PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

NCT ID: NCT04712994

Last Updated: 2025-01-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1958 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pre-Exposure Prophylaxis HIV Infections Pregnancy Related

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PrEP Optimization Strategies

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).

Group Type EXPERIMENTAL

PrEP Optimization Interventions

Intervention Type OTHER

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.

Comparator

Four facilities will be assigned to the comparator group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Unwilling or unable to provide informed consent
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Grace John-Stewart

Associate Professor, School of Medicine: Global Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Grace John-Stewart, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kendu Sub-District Hospital

Homa Bay, , Kenya

Site Status

Ober Health Center

Homa Bay, , Kenya

Site Status

Masogo Sub-County Hospital

Kisumu, , Kenya

Site Status

Nyahera Sub Sub County Hospital

Kisumu, , Kenya

Site Status

Bondo County Referral Hospital

Siaya, , Kenya

Site Status

Madiany Sub County Hospital

Siaya, , Kenya

Site Status

Malanga Health Center

Siaya, , Kenya

Site Status

Uyawi Sub County Hospital

Siaya, , Kenya

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Kenya

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38045529 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HD094630

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AI125498

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008392

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.