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Evidence-based Differentiated Care for HIV in South-Eastern Africa: Shaping the post 2020 agenda

Applicant Labhardt Niklaus
Number 181355
Funding scheme Eccellenza
Research institution Swiss Tropical and Public Health Institute Dept. of Medicine / Clinical Research Unit Universität Basel
Institution of higher education University of Basel - BS
Main discipline Tropical Medicine
Start/End 01.01.2019 - 31.12.2023
Approved amount 1'559'950.00
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All Disciplines (2)

Discipline
Tropical Medicine
Public Health and Health Services

Keywords (8)

Antiretroviral Therapy; Sub-Saharan Africa; HIV/AIDS; HIV/AIDS guidelines and policies; Differentiated Care; Service Delivery; Pragmatic trials; Cluster-randomized trials

Lay Summary (German)

Lead
"Differentiated Care" steht für neue, innovative Ansätze um Personen mit HIV möglichst niederschwellig und nachhaltig Testung und Therapie von HIV anzubieten. Gerade im Südöstlichen Afrika, wo die HIV Pandemie die Bevölkerung besonders hart trifft, braucht es neue Methoden um möglichst Allen einen Test und nachfolgend eine Therapie anbieten zu können.In diesem Projekt werden in mehreren klinischen Studien innovative Ansätze getestet um kosteneffiziente Wege zu finden, die es erlauben trotz knapper Mittel auch in abgelegenen ländlichen Regionen mit minimaler medizinischer Infrastruktur eine hochstehende und nachhaltige HIV Therapie durchzuführen.
Lay summary

Hintergrund

Trotz massiver Fortschritte in den vergangenen 10 Jahren bleibt HIV/AIDS eine der führenden Ursachen für Krankheit und Tod im Südöstlichen Afrika. Die grosse Herausforderung für die kommenden 10 Jahre wird es sein, einer steigenden Anzahl Personen mit HIV leicht zugängliche antiretrovirale Therapie anzubieten, während gleichzeitig global die finanziellen Mittel für HIV Programme abnehmen. Um eine Kontrolle der HIV Epidemie in Hochprävalenz Ländern mit geringen Ressourcen zu erreichen, braucht es klinische und operationelle Forschung, die vereinfachte und v.a. kosteneffiziente Ansätze zum Testen und Therapieren von HIV untersucht.

Projekt

Das Projekt umfasst vier randomisiert klinische Studien, alle mit dem Ziel, neue, kosteneffektive Ansätze zur Verbesserung von HIV Programmen im Südöstlichen Afrika zu testen und so zu zukünftigen Behandlungsrichtlinien beizutragen. Alle vier randomisierten Studien werden in Lesotho, in zwei ländlichen Distrikten mit drei Spitälern und 21 Gesundheitszentren wo insgesamt über 30'000 Patientinnen und Patienten antiretrovirale Therapie erhalten, durchgeführt. Studie 4 wird zusätzlich auch Patientinnen und Patienten an Kliniken in Tanzania einschliessen. Studien 1, 2 und 3 sind Kluster randomisiert, Studie 4 individuell randomisiert. 

Die vier randomisierten Studien

Studie 1 testet ob in Interventionsklustern (Dörfern) die Anwendung von oralen HIV Selbsttests während HIV Testkampagnen die Testrate in der Gesamtpopulation erhöht und kosteneffektiv ist. Diese Studie wird in >150 Dörfern durchgeführt.

Studie 2 ist die erste randomisierte Studie, die testet, ob klinisches Management und Therapie von Patienten mit neu diagnostizierter HIV Infektion durch Laien den klinischen und virologischen Behandlungserfolg verbessert. Während einer grossen Testkampagne in ca. 200 Dörfern werden neu-diagnostizierte Patientinnen und Patienten rekrutiert. In Interventionsdörfern werden die Patientinnen und Patienten von Gesundheitshelfern betreut (monatliches klinisches check-up, Monitorisieren der Adhärenz, Medikamentenabgabe). In Kontrolldörfern findet die Betreuung wie üblich durch medizinisches Fachpersonal in einer Klinik statt.

