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Table 4 Assessments, corresponding aims, variables, and Time points

From: Protocol for a randomized controlled trial with a stepped care approach, utilizing PrEP navigation with and without contingency management, for transgender women and sexual minority men with a substance use disorder: Assistance Services Knowledge-PrEP (A.S.K.-PrEP)

Assessment Instrument

Aims

Variables

Screening

Baseline

3-mo F-U

6-mo F-U

9-mo F-U

12-mo F-U

MINI DSM-5

1,S

substance use disorder

x

     

HIV Rapid Antibody Test

1,S

HIV status

 

x

    

ASK-PrEP Admission/Follow-up Assessment

1,S

demographics; individual-level characteristics; social/structural determinants

 

x

x

x

x

x

Timeline Follow-Back*****

1,S

Current substance use

 

x

x

x

x

x

NBA* / NBA-Lite**

1,S, E

needs, barriers and facilitators

      

PrEP Care Continuum

1,S, E

PrEP initiation, adherence, persistence; PrEP advancement

 

x

x

x

x

x

HIV-ASES

1

components of PrEP self-efficacy

 

x

x

x

x

x

DBS***

1,S, E

oral daily PrEP adherence and persistence

 

x

x

x

x

x

Urine Drug Screen

1,S

current substance use

 

x

x

x

x

x

HIV Ag/Ab and Viral Load Test

1,S, E

HIV seroconversion

  

x

x

x

x

Electronic Health Records

1,S, E

PrEP care, PrEP prescriptions, PrEP advancement, liver and kidney functions

 

x

x

x

x

x

DATCAP****

2

intervention cost

 

x

x

x

x

x

NMOS

2

resource costs

 

x

x

x

x

x

PROPr

2

HRQoL, QALYs

 

x

x

x

x

x

Locator Form

n/a

  

x

x

x

x

 
  1. *Administered during first PrEP navigation session only.
  2. **Administered during all subsequent PrEP navigation sessions.
  3. ***With participants that report PrEP use only.
  4. ****Administered to study staff only.
  5. *****Administered weekly, on Wednesdays, during the Contingency Management intervention.