VITAL Start: Brief Facility-based Video Intervention

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: VITAL Start: Video-based pre-ART counseling
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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) Women who participated in the study pilot

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VITAL Start<br>VITAL Start: Video-based pre-ART counseling | Behavioral: VITAL Start: Video-based pre-ART counseling<br>* 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.<br>|
| Placebo Comparator: Standard of Care<br>pre-ART education as conducted via routine facility methods | Behavioral: Standard of Care<br>* Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Good Self-reported Behavioral Adherence | 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 a binary variable, with a score >/=90 good adherence and <90 not good adherence. | 12 months | 
| Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | The concentration of two metabolites, Tenofovir diphosphate (TFVdp) and lamivudine triphosphate (3TCtp), was used to objectively measure ART adherence. The concentration of each metabolite was classified as low, medium, or high. TFVdp (low: <560; medium: 560 to 1399; and high: 1400 to 20900 fmol/sample) and 3TCtp (low: <400; medium: 400 to 799; and high: 800 to 2100 fmol/sample). For either metabolite, the high category suggests the participant had good (daily) ART adherence. | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-ART, pregnant women, viral suppression, retention, video intervention, counseling, HIV, adherence, PMTCT