The Jilinde (Bridge to Scale) project is designed as a “learning laboratory” to implement oral PrEP at scale, while simultaneously deriving lessons to understand the barriers and enablers to PrEP scale-up. Jilinde is a Kiswahili word that means “protect yourself.” This five-year (2016–2021) project is implemented in Kenya by a consortium of five partners that includes: Jhpiego, the National AIDS and STIs Control Program (NASCOP), International Center for Reproductive Health - Kenya, Population Services Kenya, and Avenir Health.

The project is implemented in 10 priority counties in Kenya, which were selected according to the severity of the HIV epidemic as illustrated in Figure 1.

Data on the geographic incidence and burden of HIV was used to prioritize intervention counties based on an incidence threshold of 0.081% - 0.13% for medium incidence and 0.131% or more for high incidence, per 100 person-years ²⁸ . Consequently, Jilinde is implemented in five high-incidence counties (Kisumu, Migori, Nairobi, Kiambu, and Mombasa) and five medium-incidence counties (Machakos, Kisii, Kilifi, Kwale and Taita Taveta). These counties were selected because they have high concentrations of KP, high HIV prevalence (and incidence) rates among the general population, and are the focus of existing HIV prevention, care, and treatment efforts.

The overlapping domains of supply, demand, and government and community ownership all contribute to a learning laboratory approach to improving implementation of PrEP. Figure 2 outlines this framework showing the interrelatedness of the domains.

Jilinde’s theory of change is premised on this framework as a model for sustainable PrEP scale-up in Kenya. Implementation of this model should lead to increased political will and demonstrate the feasibility and effectiveness of PrEP scale-up. If successful, this should contribute to successful PrEP scale-up in Kenya. Dissemination of lessons from Kenya should contribute to successful PrEP scale-up in other countries and an overall reduction in HIV incidence in the long-term. The anticipated outcomes and potential impact from this model are summarized in Figure 3.

Service delivery is the cornerstone of the Jilinde project, which leverages existing health infrastructure, staff, and outreach of existing clinical sites to scale up routine delivery of oral PrEP. The project strengthens clinical sites that were already serving KP and AGYW clients, integrating PrEP into existing combination HIV prevention activities. These clinical sites include: drop-in-centers (DICEs), which are stand-alone clinics that mainly serve KP; public health facilities; and private health facilities. To address access challenges, these sites also provide PrEP services through community delivery models that include safe spaces for AGYW and hotspot outreaches for KP. Service delivery points are being strengthened to provide oral PrEP by ensuring availability of commodities, building health service provider PrEP competency, enhancing referral pathways, and offering outreach services in times and places convenient for KP and AGYW.

Systematic delivery of PrEP clinical services was preceded by engagement meetings with the county health management teams to build a consensus on the implementation agenda. Once county scale-up roadmaps were developed, health facilities were selected by the project team and the county health management team to take part, by way of a facility assessment to establish capacity gaps in providing HIV services and status of infrastructure for delivering PrEP. Jilinde supported NASCOP to train a pool of PrEP national master trainers drawn from all 47 counties, who have since cascaded the PrEP training to health service providers within their respective counties, using the nationally approved training curriculum. Additional training focuses on sensitivity in working with KP and AGYW. The trainings are building service providers’ knowledge and skills to initiate and follow up with PrEP clients and increase health service providers’ sensitivity and willingness to work respectfully with KP and AGYW.

The project collaborated with NASCOP to establish a centralized national supply chain for PrEP commodities that leveraged the existing antiretroviral drugs pipeline via the Kenya Medical Supplies Authority (KEMSA). Initial donations of PrEP medication to jumpstart the scale-up were integrated into KEMSA for national-level distribution. To ensure seamless ordering, consumption, and reporting on PrEP commodities, existing logistics management information system tools were revised by NASCOP to include PrEP and then printed and distributed. Health service providers were trained on recording of site-level consumption data and ordering of commodities. DICEs were linked to government-owned health facilities as satellite sites in order to receive PrEP commodities through the national pipeline. An initial “push” order of commodities was initiated by NASCOP to select sites to jumpstart the national scale-up. Subsequently, health facilities shifted to a “pull” system through routine reporting of commodity consumption.

Establishing client flow, especially for the high-volume facilities, was critical, since PrEP clients often needed to visit multiple service points within a facility, including the HIV testing room, clinical diagnosis room, and pharmacy. Whole-site orientations with all staff in the facilities were conducted to build support for the intervention across all cadres within the sites. Health facilities began client enrollment once all these critical steps were implemented. Subsequently, sites also established measures for client follow-up to enhance adherence and continuation. In addition, service providers are offered continuous support and mentorship for quality improvement. Figure 4 summarizes the stepwise process of setting up PrEP services in the clinical sites.

The project is also strengthening the capacity of the county health management teams to provide ongoing supportive supervision and mentoring of trained providers and counselors. This is intended to ensure the retention of knowledge and skills, as well as the maintenance of high-quality services. Periodic supportive supervision visits are enabling sharing of real-life implementation challenges that inform scale-up and case studies that drive changes in approach if needed.

