HIV Infections, Pre-Exposure Prophylaxis, Pregnancy Related
Conditions
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.
Interventions
There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
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. 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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys
Exclusion criteria
* Unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction | 6 months | 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. |
| Change in PrEP Fidelity | 6 months | 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. |
| Timeliness of Services | 6 months | Time (minutes) spent receiving services from health care workers |
| Waiting Time | 6 months | Time (minutes) spent waiting to receive services |
| HCW Acceptability | 6 months | 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. |
| Health Care Worker (HCW) Appropriateness | 6 months | 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. |
| Change in PrEP Penetration | 6 months | Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PrEP Continuation | 6 months | Proportion of women who present for a refill among those initially prescribed PrEP |
| Client PrEP Knowledge | 6 months | Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions |
| PrEP Adherence | 6 months | Proportion of women who have \>80 percent adherence to PrEP by pill count among those initially prescribed PrEP |
| PrEP Efficiency | 6 months | Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers |
| PrEP Uptake | 6 months | Proportion of women who accept PrEP among those offered |
Countries
Kenya
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 392 |
| Comparator for Package 1 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 420 |
| 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 | 402 |
| Comparator for Package 2 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 415 |
| 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 | 419 |
| Comparator for Package 3 4 facilities were assigned to the comparator group and did not receive any implementation strategies. | 406 |
| Total | 2,454 |
Baseline characteristics
| Characteristic | Package 1 | Total | Comparator for Package 3 | Package 3 | Comparator for Package 2 | Package 2 | Comparator for Package 1 |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 24 years | 24 years | 24 years | 24 years | 24 years | 23.5 years | 25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 392 Participants | 2454 Participants | 406 Participants | 419 Participants | 415 Participants | 402 Participants | 420 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 392 participants | 2454 participants | 406 participants | 419 participants | 415 participants | 402 participants | 420 participants |
| Sex: Female, Male Female | 392 Participants | 2454 Participants | 406 Participants | 419 Participants | 415 Participants | 402 Participants | 420 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 800 | 0 / 836 | 0 / 841 | 0 / 841 | 0 / 839 | 0 / 815 |
| other Total, other adverse events | 0 / 800 | 0 / 836 | 0 / 841 | 0 / 841 | 0 / 839 | 0 / 815 |
| serious Total, serious adverse events | 0 / 800 | 0 / 836 | 0 / 841 | 0 / 841 | 0 / 839 | 0 / 815 |
Outcome results
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Package 1 | Change in PrEP Fidelity | Baseline | 9 Participants |
| Package 1 | Change in PrEP Fidelity | Intervention | 9 Participants |
| Comparator for Package 1 | Change in PrEP Fidelity | Baseline | 8 Participants |
| Comparator for Package 1 | Change in PrEP Fidelity | Intervention | 2 Participants |
| Package 2 | Change in PrEP Fidelity | Baseline | 15 Participants |
| Package 2 | Change in PrEP Fidelity | Intervention | 55 Participants |
| Comparator for Package 2 | Change in PrEP Fidelity | Baseline | 1 Participants |
| Comparator for Package 2 | Change in PrEP Fidelity | Intervention | 8 Participants |
| Package 3 | Change in PrEP Fidelity | Baseline | 23 Participants |
| Package 3 | Change in PrEP Fidelity | Intervention | 61 Participants |
| Comparator for Package 3 | Change in PrEP Fidelity | Baseline | 14 Participants |
| Comparator for Package 3 | Change in PrEP Fidelity | Intervention | 8 Participants |
Primary
Change in PrEP Penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Package 1 | Change in PrEP Penetration | Baseline | 13 Participants |
| Package 1 | Change in PrEP Penetration | Intervention | 23 Participants |
| Comparator for Package 1 | Change in PrEP Penetration | Baseline | 23 Participants |
| Comparator for Package 1 | Change in PrEP Penetration | Intervention | 7 Participants |
| Package 2 | Change in PrEP Penetration | Baseline | 35 Participants |
| Package 2 | Change in PrEP Penetration | Intervention | 93 Participants |
| Comparator for Package 2 | Change in PrEP Penetration | Baseline | 3 Participants |
| Comparator for Package 2 | Change in PrEP Penetration | Intervention | 22 Participants |
| Package 3 | Change in PrEP Penetration | Baseline | 49 Participants |
| Package 3 | Change in PrEP Penetration | Intervention | 146 Participants |
| Comparator for Package 3 | Change in PrEP Penetration | Baseline | 23 Participants |
| Comparator for Package 3 | Change in PrEP Penetration | Intervention | 27 Participants |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Package 1 | Client Satisfaction | Baseline | 22 units on a scale |
| Package 1 | Client Satisfaction | Intervention | 21 units on a scale |
| Comparator for Package 1 | Client Satisfaction | Baseline | 22 units on a scale |
| Comparator for Package 1 | Client Satisfaction | Intervention | 21 units on a scale |
| Package 2 | Client Satisfaction | Baseline | 21 units on a scale |
| Package 2 | Client Satisfaction | Intervention | 21 units on a scale |
| Comparator for Package 2 | Client Satisfaction | Baseline | 20 units on a scale |
| Comparator for Package 2 | Client Satisfaction | Intervention | 21 units on a scale |
