NCT05271903

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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.

Conditions

• Hiv
• Stigmatization
• Pregnancy Related

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2022-01-31
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-03-09
• Last updated: 2025-10-20
• Results posted: 2025-10-20

Locations

1 site across 1 country: Tanzania