Jilinde’s approach to demand generation is two-fold: use of mass media for raising awareness of PrEP in the general population and targeted communication to the priority populations to generate demand for PrEP, primarily through interpersonal communication. The project has invested in awareness creation for the general population through mass media platforms including television, national and local radio advertising, and talk shows. Furthermore, social media platforms (mainly Facebook, Twitter, and WhatsApp) have been used to facilitate discourse on PrEP. In addition, promotional events and community engagement fora have given visibility to and ignited community conversations on PrEP. This has proven to be important as it provides an environment that enables clients to start and continue using PrEP.

To determine targeted demand creation components, the project is employing innovative methodologies including behavioral economics research, consumer market research, and human-centered design processes to ensure resonance and relevance of messaging. The project is ascertaining end-user perceptions through insights derived from market research and behavioral economics to adequately segment the target audience for demand creation purposes. Through this audience segmentation, the demand creation strategies are adopting a multipronged and multifaceted approach that takes into account the diversity of KPs and AGYW. This has enabled the project to adopt a targeted approach as opposed to a mass “one size fits all” approach. Using human-centered design methodologies, the project developed messages and materials that address the key barriers identified by users themselves. The project used a rapid, iterative process that included pre-testing, piloting, and scaling up of proven interventions. The choice of messengers is also fundamental, and the project is leveraging the robust peer outreach system currently employed as part of the national KP service standards. Jilinde is engaging gatekeepers, KP community members, and civil society organizations with strong roots and experience in KP programming to roll out the demand creation activities identified as most promising.

Adherence support. Evidence from clinical trials shows that PrEP effectiveness is dependent on medication adherence; studies reporting high adherence reported high efficacy, while those that reported low adherence reported little or no efficacy ^{29– 31} . Given that Jilinde is implementing PrEP in routine service delivery, adherence support has been integrated into existing activities through the following approaches:

For effective and sustainable oral PrEP scale-up, ownership of the intervention by the community and the government at all levels is critical – institutionalization will help ensure the sustainability of both demand and supply. Jilinde is working with the national government through NASCOP’s leadership to formulate and update appropriate policies and guidelines, coordinate national PrEP rollout through strengthened technical working groups, enhance integration and quality of PrEP service delivery, and develop and roll out a national combination prevention communication strategy. Through participation in the quantification and forecasting of PrEP commodity requirements, the project is contributing to the formulation of a long-term national commodity security strategy. At the county level, Jilinde is working closely with devolved government stakeholders to prioritize PrEP in work plans, establish coordination structures, effectively integrate PrEP in routine service delivery, and support county leadership in the scale-up efforts.

Successful implementation of the project is dependent on a supportive and enabling policy environment. Keeping these insights in mind, Jilinde is collaborating closely with critical stakeholders, influencers, decision-makers, and target beneficiaries such as AGYW and KP networks in the design, implementation, and monitoring of PrEP rollout, informed by a stakeholder engagement plan developed through stakeholder mapping and analysis. Through this plan, key stakeholders – including bar and brothel owners, parents of AGYW, religious leaders, and general community members – are engaged routinely by the project to create an enabling environment for the delivery of PrEP services, thereby creating safe spaces for health promotion events and outreaches for PrEP provision and protecting KP and AGYW on PrEP from harassment. Jilinde is using the evidence generated by the project to make decisions on adaptations needed to galvanize support and ownership for sustainability.

Jilinde is using two evaluation approaches: developmental evaluation (DE) and prospective utilization-focused evaluation (UFE). Participatory DE is being used to guide continuous, iterative program learning through implementation experiences and documentation of learning toward the goal of evolving the implementation approach. The critical feature of DE is the right people reflecting on the right data at the right time and then using those reflections to inform changes in the intervention ³⁴ . Use of DE is enabling Jilinde implementation to be agile, making iterative adjustments to minimize program risks and maximize learning. Jilinde is also collecting formative, process, and summative data to answer a set of essential learning questions in a structured and rigorous way. In addition, Jilinde is using UFE to help answer specific national oral PrEP research questions outlined in the national framework for the implementation of PrEP in Kenya ³⁵ . The UFE is focused on understanding client and user experiences, health managers and service provider experiences, community perceptions, user feedback on demand generation, and client acceptability and adherence. Jilinde is using this evidence to ensure real-time feedback on the effectiveness of interventions, rapidly identify the need for course corrections or changes in strategy, and enable the sharing of learning with different groups. This learning is essential to inform improvements in routine service delivery and specific recommendations for scale-up of PrEP in Kenya and other countries.

As part of the learning laboratory, Jilinde is also assessing the cost of implementing and delivering PrEP from a service delivery perspective and the client perspective. By understanding both the full cost and unit cost of a PrEP program, it will be possible to estimate and project future resource needs associated with scaling up PrEP nationally. Contingent valuation analysis will provide information about the factors that influence the valuation of services by PrEP clients by assessing their maximum willingness to pay for PrEP services. In addition to assessing the costs of oral PrEP to service providers and clients, Jilinde is also conducting modeling to estimate the impact and cost-effectiveness of PrEP for different populations in Kenya using the Goals Model ³⁶ . Modeling of the impact of PrEP services’ use on HIV incidence and costs (e.g., cost of PrEP vs. cost savings due to HIV infections averted) will provide evidence in the Kenyan situation for scale-up, provide specific recommendations on where and how to rapidly take oral PrEP to scale, and what programmatic outcomes to improve to increase epidemic impact and cost-effectiveness.