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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

â–ª Data abstracted from clinical delivery tools

â–ª Define profile of screened and initiated on PrEP and whether persons are appropriately put on PrEP

Technical assistance reports and rapid cycle debriefs.

â–ª Rapid cycle debriefs and TA reports prepared at baseline and 6-monthly

â–ª Document detailed knowledge of process of integration of PrEP delivery and track changes in PrEP implementation processes

â–ª Rapid cycle analysis to convey to facilities for quality improvement

Qualitative interviews: women, healthcare providers, and policy key informants

â–ª Purposefully sampled client and key informants involved in the delivery

â–ª Characterize process of adoption and integration of PrEP delivery and track changes in PrEP implementation processes, including barriers and facilities

Quantitative surveys

â–ª Healthcare providers

â–ª Random cross-sectional exit surveys with women at the end of clinic visit

▪ Assess acceptability, clinics’ readiness to implement, clinic inner settings

â–ª 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

â–ª Primary data collection

â–ª Activity-based costing, and time and motions studies

Clinic and client flow mapping

â–ª Primary data collection

â–ª Establish baseline flow, track how new services are incorporated in the flow and bottlenecks, and document patient wait-time

Standardized patient actors

â–ª Standardized clients make unannounced visit to subset of clinics and complete a checklist

â–ª Assess implementation fidelity by documenting type of services offered, quality of services received, and provider attitudes

Random blood draw

â–ª Dried blood spots collected at ~10% visits on persons using PrEP

â–ª Objective assessment of PrEP adherence (tenofovir levels)

Nested observational cohort

â–ª Women identified as eligible for PrEP, both who initiate and those who decline

â–ª 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