An interventional study of VITAL Start: Video-based pre-ART counseling and Standard of Care in HIV/AIDS, sponsored by Baylor College of Medicine. Completed at 1 site in Malawi. Open to female participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Other
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.
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 800 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
VITAL Start: Video-based pre-ART counseling
Behavioral: VITAL Start: Video-based pre-ART counseling
pre-ART education as conducted via routine facility methods
Behavioral: Standard of Care
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.
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
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: Month 12
| Milestone | Standard of Care | VITAL Start |
|---|---|---|
| Started | 395 | 405 |
| Completed | 304 | 314 |
| Not completed | 91 | 91 |
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.
| Participants | Standard of Care | VITAL Start |
|---|---|---|
| Composite of Retention in ART Clinic and Viral Suppression | 206 | 220 |
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.
| Participants | Standard of Care | VITAL Start |
|---|---|---|
| Number of Participants With Good Self-reported Behavioral Adherence | 248 | 248 |
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.
| Participants | Standard of Care | VITAL Start |
|---|---|---|
| TFVdp — Low | 67 | 64 |
| TFVdp — Medium | 38 | 35 |
| TFVdp — High | 188 | 200 |
| 3TCtp — Low | 130 | 115 |
| 3TCtp — Medium | 122 | 138 |
| 3TCtp — High | 41 | 46 |
Collected over through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VITAL Start | 0/405 (0%) | 0/405 (0%) | 22/405 (5.4%) |
| Standard of Care | 3/395 (0.8%) | 3/395 (0.8%) | 14/395 (3.5%) |
| Event | VITAL Start | Standard of Care |
|---|---|---|
| DeathRespiratory, thoracic and mediastinal disorders | 0/405 | 2/395 |
| DeathBlood and lymphatic system disorders | 0/405 | 1/395 |
| Event | VITAL Start | Standard of Care |
|---|---|---|
| Intimate partner violence and social harmSocial circumstances | 22/405 | 14/395 |
| Age, Continuous(years) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| Mean | 27.08 ± 5.68 | 27.52 ± 5.67 | 27.30 ± 5.68 |
| Age, Customized(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| 15-19 years | 28 | 21 | 49 |
| 20-29 years | 245 | 247 | 492 |
| 30-39 years | 114 | 125 | 239 |
| 40 years or above | 6 | 8 | 14 |
| Sex: Female, Male(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| Female | 393 | 401 | 794 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 393 | 401 | 794 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Education(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| No education | 17 | 22 | 39 |
| Some primary school (standard 1-5) | 108 | 83 | 191 |
| Primary completed (standard 6-8) | 114 | 135 | 249 |
| Some secondary (forms 1-2) | 72 | 78 | 150 |
| Secondary completed (forms 3-4) | 66 | 69 | 135 |
| Post-secondary | 16 | 14 | 30 |
| Head of household(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| No | 320 | 330 | 650 |
| Yes | 73 | 71 | 144 |
| Number of pregnancies(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| First | 55 | 62 | 117 |
| Second/third/fourth | 290 | 285 | 575 |
| More than four | 48 | 54 | 102 |
| ART Regimen(Participants) | Standard of Care | VITAL Start | Total |
|---|---|---|---|
| DTG-based ART | 192 | 196 | 388 |
| EFV and other ART | 201 | 205 | 406 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Data will be analysed by blinded study staff
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acquired Immunodeficiency Syndrome→
Baylor College of Medicine