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 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).
Interventions
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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
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. 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.
Eligibility
Sex/Gender
FEMALE
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 6 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 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed. |
| PrEP Fidelity | 6 months | Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling |
| Timeliness of Services | 6 months | Time (minutes) spent receiving services from health care works |
| 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. |
| 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 |
| 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 |
| Client PrEP Knowledge | 6 months | Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions |
| 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 (1958) includes the sum of participants who started in the participant flow module below (1919), as well as the 39 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 |
|---|---|
| PrEP Optimization Strategies -- Baseline 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).
PrEP Optimization Interventions: 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. | 480 |
| Comparator -- Baseline Four facilities will be assigned to the comparator group. | 480 |
| PrEP Optimization Strategies -- Intervention Period 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).
PrEP Optimization Interventions: 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. | 481 |
| Comparator -- Intervention Period Four facilities will be assigned to the comparator group. | 479 |
| Total | 1,920 |
Baseline characteristics
| Characteristic | PrEP Optimization Strategies -- Baseline | Total | Comparator -- Intervention Period | PrEP Optimization Strategies -- Intervention Period | Comparator -- Baseline |
|---|---|---|---|---|---|
| Age, Continuous | 24 years | 25 years | 25 years | 25 years | 25 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 480 Participants | 1920 Participants | 479 Participants | 481 Participants | 480 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Kenya | 480 participants | 960 participants | 479 participants | 481 participants | 480 participants |
| Sex: Female, Male Female | 480 Participants | 1920 Participants | 479 Participants | 481 Participants | 480 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 961 | 0 / 958 |
| other Total, other adverse events | 0 / 961 | 0 / 961 |
| serious Total, serious adverse events | 0 / 961 | 0 / 958 |
Outcome results
Primary
Client Satisfaction
Total on 6 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 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 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) |
|---|---|---|---|
| PrEP Optimization Strategies | Client Satisfaction | Intervention | 23.0 score on a scale |
| PrEP Optimization Strategies | Client Satisfaction | Baseline | 21.0 score on a scale |
| Comparator | Client Satisfaction | Baseline | 23.0 score on a scale |
| Comparator | Client Satisfaction | Intervention | 23.0 score 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 39 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) |
|---|---|---|
| PrEP Optimization Strategies | HCW Acceptability | 20.0 score 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 39 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) |
|---|---|---|
| PrEP Optimization Strategies | Health Care Worker (HCW) Appropriateness | 19.5 score on a scale |
Primary
PrEP Fidelity
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
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) |
|---|---|---|---|
| PrEP Optimization Strategies | PrEP Fidelity | Baseline | 14 Participants |
| PrEP Optimization Strategies | PrEP Fidelity | Intervention | 28 Participants |
| Comparator | PrEP Fidelity | Baseline | 4 Participants |
| Comparator | PrEP Fidelity | Intervention | 5 Participants |
Primary
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) |
|---|---|---|---|
| PrEP Optimization Strategies | PrEP Penetration | Baseline | 30 Participants |
| PrEP Optimization Strategies | PrEP Penetration | Intervention | 46 Participants |
| Comparator | PrEP Penetration | Baseline | 17 Participants |
| Comparator | PrEP Penetration | Intervention | 8 Participants |
Primary
Timeliness of Services
Time (minutes) spent receiving services from health care works
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) |
|---|---|---|---|
| PrEP Optimization Strategies | Timeliness of Services | Baseline | 18 minutes |
| PrEP Optimization Strategies | Timeliness of Services | Intervention | 17 minutes |
| Comparator | Timeliness of Services | Baseline | 16 minutes |
| Comparator | Timeliness of Services | Intervention | 14 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) |
|---|---|---|---|
| PrEP Optimization Strategies | Waiting Time | Baseline | 49 minutes |
| PrEP Optimization Strategies | Waiting Time | Intervention | 55 minutes |
| Comparator | Waiting Time | Baseline | 37 minutes |
| Comparator | Waiting Time | Intervention | 29 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) |
|---|---|---|---|
| PrEP Optimization Strategies | Client PrEP Knowledge | Baseline | 5 Participants |
| PrEP Optimization Strategies | Client PrEP Knowledge | Intervention | 56 Participants |
| Comparator | Client PrEP Knowledge | Baseline | 0 Participants |
| Comparator | Client PrEP Knowledge | Intervention | 5 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.
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) |
|---|---|---|---|
| PrEP Optimization Strategies | PrEP Continuation | Baseline | 1 Participants |
| PrEP Optimization Strategies | PrEP Continuation | Intervention | 1 Participants |
| Comparator | PrEP Continuation | Baseline | 1 Participants |
| Comparator | PrEP Continuation | Intervention | 2 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.
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) |
|---|---|---|---|
| PrEP Optimization Strategies | PrEP Uptake | Baseline | 0 Participants |
| PrEP Optimization Strategies | PrEP Uptake | Intervention | 0 Participants |
| Comparator | PrEP Uptake | Baseline | 1 Participants |
| Comparator | PrEP Uptake | Intervention | 1 Participants |