Maternal HealthCPIPE2NCT05019131
Caring for Providers to Improve Patient Experience Study Phase 2 in Migori County
A study testing Training, Peer support and mentorship and Leadership engagement in people with Maternal Health and Mental Health, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Maternal Health, Mental Health, Healthcare Provider
- What is being tested?
- Training, Peer support and mentorship and Leadership engagement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteKenya
- Study dates
- 16 Aug 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providers working in maternity units of the intervention facilities are all eligible.
Who cannot join
- Inability to attend scheduled training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Provider Stress and Unconscious Bias to Improve Quality of Maternal Health Care
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.
Read the detailed description
Poor person-centered maternal health care (PCMHC) contributes to high maternal and neonatal mortality in sub-Saharan Africa (SSA), and disparities in PCMHC are driving disparities in use of maternal health services., However, little research exists on how to improve PCMHC and reduce disparities. The investigators seek to fill this gap with this project. They propose targeting health provider stress and unconscious bias as fundamental factors driving both poor PCMHC and disparities in PCMHC. Health care provider stress and unconscious bias are important to consider because: (1) providers in low-resource settings often work under very stressful conditions; (2) unconscious bias is prevalent in every society including SSA; and (3) these factors are mutually reinforcing drivers of poor quality care and disparities in person-centered care. In the first phase of the project (CPIPE1), they conducted research to examine (1) the factors associated with PCMHC and identified provider stress and unconscious bias as key contributing factors. They also examined the levels of provider stress and unconscious bias and the types of stressors and biases in Migori County, Kenya. The results of that research will be used to inform this phase (CPIPE2), the aims of which are to: (1) design a multicomponent theory and evidence-based intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels using a pretest-posttest control group design. They will use the results of the pilot to refine the intervention and develop an R01 proposal for a multi-site evaluation with a larger sample and longer follow up to assess impact on PCMHC. This study will yield valuable information to inform quality improvement efforts for PCMHC.
- Conditions
- Maternal Health, Mental Health, Healthcare Provider, Adverse Outcomes, Stress, Stress, Psychological
- Being tested
- Training, Peer support and mentorship, Leadership engagement, Embedded champions
- Keywords
- providers, mental health, unconscious bias, prejudice, Kenya, stress, burnout, person-centered care, quality of care, discrimination
- Medical subject headings
- Psychological Well-Being, Stress, Psychological, Burnout, Psychological, Social Discrimination, Bias, Implicit, Prejudice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
trainings to reduce conscious bias and stress
Peer support and mentorshipBehavioural
facilitated peer and mentorship opportunities
Leadership engagementBehavioural
Engaged leadership at the county and facility levels
Embedded championsBehavioural
Facilitate local champions to promote intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 1. Training: The investigators will develop a training for providers that addresses the following topics: Stress \& positive coping mechanisms; Unconscious bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication;
2. Peer support and mentorship: The investigators will identify what works best for these groups in terms of group composition, size, and how the groups want to interact.
3. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County.
4. Embedded champions: To facilitate ongoing engagement, the investigators will identify local leaders, and invite them to training where they will be taught how to facilitate peer support groups and serve as champions. Receives: Behavioral: Training; Behavioral: Peer support and mentorship; Behavioral: Leadership engagement; Behavioral: Embedded champions |
| Control arm | No intervention | Will not receive any training during the intervention period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Measured: Baseline and 6 months
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Measured: Baseline and 6 months
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months
The stress knowledge and attitudes score is measured by 14 survey questions with scores ranging from 0 to 14. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management. We used 13 of the items from the 14-item survey scale. The score range used is 0 to 13- as noted in the limitations section.
Measured: Baseline and 6 months
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months
The unconscious bias knowledge and attitudes score is measured by 17 survey questions with scores ranging from 0 to 17. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias and unconscious bias mitigation
Measured: Baseline and 6 months
Secondary outcomes (4)
Change in Hair Cortisol Levels From Baseline to 6 Months
There are no specified cut-offs for cortisol levels, but, on average, higher cortisol levels indicate higher stress.
