Health TrialsbyHealthPanel

HIV Testing Counselor-led Care to Catalyze Integration of PrEP Delivery in Family Planning Clinics

ConditionsHuman Immunodeficiency Virus (HIV)HIV Pre-exposure Prophylaxis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversity of Washington

About this trial

This is a cluster randomized, stepped wedge implementation study to introduce HIV testing services (HTS) counselor-led PrEP care in public health clinics in Kenya.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥15 years of age

Accessing health services at participating public health facilities.

Not known to be living with HIV prior to the visit when their clinical data is first abstracted

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • HTS counselor-led PrEP care model

    Other intervention

    PrEP delivery ,including HIV testing, eligibility assessment, dispensing, adherence counseling, and provision of refills, provided by an HTS counselor

Treatment groups

30,000 Participants
are divided into 2 treatment groups
Group A: Control (Usual care)No intervention 0 interventions
Group B: HTS counselor-led PrEP care modelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

PrEP screening

Using individual client-level data at clinics, compare proportion of clients completing PrEP eligibility screening in usual care (control) versus intervention time points

Time frame
Up to 42 months
2

PrEP initiation

Using individual client-level data at clinics, compare PrEP initiation in usual care (control) versus intervention time points. PrEP initiation will be measured as the proportion of eligible clients starting PrEP use documented on ministry of health (MOH) tools.

Time frame
Up to 42 months
3

PrEP continuation

Using individual client-level data at clinics, compare PrEP continuation in usual care (control) versus intervention time points. PrEP continuation among clients initiating PrEP will be determined by clinic visit attendance and pharmacy PrEP refill records obtained by abstraction of MOH clinic records.

Time frame
Up to 42 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Washington

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov
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