Trial Outcomes & Findings for Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania (NCT NCT05271903)

NCT ID: NCT05271903

Last Updated: 2025-10-20

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

3 months

Results posted on

2025-10-20

Participant Flow

In this pilot trial, the primary outcome measure (change in respectful maternity care score) was assessed with the health care providers (n=60) who were enrolled and exposed to the MAMA training intervention.

Participant milestones

Participant milestones
Measure
MAMA Training
2.5 day health care provider simulation training for respectful and non-stigmatizing labor and delivery care for people living with HIV.
Overall Study
STARTED
60
Overall Study
COMPLETED
60
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Intervention
n=60 Participants
The MAMA intervention, which is a simulation training intervention for labor and delivery prviders. 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.
Age, Continuous
35.2 years
STANDARD_DEVIATION 8.5 • n=99 Participants
Sex: Female, Male
Female
29 Participants
n=99 Participants
Sex: Female, Male
Male
31 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
60 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
60 Participants
n=99 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
Tanzania
60 participants
n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Includes only the health care providers (n=60) who received the intervention.

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).

Outcome measures

Outcome measures
Measure
MAMA Training
n=60 Participants
2.5 day health care provider simulation training for respectful and non-stigmatizing labor and delivery care for people living with HIV.
Change in Respectful Maternity Care
21.8 score on a scale
Standard Deviation 3.1

Adverse Events

Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Watt

University of Utah

Phone: 801-587-2100

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place