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.
Anti-HIV Agents
/ therapeutic use
Audiovisual Aids
Counseling
/ methods
Female
HIV Infections
/ drug therapy
Health Personnel
Humans
Infectious Disease Transmission, Vertical
/ prevention & control
Malawi
Medication Adherence
/ psychology
Multicenter Studies as Topic
Pregnancy
Pregnancy Complications, Infectious
/ drug therapy
Pregnant Women
/ psychology
Randomized Controlled Trials as Topic
Self Report
Treatment Adherence and Compliance
ART (antiretroviral therapy)
Adherence
HIV
PMTCT (prevention of mother-to-children transmission)
Retention
Video
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
19 Feb 2020
19 Feb 2020
Historique:
received:
14
11
2019
accepted:
01
02
2020
entrez:
21
2
2020
pubmed:
23
2
2020
medline:
19
12
2020
Statut:
epublish
Résumé
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. 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 standard-of-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. This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes. ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.
Sections du résumé
BACKGROUND
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
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 standard-of-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.
DISCUSSION
CONCLUSIONS
This is a robust evaluation of an innovative facility-based video intervention for pregnant women living with HIV, with the potential to improve maternal and infant outcomes.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT03654898. Registered on 31 August 2018.
Identifiants
pubmed: 32075677
doi: 10.1186/s13063-020-4131-8
pii: 10.1186/s13063-020-4131-8
pmc: PMC7031891
doi:
Substances chimiques
Anti-HIV Agents
0
Banques de données
ClinicalTrials.gov
['NCT03654898']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
207Subventions
Organisme : FIC NIH HHS
ID : K01 TW009644
Pays : United States
Organisme : NIMH NIH HHS
ID : R01 MH115793
Pays : United States
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