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Table 1 Study design and overview of approach to on-site bundled rapid HIV and HCV testing

From: On-site bundled rapid HIV/HCV testing in substance use disorder treatment programs: study protocol for a hybrid design randomized controlled trial

  ADAPT-IT3 Steps Participants Data Collection Method Output
Patients Providers Managers
(Intervention Development) (1) Assessment 30 to 40 10 to 14 3 to 5 Focus groups Focus group discussion with patients and providers separately. Capacity assessment with program managers Not applicable (n/a)
(2) Design n/a n/a n/a n/a Investigative team reviews assessment data and then devises preliminary approach to developing and refining bundled rapid HIV/HCV testing procedures. Draft protocol 0 of intervention
(3) Administration 10 2-4 3-5 “Theater test” (patients observe and respond to demonstration of Draft 0) Mock intervention is implemented in front of selected patients and providers (from step 1). Draft protocol 0 of intervention
(4) Production n/a n/a n/a n/a Exit survey follows performance, informs open discussion about modification. Draft protocol 1 of intervention
(5) Topical experts n/a n/a n/a n/a Investigative team incorporates feedback from theater tests into testing algorithm and manual, develops quality assurance plan. Draft protocol 1 of intervention
(6) Integration n/a n/a n/a n/a Integrate content from patient/program advisors, and topical experts. Draft protocol 2 of intervention
(RCT) (7) Training n/a 2 to 4 3 to 5 n/a Train program and study staff to implement draft protocol. Draft protocol 2 of intervention
(8a) Testing (Pilot) 20 2 to 4 3 to 5 Exit interviews Pilot with patients who are representative of target population. Feedback through exit interviews with patients, and feedback from managers and providers who observed the pilot. Produce draft three based on pilot. Refresher training, as appropriate, for program and study staff on draft three of the intervention protocol. Draft protocol 3 of intervention
(8b) Testing (RCT) 239 2 to 4 3 to 5 Baseline + follow-up assessments Test draft three of the protocol Analyze RCT results to determine efficacy. Assessment of study outcomes
(TRANSLATION) (9) Translation 20 to 30 5 to 10 3- 5 Focus groups Elicit reactions of RCT participants. Classify perceived barriers/facilitators to acceptance of bundled rapid testing, referral, and linkage services (patients); and adoption of bundled rapid testing and linkage services (providers and managers). Multilevel diffusion strategy