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

October 1, 2025 updated by: Melissa Watt, University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Moshi, Tanzania
        • Kilimanjaro Christian Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Labor and delivery providers who are:

  • Over age 18
  • Employed by a study clinic
  • Work in the labor and delivery ward

Exclusion Criteria:

  • Has not provided clinical care in the labor and delivery ward in past 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
The MAMA intervention, which is a simulation training intervention for labor and delivery prviders.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

Fogarty International Center of the National Institute of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 27, 2022

First Posted (Actual)

March 9, 2022

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21TW012001-01 (U.S. NIH Grant/Contract)
  • R21TW012001 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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