Table 3.

VITAL Start trial outcomes and schedule of measures

Schedule (month number)	0	1	3	6	12
Informed consent	x
Allocation	x
Intervention	x
Aim 1: Retention and adherence (viral load [VL] < 1000 copies/ml) at 12 months
Retention in care (data abstraction from facility records)		x	x	x	x
Viral suppression (VL < 1000 copies/ml)				x	x
Aim 1b: Behavioral adherence
Self-reported adherence [66, 67]		x	x	x	x
ART side effects		x	x	x	x
Pharmacy refill data abstraction [68]		x	x	x	x
Tenofovir diphosphate level					x
Aim 1c: Knowledge and psychosocial impact
HIV/ART knowledge and attitudes survey [69]	x		x		x
Adherence self-efficacy [70, 71]	x	x		x	x
Motivation and behavior skills assessment: LifeWindows tool [72]		x		x	x
Self-reported partner disclosure and World Health Organization intimate partner violence survey [73]	x	x		x	x
Multidimensional Scale of Perceived Social Support (MSPSS) [74] and self-reporting questionnaire [75]	x	x		x	x
Shortened Alcohol Use Disorders Identification Test [76] and Drug Use Disorders Identification Test [77]	x	x		x	x
Patient-Provider Relationship Scale [78, 79]		x			x
Aim 2: Implementation outcomes
Participant satisfaction surveys	x
Interviews with participants, partners, health care workers	x	x	x	x	x
Trial fidelity evaluations	x
Contamination assessment		x		x	x
Time-motion assessments in line with Suggested Time And Motion Procedures (STAMP) checklist [80]	x
Aim 3: Cost-effectiveness analysis. Data collected throughout trial period. Start-up: video creation, training, tablets and accessories (security cable, power bank). Recurring: tablet maintenance; personnel time and salaries