Studie 3 testet in Inverventionskliniken in Lesotho  ob automatisierte SMSBenachrichtigung an Patientinnen und Patienten über das Resultat ihrer letzten Viruslastmessung inklusive automatisiert vorgeschlagenem Prozedere an die Patient*innen und Behandelnden je nach Resultat, den klinischen und virologischen Verlauf verbessert und ob es kosteneffektiv ist.

Studie 4 untersucht ob Anwendung genotypischer Resistenztestung bei Kindern und Jugendlichen mit Therapieversagen unter antiretroviraler Therapie das Management und somit den klinischen und virologischen Verlauf verbessert.

Direct link to Lay Summary Last update: 07.05.2022

Responsible applicant and co-applicants

Employees

Publications

Publication
eHealth supported multi-months dispensing of antiretroviral therapy: a mixed-methods preference assessment in rural Lesotho
Scherrer Ramona, Tschumi Nadine, Lejone Thabo Ishmael, Kopo Mathebe, Motaboli Lipontso, Mothobi Buoang, Amstutz Alain, Deml Michael J., Lerotholi Malebanye, Labhardt Niklaus Daniel (2022), eHealth supported multi-months dispensing of antiretroviral therapy: a mixed-methods preference assessment in rural Lesotho, in Pilot and Feasibility Studies, 8(1), 61-61.
Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial
Tschumi Nadine, Lerotholi Malebanye, Kopo Mathebe, Kao Mpho, Lukau Blaise, Nsakala Bienvenu, Chejane Ntoiseng, Motaboli Lipontso, Lee Tristan, Barnabas Ruanne, Shapiro Adrienne E., van Heerden Alastair, Lejone Thabo I., Amstutz Alain, Brown Jennifer A., Heitner Jesse, Belus Jennifer M., Chammartin Frédérique, Labhardt Niklaus D. (2022), Assessment of a viral load result-triggered automated differentiated service delivery model for people taking ART in Lesotho (the VITAL study): Study protocol of a cluster-randomized trial, in PLOS ONE, 17(5), e0268100-e0268100.
Same‐day antiretroviral therapy initiation for people living with HIV who have tuberculosis symptoms: a systematic review
Burke Rachael M., Rickman Hannah M., Singh Vindi, Kalua Thokozani, Labhardt Niklaus D., Hosseinipour Mina, Wilkinson Robert J., MacPherson Peter (2022), Same‐day antiretroviral therapy initiation for people living with HIV who have tuberculosis symptoms: a systematic review, in HIV Medicine, 23(1), 4-15.
Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial
Labhardt Niklaus D, Smit Mikaela, Petignat Ianis, Perneger Thomas, Marinosci Annalisa, Ustero Pilar, Diniz Ribeiro Maria Pia, Ragozzino Silvio, Nicoletti Giovanni Jacopo, Faré Pietro Benedetto, Andrey Diego O, Jacquerioz Frederique, Lebowitz Dan, Agoritsas Thomas, Meyer Benjamin, Spechbach Hervé, Salamun Julien, Guessous Idris, Chappuis François, Kaiser Laurent, Decosterd Laurent Arthur, Grinsztejn Beatriz, Bernasconi Enos, Cardoso Sandra Wagner, et al. (2021), Post-exposure Lopinavir-Ritonavir Prophylaxis versus Surveillance for Individuals Exposed to SARS-CoV-2: The COPEP Pragmatic Open-Label, Cluster Randomized Trial, in eClinicalMedicine, 42, 101188-101188.
Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial
Amstutz Alain, Lejone Thabo Ishmael, Khesa Lefu, Kopo Mathebe, Kao Mpho, Muhairwe Josephine, Bresser Moniek, Räber Fabian, Klimkait Thomas, Battegay Manuel, Glass Tracy Renée, Labhardt Niklaus Daniel (2021), Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomized clinical trial, in PLOS Medicine, 18(10), e1003839-e1003839.
Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor‐ to dolutegravir‐based antiretroviral therapy: A prospective cohort study in Lesotho (DO‐REAL study)