| Package 3 | Client Satisfaction | Baseline | 22 units on a scale |
| Package 3 | Client Satisfaction | Intervention | 22 units on a scale |
| Comparator for Package 3 | Client Satisfaction | Baseline | 21 units on a scale |
| Comparator for Package 3 | Client Satisfaction | Intervention | 22 units on a scale |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Package 1 | HCW Acceptability | 18.5 units on a scale |
| Comparator for Package 1 | HCW Acceptability | 18 units on a scale |
| Package 2 | HCW Acceptability | 20 units on a scale |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Package 1 | Health Care Worker (HCW) Appropriateness | 18 units on a scale |
| Comparator for Package 1 | Health Care Worker (HCW) Appropriateness | 19 units on a scale |
| Package 2 | Health Care Worker (HCW) Appropriateness | 20 units on a scale |
Primary
Timeliness of Services
Time (minutes) spent receiving services from health care workers
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Package 1 | Timeliness of Services | Baseline | 15 minutes |
| Package 1 | Timeliness of Services | Intervention | 15 minutes |
| Comparator for Package 1 | Timeliness of Services | Baseline | 14 minutes |
| Comparator for Package 1 | Timeliness of Services | Intervention | 12 minutes |
| Package 2 | Timeliness of Services | Baseline | 13 minutes |
| Package 2 | Timeliness of Services | Intervention | 13 minutes |
| Comparator for Package 2 | Timeliness of Services | Baseline | 12 minutes |
| Comparator for Package 2 | Timeliness of Services | Intervention | 15 minutes |
| Package 3 | Timeliness of Services | Baseline | 14 minutes |
| Package 3 | Timeliness of Services | Intervention | 15 minutes |
| Comparator for Package 3 | Timeliness of Services | Baseline | 15 minutes |
| Comparator for Package 3 | Timeliness of Services | Intervention | 15 minutes |
Primary
Waiting Time
Time (minutes) spent waiting to receive services
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Package 1 | Waiting Time | Baseline | 47 minutes |
| Package 1 | Waiting Time | Intervention | 42.5 minutes |
| Comparator for Package 1 | Waiting Time | Baseline | 33 minutes |
| Comparator for Package 1 | Waiting Time | Intervention | 38 minutes |
| Package 2 | Waiting Time | Baseline | 37 minutes |
| Package 2 | Waiting Time | Intervention | 43 minutes |
| Comparator for Package 2 | Waiting Time | Baseline | 33 minutes |
| Comparator for Package 2 | Waiting Time | Intervention | 31.5 minutes |
| Package 3 | Waiting Time | Baseline | 47 minutes |
| Package 3 | Waiting Time | Intervention | 35.5 minutes |
| Comparator for Package 3 | Waiting Time | Baseline | 32.5 minutes |
| Comparator for Package 3 | Waiting Time | Intervention | 35 minutes |
Secondary
Client PrEP Knowledge
Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Package 1 | Client PrEP Knowledge | Intervention | 3 Participants |
| Package 1 | Client PrEP Knowledge | Baseline | 3 Participants |
| Comparator for Package 1 | Client PrEP Knowledge | Intervention | 1 Participants |
| Comparator for Package 1 | Client PrEP Knowledge | Baseline | 6 Participants |
| Package 2 | Client PrEP Knowledge | Intervention | 1 Participants |
| Package 2 | Client PrEP Knowledge | Baseline | 0 Participants |
| Comparator for Package 2 | Client PrEP Knowledge | Baseline | 0 Participants |
| Comparator for Package 2 | Client PrEP Knowledge | Intervention | 2 Participants |
| Package 3 | Client PrEP Knowledge | Baseline | 0 Participants |
| Package 3 | Client PrEP Knowledge | Intervention | 0 Participants |
| Comparator for Package 3 | Client PrEP Knowledge | Intervention | 0 Participants |
| Comparator for Package 3 | Client PrEP Knowledge | Baseline | 0 Participants |
Secondary
PrEP Adherence
Proportion of women who have \>80 percent adherence to PrEP by pill count among those initially prescribed PrEP
Time frame: 6 months
Population: 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.
Secondary
PrEP Continuation
Proportion of women who present for a refill among those initially prescribed PrEP
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Package 1 | PrEP Continuation | Baseline | 2 Participants |
| Package 1 | PrEP Continuation | Intervention | 6 Participants |
| Comparator for Package 1 | PrEP Continuation | Baseline | 6 Participants |
| Comparator for Package 1 | PrEP Continuation | Intervention | 1 Participants |
| Package 2 | PrEP Continuation | Baseline | 2 Participants |
| Package 2 | PrEP Continuation | Intervention | 15 Participants |
| Comparator for Package 2 | PrEP Continuation | Baseline | 0 Participants |
| Comparator for Package 2 | PrEP Continuation | Intervention | 5 Participants |
| Package 3 | PrEP Continuation | Baseline | 5 Participants |
| Package 3 | PrEP Continuation | Intervention | 9 Participants |
| Comparator for Package 3 | PrEP Continuation | Baseline | 8 Participants |
| Comparator for Package 3 | PrEP Continuation | Intervention | 5 Participants |
Secondary
PrEP Efficiency
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Time frame: 6 months
Population: 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.
Secondary
PrEP Uptake
Proportion of women who accept PrEP among those offered
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Package 1 | PrEP Uptake | Baseline | 2 Participants |
| Package 1 | PrEP Uptake | Intervention | 2 Participants |
| Comparator for Package 1 | PrEP Uptake | Baseline | 2 Participants |
| Comparator for Package 1 | PrEP Uptake | Intervention | 3 Participants |
| Package 2 | PrEP Uptake | Baseline | 2 Participants |
| Package 2 | PrEP Uptake | Intervention | 15 Participants |
| Comparator for Package 2 | PrEP Uptake | Baseline | 0 Participants |
| Comparator for Package 2 | PrEP Uptake | Intervention | 5 Participants |
| Package 3 | PrEP Uptake | Baseline | 7 Participants |
| Package 3 | PrEP Uptake | Intervention | 11 Participants |
| Comparator for Package 3 | PrEP Uptake | Baseline | 4 Participants |
| Comparator for Package 3 | PrEP Uptake | Intervention | 4 Participants |