HivNCT05271903
Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania
A study testing MAMA Intervention in people with Hiv and Stigmatization, run by University of Utah at 1 site in Tanzania.
Trial summary
This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Stigmatization, Pregnancy Related
- What is being tested?
- MAMA Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTanzania
- Study dates
- 31 Jan 2022to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Labor and delivery providers who are:
- Over age 18
- Employed by a study clinic
- Work in the labor and delivery ward
Who cannot join
- Has not provided clinical care in the labor and delivery ward in past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Simulation and Experiential Learning Intervention for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania
This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. The primary endpoint will be patient-rated changes in respectful maternity care, comparing women who deliver in the pre-intervention time period and women who deliver in the post-intervention period.
Read the detailed description
The study will pilot test the MAMA intervention in six clinics in the Kilimanjaro Region. 60 L\&D providers will be enrolled across the sites. Patient level outcomes will be assessed using an interrupted time series design. Approximately 206 participants will be enrolled (103 in the pre-intervention period and 103 in the post-intervention period). The primary outcome will be patients' reported experiences of respectful maternity care (RMC). Secondary outcomes will be internalized HIV stigma, trust in health care, birth outcomes, HIV care engagements at 3 months, anticipated HIV stigma, and attitudes to long-term antiretroviral therapy. Our enrollment targets (103 per condition) will allow for detection of a medium effect of 0.4 in the change of RMC overall scores with 80% power and α=0.05. Pre- and post- surveys will be conducted for providers enrolled in the intervention, assessing outcomes related to practices of RMC, stigma toward WLHIV, self efficacy and clinical knowledge.
- Conditions
- Hiv, Stigmatization, Pregnancy Related
- Being tested
- MAMA Intervention
- Keywords
- HIV, stigma, childbirth, simulation training
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Stereotyping, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAMA InterventionBehavioural
The MAMA intervention will be based on PRONTO International's simulation training program to improve obstetric care delivery. The PRONTO curriculum is based on simulation and debrief of clinical scenarios, case-based learning, skills stations, and interactive teamwork and communication activities. Through the training, providers review and learn clinical skills related to obstetric care and emergencies, while reflecting on and practicing principles of respectful maternity care. The simulation exercises give providers and opportunity to "act" as the patient and develop empathy for the patient experience, and debriefing after simulation includes a reflection and discussion about RMC principles. The training will be two full days, followed by a refresher training in the clinical setting after one month.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. Receives: Behavioral: MAMA Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respectful Maternity Care
Practices of respectful maternity care were assessed using the measure "Person-centered maternity care" that Afulani et al validated in Kenya and Ghana. The scale includes nine questions that asked how often they had used person-centered practices in the past month. Items had four response options (never to always) and were summed. Scale has a possible range of 0 to 27, with higher values reflecting better outcomes (i.e., more respectful care).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start31 Jan 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 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 (3)Papers the sponsor has linked to this study.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- MAMA intervention: a simulation training for labor and delivery providers
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Melissa Watt, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271903
- Sponsor's protocol ID
- 1R21TW012001-01
- Other IDs
- R21TW012001
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2022
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data from the formative and pilot trial work in this R21 will be freely shared within the constraints required for the protection of confidentiality for study subjects. With a data transfer agreement from out Institutional Review Board, we are willing to share raw data with researchers and program leaders from other institutions.
Publications
Hanson OR, Weglarz AJ, Barabara ML, Cohen SR, Minja LM, Mlay PS, Stephens MJ, Olomi GA, Mlay J, Mmbaga BT, Watt MH. HIV-related Shame among Women Giving Birth in Tanzania: A Mixed Methods Study. AIDS Behav. 2024 Jul;28(7):2276-2285. doi: 10.1007/s10461-024-04322-1. Epub 2024 Mar 25.
PubMed 38526642Watt MH, Minja LM, Barabara M, Mlay P, Stephens MJ, Olomi G, Mlay J, Marchand V, Mmbaga BT, Hanson OR, Cohen SR. A simulation and experiential learning intervention for labor and delivery providers to address HIV stigma during childbirth in Tanzania: study protocol for the evaluation of the MAMA intervention. BMC Pregnancy Childbirth. 2023 Mar 16;23(1):181. doi: 10.1186/s12884-023-05482-z.
PubMed 36927460Watt MH, Cohen SR, Minja LM, Barabara M, Mlay P, Stephens MJ, Olomi G, Mlay J, Marchand V, Mmbaga BT. A simulation and experiential learning intervention for labor and delivery providers to address HIV stigma during childbirth in Tanzania: Study protocol for the evaluation of the MAMA intervention. Res Sq [Preprint]. 2023 Jan 30:rs.3.rs-2285235. doi: 10.21203/rs.3.rs-2285235/v1.
