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Table 1 Data sources

From: Integrating PrEP delivery in public health family planning clinics: a protocol for a pragmatic stepped wedge cluster randomized trial in Kenya

Data source Description Purpose
Data abstraction ▪ Data abstracted from clinical delivery tools ▪ Define profile of screened and initiated on PrEP and whether persons are appropriately put on PrEP
Technical assistance reports and rapid cycle debriefs. ▪ Rapid cycle debriefs and TA reports prepared at baseline and 6-monthly ▪ Document detailed knowledge of process of integration of PrEP delivery and track changes in PrEP implementation processes
▪ Rapid cycle analysis to convey to facilities for quality improvement
Qualitative interviews: women, healthcare providers, and policy key informants ▪ Purposefully sampled client and key informants involved in the delivery ▪ Characterize process of adoption and integration of PrEP delivery and track changes in PrEP implementation processes, including barriers and facilities
Quantitative surveys ▪ Healthcare providers
▪ Random cross-sectional exit surveys with women at the end of clinic visit
▪ Assess acceptability, clinics’ readiness to implement, clinic inner settings
▪ HIV and STI risk perception, characteristics of women accessing through FP clinics, stigma, and satisfaction with services offered.
Activity-based costing, and time and motions studies ▪ Primary data collection ▪ Activity-based costing, and time and motions studies
Clinic and client flow mapping ▪ Primary data collection ▪ Establish baseline flow, track how new services are incorporated in the flow and bottlenecks, and document patient wait-time
Standardized patient actors ▪ Standardized clients make unannounced visit to subset of clinics and complete a checklist ▪ Assess implementation fidelity by documenting type of services offered, quality of services received, and provider attitudes
Random blood draw ▪ Dried blood spots collected at ~10% visits on persons using PrEP ▪ Objective assessment of PrEP adherence (tenofovir levels)
Nested observational cohort ▪ Women identified as eligible for PrEP, both who initiate and those who decline ▪ Detailed individual-level outcomes: HIV risk behaviors, HIV risk perception, HIV incidence, HIV prevention decision making, contraception use, stigma, STI burden, PrEP retention, and reasons for discontinuation