Clinical trial NCT04712994: PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Official title: PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Exposure Prophylaxis
HIV Infections
Pregnancy Related
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-01-19
Enrollment: 1958
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A difference-in-difference design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced and compares that with the expected change before and after in comparison clinics. One package of interventions (video-based PrEP counseling, HIV Self-Testing \[HIVST\], and optimized PrEP delivery) will be implemented at four intervention facilities and here will be 4 comparison facilities will undergo the same data collection procedures.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

Detailed 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 a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Unwilling or unable to provide informed consent

Primary outcomes:
measure: PrEP Penetration
timeFrame: 6 months
measure: PrEP Fidelity
timeFrame: 6 months
measure: Timeliness of Services
timeFrame: 6 months
measure: Waiting Time
timeFrame: 6 months
measure: HCW Acceptability
timeFrame: 6 months
measure: Health Care Worker (HCW) Appropriateness
timeFrame: 6 months
measure: Client Satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: PrEP Uptake
timeFrame: 6 months
measure: PrEP Continuation
timeFrame: 6 months
measure: PrEP Adherence
timeFrame: 6 months
measure: PrEP Efficiency
timeFrame: 6 months
measure: Client PrEP Knowledge
timeFrame: 6 months
Other outcomes:
Locations:
city: Homa Bay
country: Kenya
facility: Kendu Sub-District Hospital
city: Homa Bay
country: Kenya
facility: Ober Health Center
city: Kisumu
country: Kenya
facility: Masogo Sub-County Hospital
city: Kisumu
country: Kenya
facility: Nyahera Sub Sub County Hospital
city: Siaya
country: Kenya
facility: Bondo County Referral Hospital
city: Siaya
country: Kenya
facility: Madiany Sub County Hospital
city: Siaya
country: Kenya
facility: Malanga Health Center
city: Siaya
country: Kenya
facility: Uyawi Sub County Hospital
Study officials:
affiliation: University of Washington
name: Grace John-Stewart, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: