Table 2 Full schedule of assessments

Administrative and behavioral procedures

 Informed consent

X

 Locator information

X

X

X

X

X

 MOUD counseling

X

X

X

X

X

 HIV risk reduction counseling and test results

X

X

X

X

X

 Offer condoms and lubricant

X

X

X

X

X

 Provide/facilitate access to harm reduction

X

X

X

X

X

 Demographic information

X

 Randomization

X

 Behavioral data collection

X

X

X

 Introduction to peer navigator

X

 Conclusion of peer navigation

X

Clinical evaluations/procedures

 Assessment for COVID-19²

X

X

X

X

X

 Assessment for OUD³, recent injection drug use (track marks)⁴

X

X

 Targeted medical history to include MOUD treatment history, HIV risk behaviors, participation in other research studies⁵

X

X

(X)

X⁶

X⁶

 Basic physical exam⁷

X

(X)

 Screen for mental health needs and refer for services as indicated

X

(X)

X

X

 Initiate (intervention arm) or refer (active control arm) for HIV treatment or PrEP

(X⁸)

(X⁸)

 COWS assessment and initiate mobile unit-based MOUD treatment program (intervention arm only)

(X⁹)

(X⁹)

 Provide clinical management of MOUD and HIV infection or PrEP, including medication or prescription dispensation, as indicated

X

 HAV vaccination referral

X¹⁰

 HBV vaccination referral

X¹⁰

 HBV treatment/treatment referral

X^10,11

 HCV treatment referral

X¹⁰

X

 Development of a clinical plan

X

 Empiric treatment of STIs (if symptomatic)

(X)

(X)

(X)

(X)

 Provide lab-based STI results and, if indicated, treatment (intervention arm) or referral (active control arm)

X¹²

 Provide lab-based STI results, and, if indicated, referral

X¹²

X¹²

 Provide clinical assessment and management or referral for other medical conditions

X

 Blood collection

X

X

(X)

X

X

 Urine collection

X

X

(X)

X

X

 Swabs for STI testing¹³

X

(X)

X

X

Laboratory evaluations/procedures

 HIV rapid testing

X

X¹⁴

(X)¹⁵

X¹⁵

X¹⁵

 Laboratory-based HIV testing (see SSP manual)

X¹⁶

X¹⁵

(X)¹⁵

X¹⁵

X¹⁵

 HIV viral load (people living with HIV only)

X

(X)

X

X

 CD4 cell count (people living with HIV only)

X

(X)

 MOUD testing (urine)¹⁷

X

X

X

X

 Substance use testing (urine)¹⁸

X

X

(X)

X

X

 Fentanyl testing (urine)

X

X

(X)

X

X

 Pregnancy testing (urine)¹⁹

X

(X)

(X)

(X)

 STI testing (syphilis, GC/CT NAAT)

X

(X)

X

X

 HCV Ab testing²⁰

X

(X)

X

 HCV RNA (viral load)²¹

X

(X)

X

X

 HBV testing (HBsAg, HbsAb, HbcAb)

X

(X)

 Other HBV-related testing²³

(X)

(X)

 HAV Ab testing

X

(X)

 Heme/Chem testing²³

X

 Plasma storage²⁴

X

X

X

X

 Urine storage²⁵

X

X

X

 DBS storage (people without HIV only)²⁶

X

X

X

 Serum storage for SARS-CoV-2 testing²⁷

X

X

X