Measured: Baseline and 6 months
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
There are no specified cut-offs for HRV but, on average, lower HRV scores indicate higher stress
Measured: Baseline and 6 months
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
IAT scores vary between -2 and +2. For this study, higher positive scores indicates a stronger implicit association between high status with good patient and low status with difficult patient
Measured: Baseline and 6 months
Change in Explicit Bias Scores From Baseline to 6 Months
The explicit bias scores are from responses to a vignette and range from 4 to 28. Higher scores indicate more explicit bias
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start16 Aug 2021
- Primary completion24 Jun 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (84)Papers the sponsor has linked to this study.
- Other trials for Maternal HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Patience Afulani, PhD, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019131
- Sponsor's protocol ID
- A135552
- Other IDs
- R00HD093798
- Acronym
- CPIPE2
- Status last verified
- May 2025
- First submitted
- 18 Aug 2021
- Last updated
- 7 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WHO, UNICEF, UNFPA, The World Bank, United Nations Population Division. Trends in maternal mortality: 1990 to 2013 [Internet]. WHO. 2014 [cited 2014 Jul 17]. Available from: http://www.who.int/reproductivehealth/publications/monitoring/9789241503631/en/index.html
Gabrysch S, Campbell OM. Still too far to walk: literature review of the determinants of delivery service use. BMC Pregnancy Childbirth. 2009 Aug 11;9:34. doi: 10.1186/1471-2393-9-34.
PubMed 19671156Moyer CA, Mustafa A. Drivers and deterrents of facility delivery in sub-Saharan Africa: a systematic review. Reprod Health. 2013 Aug 20;10:40. doi: 10.1186/1742-4755-10-40.
PubMed 23962135Graham WJ, McCaw-Binns A, Munjanja S. Translating coverage gains into health gains for all women and children: the quality care opportunity. PLoS Med. 2013;10(1):e1001368. doi: 10.1371/journal.pmed.1001368. Epub 2013 Jan 15.
PubMed 23335862van den Broek NR, Graham WJ. Quality of care for maternal and newborn health: the neglected agenda. BJOG. 2009 Oct;116(Suppl 1):18-21. doi: 10.1111/j.1471-0528.2009.02333.x.
PubMed 19740165Bohren MA, Hunter EC, Munthe-Kaas HM, Souza JP, Vogel JP, Gulmezoglu AM. Facilitators and barriers to facility-based delivery in low- and middle-income countries: a qualitative evidence synthesis. Reprod Health. 2014 Sep 19;11(1):71. doi: 10.1186/1742-4755-11-71.
PubMed 25238684Friberg IK, Kinney MV, Lawn JE, Kerber KJ, Odubanjo MO, Bergh AM, Walker N, Weissman E, Chopra M, Black RE; Science in Action: Saving the lives of Africa's Mothers, Newborns, and Children working group; Axelson H, Cohen B, Coovadia H, Diab R, Nkrumah F. Sub-Saharan Africa's mothers, newborns, and children: how many lives could be saved with targeted health interventions? PLoS Med. 2010 Jun 21;7(6):e1000295. doi: 10.1371/journal.pmed.1000295.
PubMed 20574515Miller S, Abalos E, Chamillard M, Ciapponi A, Colaci D, Comande D, Diaz V, Geller S, Hanson C, Langer A, Manuelli V, Millar K, Morhason-Bello I, Castro CP, Pileggi VN, Robinson N, Skaer M, Souza JP, Vogel JP, Althabe F. Beyond too little, too late and too much, too soon: a pathway towards evidence-based, respectful maternity care worldwide. Lancet. 2016 Oct 29;388(10056):2176-2192. doi: 10.1016/S0140-6736(16)31472-6. Epub 2016 Sep 16.
PubMed 27642019Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century [Internet]. 2001. Available from: http://www.iom.edu/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-System-for-the-21st-Century.aspx
Bohren MA, Vogel JP, Hunter EC, Lutsiv O, Makh SK, Souza JP, Aguiar C, Saraiva Coneglian F, Diniz AL, Tuncalp O, Javadi D, Oladapo OT, Khosla R, Hindin MJ, Gulmezoglu AM. The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review. PLoS Med. 2015 Jun 30;12(6):e1001847; discussion e1001847. doi: 10.1371/journal.pmed.1001847. eCollection 2015 Jun.
