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VITAL Start: Brief Facility-based Video Intervention

NCT03654898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-11-24

Study results available
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Summary

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.

Conditions

Interventions

BEHAVIORAL

VITAL Start: Video-based pre-ART counseling

Patients in the experimental group will receive VITAL start pre-ARV counseling (approximately 27 minutes video followed by 10 minute guided Q \& A to reinforce key messages and provide an opening for individual counseling=approximately total 37 minutes). This will be delivered by study staff.

BEHAVIORAL

Standard of Care

Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Maria Kim, MD, MSc · Baylor College of Medicine Childrens foundation Malawi

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-10-26
Completion
2022-10-26

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654898 on ClinicalTrials.gov