Table 4. Trial Assessments.
| Study week number | Screening | Randomisation | W0 | W4 (SCT-only) |
W8 | W16 | W24 | W32 | W40 | W48 | W60 | W72 | W84 | W96 | Followup beyond W96 |
Close-out visit |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Signed Informed consent | X | Confirm | ||||||||||||||
| Clinical assessment [1] |
X | X | X | X | X | X | X | X | X | X | X | X | X | X | Every 12 weeks | X |
| Vital Signs | X | X | X | X | X | Every 48 weeks | X | |||||||||
| Dispensing antiretroviral drugs (Trial IMP) | X | X | X | X | X | X | X | X | X | X | X | X | Every 12 weeks | X | ||
| Laboratory Assessments | ||||||||||||||||
| Pregnancy test (urine) - only female participants [2] | X | X | X | X | X | X | X | X | X | X | X | X | X | X | Every 12 weeks | X |
| HBsAg Screening | Done once for all participants, except for female participants who become pregnant, where it is repeated. | |||||||||||||||
| HIV-1 RNA VL [3] | X | (X) | X | (X) | X | Every 48 weeks | X | |||||||||
| Haematology [4 | X | X | X | |||||||||||||
| Biochemistry [5] | X | X | ||||||||||||||
| Lipids (same draw as biochemistry) | X | X | ||||||||||||||
| HbA1c | X | X | X | As per local practice | ||||||||||||
| T-cell lymphocyte subsets (same draw as haematology) [6] | X | X | X | Every 48 weeks | ||||||||||||
| Other Assessments | ||||||||||||||||
| Adherence assessment [7] |
X | X | X | X | X | X | X | X | X | X | X | X | Every 12 weeks | X | ||
| Acceptability questionnaire (HATQoL questionnaire) | X | X | X | X | Every 48 weeks | X | ||||||||||
| Mood survey | X | X | X | X | X | X | Every 48 weeks | X | ||||||||
| C-SSRS questionnaire |
X | X | X | X | X | X | X | Every 48 weeks | X | |||||||
| EQ5D | X | X | X | X | X | |||||||||||
| Sample Storage | ||||||||||||||||
| Mandatory plasma storage sample [8] | X | X | X | X | X | X | X | X | X | X | X | X | Every 24 weeks | X | ||
| Optional plasma storage sample [9] | X | X | X | |||||||||||||
| Urine storage sample [9] | X | X | ||||||||||||||
| MEMS Caps [10] | X | X | X | X | X | X | X | |||||||||
Every effort is made to minimise loss to follow up. Participants who miss clinic visits are traced using home visits and mobile phone calls. If a participant or their carer chooses to discontinue participation in the trial, prior to transferring to routine clinic follow-up, the participant will be asked to have assessments performed as appropriate for a close-out trial visit, although they would be at liberty to refuse any or all individual components of the assessment. It shall be discussed with the participant and their carer whether they are willing to be contacted in the future, in order to collect routine data for the trial, or, if not, whether data may be collected from their medical notes.
() Optional if done in routine care.
[1] Clinical assessment includes medical and ART history, clinical examination, weight, height, mid upper arm circumference, waist circumference, paediatric WHO staging for HIV and adverse events (starting from week 0). [2] For girls who have reached menarche.[3] Real-time/local VL to be done at screening, weeks 48 and 96 and then every 48 weeks (with confirmatory VLs for HIV-1 RNA ≥50 c/mL); more frequent VLs may be done if site routine VLs are more frequent. An additional VL is required if treatment failure is suspected. Retrospective VL testing is performed using routine stored plasma [15][15] at the scheduled trial visits when a real-time VL is not done. [4] Haematology: haemoglobin, red blood cells, white blood cells, lymphocytes, neutrophils, platelets. [5] Biochemistry: urea, creatinine, albumin, alanine transaminase, aspartate transaminase, bilirubin. [6] CD3+, CD4+, CD8+ T-lymphocyte percentage and absolute, total lymphocyte count. [7] Pill count (except week 0) and adherence questionnaire [8] At all scheduled trial visits plasma samples are stored for future batch testing for retrospective VL, and low-level viremia and resistance testing in a subset of samples. Additionally, a plasma sample is stored at unscheduled visits if treatment failure is suspected (all trial participants), stored samples are used for the evaluation of the total HIV-1 DNA and resistance mutations on HIV-1 proviral DNA using the next generation sequencing (NGS). [9] Only in participants who have provided additional consent/assent for the storage of optional samples [10] Only in participants invited (and who have consented/assented) to take part in the MEMS Caps sub-study. Only conducted in Uganda and Kenya.
Abbreviations: IMP = investigational medicinal product; C-SSRS = Columbia-suicide severity rating scale; HbA1AC = haemoglobin A1c; HBsAg = hepatitis B surface antigen; HATQoL = HIV/AIDS targeted quality of life; PK = pharmacokinetic; HIV-1 RNA VL = HIV RNA human immunodeficiency Virus-1 ribonucleic acid viral load; C-SSRS = Columbia-suicide severity rating scale; EQD5D = EuroQol-5 dimension; MEMS = medication event monitoring system; CD3+, CD4+, CD8+ = cluster of differentiation 3, -4, -8; VL = viral load; NGS = next generation sequencing; DNA = deoxyribonucleic acid; MEMS = medication event monitoring system