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| ID | Type | Description | Link |
|---|---|---|---|
| R21TW012001 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Fogarty International Center of the National Institute of Health | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAMA Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
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Inclusion Criteria:
Labor and delivery providers who are:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kilimanjaro Christian Medical Centre | Moshi | Tanzania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38526642 | Derived | 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. | |
| 36927460 | Derived | Watt 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. |
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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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In this pilot trial, the primary outcome measure (change in respectful maternity care score) was assessed with the health care providers (n=60) who were enrolled and exposed to the MAMA training intervention.
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| ID | Title | Description |
|---|---|---|
| FG000 | MAMA Training | 2.5 day health care provider simulation training for respectful and non-stigmatizing labor and delivery care for people living with HIV. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. MAMA Intervention: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Includes only the health care providers (n=60) who received the intervention. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
Intervenmtion period (2.5 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. MAMA Intervention: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Watt | University of Utah | 801-587-2100 | melissa.watt@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2025 | Oct 1, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2020 | Jan 7, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D013240 | Stereotyping |
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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MAMA intervention: a simulation training for labor and delivery providers
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| 36778232 | Derived | Watt 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. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |