive services (time frame: 12 months after the intervention starts). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.