Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
Official Title
Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)
Acronym
PrEPARE
Organization
University of WashingtonOTHER
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 1, 2022Actual
Primary Completion Date
Dec 15, 2023Actual
Completion Date
Dec 15, 2023Actual
First Submitted Date
Jul 26, 2022
First Submission Date that Met QC Criteria
Jul 28, 2022
First Posted Date
Aug 1, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Dec 15, 2024
Results First Submitted that Met QC Criteria
Feb 4, 2025
Results First Posted Date
Feb 26, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 4, 2025
Last Update Posted Date
Feb 26, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Anjuli Wagner, Assistant Professor, Global Health, University of WashingtonPrincipal Investigator
Lead Sponsor
University of WashingtonOTHER
Collaborators
Name
Class
National Institute of Mental Health (NIMH)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
Pre-Exposure Prophylaxis
HIV Infections
Pregnancy Related
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
5,173Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Package 1
Experimental
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
Other: PrEP Optimization Interventions
Comparator for Package 1
No Intervention
4 facilities were assigned to the comparator group and never received any implementation strategy.
Package 2
Experimental
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
Other: PrEP Optimization Interventions
Package 3
Experimental
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
Other: PrEP Optimization Interventions
Comparison for Package 2
No Intervention
4 facilities were assigned to the comparator group and never received any implementation strategy.
Comparison for Package 3
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PrEP Optimization Interventions
Other
There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
Package 1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change in PrEP Penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
6 months
Change in PrEP Fidelity
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.
6 months
Timeliness of Services
Time (minutes) spent receiving services from health care workers
6 months
Waiting Time
Time (minutes) spent waiting to receive services
6 months
HCW Acceptability
Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
6 months
Health Care Worker (HCW) Appropriateness
Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
6 months
Secondary Outcomes
Measure
Description
Time Frame
PrEP Uptake
Proportion of women who accept PrEP among those offered
6 months
PrEP Continuation
Proportion of women who present for a refill among those initially prescribed PrEP
Other Outcomes
Not provided
Eligibility Module
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
Accepts Healthy Volunteers
Yes
Sex
Female
Sex/Gender Based
Yes
Sex/Gender Description
Anyone presenting for maternal child health services can be included in the study.
Minimum Age
15 Years
Maximum Age
100 Years
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Anjuli Wagner, PhD
University of Washington
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Ober Health Center
Homa Bay
Kenya
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Undecided
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
The enrollment number in the protocol section (5,173) includes the sum of participants who started in the participant flow module below (4,972), as well as the 201 additional health care workers who provided cross-sectional data in the intervention group during the intervention period. There was no drop-off between consent and enrollment.
Recruitment Details
Not provided
Type of Units Analyzed
Facilities
Arm/Group Information
ID
Title
Description
FG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
FG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
FG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
FG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
FG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
FG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Periods
Title
Milestones
Reasons Not Completed
Baseline Period (3 Months)
Type
Comment
Milestone Data
STARTED
FG000392 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG001420 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG002402 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
COMPLETED
FG000392 subjects4 units
FG001420 subjects4 units
FG002402 subjects4 units
FG003415 subjects
NOT COMPLETED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG0030 subjects0 units
Intervention Period (3 Months)
Type
Comment
Milestone Data
STARTED
FG000408 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG001416 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG002
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
BG001
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change in PrEP Penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
Adverse Events Module
Frequency Threshold
0
Time Frame
1 cross-sectional visit. In this cross-sectional study, there were no participants followed longitudinally. Adverse events were not collected systematically within this minimal risk, cross-sectional study.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
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. Three rounds of difference-in-differences tests will be used to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three rounds 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.
Primary Purpose
Health Services Research
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
No Intervention
4 facilities were assigned to the comparator group and never received any implementation strategy.
Package 2
Package 3
Client Satisfaction
Total on 7 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
6 months
6 months
Client PrEP Knowledge
Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
6 months
PrEP Adherence
Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP
6 months
PrEP Efficiency
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
6 months
FG003415 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG004419 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG005406 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
4 units
FG004419 subjects4 units
FG005406 subjects4 units
FG0040 subjects0 units
FG0050 subjects0 units
439 subjects
4 units
The total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG003426 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG004420 subjects4 unitsThe total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.
