Pre-Exposure ProphylaxisPrEPARENCT05482360

Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya

A study testing PrEP Optimization Interventions in people with Pre-Exposure Prophylaxis and HIV Infections, run by University of Washington at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series. Read more about this study

Who is it for?: Ages 15 to 100 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
What is being tested?: PrEP Optimization Interventions
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5,173 participants
Where: 1 siteKenya
Study dates: 1 Jan 2022to 15 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 100 years
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Who cannot join

Unwilling or unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Kenya1 site

Ober Health Center
Homa Bay

Other trials in Kenya

About this study

Official title: Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Read the 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: Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
Being tested: PrEP Optimization Interventions
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrEP Optimization InterventionsOther
There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders

Study groups in NCT05482360
Study group	Role	What they receive
Package 1	Experimental	Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH Receives: 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 Receives: 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 Receives: 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	No intervention	4 facilities were assigned to the comparator group and never received any implementation strategy.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in PrEP Penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Measured: 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.
Measured: 6 months
Timeliness of Services
Time (minutes) spent receiving services from health care workers
Measured: 6 months
Waiting Time
Time (minutes) spent waiting to receive services
Measured: 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.
Measured: 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.
Measured: 6 months
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.
Measured: 6 months

Secondary outcomes (5)

PrEP Uptake
Proportion of women who accept PrEP among those offered
Measured: 6 months
PrEP Continuation
Proportion of women who present for a refill among those initially prescribed PrEP
Measured: 6 months
Client PrEP Knowledge
Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
Measured: 6 months
PrEP Adherence
Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP
Measured: 6 months
PrEP Efficiency
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202215 Dec 2023

First posted1 Aug 2022
Study start1 Jan 2022
Primary completion15 Dec 2023
Study completion15 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pre-Exposure ProphylaxisStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 5,173 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05482360
Sponsor's protocol ID: STUDY00008392-A
Other IDs: K01MH121124
Acronym: PrEPARE
Status last verified: Feb 2025
First submitted: 26 Jul 2022
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy

All Pre-Exposure Prophylaxis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)
ClinicalTrials.gov ID: NCT05482360
Acronym / sponsor ID: PrEPARE / STUDY00008392-A
Conditions: Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
Study type: Interventional
Recruitment status: Completed
Enrolment: 5,173 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Jan 2022 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 1 Aug 2022 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6
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.

Arm	Type	Receives
Package 1	Experimental	Other: PrEP Optimization InterventionsPackage 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH
Comparator for Package 1	No intervention	–4 facilities were assigned to the comparator group and never received any implementation strategy.
Package 2	Experimental	Other: PrEP Optimization InterventionsPackage 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
Package 3	Experimental	Other: PrEP Optimization InterventionsPackage 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH
Comparison for Package 2	No intervention	–4 facilities were assigned to the comparator group and never received any implementation strategy.
Comparison for Package 3	No intervention	–4 facilities were assigned to the comparator group and never received any implementation strategy.

Who may qualify

Ages: 15 to 100 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys

Key exclusion criteria (1 listed)

Unwilling or unable to provide informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrEP Optimization InterventionsThere were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Other	Package 1, Package 2, Package 3

Primary outcome

Change in PrEP Penetration
Time frame: 6 months
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Change in PrEP Fidelity
Time frame: 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
Time frame: 6 months
Time (minutes) spent receiving services from health care workers
Waiting Time
Time frame: 6 months
Time (minutes) spent waiting to receive services
HCW Acceptability
Time frame: 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
Time frame: 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.
Client Satisfaction
Time frame: 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.

5 secondary outcomes

PrEP Uptake
Time frame: 6 months
PrEP Continuation
Time frame: 6 months
Client PrEP Knowledge
Time frame: 6 months
PrEP Adherence
Time frame: 6 months
PrEP Efficiency
Time frame: 6 months

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Package 1	392	392
Comparator for Package 1	420	420
Package 2	402	402
Comparator for Package 2	415	415
Package 3	419	419
Comparator for Package 3	406	406

Primary outcome: Change in PrEP Penetration

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Package 1 n = 800	Comparator for Package 1 n = 836	Package 2 n = 841	Comparator for Package 2 n = 841	Package 3 n = 839	Comparator for Package 3 n = 815
Baseline	13	23	35	3	49	23
Intervention	23	7	93	22	146	27

Population analysed: 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.

Primary outcome: Change in PrEP Fidelity

Time frame: 6 months. Count of participants. Unit: Participants

Measure	Package 1 n = 327	Comparator for Package 1 n = 322	Package 2 n = 365	Comparator for Package 2 n = 342	Package 3 n = 309	Comparator for Package 3 n = 299
Baseline	9	8	15	1	23	14
Intervention	9	2	55	8	61	8

Primary outcome: Timeliness of Services

Time frame: 6 months. Median (Inter-Quartile Range). Unit: minutes

Measure	Package 1 n = 384	Comparator for Package 1 n = 384	Package 2 n = 383	Comparator for Package 2 n = 384	Package 3 n = 384	Comparator for Package 3 n = 384
Baseline	15 (10 to 29)	14 (9.5 to 26.5)	13 (9 to 23)	12 (8 to 21)	14 (8 to 29)	15 (10 to 29)
Intervention	15 (10 to 31.5)	12 (8.5 to 21.5)	13 (9 to 22)	15 (10.5 to 26)	15 (10.5 to 28.5)	15 (10 to 29)

Primary outcome: Waiting Time

Time frame: 6 months. Median (Inter-Quartile Range). Unit: minutes

Measure	Package 1 n = 384	Comparator for Package 1 n = 384	Package 2 n = 383	Comparator for Package 2 n = 384	Package 3 n = 384	Comparator for Package 3 n = 384
Baseline	47 (22 to 77.5)	33 (13. to 57.5)	37 (18 to 66)	33 (14.5 to 63)	47 (22 to 81)	32.5 (16 to 69)
Intervention	42.5 (28 to 64)	38 (14.5 to 73)	43 (25 to 66.5)	31.5 (15 to 56)	35.5 (23 to 58)	35 (14 to 71.5)

5 secondary outcomes are reported in the full results.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Package 1	0 of 800 (0%)	0 of 800 (0%)	0 of 800
Comparator for Package 1	0 of 836 (0%)	0 of 836 (0%)	0 of 836
Package 2	0 of 841 (0%)	0 of 841 (0%)	0 of 841
Comparator for Package 2	0 of 841 (0%)	0 of 841 (0%)	0 of 841
Package 3	0 of 839 (0%)	0 of 839 (0%)	0 of 839
Comparator for Package 3	0 of 815 (0%)	0 of 815 (0%)	0 of 815

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Pre-Exposure Prophylaxis

Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anjuli Wagner, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PrEP Optimization Interventions in people with Pre-Exposure Prophylaxis and HIV Infections, run by University of Washington at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PrEP Penetration (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05482360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.