Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Simulation and Experiential Learning Intervention for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania

Conditions
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Hiv, Stigmatization, Pregnancy Related

Intervention / Treatment
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* Behavioral: MAMA Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For labor and delivery providers: Over age 18 Employed by a study clinic Work in the labor and delivery ward For birthing women: Over age 18 Gave birth in a study clinic Diagnosed with HIV Exclusion Criteria: For labor and delivery providers: Has not provided clinical care in the labor and delivery ward in past 6 months For birthing women: Under age 18 Unconfirmed HIV status

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: MAMA intervention: a simulation training for labor and delivery providers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. | Behavioral: MAMA Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in respectful maternity care | Person-centered maternity care. This 24-item scale was initially validated in Kenya and India, and used for PRONTO evaluations in Ghana. It has been shown to have high content, construct and criterion validity, and good reliability. The scale was designed with three subscales (dignity and respect, community and autonomy, and supportive care), but factor analysis has supported a single dominant factor. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, stigma, childbirth, simulation training