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VITAL Start: Brief Facility-based Video Intervention (VITAL)

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ClinicalTrials.gov Identifier: NCT03654898
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Maria Hyoun Kim, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: VITAL Start: Video-based pre-ART counseling Behavioral: Standard of Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 892 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Investigators, Data analysis
Primary Purpose: Other
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
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: VITAL Start
VITAL Start: Video-based pre-ART counseling
Behavioral: 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.

Placebo Comparator: Standard of Care
pre-ART education as conducted via routine facility methods
Behavioral: 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




Primary Outcome Measures :
  1. Composite of retention in ART clinic and viral suppression [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Behavioral adherence, self-reported [ Time Frame: 12 months ]

    Self-reported adherence will be measured by a three-item adherence scale. The three items will include an assessment of the number of days with missed ART doses in the preceding 30 days; a scale rating of how good a job the participant did taking their medicines in the preceding 30 days and a scale rating of how often the participant took their medicines the way they were supposed to in the preceding 30 days. Item responses for the three adherence items will be linearly transformed to a 0-100 scale.

    Scores will be analyzed as both a continuous and binary variable (binary according to cut-off score of either <90 and <100: good adh vs. not good adh).


  2. Behavioral adherence by pharmacy refill [ Time Frame: 12 months ]
    Behavioral adherence as assessed by pharmacy refill will be calculated from clinical pharmacy ART dispensing records

  3. Behavioral adherence by pharmokinetic antiretroviral medication level [ Time Frame: 12 months ]
    Behavioral adherence as measured by ART drug concentration will be assessed by laboratory assessment of drug levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03654898


Contacts
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Contact: Tapiwa Tembo, Msc 2651751047 ttembo@tingathe.org

Locations
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Malawi
Baylor-Malawi Recruiting
Lilongwe, Malawi
Contact: Maria H Kim, MD    2651751047    mkim@tingathe.org   
Contact: Tapiwa Tembo, MSc    2651751047    ttembo@tingathe.org   
Sponsors and Collaborators
Baylor College of Medicine
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Maria Kim, MD, MSc Baylor College of Medicine Childrens foundation Malawi

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Responsible Party: Maria Hyoun Kim, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03654898     History of Changes
Other Study ID Numbers: H-39785
R01MH115793-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be analysed by blinded study staff

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Hyoun Kim, Baylor College of Medicine:
pregnant women
viral suppression
retention
video intervention
pre-ART
counseling
HIV
adherence
PMTCT