Skip to main content

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