VITAL Start: Brief Facility-based Video Intervention (VITAL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03654898|
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS||Behavioral: VITAL Start: Video-based pre-ART counseling Behavioral: Standard of Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||892 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Investigators, Data analysis|
|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|
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
- 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.
- 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).
- 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
- 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.
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
|Contact: Tapiwa Tembo, Mscemail@example.com|
|Contact: Maria H Kim, MD 2651751047 firstname.lastname@example.org|
|Contact: Tapiwa Tembo, MSc 2651751047 email@example.com|
|Principal Investigator:||Maria Kim, MD, MSc||Baylor College of Medicine Childrens foundation Malawi|