PubMed 36778232
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Simulation and Experiential Learning Intervention for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania
- ClinicalTrials.gov ID
- NCT05271903
- Acronym / sponsor ID
- 1R21TW012001-01
- Conditions
- Hiv, Stigmatization, Pregnancy Related
- Keywords
- HIV, stigma, childbirth, simulation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. The primary endpoint will be patient-rated changes in respectful maternity care, comparing women who deliver in the pre-intervention time period and women who deliver in the post-intervention period.
Detailed description
The study will pilot test the MAMA intervention in six clinics in the Kilimanjaro Region. 60 L\&D providers will be enrolled across the sites. Patient level outcomes will be assessed using an interrupted time series design. Approximately 206 participants will be enrolled (103 in the pre-intervention period and 103 in the post-intervention period). The primary outcome will be patients' reported experiences of respectful maternity care (RMC). Secondary outcomes will be internalized HIV stigma, trust in health care, birth outcomes, HIV care engagements at 3 months, anticipated HIV stigma, and attitudes to long-term antiretroviral therapy. Our enrollment targets (103 per condition) will allow for detection of a medium effect of 0.4 in the change of RMC overall scores with 80% power and α=0.05. Pre- and post- surveys will be conducted for providers enrolled in the intervention, assessing outcomes related to practices of RMC, stigma toward WLHIV, self efficacy and clinical knowledge.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MAMA intervention: a simulation training for labor and delivery providers
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MAMA InterventionThe MAMA intervention, which is a simulation training intervention for labor and delivery prviders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over age 18
- Employed by a study clinic
- Work in the labor and delivery ward
Key exclusion criteria (1 listed)
- Has not provided clinical care in the labor and delivery ward in past 6 months
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 |
|---|---|---|
| MAMA InterventionThe MAMA intervention will be based on PRONTO International's simulation training program to improve obstetric care delivery. The PRONTO curriculum is based on simulation and debrief of clinical scenarios, case-based learning, skills stations, and interactive teamwork and communication activities. Through the training, providers review and learn clinical skills related to obstetric care and emergencies, while reflecting on and practicing principles of respectful maternity care. The simulation exercises give providers and opportunity to "act" as the patient and develop empathy for the patient experience, and debriefing after simulation includes a reflection and discussion about RMC principles. The training will be two full days, followed by a refresher training in the clinical setting after one month. | Behavioural | Intervention |
Primary outcome
Change in Respectful Maternity Care
Time frame: 3 months
Practices of respectful maternity care were assessed using the measure "Person-centered maternity care" that Afulani et al validated in Kenya and Ghana. The scale includes nine questions that asked how often they had used person-centered practices in the past month. Items had four response options (never to always) and were summed. Scale has a possible range of 0 to 27, with higher values reflecting better outcomes (i.e., more respectful care).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38526642Hanson OR, Weglarz AJ, Barabara ML, Cohen SR, Minja LM, Mlay PS, Stephens MJ, Olomi GA, Mlay J, Mmbaga BT, Watt MH. HIV-related Shame among Women Giving Birth in Tanzania: A Mixed Methods Study. AIDS Behav. 2024 Jul;28(7):2276-2285. doi: 10.1007/s10461-024-04322-1. Epub 2024 Mar 25.
- Derived from this study: PubMed 36927460Watt MH, Minja LM, Barabara M, Mlay P, Stephens MJ, Olomi G, Mlay J, Marchand V, Mmbaga BT, Hanson OR, Cohen SR. A simulation and experiential learning intervention for labor and delivery providers to address HIV stigma during childbirth in Tanzania: study protocol for the evaluation of the MAMA intervention. BMC Pregnancy Childbirth. 2023 Mar 16;23(1):181. doi: 10.1186/s12884-023-05482-z.
- Derived from this study: PubMed 36778232Watt MH, Cohen SR, Minja LM, Barabara M, Mlay P, Stephens MJ, Olomi G, Mlay J, Marchand V, Mmbaga BT. A simulation and experiential learning intervention for labor and delivery providers to address HIV stigma during childbirth in Tanzania: Study protocol for the evaluation of the MAMA intervention. Res Sq [Preprint]. 2023 Jan 30:rs.3.rs-2285235. doi: 10.21203/rs.3.rs-2285235/v1.
- Individual participant dataSharing planned: No. The data from the formative and pilot trial work in this R21 will be freely shared within the constraints required for the protection of confidentiality for study subjects. With a data transfer agreement from out Institutional Review Board, we are willing to share raw data with researchers and program leaders from other institutions.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAMA Intervention in people with Hiv and Stigmatization, run by University of Utah at 1 site in Tanzania.
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 4 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 20 Oct 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 Tanzania. 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 20 Oct 2025). 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 Respectful Maternity Care (time frame: 3 months). 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 NCT05271903, which also lists 3 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 20 Oct 2025.