Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial

Table 3 Descriptions of mHealth Lakefolk Actively Keeping Engaged (mLAKE) trial primary (1°) and secondary (2°) study outcomes^a

	Outcome	Description	Numerator/event	Denominator
1°	HIV care coverage^b	Proportion	# linked to HIV care	# HIV-positive
1°	ART coverage^b	Proportion	# on antiretroviral therapy (ART)	# HIV-positive
1°	MC coverage^b	Proportion	# non-Muslim men circumcised	All non-Muslim men aged 15–49 years
1°	HIV population viremia prevalence (PVP)	Proportion	HIV+ c VL > 400	All study participants
2°	HIV incidence	Rate	# new HIV infections	HIV-negative person-years
2°	HTS coverage	Proportion	# ever tested and received HIV results	All study participants
2°	ART treatment failure^c	Proportion	Composite: virologic failure or Mortality or lost to follow-up or stopped ART	# initiated on ART
2°	Consistent condom use^b	Proportion	# using condoms consistently past 12 months	# sexually active

^aOutcomes described at the cluster level; outcomes may also be analyzed at the individual level
^bSelf-reported
^cOutcomes will also be individually analyzed. Virologic failure = any viral load (VL) > 1000 copies/mL. Lost to follow-up = no clinic visit > 180 days
ART antiretroviral therapy, HTS HIV Testing Services, MC male circumcision

ISSN: 1745-6215