HIV/AIDS
Conditions
Interventions
6 months dispensing interval of ART to HIV stable patients in Adherence clubs
Standard of Care i.e. no intervention
Sponsors
MSF Brussels Operational Research Unit
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adherence Club inclusion criteria >90% of patients in the AC consent to be enrolled in study prior to randomization Participant inclusion criteria Age 18 years or older On ART for at least 6-months Most recent documented viral load <400 copies/mL (not older than 12 months)) Able to provide informed consent for research
Exclusion criteria
Exclusion criteria: Adherence Clubs (ACs) exclusion criteria ACs catering to patients who require regular clinical follow-up (e.g. Family Clubs, Youth Clubs) ACs facilitated by nurses with limited group interaction/ support and/or which function more as ART pick-up point (e.g. evening clubs) Participant exclusion criteria Intention to relocate out of Cape Town permanently during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the retention and viral suppression outcomes of patients receiving their ART care and medicine supply through Standard ACs vs. 6-monthly ACs over 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine: a. Medicine supply chain feasibility of 6-monthly ACs implementation, including medicine losses and wastage associated with the 6 month supply of ART. b. Impact on clinic congestion. 1. Patient related: a. number of uncollected ART pre-packs at AC visits (including expiry date of medicine in uncollected pack); b. number of study participants regimen switched during study (including date of switch); c. number of returned ART opened or unopened pre-packs by AC patients to the clinic at club or clinic visits (including expiry date of medicine in pack and whether as a result of regimen switch); d. number of study participants reporting ART medicine losses and the reported reason for such losses including but not limited to theft, damage or destruction in the home or unauthorized loan or provision to another person who ran out of ART; e. number of study participants requests for additional ART supply from the clinic pharmacy in between AC visits and the reasons for such requests. 2. System related: a. number of short supplies due to medicine supply shortages, supply chain gaps and expiry date related losses; b. The medicines with quantities wasted due to any of: expiry, re-issue (per (1. d) above), regimen switch, non-collection or any other reason. | — |
Countries
South Africa
Contacts
Public ContactRodd Gerstenhaber
Principal Investigator MSF
Outcome results
None listed