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

Not Applicable

Completed

• Conditions: Pregnancy Related; Hiv; Stigmatization
• Interventions: Behavioral: MAMA Intervention

• Registration Number: NCT05271903
• Lead Sponsor: University of Utah

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.

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 Timeline

• Study Start: 2022-01-31
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-27
• Study First Posted: 2022-03-09
• Primary Completion: 2023-06-01
• Study Completion: 2023-07-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in respectful maternity care	3 months	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.

Trial Locations

Locations (1)

Kilimanjaro Christian Medical Centre; 🇹🇿 Moshi, Tanzania