Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya (PrEPARE)

University of Washington

Status: Completed

Conditions: Pre-Exposure Prophylaxis; Pregnancy Related; HIV Infections

Treatments: Other: PrEP Optimization Interventions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05482360

K01MH121124 (U.S. NIH Grant/Contract)

STUDY00008392-A

Details and patient eligibility

About

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Full description

This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include three packages of strategies identified by stakeholders.

Enrollment: 5,690 patients

Sex: Female

Ages: 15 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Exclusion criteria

• Unwilling or unable to provide informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,690 participants in 2 patient groups

PrEP Optimization Strategies

Experimental group

Description:

Up to 12 facilities will be assigned one of three intervention groups (4 facilities per group). The strategies have no yet been identified but will be through other activities in the PrEPARE study.

Treatment:

Other: PrEP Optimization Interventions

Comparator

No Intervention group

Description:

Up to 4 facilities will be assigned to the comparator group.