Papers by Rodd Gerstenhaber
F1000Research, May 5, 2017
Journal of the International AIDS Society, Dec 1, 2020
Introduction: The antiretroviral therapy (ART) adherence club (AC) model has supported clinically... more Introduction: The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and six-month refill intervention ACs in a primary care facility in Khayelitsha, South Africa. Methods: Existing community-based and facility-based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two-month refills with a four-month refill over year-end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six-month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention-to-treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC. Results: Of 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of À1.0% (95% CI: À3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0). Conclusions: Intervention AC patients receiving six-month ART refills showed non-inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.
BMC Infectious Diseases, Jul 30, 2019
Background: The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery ... more 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 sixmonth 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.
Refugee Survey Quarterly, 2019
Despite the difficulties experienced by asylum-seekers in South Africa, little research has explo... more Despite the difficulties experienced by asylum-seekers in South Africa, little research has explored long-term asylum applicants. This exploratory qualitative study describes how protracted asylum procedures and associated conditions are experienced by Congolese asylum-seekers in Tshwane, South Africa. Eighteen asylum-seekers and eight key informants participated in the study. All asylum-seekers had arrived in South Africa between 2003 and 2013, applied for asylum within a year of arrival in Tshwane, and were still in the asylum procedure at the time of the interview, with an average of 9 years since their application. Thematic analysis was used to analyse the data. The findings presented focus on the process of leaving the Democratic Republic of Congo, applying for asylum and aspirations of positive outcomes for one’s life. Subsequently, it describes the reality of prolonged periods of unfulfilled expectations and how protracted asylum procedures contribute to poor mental health. F...
BACKGROUND Youth-friendly services increase the uptake of HIV testing among 12-24 year olds. Mede... more BACKGROUND Youth-friendly services increase the uptake of HIV testing among 12-24 year olds. Medecins Sans Frontieres, partnered with Aviro Health to develop a series of youth-friendly sexual health educational videos, as well as a digital HIV counselling support syllabus, the “HIV Journey”. Both were hosted on a data-free web-based platform, named Khetha. OBJECTIVE To determine if Khetha would encourage youth to link to testing, and if youth would use the platform when undertaking an HIV test, a pilot was conducted at 2 youth clinics in the peri-urban, low socioeconomic suburb of Khayelitsha in Cape Town, South Africa. METHODS Recruitment ran from October 2020 to March 2021, with 3 methods utilised: a peer-recruiter enrolled youth in the waiting room of the clinics, 2 outreach events were held in the community surrounding the clinics, and 2 Facebook advertising campaigns were run. Youth were supplied a pamphlet, or Facebook-messaged, a unique code which allowed access to Khetha. Yo...
SPIRIT Checklist. (DOC 119 kb)
Randomization SOP. The Standard operating Procedure for how randomization was performed during st... more Randomization SOP. The Standard operating Procedure for how randomization was performed during study. (DOC 132 kb)
Patient Informed Consent form. Consent form used for study (DOCX 37 kb)
Pre-study engagement processes. Description of the various engagements and consultations that too... more Pre-study engagement processes. Description of the various engagements and consultations that took place before study protocol was submitted (DOCX 15 kb)
Journal of the International AIDS Society, 2020
Introduction: The antiretroviral therapy (ART) adherence club (AC) model has supported clinically... more Introduction: The antiretroviral therapy (ART) adherence club (AC) model has supported clinically stable HIV patients' retention with group ART refills and psychosocial support. Reducing visit frequency by increasing ART refills to six months could further benefit patients and unburden health systems. We conducted a pragmatic non-inferiority cluster randomized trial comparing standard of care (SoC) ACs and six-month refill intervention ACs in a primary care facility in Khayelitsha, South Africa. Methods: Existing community-based and facility-based ACs were randomized to either SoC or intervention ACs. SoC ACs met five times annually, receiving two-month refills with a four-month refill over year-end. Blood was drawn at one AC visit with a clinical assessment at the next. Intervention ACs met twice annually receiving six-month refills, with an individual blood collection visit before the annual clinical assessment AC visit. The first study visits were in October and November 2017 and participants followed for 27 months. We report retention in care, viral load completion and viral suppression (<400 copies/mL) 24 months after enrolment and calculated intention-to-treat risk differences for the primary outcomes using generalized estimating equations specifying for clustering by AC. Results: Of 2150 participants included in the trial, 977 were assigned to the intervention arm (40 ACs) and 1173 to the SoC (48 ACs). Patient characteristics at enrolment were similar across groups. Retention in care at 24 months was similarly high in both arms: 93.6% (1098/1173) in SoC and 92.6% (905/977) in the intervention arm, with a risk difference of À1.0% (95% CI: À3.2 to 1.3). The intervention arm had higher viral load completion (90.8% (999/1173) versus 85.1% (887/977)) and suppression (87.3% (969 /1173) versus 82.6% (853/977)) at 24 months, with a risk difference for completion of 5.5% (95% CI: 1.5 to 9.5) and suppression of 4.6% (95% CI: 0.2 to 9.0). Conclusions: Intervention AC patients receiving six-month ART refills showed non-inferior retention in care, viral load completion and viral load suppression to those in SoC ACs, adding to a growing literature showing good outcomes with extended ART dispensing intervals.
BMC Infectious Diseases, 2019
Background: The antiretroviral therapy (ART) adherence club (AC) differentiated service delivery ... more 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 sixmonth 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.
Tropical Medicine & International Health, 2014
objectives Further scale-up of antiretroviral therapy (ART) to those in need while supporting the... more objectives Further scale-up of antiretroviral therapy (ART) to those in need while supporting the growing patient cohort on ART requires continuous adaptation of healthcare delivery models. We describe several approaches to manage stable patients on ART developed by M edecins Sans Fronti eres together with Ministries of Health in four countries in sub-Saharan Africa. methods Using routine programme data, four approaches to simplify ART delivery for stable patients on ART were assessed from a patient and health system perspective: appointment spacing for clinical and drug refill visits in Malawi, peer educator-led ART refill groups in South Africa, community ART distribution points in DRC and patient-led community ART groups in Mozambique. results All four approaches lightened the burden for both patients (reduced travel and lost income) and health system (reduced clinic attendance). Retention in care is high: 94% at 36 months in Malawi, 89% at 12 months in DRC, 97% at 40 months in South Africa and 92% at 48 months in Mozambique. Where evaluable, service provider costs are reported to be lower. conclusion Separating ART delivery from clinical assessments was found to benefit patients and programmes in a range of settings. The success of community ART models depends on sufficient and reliable support and resources, including a flexible and reliable drug supply, access to quality clinical management, a reliable monitoring system and a supported lay workers cadre. Such models require ongoing evaluation and further adaptation to be able to reach out to more patients, including specific groups who may be challenged to meet the demands of frequent clinic visits and the integrated delivery of other essential chronic disease interventions.
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Papers by Rodd Gerstenhaber