FG005409 subjects4 units
COMPLETED
FG000408 subjects4 units
FG001416 subjects4 units
FG002439 subjects4 units
FG003426 subjects4 units
FG004420 subjects4 units
FG005409 subjects4 units
NOT COMPLETED
FG0000 subjects0 units
FG0010 subjects0 units
FG0020 subjects0 units
FG0030 subjects0 units
FG0040 subjects0 units
FG0050 subjects0 units
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
BG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
BG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
BG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
BG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
BG006
Total
Total of all reporting groups
392
BG001420
BG002402
BG003415
BG004419
BG005406
BG0062454
Inter-Quartile Range
years
Title
Denominators
Categories
Title
Measurements
BG00024(21 to 28)
BG00125(22 to 29)
BG00223.5(21 to 28)
BG00324(22 to 29)
BG00424(21 to 27)
BG00524(21 to 29)
BG00624(21 to 28)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000392
BG001420
BG002402
BG003415
BG004419
BG005406
BG0062454
Male
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
Asian
BG0000
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG000392
BG001420
BG002402
BG003415
BG004
White
BG0000
BG0010
BG0020
BG0030
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
Kenya
Title
Measurements
BG000392
BG001420
BG002402
BG003415
BG004419
BG005406
BG0062454
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000800
OG001836
OG002841
OG003841
OG004839
OG005815
Title
Denominators
Categories
Baseline
ParticipantsOG000392
ParticipantsOG001420
ParticipantsOG002402
ParticipantsOG003415
ParticipantsOG004419
ParticipantsOG005406
Title
Measurements
OG00013
OG00123
OG00235
OG003
Intervention
ParticipantsOG000408
ParticipantsOG001416
ParticipantsOG002439
ParticipantsOG003426
Primary
Change in PrEP Fidelity
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000327
OG001322
OG002365
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000179
ParticipantsOG001163
ParticipantsOG002174
ParticipantsOG003
Primary
Timeliness of Services
Time (minutes) spent receiving services from health care workers
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Median
Inter-Quartile Range
minutes
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000384
OG001384
OG002383
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000192
ParticipantsOG001192
ParticipantsOG002191
ParticipantsOG003
Primary
Waiting Time
Time (minutes) spent waiting to receive services
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Median
Inter-Quartile Range
minutes
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000384
OG001384
OG002383
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000192
ParticipantsOG001192
ParticipantsOG002191
ParticipantsOG003
Primary
HCW Acceptability
Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
This outcome was assessed on a group of HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.
Posted
Median
Inter-Quartile Range
units on a scale
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG002
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
Units
Counts
Participants
OG00064
OG00192
OG00245
Title
Denominators
Categories
Title
Measurements
OG00018.5(16 to 20)
OG00118(16 to 20)
OG00220(18 to 20)
Primary
Health Care Worker (HCW) Appropriateness
Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
This outcome was assessed on a group of HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.
Posted
Median
Inter-Quartile Range
units on a scale
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG002
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
Units
Counts
Participants
OG00064
OG00192
OG00245
Title
Denominators
Categories
Title
Measurements
OG00018(16 to 20)
OG00119(16 to 20)
OG00220(17 to 20)
Primary
Client Satisfaction
Total on 7 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Median
Inter-Quartile Range
units on a scale
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000800
OG001836
OG002841
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000392
ParticipantsOG001420
ParticipantsOG002402
ParticipantsOG003
Secondary
PrEP Uptake
Proportion of women who accept PrEP among those offered
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
This analysis population is a subset of the total because it only includes those who were offered PrEP, as noted in the denominator description of the indicator.
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG00032
OG00131
OG00277
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00214
ParticipantsOG003
Secondary
PrEP Continuation
Proportion of women who present for a refill among those initially prescribed PrEP
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
This analysis population is a subset of the total because it only includes those who were initially prescribed PrEP, as noted in the denominator description of the indicator.
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG00032
OG00131
OG00277
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG00012
ParticipantsOG00124
ParticipantsOG00214
ParticipantsOG003
Secondary
Client PrEP Knowledge
Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.
Posted
Count of Participants
Participants
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG000800
OG001836
OG002841
OG003
Title
Denominators
Categories
Baseline
ParticipantsOG000392
ParticipantsOG001420
ParticipantsOG002402
ParticipantsOG003
Secondary
PrEP Adherence
Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP
During preparatory activities for data collection, it was determined that it was not feasible to extract patient adherence information,; this outcome was neither collected nor compared. It was not feasible to extract patient adherence information because routine program data at each facility different substantially in how it quantified adherence to PrEP; it was not possible, nor meaningful to collect or analyze these data.
Posted
6 months
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and never received any implementation strategy.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG004
Comparison for Package 2
4 facilities were assigned to the comparator group and never received any implementation strategy.
OG005
Comparison for Package 3
4 facilities were assigned to the comparator group and never received any implementation strategy.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
Secondary
PrEP Efficiency
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
During preparatory activities for data collection, it was determined that it was not feasible to collect efficiency. This outcome was neither collected nor compared. It was not feasible to quantify efficiency in the way in which we originally envisioned due to the heterogeneity between sites and within sites on how service provision was organized and delivered.
Posted
6 months
Facility
Facility
ID
Title
Description
OG000
Package 1
Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
OG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
OG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG003
0
800
0
800
0
800
EG001
Comparator for Package 1
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
0
836
0
836
0
836
EG002
Package 2
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
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
0
841
0
841
0
841
EG003
Comparator for Package 2
4 facilities were assigned to the comparator group and did not receive any implementation strategies.
0
841
0
841
0
841
EG004
Package 3
Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
0
839
0
839
0
839
EG005
Comparator for Package 3
4 facilities were assigned to the comparator group and did not receive any implementation strategies.