# Scaling up for impact: HIV testing counselor-led pathway to accelerate PrEP delivery at scale

> **NIH NIH R01** · UNIVERSITY OF WASHINGTON · 2024 · $698,683

## Abstract

ABSTRACT
We have entered an exciting era for PrEP with two additional non-oral products, a monthly dapivirine vaginal
ring and a bi-monthly injectable cabotegravir, with several more options in various stages of clinical development.
While the effectiveness of these interventions is now well established, uptake and persistence on PrEP depend
not only on client-level factors but also on how well opportunity costs and health system barriers can be navigated
by potential PrEP clients. Thus, taking these novel PrEP interventions to full scale will require simplifying and
diversifying models for delivery, to achieve options that are accessible, scalable, and meet the needs of clients
and health systems. Since 2020, in collaboration with the Kenyan Ministry of Health we have demonstrated PrEP
can be delivered in African family planning clinics (FP) using existing staff and infrastructure in a programmatic
stepped-wedge cluster-randomized trial (FP-Plus project), significantly increasing the proportion of general
population women screened for PrEP from 3% to 93% and PrEP initiations among eligible women from <3% to
46%. We have also learned that there are several key health system barriers, such as heavy workload and
lengthy clinic visits that burden the health system and limit expanded delivery at scale up. Within the FP-Plus
project, we piloted model that allows HIV testing (HTS) counselors to screen and determine PrEP eligibility and
that it both reduced clinic time by 60% and resulted in higher PrEP initiations and early PrEP continuation versus
comparable control clinics maintaining usual care. We hypothesize that PrEP care can be done by HTS
providers, in a single HIV testing encounter with clinician oversight as needed, in a way that will be more time-
efficient and client-centered and will be acceptable, scalable, and readily transferable to other African settings.
With an interdisciplinary team and our deep knowledge of the Kenya health system, we will use a participatory
research approach with key stakeholders to co-develop and refine the core components of a ‘scalable unit’
composed of a simplified HTS counselor-led PrEP care intervention and an MOH feasible technical advisory and
provider training support delivery at scale (Aim 1). We will then road test the effectiveness and impact of HTS
counselor-led PrEP care to catalyze expansion of PrEP delivery at scale in 20 Kenyan health facilities
representing a spectrum of clinical contexts likely to occur at full scale implementation (Aim 2). Lastly, we will
use mixed methods to triangulate multilevel determinants of delivery at scale, including behavior science studies
to understand and incorporate women perspectives, explore partner and community influence, and barriers to
PrEP access and use; clinic and provider capacity to deliver multiple PrEP products; and key stakeholders’
power, interests, and perspectives (Aim 3). We have already demonstrated that PrEP can be delivered in African
health ...

## Key facts

- **NIH application ID:** 11006585
- **Project number:** 1R01MH136842-01A1
- **Recipient organization:** UNIVERSITY OF WASHINGTON
- **Principal Investigator:** John Kinuthia
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $698,683
- **Award type:** 1
- **Project period:** 2024-09-10 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11006585

## Citation

> US National Institutes of Health, RePORTER application 11006585, Scaling up for impact: HIV testing counselor-led pathway to accelerate PrEP delivery at scale (1R01MH136842-01A1). Retrieved via AI Analytics 2026-07-07 from https://api.ai-analytics.org/grant/nih/11006585. Licensed CC0.

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