NCT03654898

VITAL Start: Brief Facility-based Video Intervention

VITAL Start (Video-intervention to Inspire Treatment Adherence for Life): Brief Facility-based Video Intervention to Improve Retention and Adherence to ART Among Pregnant and Breastfeeding Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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.

Detailed description

Universal HIV testing and treatment can accelerate population-level ART initiation and is critical to realize the UNAIDS 90-90-90 goals. Malawi pioneered Option B+ (B+), a novel application of test-and-treat that provided life-long ART for HIV+ pregnant and breastfeeding women. While maternal ART uptake improved 7-fold, retention and adherence remained suboptimal: only 59% were retained after two years, and of these, only two-thirds achieved adequate ART adherence. Other B+ countries are observing suboptimal retention. VITAL Start (Video-intervention to Inspire Treatment Adherence for Life) is a brief facility-based video intervention, created with formative participatory research, applied theoretical frameworks, and evidence-based message framing techniques. VITAL Start was designed to help optimize retention and adherence to ART among pregnant and breastfeeding women in Malawi. The study will evaluate the impact, implementation and cost effectiveness of VITAL Start in a multisite randomized controlled trial (RCT) in Malawi with the primary composite outcome of retention and adherence (viral suppression) 12 months after starting antiretroviral therapy (ART). The study will also examine the delivery of VITAL Start via surveys and interviews with patients and partners and conduct cost-effectiveness analyses. If successful, VITAL Start will provide an intervention that (1) standardizes and improves counseling at a critical teaching moment through an engaging and culturally sensitive experience, (2) is inexpensive and rapidly scalable without decelerating ART expansion, and (3) allows more efficient use of health care worker time.

Conditions

• HIV/AIDS

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2018-08-31
• Last updated: 2023-11-24
• Results posted: 2023-11-24

Locations

1 site across 1 country: Malawi