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Completed

NCT Number: NCT05271903

Simulation Training 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.

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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Behavior Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Pregnancy Related RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Social Behavior Social Stigma Stereotyping Stigmatization Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Fogarty International Center of the National Institute of Health

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 9, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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