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

Hiv Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271903
• Other study ID #: 1R21TW012001-01
• Secondary ID: R21TW012001
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: October 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: July 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For labor and delivery providers:

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

For birthing women:

• Over age 18
• Gave birth in a study clinic
• Diagnosed with HIV Exclusion Criteria:

For labor and delivery providers:

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

For birthing women:

• Under age 18
• Unconfirmed HIV status

Related Conditions & MeSH terms

• Hiv
• Pregnancy Related
• Stigmatization

Intervention

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.

Locations

Country	Name	City	State
Tanzania	Kilimanjaro Christian Medical Centre	Moshi

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Fogarty International Center of the National Institute of Health

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in respectful maternity care	Person-centered maternity care. This 24-item scale was initially validated in Kenya and India, and used for PRONTO evaluations in Ghana. It has been shown to have high content, construct and criterion validity, and good reliability. The scale was designed with three subscales (dignity and respect, community and autonomy, and supportive care), but factor analysis has supported a single dominant factor.	3 months