PubMed 26126110Abuya T, Warren CE, Miller N, Njuki R, Ndwiga C, Maranga A, Mbehero F, Njeru A, Bellows B. Exploring the prevalence of disrespect and abuse during childbirth in Kenya. PLoS One. 2015 Apr 17;10(4):e0123606. doi: 10.1371/journal.pone.0123606. eCollection 2015.
PubMed 25884566Moyer CA, Adongo PB, Aborigo RA, Hodgson A, Engmann CM. 'They treat you like you are not a human being': maltreatment during labour and delivery in rural northern Ghana. Midwifery. 2014 Feb;30(2):262-8. doi: 10.1016/j.midw.2013.05.006. Epub 2013 Jun 19.
PubMed 23790959Tuncalp O, Hindin MJ, Adu-Bonsaffoh K, Adanu R. Listening to women's voices: the quality of care of women experiencing severe maternal morbidity, in Accra, Ghana. PLoS One. 2012;7(8):e44536. doi: 10.1371/journal.pone.0044536. Epub 2012 Aug 31.
PubMed 22952992Koblinsky M, Moyer CA, Calvert C, Campbell J, Campbell OM, Feigl AB, Graham WJ, Hatt L, Hodgins S, Matthews Z, McDougall L, Moran AC, Nandakumar AK, Langer A. Quality maternity care for every woman, everywhere: a call to action. Lancet. 2016 Nov 5;388(10057):2307-2320. doi: 10.1016/S0140-6736(16)31333-2. Epub 2016 Sep 16.
PubMed 27642018Ratcliffe HL, Sando D, Lyatuu GW, Emil F, Mwanyika-Sando M, Chalamilla G, Langer A, McDonald KP. Mitigating disrespect and abuse during childbirth in Tanzania: an exploratory study of the effects of two facility-based interventions in a large public hospital. Reprod Health. 2016 Jul 18;13(1):79. doi: 10.1186/s12978-016-0187-z.
PubMed 27424608
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Provider Stress and Unconscious Bias to Improve Quality of Maternal Health Care
- ClinicalTrials.gov ID
- NCT05019131
- Acronym / sponsor ID
- CPIPE2 / A135552
- Conditions
- Maternal Health, Mental Health, Healthcare Provider, Adverse Outcomes, Stress, Stress, Psychological
- Keywords
- providers, mental health, unconscious bias, prejudice, Kenya, stress, burnout, person-centered care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 24 Jun 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Posted 12 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The activities described in this proposal are aimed at addressing health care provider stress and unconscious bias to improve quality of maternal health care, particularly related to the person-centered dimensions of care-i.e. care that is respectful and responsive to women's needs, preferences, and values. The investigators focus on health provider stress and unconscious bias because they are key drivers of poor-quality care that are often not addressed in interventions designed to improve quality of maternal health care. The investigators plan to (1) design an intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels.
