Back to resultsPrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Primary Purpose
Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
Status
Completed
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
- Kendu Sub-District Hospital
- Ober Health Center
- Masogo Sub-County Hospital
- Nyahera Sub Sub County Hospital
- Bondo County Referral Hospital
- Madiany Sub County Hospital
- Malanga Health Center
- Uyawi Sub County Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PrEP Optimization Strategies
Comparator
Arm Description
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
Four 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
NCT04712994
First Posted
December 30, 2020
Last Updated
August 4, 2023
Sponsor
University of Washington
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)
1. Study Identification
Unique Protocol Identification Number
NCT04712994
Brief Title
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Official Title
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
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)
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 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).
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
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1958 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PrEP Optimization Strategies
Arm Type
Experimental
Arm Description
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
Arm Title
Comparator
Arm Type
No Intervention
Arm Description
Four facilities will be assigned to the comparator group.
Intervention Type
Other
Intervention Name(s)
PrEP Optimization Interventions
Intervention Description
A bundle of strategies (video-based PrEP counselling, HIV Self-Testing [HIVST] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace John-Stewart, MD, MPH, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kendu Sub-District Hospital
City
Homa Bay
Country
Kenya
Facility Name
Ober Health Center
City
Homa Bay
Country
Kenya
Facility Name
Masogo Sub-County Hospital
City
Kisumu
Country
Kenya
Facility Name
Nyahera Sub Sub County Hospital
City
Kisumu
Country
Kenya
Facility Name
Bondo County Referral Hospital
City
Siaya
Country
Kenya
Facility Name
Madiany Sub County Hospital
City
Siaya
Country
Kenya
Facility Name
Malanga Health Center
City
Siaya
Country
Kenya
Facility Name
Uyawi Sub County Hospital
City
Siaya
Country
Kenya
12. IPD Sharing Statement
Learn more about this trial
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
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