HIV/AIDS
Conditions
Keywords
pregnant women, viral suppression, retention, video intervention, pre-ART, counseling, HIV, adherence, PMTCT
Brief summary
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
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.
Interventions
BEHAVIORALVITAL 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.
BEHAVIORALStandard 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
Sponsors
National Institute of Mental Health (NIMH)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
Investigators, Data analysis
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Retention in ART Clinic and Viral Suppression | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Good Self-reported Behavioral Adherence | 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 a binary variable, with a score \>/=90 good adherence and \<90 not good adherence. |
| Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | Month 12 | 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. |
Countries
Malawi
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 393 |
| 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. | 401 |
| Total | 794 |
Baseline characteristics
| Characteristic | VITAL Start | Standard of Care | Total |
|---|---|---|---|
| Age, Continuous | 27.52 years STANDARD_DEVIATION 5.67 | 27.08 years STANDARD_DEVIATION 5.68 | 27.30 years STANDARD_DEVIATION 5.68 |
| Age, Customized 15-19 years | 21 Participants | 28 Participants | 49 Participants |
| Age, Customized 20-29 years | 247 Participants | 245 Participants | 492 Participants |
| Age, Customized 30-39 years | 125 Participants | 114 Participants | 239 Participants |
| Age, Customized 40 years or above | 8 Participants | 6 Participants | 14 Participants |
| ART Regimen DTG-based ART | 196 Participants | 192 Participants | 388 Participants |
| ART Regimen EFV and other ART | 205 Participants | 201 Participants | 406 Participants |
| Education No education | 22 Participants | 17 Participants | 39 Participants |
| Education Post-secondary | 14 Participants | 16 Participants | 30 Participants |
| Education Primary completed (standard 6-8) | 135 Participants | 114 Participants | 249 Participants |
| Education Secondary completed (forms 3-4) | 69 Participants | 66 Participants | 135 Participants |
| Education Some primary school (standard 1-5) | 83 Participants | 108 Participants | 191 Participants |
| Education Some secondary (forms 1-2) | 78 Participants | 72 Participants | 150 Participants |
| Head of household No | 330 Participants | 320 Participants | 650 Participants |
| Head of household Yes | 71 Participants | 73 Participants | 144 Participants |
| Number of pregnancies First | 62 Participants | 55 Participants | 117 Participants |
| Number of pregnancies More than four | 54 Participants | 48 Participants | 102 Participants |
| Number of pregnancies Second/third/fourth | 285 Participants | 290 Participants | 575 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 401 Participants | 393 Participants | 794 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 401 Participants | 393 Participants | 794 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 405 | 3 / 395 |
| other Total, other adverse events | 22 / 405 | 14 / 395 |
| serious Total, serious adverse events | 0 / 405 | 3 / 395 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Composite of Retention in ART Clinic and Viral Suppression | 206 Participants |
| VITAL Start | Composite of Retention in ART Clinic and Viral Suppression | 220 Participants |
p-value: 0.49Chi-squared
p-value: 0.6795% CI: [0.8, 1.42]Regression, Logistic
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.
Time frame: Month 12
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | Low | 67 Participants |
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | Medium | 38 Participants |
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | High | 188 Participants |
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | Low | 130 Participants |
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | Medium | 122 Participants |
| Standard of Care | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | High | 41 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | Medium | 138 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | Low | 64 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | Low | 115 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | Medium | 35 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | 3TCtp | High | 46 Participants |
| VITAL Start | Number of Participants With Good (Daily) ART Adherence Was Measured by Drug Concentration in the Blood | TFVdp | High | 200 Participants |
Comparison: Test 1 was for TFVdp while test 2 was for 3TCtp.p-value: 0.78Chi-squared
Comparison: Test 2 was for 3TCtp while test 1 was for TFVdp.p-value: 0.34Chi-squared
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.
Time frame: 12 months
Population: The outcome was assessed only among those who had a study visit at month 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard of Care | Number of Participants With Good Self-reported Behavioral Adherence | 248 Participants |
| VITAL Start | Number of Participants With Good Self-reported Behavioral Adherence | 248 Participants |
p-value: 0.4Chi-squared