Trial Outcomes & Findings for VITAL Start: Brief Facility-based Video Intervention (NCT NCT03654898)
NCT ID: NCT03654898
Last Updated: 2023-11-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
800 participants
Primary outcome timeframe
12 months
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
395
|
405
|
|
Overall Study
COMPLETED
|
304
|
314
|
|
Overall Study
NOT COMPLETED
|
91
|
91
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VITAL Start: Brief Facility-based Video Intervention
Baseline characteristics by cohort
| Measure |
Standard of Care
n=393 Participants
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
|
VITAL Start
n=401 Participants
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.
|
Total
n=794 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.08 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
27.52 years
STANDARD_DEVIATION 5.67 • n=7 Participants
|
27.30 years
STANDARD_DEVIATION 5.68 • n=5 Participants
|
|
Age, Customized
15-19 years
|
28 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Age, Customized
20-29 years
|
245 Participants
n=5 Participants
|
247 Participants
n=7 Participants
|
492 Participants
n=5 Participants
|
|
Age, Customized
30-39 years
|
114 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Age, Customized
40 years or above
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
393 Participants
n=5 Participants
|
401 Participants
n=7 Participants
|
794 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
393 Participants
n=5 Participants
|
401 Participants
n=7 Participants
|
794 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Education
No education
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Education
Some primary school (standard 1-5)
|
108 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Education
Primary completed (standard 6-8)
|
114 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Education
Some secondary (forms 1-2)
|
72 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Education
Secondary completed (forms 3-4)
|
66 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Education
Post-secondary
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Head of household
No
|
320 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
650 Participants
n=5 Participants
|
|
Head of household
Yes
|
73 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Number of pregnancies
First
|
55 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Number of pregnancies
Second/third/fourth
|
290 Participants
n=5 Participants
|
285 Participants
n=7 Participants
|
575 Participants
n=5 Participants
|
|
Number of pregnancies
More than four
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
ART Regimen
DTG-based ART
|
192 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
ART Regimen
EFV and other ART
|
201 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
406 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThis 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.
Outcome measures
| Measure |
Standard of Care
n=393 Participants
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
|
VITAL Start
n=401 Participants
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.
|
|---|---|---|
|
Composite of Retention in ART Clinic and Viral Suppression
|
206 Participants
|
220 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The outcome was assessed only among those who had a study visit at month 12.
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.
Outcome measures
| Measure |
Standard of Care
n=302 Participants
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
|
VITAL Start
n=312 Participants
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.
|
|---|---|---|
|
Number of Participants With Good Self-reported Behavioral Adherence
|
248 Participants
|
248 Participants
|
SECONDARY outcome
Timeframe: Month 12The 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.
Outcome measures
| Measure |
Standard of Care
n=293 Participants
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
|
VITAL Start
n=299 Participants
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.
|
|---|---|---|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
TFVdp · Low
|
67 Participants
|
64 Participants
|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
TFVdp · Medium
|
38 Participants
|
35 Participants
|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
TFVdp · High
|
188 Participants
|
200 Participants
|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
3TCtp · Low
|
130 Participants
|
115 Participants
|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
3TCtp · Medium
|
122 Participants
|
138 Participants
|
|
Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood
3TCtp · High
|
41 Participants
|
46 Participants
|
Adverse Events
VITAL Start
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Standard of Care
Serious events: 3 serious events
Other events: 14 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
VITAL Start
n=405 participants at risk
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
n=395 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Death
|
0.00%
0/405 • through study completion, an average of 1 year
|
0.51%
2/395 • through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Death
|
0.00%
0/405 • through study completion, an average of 1 year
|
0.25%
1/395 • through study completion, an average of 1 year
|
Other adverse events
| Measure |
VITAL Start
n=405 participants at risk
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
n=395 participants at risk
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
|
|---|---|---|
|
Social circumstances
Intimate partner violence and social harm
|
5.4%
22/405 • through study completion, an average of 1 year
|
3.5%
14/395 • through study completion, an average of 1 year
|
Additional Information
Maria Kim
Baylor College of Medicine Childrens Foundation Malawi
Phone: +26599869090
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place