Detailed description
Poor person-centered maternal health care (PCMHC) contributes to high maternal and neonatal mortality in sub-Saharan Africa (SSA), and disparities in PCMHC are driving disparities in use of maternal health services., However, little research exists on how to improve PCMHC and reduce disparities. The investigators seek to fill this gap with this project. They propose targeting health provider stress and unconscious bias as fundamental factors driving both poor PCMHC and disparities in PCMHC. Health care provider stress and unconscious bias are important to consider because: (1) providers in low-resource settings often work under very stressful conditions; (2) unconscious bias is prevalent in every society including SSA; and (3) these factors are mutually reinforcing drivers of poor quality care and disparities in person-centered care. In the first phase of the project (CPIPE1), they conducted research to examine (1) the factors associated with PCMHC and identified provider stress and unconscious bias as key contributing factors. They also examined the levels of provider stress and unconscious bias and the types of stressors and biases in Migori County, Kenya. The results of that research will be used to inform this phase (CPIPE2), the aims of which are to: (1) design a multicomponent theory and evidence-based intervention that enables providers to identify and manage their stress and unconscious bias; (2) pilot the intervention to assess its feasibility and acceptability; and (3) assess preliminary effect of the intervention on: (a) provider knowledge, attitudes, and behaviors related to stress and unconscious bias; and (b) provider stress levels using a pretest-posttest control group design. They will use the results of the pilot to refine the intervention and develop an R01 proposal for a multi-site evaluation with a larger sample and longer follow up to assess impact on PCMHC. This study will yield valuable information to inform quality improvement efforts for PCMHC.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Training, Behavioral: Peer support and mentorship, Behavioral: Leadership engagement, Behavioral: Embedded champions1. Training: The investigators will develop a training for providers that addresses the following topics: Stress \& positive coping mechanisms; Unconscious bias awareness and mitigation; Person-centered maternity care; Dealing with difficult situations; and Teamwork and communication; 2. Peer support and mentorship: The investigators will identify what works best for these groups in terms of group composition, size, and how the groups want to interact. 3. Leadership engagement: To ensure leadership buy in, support and sustainability of the intervention, the investigators will engage leadership of the County. 4. Embedded champions: To facilitate ongoing engagement, the investigators will identify local leaders, and invite them to training where they will be taught how to facilitate peer support groups and serve as champions. |
| Control arm | No intervention | –Will not receive any training during the intervention period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Providers working in maternity units of the intervention facilities are all eligible.
Key exclusion criteria (1 listed)
- Inability to attend scheduled training.
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 |
|---|---|---|
| Trainingtrainings to reduce conscious bias and stress | Behavioural | Intervention arm |
| Peer support and mentorshipfacilitated peer and mentorship opportunities | Behavioural | Intervention arm |
| Leadership engagementEngaged leadership at the county and facility levels | Behavioural | Intervention arm |
| Embedded championsFacilitate local champions to promote intervention | Behavioural | Intervention arm |
Primary outcome
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months
Time frame: Baseline and 6 months
The Perceived Stress Scale (PSS) score ranges from 0 to 40 with higher scores indicating higher perceived stress.
Change in Shirom-Melamed Burnout Measure (SMBM) Score From Baseline to 6 Months
Time frame: Baseline and 6 months
The Shirom-Melamed Burnout Measure range from 1 to 7 with higher scores indicating higher burnout
Change in Stress Knowledge and Attitudes Score From Baseline to 6 Months
Time frame: Baseline and 6 months
The stress knowledge and attitudes score is measured by 14 survey questions with scores ranging from 0 to 14. Higher scores indicate higher knowledge and positive attitudes regarding stress and stress management. We used 13 of the items from the 14-item survey scale. The score range used is 0 to 13- as noted in the limitations section.
Change in Unconscious Bias Knowledge and Attitudes Score From Baseline to 6 Months
Time frame: Baseline and 6 months
The unconscious bias knowledge and attitudes score is measured by 17 survey questions with scores ranging from 0 to 17. Higher scores indicate higher knowledge and positive attitudes regarding unconscious bias and unconscious bias mitigation
4 secondary outcomes
Change in Hair Cortisol Levels From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Heart Rate Variability (HRV) Levels From Baseline to 6 Months
Time frame: Baseline and 6 months
Change in Socioeconomic Status-person Centered Maternity Care Implicit Association Test (IAT) Score
Time frame: Baseline and 6 months
Change in Explicit Bias Scores From Baseline to 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundWHO, UNICEF, UNFPA, The World Bank, United Nations Population Division. Trends in maternal mortality: 1990 to 2013 [Internet]. WHO. 2014 [cited 2014 Jul 17]. Available from: http://www.who.int/reproductivehealth/publications/monitoring/9789241503631/en/index.html
- Background: PubMed 19671156Gabrysch S, Campbell OM. Still too far to walk: literature review of the determinants of delivery service use. BMC Pregnancy Childbirth. 2009 Aug 11;9:34. doi: 10.1186/1471-2393-9-34.
- Background: PubMed 23962135Moyer CA, Mustafa A. Drivers and deterrents of facility delivery in sub-Saharan Africa: a systematic review. Reprod Health. 2013 Aug 20;10:40. doi: 10.1186/1742-4755-10-40.
