NCT03654898: VITAL

VITAL Start: Brief Facility-based Video Intervention

Completed NA Results posted Last updated 24 November 2023

What this trial tests

NA trial testing VITAL Start: Video-based pre-ART counseling in HIV/AIDS in 800 participants. Completed in 26 October 2022.

Timeline

1 October 2018

Primary endpoint
26 October 2022

26 October 2022

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	800
Start date	1 October 2018
Primary completion	26 October 2022
Estimated completion	26 October 2022
Sites	1 location across Malawi

Drugs / interventions tested

• VITAL Start: Video-based pre-ART counseling
• Standard of Care

Conditions studied

• HIV/AIDS — all drugs for HIV/AIDS →

Sponsor

Baylor College of Medicine

Who can join

16 and older, female only, with HIV/AIDS. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Composite of Retention in ART Clinic and Viral Suppression Primary · 12 months

This outcome is an aggregate measure. The study will measure if participants are both retained in ART clinic and also virally suppressed. Participants will be considered retained in care if they are verified by clinic records as active on ART. Amongst those retained the study will then assess viral suppression which will be measured as viral load less than 1,000 copies per milliliter.

Group	Value	95% CI
Standard of Care	206
VITAL Start	220

Number of Participants With Good Self-reported Behavioral Adherence Secondary · 12 months

Self-reported adherence will be measured by a three-item adherence scale. The three items will include an assessment of the number of days with missed ART doses in the preceding 30 days; a scale rating of how good a job the participant did taking their medicines in the preceding 30 days and a scale rating of how often the participant took their medicines the way they were supposed to in the preceding 30 days. Item responses for the three adherence items will be linearly transformed to a 0-100 scale. Scores will be analyzed as a binary variable, with a score \>/=90 good adherence and \<90 not

Group	Value	95% CI
Standard of Care	248
VITAL Start	248

Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood Secondary · Month 12

The concentration of two metabolites, Tenofovir diphosphate (TFVdp) and lamivudine triphosphate (3TCtp), was used to objectively measure ART adherence. The concentration of each metabolite was classified as low, medium, or high. TFVdp (low: \<560; medium: 560 to 1399; and high: 1400 to 20900 fmol/sample) and 3TCtp (low: \<400; medium: 400 to 799; and high: 800 to 2100 fmol/sample). For either metabolite, the high category suggests the participant had good (daily) ART adherence.

TFVdp

Group	Value	95% CI
Standard of Care	67
VITAL Start	64
Standard of Care	38
VITAL Start	35
Standard of Care	188
VITAL Start	200

3TCtp

Group	Value	95% CI
Standard of Care	130
VITAL Start	115
Standard of Care	122
VITAL Start	138
Standard of Care	41
VITAL Start	46

Adverse events — posted to ClinicalTrials.gov

Time frame: through study completion, an average of 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

VITAL Start

Serious: 0/405 (0%)

Deaths: 0/405

Standard of Care

Serious: 3/395 (1%)

Deaths: 3/395

Serious adverse events (2 terms)

Reaction	System	VITAL Start	Standard of Care
Death	Respiratory, thoracic and mediastinal disorders	—	—
Death	Blood and lymphatic system disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	VITAL Start	Standard of Care
Intimate partner violence and social harm	Social circumstances	—	—

Most-reported serious reactions: Death, Death.

Data from ClinicalTrials.gov NCT03654898 adverse events section.

Sponsor's own description

This a multi-center, parallel group, randomized controlled outcome assessor blinded trial with a qualitative descriptive component that seeks to assess the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant and breastfeeding women with HIV infection.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.
   Foster C, Ayers S, Fidler S. · · 2020 · cited 30× · PMID 32523693 · DOI 10.1177/2049936120920177
2. 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.
   Kim MH, Tembo TA, Mazenga A, Yu X, et al · · 2020 · cited 12× · PMID 32075677 · DOI 10.1186/s13063-020-4131-8
3. The relationship between adverse childhood experiences and common mental disorders among pregnant women living with HIV in Malawi.
   Masiano SP, Yu X, Tembo T, Wetzel E, et al · · 2022 · cited 10× · PMID 35752220 · DOI 10.1016/j.jad.2022.06.028
4. The prevalence, incidence, and recurrence of intimate partner violence and its association with adverse childhood experiences among pregnant and breastfeeding women living with HIV in Malawi.
   Masiano SP, Tembo TA, Yu X, Wetzel E, et al · · 2023 · cited 3× · PMID 36654873 · DOI 10.1177/20499361221148875