N/A
Completed N=800
VITAL Start: Brief Facility-based Video Intervention
Source: ClinicalTrials.gov NCT03654898 ↗Enrolled (actual)
800
Serious AEs
0.4%
Results posted
Nov 2023
Primary outcomePrimary: Composite of Retention in ART Clinic and Viral Suppression — 206; 220 Participants — p=0.49
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Retention in ART Clinic and Viral Suppression |
206; 220 | 0.49 |
| SECONDARY Number of Participants With Good Self-reported Behavioral Adherence |
248; 248 | 0.40 |
| SECONDARY Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood |
67; 64; 38; 35; 188; 200 | 0.78 |
Eligibility Criteria
Inclusion Criteria
- Women who are HIV positive by two antibody rapid tests approved by the Malawi Ministry of Health
- Women age ≥18 years or 16-17 years if married or have a child
- Women who understand chichewa
- Women who are willing to provide informed consent
- Women who intend to remain in the health center catchment area for at least 6 months
Exclusion Criteria
- Women already on ART
- Women with significant pre-existing psychiatric comorbidity at enrollment that may impact ability to provide consent according to the clinical judgment of study personnel (including cognitive impairment or known psychotic disorder)
- Women who participated in the study pilot
Data sourced from ClinicalTrials.gov (NCT03654898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.