Clinical trial NCT03654898: VITAL Start: Brief Facility-based Video Intervention
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: pregnant women
viral suppression
retention
video intervention
pre-ART
counseling
HIV
adherence
PMTCT
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2018-08-31
Enrollment: 800
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

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

Primary outcomes:
measure: Composite of Retention in ART Clinic and Viral Suppression
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Good Self-reported Behavioral Adherence
timeFrame: 12 months
measure: Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
timeFrame: Month 12
Other outcomes:
Locations:
city: Lilongwe
country: Malawi
facility: Baylor-Malawi
Study officials:
affiliation: Baylor College of Medicine Childrens foundation Malawi
name: Maria Kim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MH, Tembo TA, Mazenga A, Yu X, Myer L, Sabelli R, Flick R, Hartig M, Wetzel E, Simon K, Ahmed S, Nyirenda R, Kazembe PN, Mphande M, Mkandawire A, Chitani MJ, Markham C, Ciaranello A, Abrams EJ. 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. Trials. 2020 Feb 19;21(1):207. doi: 10.1186/s13063-020-4131-8.