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Table 1 Primary and secondary outcomes for objective 1

From: Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services

 

Definition

Measure

Primary outcome

 HIV Prevention via PrEP

Taking PrEP at 3-, 6-, 9-, and 12-month follow-up

Intracellular levels of tenofovir diphosphate (TFV-DP) by DBS or cabotegravir injection in previous 8 weeks by electronic health record abstraction

 HIV Prevention via MOUD

Taking MOUD at 3-, 6-, 9-, and 12-month follow-up

Norbuprenorphine or methadone on UDS or naltrexone or buprenorphine extended-release injection in previous 4 weeks by electronic health record abstraction

Secondary outcomes

 Syringe coverage

Dispensing syringes to cover each injection event

Number of syringes distributed/(number of injections per day × days between exchanges) from SSP administrative data

 PrEP Adherence

Taking PrEP at least 4 times per week

TFV-DP level of 700 fmol/punch on DBS for TDF [64]; TFV-DP level of 950 fmol/punch on DBS for TAF[65]

 Engagement in HCV treatment

Receiving a prescription for DAA

DAA prescsiption confirmed on electronic health record abstraction

 HCV cure (SVR 12)

Initiating HCV treatment and achieving undetectable HCV RNA PCR at least 12 weeks after completion of therapy

Negative HCV RNA PCR (viral load) at least 12 weeks post treatment completion

 Treatment of STIs

Receiving treatment for STI after a positive screen

Prescription of appropriate antibiotics (may differ based on allergies) from electronic health record abstraction

 Time to harm

Time to: (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose

(1) Electronic health record abstraction; (2, 3) IDEA test results; (4) electronic health record abstraction or medical examiner database

 Number of harms

Count of (1) emergency department visit or hospitalization for injection-related infection or overdose; (2) incident HIV infection; (3) incident HCV infection; or (4) death from overdose

(1) Electronic health record abstraction; (2, 3) IDEA test results (4) electronic health record abstraction or medical examiner database