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Table 1 Variables, measures, and methods of analysis for ESSAHM trial

From: Enhanced syphilis screening among HIV-positive men (ESSAHM): a study protocol for a clinic-randomized trial with stepped wedge design

Variable/outcome

Hypothesis

Outcome measure

Methods of analysis

1) Primary: syphilis case detection

75 % increase over baseline rate

New, previously untreated syphilis case as a binary measure

GLMM models using SAS PROC GLIMMIX with logit function

2) Secondary:

a. screening coverage

Increase to 85 % of men testing annually

Tested one or more times in 6-month study period as a binary measure

GLMM models using SAS PROC GLIMMIX with logit function

Compare proportion tested and modify to annualized rates

b. screening frequency

Increase to median of 3 tests per person/year

Number of tests per year as Poisson count outcome data

GLMM models using SAS PROC GLIMMIX with log link function

c. reached men at highest risk for syphilis by examining OHTN Cohort Studya subgroup

Increases in screening coverage and frequency (2a&b) occur in the among men at highest risk for syphilis according to sexual behaviors

Outcome measures for screening coverage and screening frequency

GLMM models using SAS PROC GLIMMIX with logit and log link function

  1. GLMM general linear mixed models
  2. aOntario HIV Treatment Network Cohort Study, an ongoing clinical HIV cohort taking place at the four participating clinics of the trial [37]. An estimated 40 % of men in HIV care at these clinics are active participants of that cohort