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

Abstract

Background: Improving maternal antiretroviral therapy (ART) retention and adherence is a critical challenge facing prevention of mother-to-child transmission (PMTCT) of HIV programs. There is an urgent need for evidence-based, cost-effective, and scalable interventions to improve maternal adherence and retention that can be feasibly implemented in overburdened health systems. Brief video-based interventions are a promising but underutilized approach to this crisis. We describe a trial protocol to evaluate the effectiveness and implementation of a standardized educational video-based intervention targeting HIV-infected pregnant women that seeks to optimize their ART retention and adherence by providing a VITAL Start (Video intervention to Inspire Treatment Adherence for Life) before committing to lifelong ART. Methods: This study is a multisite parallel group, randomized controlled trial assessing the effectiveness of a brief facility-based video intervention to optimize retention and adherence to ART among pregnant women living with HIV in Malawi. A total of 892 pregnant women living with HIV and not yet on ART will be randomized to standardof-care pre-ART counseling or VITAL Start. The primary outcome is a composite of retention and adherence (viral load < 1000 copies/ml) 12 months after starting ART. Secondary outcomes include assessments of behavioral adherence (self-reported adherence, pharmacy refill, and tenofovir diphosphate concentration), psychosocial impact, and resource utilization. We will also examine the implementation of VITAL Start via surveys and qualitative interviews with patients, partners, and health care workers and conduct cost-effectiveness analyses.

Video-Based Intervention for Improving Maternal Retention and Adherence to HIV Treatment: Patient Perspectives and Experiences

“…This qualitative process evaluation was conducted with women at all three sites of the VITAL Start study [25]. Two of the sites, Area 25 and Kawale, are large urban health centers in Malawi's capital city, Lilongwe.…”

“…Baylor-Malawi decided to create the video intervention because many of the barriers to maternal retention and ART adherence related to lack of information and empowerment of women to prevent vertical HIV transmissions, as well as to help standardize pre-ART counseling and overcome shortages of skilled healthcare workers that provide pre-ART counseling. The intervention can be delivered by lay health care workers and does not require as much healthcare worker time as the standard of care-pre-ART counseling delivered using flipcharts, as recommended by the Malawi Ministry of Health [24,25]. On average, it takes 37 min to deliver the intervention (27-min video and 10 min post-video Q&A session) compared to the standard of care, which takes about two hours.…”

“…The VITAL Start intervention is currently being evaluated in an NIH-funded multicenter individual randomized controlled, outcome assessor-blinded clinical trial at three government health facilities in Malawi [25]. The trial's primary aim is to evaluate the effects of VITAL Start on maternal ART adherence and retention in HIV care [25].…”

“…The VITAL Start intervention is currently being evaluated in an NIH-funded multicenter individual randomized controlled, outcome assessor-blinded clinical trial at three government health facilities in Malawi [25]. The trial's primary aim is to evaluate the effects of VITAL Start on maternal ART adherence and retention in HIV care [25]. The study includes pregnant women who are HIV positive by two antibody rapid tests, age ≥18 years or 16-17 years if married or have a child, understand Chichewa (the local language in Malawi), willing to provide informed consent, and intend to remain in the health center catchment area for ≥6 months.…”

“…After watching the video, participants have a brief follow up one-on-one post-video discussion with the counselor. Participants randomized to the control group receive the standard of care (pre-ART counseling delivered by a healthcare worker using the National Counselling Flip Chart) [24,25]. Further details about the trial are documented elsewhere [25].…”