- Background: PubMed 23335862Graham WJ, McCaw-Binns A, Munjanja S. Translating coverage gains into health gains for all women and children: the quality care opportunity. PLoS Med. 2013;10(1):e1001368. doi: 10.1371/journal.pmed.1001368. Epub 2013 Jan 15.
- Background: PubMed 19740165van den Broek NR, Graham WJ. Quality of care for maternal and newborn health: the neglected agenda. BJOG. 2009 Oct;116(Suppl 1):18-21. doi: 10.1111/j.1471-0528.2009.02333.x.
- Background: PubMed 25238684Bohren MA, Hunter EC, Munthe-Kaas HM, Souza JP, Vogel JP, Gulmezoglu AM. Facilitators and barriers to facility-based delivery in low- and middle-income countries: a qualitative evidence synthesis. Reprod Health. 2014 Sep 19;11(1):71. doi: 10.1186/1742-4755-11-71.
- Background: PubMed 20574515Friberg IK, Kinney MV, Lawn JE, Kerber KJ, Odubanjo MO, Bergh AM, Walker N, Weissman E, Chopra M, Black RE; Science in Action: Saving the lives of Africa's Mothers, Newborns, and Children working group; Axelson H, Cohen B, Coovadia H, Diab R, Nkrumah F. Sub-Saharan Africa's mothers, newborns, and children: how many lives could be saved with targeted health interventions? PLoS Med. 2010 Jun 21;7(6):e1000295. doi: 10.1371/journal.pmed.1000295.
- Background: PubMed 27642019Miller S, Abalos E, Chamillard M, Ciapponi A, Colaci D, Comande D, Diaz V, Geller S, Hanson C, Langer A, Manuelli V, Millar K, Morhason-Bello I, Castro CP, Pileggi VN, Robinson N, Skaer M, Souza JP, Vogel JP, Althabe F. Beyond too little, too late and too much, too soon: a pathway towards evidence-based, respectful maternity care worldwide. Lancet. 2016 Oct 29;388(10056):2176-2192. doi: 10.1016/S0140-6736(16)31472-6. Epub 2016 Sep 16.
- BackgroundInstitute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century [Internet]. 2001. Available from: http://www.iom.edu/Reports/2001/Crossing-the-Quality-Chasm-A-New-Health-System-for-the-21st-Century.aspx
- Background: PubMed 26126110Bohren MA, Vogel JP, Hunter EC, Lutsiv O, Makh SK, Souza JP, Aguiar C, Saraiva Coneglian F, Diniz AL, Tuncalp O, Javadi D, Oladapo OT, Khosla R, Hindin MJ, Gulmezoglu AM. The Mistreatment of Women during Childbirth in Health Facilities Globally: A Mixed-Methods Systematic Review. PLoS Med. 2015 Jun 30;12(6):e1001847; discussion e1001847. doi: 10.1371/journal.pmed.1001847. eCollection 2015 Jun.
- Background: PubMed 25884566Abuya T, Warren CE, Miller N, Njuki R, Ndwiga C, Maranga A, Mbehero F, Njeru A, Bellows B. Exploring the prevalence of disrespect and abuse during childbirth in Kenya. PLoS One. 2015 Apr 17;10(4):e0123606. doi: 10.1371/journal.pone.0123606. eCollection 2015.
- Background: PubMed 23790959Moyer CA, Adongo PB, Aborigo RA, Hodgson A, Engmann CM. 'They treat you like you are not a human being': maltreatment during labour and delivery in rural northern Ghana. Midwifery. 2014 Feb;30(2):262-8. doi: 10.1016/j.midw.2013.05.006. Epub 2013 Jun 19.
- Individual participant dataSharing planned: No
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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.
Patience Afulani, PhD, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training, Peer support and mentorship and Leadership engagement in people with Maternal Health and Mental Health, run by University of California, San Francisco at 1 site in Kenya.
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 1 inclusion and 1 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 7 May 2025. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Perceived Stress Scale (PSS) Score From Baseline to 6 Months (time frame: Baseline and 6 months). 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?
On the ClinicalTrials.gov record for NCT05019131, which also lists 84 linked publications.
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 7 May 2025.