VITAL Start: Brief Facility-based Video Intervention

Baylor College of Medicine

Status

Completed

Conditions

HIV/AIDS

Treatments

Behavioral: VITAL Start: Video-based pre-ART counseling

Behavioral: Standard of Care

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03654898

H-39785

R01MH115793-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 patients

Sex

Female

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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