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Table 1 Application of the RE-AIM framework to evaluate the programmatic scale-up of PrEP integrated into public health HIV clinics

From: Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya

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