VITAL Start: Brief Facility-based Video Intervention

NCT03654898 | Completed Results

• 2 other identifiers: H-39785R01MH115793-01A1
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV/AIDS

Keywords

pregnant women; viral suppression; retention; video intervention; pre-ART; counseling; HIV; adherence; PMTCT

Outcome Measures

Primary Outcomes (1)

• Composite of Retention in ART Clinic and Viral Suppression

  This outcome is an aggregate measure. The study will measure if participants are both retained in ART clinic and also virally suppressed. Participants will be considered retained in care if they are verified by clinic records as active on ART. Amongst those retained the study will then assess viral suppression which will be measured as viral load less than 1,000 copies per milliliter.

  12 months

Secondary Outcomes (2)

• Number of Participants With Good Self-reported Behavioral Adherence

  12 months

• Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood

  Month 12

Study Arms (2)

VITAL Start

ACTIVE COMPARATOR

VITAL Start: Video-based pre-ART counseling

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

Standard of Care

PLACEBO COMPARATOR

pre-ART education as conducted via routine facility methods

Behavioral: Standard of Care

Interventions

VITAL Start: Video-based pre-ART counseling BEHAVIORAL

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.

VITAL Start

Standard of Care BEHAVIORAL

Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart

Standard of Care

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Baylor-Malawi

Lilongwe, Malawi

Location

Related Publications (1)

• 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.

  PMID: 32075677 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

1. Recruitment was slow due to the declining number of women living with HIV not already on ART at antenatal care clinics. 2. Recruitment was interrupted by the COVID-19 pandemic.

Results Point of Contact

• Title: Maria Kim
• Organization: Baylor College of Medicine Childrens Foundation Malawi

mkim@tingathe.org

+26599869090

Study Officials

• Maria Kim, MD, MSc

  Baylor College of Medicine Childrens foundation Malawi

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Investigators, Data analysis
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 31, 2018
• Study Start: October 1, 2018
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 24, 2023
• Results First Posted: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)