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

5,173 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)

5,173 participants in 6 patient groups

Package 1

Experimental group

Description:

Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH

Treatment:

Other: PrEP Optimization Interventions

Comparator for Package 1

No Intervention group

Description:

4 facilities were assigned to the comparator group and never received any implementation strategy.

Package 2

Experimental group

Description:

Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH

Treatment:

Other: PrEP Optimization Interventions

Package 3

Experimental group

Description:

Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH

Treatment:

Other: PrEP Optimization Interventions

Comparison for Package 2

No Intervention group

Description:

4 facilities were assigned to the comparator group and never received any implementation strategy.