Table 2.

Trial research methodologies

Trial	Countries	Design	Primary objective	Primary outcome	Study power	Coefficient of variation between clusters	Estimated trial impact	Duration (average follow‐up)a	Estimated completion date
BCPP	Botswana	2 arm community‐level pair‐matched cluster‐randomized trial	To evaluate whether expanded ART initiation (initially by high HIV‐1 RNA level and higher CD4 threshold, now universal ART), combined with strengthened and expanded HIV testing/linkage and male circumcision services, can significantly reduce cumulative HIV incidence at population‐level, in 16 to 64 year old community residents in Botswana.	Cumulative HIV incidence	86% (original parameters and ART initiation criteria) 72% (revised parameters based on observed data, and actual ART initiation criteria over time)	0.26	40% reduction of cumulative HIV incidence in the intervention arm	60 months (average follow‐up of 36 months)	October 2018
MaxART	Swaziland	2 arm clinic‐catchment level ‐ stepped‐wedge cluster‐randomized trial	To evaluate whether early ART initiation for all HIV+ individuals can improve retention and viral suppression at population‐level, in over 18‐year‐olds, in Swaziland's government‐managed health system.	Retention and viral suppression	80%	0.5	6% increase in 1‐year retention rate between the control phase and intervention phase	36 months	August 2017
PopART	South Africa, Zambia	3 arm community‐level triplet‐matched cluster‐randomized trial	To determine the impact of two community‐level combination prevention packages, both of which include universal HIV testing and intensified provision of HIV ART and care, on population‐level HIV incidence	Cumulative HIV incidence	>99% for Arm A versus Arm C comparison (original model parameters and ART initiation criteria); In range 44% to 95% for Arm A versus Arm C comparison (revised parameters based on trial data including on testing and treatment coverage over time)	0.15 to 0.2	60% to 65% reduction in HIV incidence in arm A in years 2 and 3 of intervention (original parameters and ART initiation criteria); 35% to 45% reduction of HIV incidence in arm A in years 2 and 3 of intervention (revised parameters)	54 months (average follow‐up of 36 months)	June 2018
SEARCH	Uganda, Kenya	2 arm 2 phase community‐level pair‐matched cluster‐randomized trial	Phase 1: To quantify the impact of early HIV diagnosis and immediate ART using a streamlined care delivery system on the three‐year cumulative HIV incidence among adults aged ≥15 years old in rural communities in Uganda and Kenya Phase 2: To quantify the impact of targeted PrEP, targeted HIV testing and targeted care interventions on top of universal treatment and streamlined care on the 3‐year cumulative HIV incidence among adults aged ≥15 years old in rural communities in Uganda and Kenya	Cumulative HIV incidence	80% in both Phase1 and Phase2	≤0.4	40% reduction in cumulative HIV incidence (both Phase 1 and 2) in the intervention arm	72 months (follow‐up of 36 months in Phase 1 and 36 months in Phase 2)	June 2017 for Phase1 June 2020 for Phase2
ANRS TasP	South Africa	2 arm community‐level cluster‐randomized trial	Phase 1: To estimate the feasibility and acceptability of early ART initiation for all HIV+ individuals combined with six monthly home‐based HIV testing of all adult members of a community and linkage‐to‐care services at population‐level in 16 and above years of age, in KwaZulu‐Natal province in South Africa. Phase 2: To compare how early ART initiation for all HIV+ individuals combined with six monthly home‐based HIV testing of all adult members of a community and linkage‐to‐care services can impact on the reduction in incidence of new HIV infections at population‐level in 16 and above years of age, in KwaZulu‐Natal province in South Africa.	Cumulative HIV incidence	80%	0.25	A 34% reduction in cumulative HIV incidence in the intervention arm	52 months (average follow‐up of 36 months)	June 2014 for Phase 1 July 2016 for Phase 2

ART, antiretroviral therapy; PrEP, pre‐exposure prophylaxis.

^aThe trial duration refers to the period between the first day an intervention was provided to a study participant and the last day an intervention was provided to a study participant. The average follow‐up refers to the average time a study participant was observed in the context of the trial.