One-stop PrEP Care Pathway to Simplify PrEP Delivery in Kenya: The One-Stop PrEP Care Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Method of PrEP delivery and consultation.
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kenya
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this cluster randomized study is to understand if using a One stop PrEP delivery model can improve the efficiency of PrEP service delivery, reduce the cost of providing PrEP and allow continuation on PrEP. The investigators will evaluate data from men and women ≥15 years of age unknown to be living with HIV seeking PrEP services at public health facilities in western Kenya.
Detailed description
This study will evaluate the effectiveness of one-stop PrEP services in 12 public health facilities in Kenya. The core implementation strategies to optimize one-stop PrEP care will include training of healthcare providers, technical assistance, joint clinic supervision with the county health officials, and abstraction of program data regarding PrEP initiations and continuations including characteristics of PrEP users for quality improvement. Within this large program, the study team will recruit a nested observational cohort to obtain detailed complementary individual clinical, behavioral, and mental health outcomes (including for clients who discontinue PrEP).
Interventions
- Other Method of PrEP delivery and consultation
All core PrEP services that include HIV testing, risk assessment, clinical review PrEP initiation, prescription, dispensing, and follow-up will be performed in a one-stop consultation with a single provider.
Primary outcome measures
- PrEP initiation [Time frame: Years 2-4 of the study, up to 36 months.]
- PrEP continuation [Time frame: up to 12 months of PrEP use.]
- PrEP adherence [Time frame: Years 2-4 of the study, up to 36 months.]
- Acceptability [Time frame: Throughout the study period, up to 36 months]
- Adoption [Time frame: Throughout the study period, up to 36 months]
- Fidelity [Time frame: Throughout the study period, up to 36 months]
- Total client wait time and staff time spent on PrEP services [Time frame: Throughout the study period, up to 36 months]
- Satisfaction with services [Time frame: Throughout the study period, up to 36 months]
- Sustainability [Time frame: up to 12 months after technical assistance support is scaled back]
Secondary outcome measures (1)
- Incremental cost of one-stop PrEP services, including costs averted, and reduced client wait times. [Time frame: up to 36 months.]
Eligibility criteria
Inclusion criteria
- ≥15 years of age
- Accessing PrEP services at implementing clinics.
- Eligible for PrEP per Kenya national guidelines
For in-depth and key delivery informant interviews
- Able and willing to provide consent
- Provides services at participating clinics (healthcare providers)
- Key policy maker
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Kenya · 1 center
- Kenya Medical Research Institute -KEMRI — Kisumu
Identifiers
NCT: NCT05905640 · STUDY00015873 · R01MH129234-01A1