Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya (PrEPARE)
Primary Purpose
Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
Status
Recruiting
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
PrEP Optimization Interventions
Sponsored by
About this trial
This is an interventional health services research trial for Pre-Exposure Prophylaxis
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
Sites / Locations
- Ober Health CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PrEP Optimization Strategies
Comparator
Arm 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.
Up to 4 facilities will be assigned to the comparator group.
Outcomes
Primary Outcome Measures
Change in PrEP penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Change in PrEP fidelity
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
Change in timeliness of services
Time (minutes) spent receiving services from health care works
Change in time waiting
Time (minutes) spent waiting to receive services
Change in HCW acceptability
Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale
Change in health care worker (HCW) appropriateness
Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale
Change in client satisfaction
Exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale
Secondary Outcome Measures
Change in PrEP uptake
Proportion of women who accept PrEP among those offered
Change in PrEP continuation
Proportion of women who present for a refill among those initially prescribed PrEP
Change in PrEP adherence
Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP
Change in PrEP efficiency
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Change client PrEP knowledge
Average score of PrEP information questions based on content covered in counseling sessions
Full Information
NCT ID
NCT05482360
First Posted
July 26, 2022
Last Updated
August 4, 2023
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05482360
Brief Title
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
Acronym
PrEPARE
Official Title
Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.
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 three packages of strategies identified by stakeholders.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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. Three rounds of interrupted-time series to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three 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)
Allocation
Non-Randomized
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PrEP Optimization Strategies
Arm Type
Experimental
Arm 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.
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Up to 4 facilities will be assigned to the comparator group.
Intervention Type
Other
Intervention Name(s)
PrEP Optimization Interventions
Intervention Description
There will be three strategies or bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders and are unknown at this time.
Primary Outcome Measure Information:
Title
Change in PrEP penetration
Description
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Time Frame
6 months
Title
Change in PrEP fidelity
Description
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
Time Frame
6 months
Title
Change in timeliness of services
Description
Time (minutes) spent receiving services from health care works
Time Frame
6 months
Title
Change in time waiting
Description
Time (minutes) spent waiting to receive services
Time Frame
6 months
Title
Change in HCW acceptability
Description
Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale
Time Frame
6 months
Title
Change in health care worker (HCW) appropriateness
Description
Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale
Time Frame
6 months
Title
Change in client satisfaction
Description
Exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in PrEP uptake
Description
Proportion of women who accept PrEP among those offered
Time Frame
6 months
Title
Change in PrEP continuation
Description
Proportion of women who present for a refill among those initially prescribed PrEP
Time Frame
6 months
Title
Change in PrEP adherence
Description
Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP
Time Frame
6 months
Title
Change in PrEP efficiency
Description
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Time Frame
6 months
Title
Change client PrEP knowledge
Description
Average score of PrEP information questions based on content covered in counseling sessions
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Anyone presenting for maternal child health services can be included in the study.
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anjuli Wagner, PhD
Phone
9784602331
Email
anjuliw@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Dettinger, MPH
Phone
206-221-1041
Email
jcdettin@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjuli Wagner, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ober Health Center
City
Homa Bay
Country
Kenya
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ben Ochieng
Phone
+254 714 487 874
Email
oben@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
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