534
Participants
Start Date
March 9, 2022
Primary Completion Date
May 31, 2026
Study Completion Date
May 31, 2026
M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result
"Standard of care viral loads are drawn at month 4, month 12 and annually thereafter. Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the Risk of Treatment Failure (ROTF) clinic for adherence support when they next attend. For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support. There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1."
M2/PRM: Immediate outreach to subject after a missed pharmacy refill
The subject will be contacted if he/she fails to collect medication from the pharmacy. A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support. There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
M3/EAM: Immediate outreach to subject after EAM-identified missed doses
The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor). There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
S1/Text: Weekly check-in texts
"Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics. Subjects will be sent weekly simple but supportive text messages e.g. how are you? with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent."
S2/Peer: Enhanced peer group support
"Subject will receive an enhanced form of peer group support. Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version. Enhanced peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks."
Mzamomhle, Cape Town
Phumlani, Cape Town
Weltevreden Valley, Cape Town
Desmond Tutu HIV Foundation
OTHER
Massachusetts General Hospital
OTHER
New York University
OTHER
National Institute of Mental Health (NIMH)
NIH
Boston University
OTHER