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Screening Period

(up to 75 days before Day 1)

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment

Intervention Period

Back

Day 1 – Baseline

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Week 1

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Week 2

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 1

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 1 + 2 weeks

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 2

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 3

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 4

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 5

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 6

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 7

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 8

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 9

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 10

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 11

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 12

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 13

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 14

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 15

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 16

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 17

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 18

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 19

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 20

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 21

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 22

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Month 23

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Back

Early Discontinuation/Withdrawal

Below is the schedule of assessments (SOA) for this stage of the study protocol.

Clinical and Other Assessments
  • Informed consent
  • Eligibility verification
  • Demography1
  • Prior ARV history
  • Medical history
  • CV risk assessment
  • Height, weight (W) and BMI
  • Vital signs
  • Physical exam (F=Full, T=Targeted)
  • CDC HIV-1 Classification
  • HIV-associated conditions
  • Concomitant Medications
  • Adverse event (AE)/ SAE assessments
  • ECG: single reading
  • ECG: triplicate reading
Laboratory Assessments
Patient Reported Outcomes
  • Columbia Suicidality Severity Rating Scale (C-SSRS)
  • Acceptability of treatment (ACCEPT)
  • Numeric Rating Scale
  • HIVTSQ (status)
  • HIVTSQ (change)
  • EQ-5D 3L
  • Implementation Science Questionnaire
  • Participant Interviews14
Study Treatment
Legend

1 Sex at birth and current gender will be collected
2 Three (3) 2mL samples of frozen plasma. These samples will be used as replacement samples if primary samples are lost or arrive at the laboratory unevaluable, or for additional evaluations as required.
3 Two (2) 2mL sample of frozen plasma
4 One (1) 4mL sample of whole blood in EDTA
5 Nine (9) 10mL samples of whole blood in sodium citrate
6 PBMC samples for subjects who do not enrol in this study will be destroyed.
7 Two (2) 10mL samples of whole blood in sodium citrate
8 Four (4) 10mL samples of whole blood in sodium citrate
9 COVID-19 testing will be PCR or antigen at Screening and Day 1 (pre-dose). COVID-19 PCR or antigen testing will be optional at all study visits should infection be suspected.
10 A separate PGx ICF must be signed. Collection may be at any time after signing ICF, but preferably on Day 1.
11 Four (4) 1mL samples of frozen plasma
12 Two (2) 1mL samples of frozen serum
13 Participants selected for interviews only, interviews to be conducted within approx. 4 weeks of M6 visit.
14 IVRS/IWRS required at all drug dispensation visits (VH3810109 and/or Cabotegravir).
15 Month 4 Only