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Table 3 VITAL Start trial outcomes and schedule of measures

From: The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi

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