Table 1.

Application of the RE-AIM framework to evaluate the programmatic scale-up of PrEP integrated into public health HIV clinics

Domain	Original RE-AIM definition	Measurement level	Project-specific outcome measures
Reach	Reach is the absolute number, proportion, and representativeness of individuals who are willing to participate in a given initiative	Individual	▪ Number of at-risk persons initiated on PrEP ▪ Demographic and behavioral characteristics of PrEP initiators
		Clinic	▪ Characteristics of implementing clinics ▪ Demand creation strategies ▪ Retention strategies
Effectiveness	The impact of an intervention on outcomes, including potential negative effects, quality of life, and economic outcomes.	Individual	▪ Incident HIV infection among PrEP users ▪ Proportion of random blood samples with detectable tenofovir levels ▪ Frequency of adverse clinical events related to PrEP use
		Program	▪ Cost and cost-effectiveness outcomes: unit cost, HIV infections averted, ICER, DALYS
Adoption	Absolute number, proportion, and representativeness of settings and intervention agents who are willing to initiate a program	Individual	▪ PrEP continuation rates ▪ Barriers/facilitators for PrEP initiation and use
		Clinic	▪ Number of clinics implementing PrEP in HIV clinics ▪ Number of MOH clinical staff trained on delivering PrEP ▪ % of trained MOH staff scoring > 80% on post-test ▪ % of trained clinical staff who delivered PrEP at least once ▪ Internal and external factors influencing PrEP implementation
Implementation	The intervention agents’ fidelity to the various elements of an intervention’s protocol	Clinic	▪ Number and % of users appropriately initiated on PrEP ▪ % of trained staff who delivered PrEP at least once ▪ Clinic innovations and adaptions ▪ Consistency of implementation across staff
Maintenance	The extent to which a program or policy becomes institutionalized or part of the routine organizational practice	Individual	▪ 6-month PrEP continuation rates
		Clinic	▪ Number of clinics implementing PrEP in HIV clinics ▪ Number of clinics that have integrated PrEP delivery in HIV clinics as an on-going part of their regular activities (i.e., have PrEP goals and targets, PrEP in service charter, routine health talks, regular staff training, implementation, PrEP data for monitoring and evaluation) ▪ Internal and external factors influencing PrEP implementation ▪ Number of clinics regularly completing PrEP M & E tools and report PrEP indicators to MOH
		National program	▪ PrEP delivery in HIV clinic continuing as part of Kenya MOH program ▪ M & E tools supplied to clinics ▪ PrEP indicators defined expected