Study period | ||||||||
Enrolment | Follow-up | Exit | ||||||
Months in study | 0 | 2 | 4 | 6 | 8 | 10 | 12 | |
Months on ART | 6 | 8 | 10 | 12 | 14 | 16 | 18 | |
Eligibility screen | X | |||||||
Informed consent | X | |||||||
Randomisation | X | |||||||
Intervention arm | POC bloods | VL, Cr | VL, Cr, CD4 | VL, Cr | ||||
Care provider | PN | EN | EN | PN | EN* | EN* | PN | |
SOC arm | Lab bloods | VL, Cr | VL, Cr, CD4 | VL, Cr | ||||
Care provider | PN | PN | PN | PN | PN* | PN* | PN | |
Demographics and social questionnaire | X | |||||||
Retention in care and virological suppression† | X | |||||||
Symptom screen, vital signs, adherence assessment | X | X | X | X | X* | X* | X | |
Laboratory full blood count, CD4, urinalysis | X | X | ||||||
Stored blood | X | X | X |
*No clinic visits at 8 and 10 months, if a participant was successfully referred into the community pharmacy pickup CCMDD programme at 6 months.
†Virological suppression measured using Roche Taqman V.2.0 in both arms.
ART, antiretroviral therapy; Cr, creatinine; EN, enrolled nurse; PN, professional nurse; POC, point of care; SOC, standard of care; STREAM, Simplifying HIV TREAtment and Monitoring; VL, viral load.