Study Results
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View full resultsBasic Information
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COMPLETED
NA
800 participants
INTERVENTIONAL
2018-10-01
2022-10-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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VITAL Start
VITAL Start: Video-based pre-ART counseling
VITAL Start: Video-based pre-ART counseling
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.
Standard of Care
pre-ART education as conducted via routine facility methods
Standard of Care
Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart
Interventions
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VITAL Start: Video-based pre-ART counseling
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.
Standard of Care
Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart
Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Maria Hyoun Kim
Assistant Professor
Principal Investigators
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Maria Kim, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine Childrens foundation Malawi
Locations
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Baylor-Malawi
Lilongwe, , Malawi
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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H-39785
Identifier Type: -
Identifier Source: org_study_id