NCT05271903

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for not_applicable hiv

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2022

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 20, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.3 years

First QC Date

February 16, 2022

Results QC Date

October 1, 2024

Last Update Submit

October 1, 2025

Conditions

Keywords

HIVstigmachildbirthsimulation training

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Intervention

EXPERIMENTAL

The MAMA intervention, which is a simulation training intervention for labor and delivery prviders.

Behavioral: MAMA Intervention

Interventions

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Labor and delivery providers who are:
  • Over age 18
  • Employed by a study clinic
  • Work in the labor and delivery ward

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, Tanzania

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeStereotypingSocial Stigma

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSocial BehaviorBehavior

Results Point of Contact

Title
Melissa Watt
Organization
University of Utah

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: MAMA intervention: a simulation training for labor and delivery providers
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 16, 2022

First Posted

March 9, 2022

Study Start

January 31, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

October 20, 2025

Results First Posted

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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.

Locations