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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH115793-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VITAL Start | Active Comparator | VITAL Start: Video-based pre-ART counseling |
|
| Standard of Care | Placebo Comparator | pre-ART education as conducted via routine facility methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VITAL Start: Video-based pre-ART counseling | Behavioral | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Kim, MD, MSc | Baylor College of Medicine Childrens foundation Malawi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor-Malawi | Lilongwe | Malawi |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32075677 | Derived | Kim MH, Tembo TA, Mazenga A, Yu X, Myer L, Sabelli R, Flick R, Hartig M, Wetzel E, Simon K, Ahmed S, Nyirenda R, Kazembe PN, Mphande M, Mkandawire A, Chitani MJ, Markham C, Ciaranello A, Abrams EJ. The Video intervention to Inspire Treatment Adherence for Life (VITAL Start): protocol for a multisite randomized controlled trial of a brief video-based intervention to improve antiretroviral adherence and retention among HIV-infected pregnant women in Malawi. Trials. 2020 Feb 19;21(1):207. doi: 10.1186/s13063-020-4131-8. |
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Data will be analysed by blinded study staff
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | VITAL Start |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 months |
|
through study completion, an average of 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intimate partner violence and social harm | Social circumstances | Non-systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Kim | Baylor College of Medicine Childrens Foundation Malawi | +26599869090 | mkim@tingathe.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 26, 2020 | Oct 15, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Investigators, Data analysis
|
| Standard of Care | Behavioral | Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart |
|
| 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 |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Head of household | Count of Participants | Participants |
|
| Number of pregnancies | Count of Participants | Participants |
|
| ART Regimen | Count of Participants | 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. |
|
|
|
| Secondary | 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. | The outcome was assessed only among those who had a study visit at month 12. | Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Month 12 |
|
|
|
|
| 0 |
| 405 |
| 0 |
| 405 |
| 22 |
| 405 |
| EG001 | 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 | 3 | 395 | 3 | 395 | 14 | 395 |
| Death | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| High |
|
| 3TCtp |
|
| 0.34 |
| Cross-tabulation |
| 2.13 |
| 2-Sided |
| Superiority |