Pre-Exposure ProphylaxisNCT04712994
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
A study testing PrEP Optimization Interventions in people with Pre-Exposure Prophylaxis and HIV Infections, run by University of Washington at 8 sites in Kenya.
Trial summary
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach. Read more about this study
- Who is it for?
- Any age, 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
- 1,958 participants
- Where
- 8 sitesKenya
- Study dates
- 1 May 2021to 31 Jan 2022
- 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 Any age
- 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
8 sites in 1 country.
8 sites in 1 country
Kenya8 sites
Kendu Sub-District Hospital
Homa Bay
Ober Health Center
Homa Bay
Masogo Sub-County Hospital
Kisumu
Nyahera Sub Sub County Hospital
Kisumu
Bondo County Referral Hospital
Siaya
Madiany Sub County Hospital
Siaya
Malanga Health Center
Siaya
Uyawi Sub County Hospital
Siaya
About this study
This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.
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 a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| PrEP Optimization Strategies | Experimental | 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). Receives: Other: PrEP Optimization Interventions |
| Comparator | No intervention | Four facilities will be assigned to the comparator group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Penetration
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
Measured: 6 months
PrEP Fidelity
Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling
Measured: 6 months
Timeliness of Services
Time (minutes) spent receiving services from health care works
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 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.
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
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
Client PrEP Knowledge
Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 May 2021
- Primary completion30 Nov 2021
- Study completion31 Jan 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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. One package of interventions (video-based PrEP counseling, HIV Self-Testing \[HIVST\], and optimized PrEP delivery) will be implemented at four intervention facilities and here will be 4 comparison facilities will undergo the same data collection procedures.
- Masking
- None (open label)
- Enrolment
- 1,958 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Grace John-Stewart, University of Washington
- Investigators
- Grace John-Stewart, MD, MPH, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712994
- Sponsor's protocol ID
- STUDY00008392
- Other IDs
- R01HD094630, R01AI125498
- Status last verified
- Dec 2024
- First submitted
- 30 Dec 2020
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sila J, Wagner AD, Abuna F, Dettinger JC, Odhiambo B, Ngumbau N, Oketch G, Sifuna E, Gomez L, Hicks S, John-Stewart G, Kinuthia J. An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya. Front Reprod Health. 2023 Nov 17;5:1205503. doi: 10.3389/frph.2023.1205503. eCollection 2023.
PubMed 38045529
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
- ClinicalTrials.gov ID
- NCT04712994
- Acronym / sponsor ID
- STUDY00008392
- Conditions
- Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,958 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Posted 8 Jan 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 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PrEP Optimization Strategies | Experimental | Other: PrEP Optimization InterventionsFour 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). |
| Comparator | No intervention | –Four facilities will be assigned to the comparator group. |
Who may qualify
- 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 InterventionsA 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. | Other | PrEP Optimization Strategies |
Primary outcome
PrEP Penetration
Time frame: 6 months
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
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
Timeliness of Services
Time frame: 6 months
Time (minutes) spent receiving services from health care works
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 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.
5 secondary outcomes
PrEP Uptake
Time frame: 6 months
PrEP Continuation
Time frame: 6 months
PrEP Adherence
Time frame: 6 months
PrEP Efficiency
Time frame: 6 months
Client PrEP Knowledge
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38045529Sila J, Wagner AD, Abuna F, Dettinger JC, Odhiambo B, Ngumbau N, Oketch G, Sifuna E, Gomez L, Hicks S, John-Stewart G, Kinuthia J. An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya. Front Reprod Health. 2023 Nov 17;5:1205503. doi: 10.3389/frph.2023.1205503. eCollection 2023.
Related trials for Pre-Exposure Prophylaxis
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingObservational study
Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
HIV Infections
Active, not recruiting
CAMELLIA Cohort: A Longitudinal Study to Understand Sexual Health and Prevention Among Women in Alabama
Hiv, Sexually Transmitted Diseases
RecruitingPhase 3
A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)
Human Immunodeficiency Virus (HIV), HIV Pre-Exposure Prophylaxis
RecruitingPhase 4
Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP
HIV Prevention, HIV Pre-exposure Prophylaxis
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.
Grace John-Stewart, MD, MPH, PhD principal investigator
University of Washington
8 sites 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 8 sites 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 8 Jan 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?
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 NCT04712994, which also lists 1 linked publication.
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 8 Jan 2025.