Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV Infections
  • Pre-exposure Prophylaxis
  • Pregnancy Related
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: An interrupted-time series 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 controls for time trends. Four rounds of interrupted-time series to evaluate four PrEP optimization interventions, three identified by stakeholders based on qualitative information in Aim 1, and one pre-developed package of interventions (video-based PrEP counselling, HIV Self-Testing [HIVST], and optimized PrEP delivery). Each of the four rounds of interrupted-time series evaluations will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Younger than 125 years
Gender
Only males

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 strategies identified by stakeholders an...

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 strategies identified by stakeholders and 1 pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Tracking Information

NCT #
NCT04712994
Collaborators
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute of Mental Health (NIMH)
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Grace John-Stewart, MD, MPH, PhD University of Washington