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