A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs

Simple item page
dc.contributor.authorWilkinson, Lynne
dc.contributor.authorGrimsrud, Anna
dc.contributor.authorCassidy, Tali
dc.contributor.authorOrrell, Catherine
dc.contributor.authorVoget, Jacqueline
dc.contributor.authorHayes, Helen
dc.contributor.authorKeene, Claire
dc.contributor.authorSteele, Sarah J
dc.contributor.authorGerstenhaber, Rodd
dc.date.accessioned2019-12-10T09:10:26Z
dc.date.available2019-12-10T09:10:26Z
dc.date.issued2019-07-30
dc.date.updated2019-08-04T03:15:27Z
dc.description.abstractAbstract Background The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients’ retention and viral suppression. Patients and health systems could benefit further by reducing visit frequency and increasing ART refills. We designed a cluster-randomized control trial comparing standard of care (SoC) ACs and six-month ART refill (Intervention) ACs in a large primary care facility in Khayelitsha, South Africa. Methods Existing ACs were randomized to either the control (SOC ACs) or intervention (Intervention ACs) arm. SoC ACs meet five times annually, receiving two-month ART refills with a four-month ART refill over year-end. Blood is drawn at the AC visit ahead of the clinical assessment visit. Intervention ACs meet twice annually receiving six-month ART refills, with a third individual visit for routine blood collection anytime two-four weeks before the annual clinical assessment AC visit. Primary outcomes will be retention in care, annual viral load assessment completion and viral load suppression. (<400copies/mL) after 2 years. Ethics approval has been granted by the University of Cape Town (HREC 652/2016) and the Medecins Sans Frontieres (MSF) Ethics Review Board (#1639). Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents. Discussion Evaluation of an extended ART refill interval in adherence clubs will provide evidence towards novel model adaptions that can be made to further improve convenience for patients and leverage health system efficiencies. Trial registration Registered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018.
dc.identifier.apacitationWilkinson, L., Grimsrud, A., Cassidy, T., Orrell, C., Voget, J., Hayes, H., ... Gerstenhaber, R. (2019). A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs. http://hdl.handle.net/11427/30688en_ZA
dc.identifier.chicagocitationWilkinson, Lynne, Anna Grimsrud, Tali Cassidy, Catherine Orrell, Jacqueline Voget, Helen Hayes, Claire Keene, Sarah J Steele, and Rodd Gerstenhaber "A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs." (2019) http://hdl.handle.net/11427/30688en_ZA
dc.identifier.citationBMC Infectious Diseases. 2019 Jul 30;19(1):674
dc.identifier.ris TY - Journal Article AU - Wilkinson, Lynne AU - Grimsrud, Anna AU - Cassidy, Tali AU - Orrell, Catherine AU - Voget, Jacqueline AU - Hayes, Helen AU - Keene, Claire AU - Steele, Sarah J AU - Gerstenhaber, Rodd AB - Abstract Background The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery model, where clinically stable ART patients receive their ART refills and psychosocial support in groups has supported clinically stable patients’ retention and viral suppression. Patients and health systems could benefit further by reducing visit frequency and increasing ART refills. We designed a cluster-randomized control trial comparing standard of care (SoC) ACs and six-month ART refill (Intervention) ACs in a large primary care facility in Khayelitsha, South Africa. Methods Existing ACs were randomized to either the control (SOC ACs) or intervention (Intervention ACs) arm. SoC ACs meet five times annually, receiving two-month ART refills with a four-month ART refill over year-end. Blood is drawn at the AC visit ahead of the clinical assessment visit. Intervention ACs meet twice annually receiving six-month ART refills, with a third individual visit for routine blood collection anytime two-four weeks before the annual clinical assessment AC visit. Primary outcomes will be retention in care, annual viral load assessment completion and viral load suppression. (<400copies/mL) after 2 years. Ethics approval has been granted by the University of Cape Town (HREC 652/2016) and the Medecins Sans Frontieres (MSF) Ethics Review Board (#1639). Results will be published in peer-reviewed journals and made widely available through presentations and briefing documents. Discussion Evaluation of an extended ART refill interval in adherence clubs will provide evidence towards novel model adaptions that can be made to further improve convenience for patients and leverage health system efficiencies. Trial registration Registered with the Pan African Clinical Trial Registry: PACTR201810631281009. Registered 11 September 2018. DA - 2019-07-30 DB - OpenUCT DP - University of Cape Town KW - Extended dispensing intervals KW - Antiretrovirals KW - Differentiated service delivery KW - HIV LK - https://open.uct.ac.za PY - 2019 T1 - A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs TI - A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs UR - http://hdl.handle.net/11427/30688 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s12879-019-4287-6
dc.identifier.urihttp://hdl.handle.net/11427/30688
dc.identifier.vancouvercitationWilkinson L, Grimsrud A, Cassidy T, Orrell C, Voget J, Hayes H, et al. A cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs. 2019; http://hdl.handle.net/11427/30688.en_ZA
dc.language.rfc3066en
dc.rights.holderThe Author(s).
dc.subjectExtended dispensing intervals
dc.subjectAntiretrovirals
dc.subjectDifferentiated service delivery
dc.subjectHIV
dc.titleA cluster randomized controlled trial of extending ART refill intervals to six-monthly for anti-retroviral adherence clubs
dc.typeJournal Article
Files
Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
12879_2019_Article_4287.pdf
Size:
1.15 MB
Format:
Adobe Portable Document Format
Description:
Download
License bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
license.txt
Size:
0 B
Format:
Item-specific license agreed upon to submission
Description:
Download
Collections
Journal Articles