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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