Brown Jennifer A., Nsakala Bienvenu L., Mokhele Kuena, Rakuoane Itumeleng, Muhairwe Josephine, Urda Lorena, Amstutz Alain, Tschumi Nadine, Klimkait Thomas, Labhardt Niklaus D. (2021), Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor‐ to dolutegravir‐based antiretroviral therapy: A prospective cohort study in Lesotho (DO‐REAL study), in HIV Medicine, 1-7.
Emergence of Human Immunodeficiency Virus-1 Drug Resistance During the 3-Month World Health Organization-Recommended Enhanced Adherence Counseling Period in the CART-1 Cohort Study
Brown Jennifer A, Mbunkah Herbert A, Lejone Thabo I, Ringera Isaac, Cheleboi Molisana, Klimkait Thomas, Metzner Karin J, Günthard Huldrych F, Labhardt Niklaus D, Kouyos Roger D, Tschumi Nadine (2021), Emergence of Human Immunodeficiency Virus-1 Drug Resistance During the 3-Month World Health Organization-Recommended Enhanced Adherence Counseling Period in the CART-1 Cohort Study, in Open Forum Infectious Diseases, 8(5), 1-7.
Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial
Brown Jennifer Anne, Amstutz Alain, Nsakala Bienvenu Lengo, Seeburg Ulrike, Vanobberghen Fiona, Muhairwe Josephine, Klimkait Thomas, Labhardt Niklaus Daniel (2021), Extensive drug resistance during low-level HIV viraemia while taking NNRTI-based ART supports lowering the viral load threshold for regimen switch in resource-limited settings: a pre-planned analysis from the SESOTHO trial, in Journal of Antimicrobial Chemotherapy, 76(5), 1294-1298.
Community-based care models for arterial hypertension management in non-pregnant adults in sub-Saharan Africa: A scoping review protocol
Fernández Lucia González, Firima Emmanuel, Huber Jacqueline, Raeber Fabian, Amstutz Alain, Gupta Ravi, Mokhohlane Joalane, Belus Jennifer M., Labhardt Niklaus Daniel (2021), Community-based care models for arterial hypertension management in non-pregnant adults in sub-Saharan Africa: A scoping review protocol, in F1000Research, 10, 487-487.
How to bring research evidence into policy? Synthesizing strategies of five research projects in low-and middle-income countries.
S Erismann, MA Pesantes, D Beran, A Leuenberger, A Farnham, de White M Berger Gonzalez, ND Labhardt, F Tediosi, P Akweongo, A Kuwawenaruwa, H Prytherch (2021), How to bring research evidence into policy? Synthesizing strategies of five research projects in low-and middle-income countries., in Health research policy and systems, 0-13.
Reaching Absent and Refusing Individuals During Home-Based HIV Testing Through Self-Testing-at What Cost?
A Amstutz, L Matsela, TI Lejone, M Kopo, TR Glass, ND Labhardt (2021), Reaching Absent and Refusing Individuals During Home-Based HIV Testing Through Self-Testing-at What Cost?, in Frontiers in medicine, 1-7.
The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial.
H Mapesi, R Gupta, HI Wilson, B Lukau, A Amstutz, A Lyimo, J Muhairwe, E Senkoro, T Byakuzana, M Mphunyane, M Bresser, TR Glass, M Lambiris, G Fink, M Weisser (2021), The coArtHA trial-identifying the most effective treatment strategies to control arterial hypertension in sub-Saharan Africa: study protocol for a randomized controlled trial., in Trials, 1-12.
Low rates of active hepatitis B and C infections among adults and children living with HIV and taking antiretroviral therapy: A multicenter screening study in Lesotho
Amstutz Alain, Nsakala Bienvenu L., Cheleboi Molisana, Lejone Thabo I., Hobbins Michael A., Battegay Manuel, Klimkait Thomas, Labhardt Niklaus D. (2020), Low rates of active hepatitis B and C infections among adults and children living with HIV and taking antiretroviral therapy: A multicenter screening study in Lesotho, in Journal of Medical Virology, 92(12), 3857-3861.
Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho
Amstutz Alain, Nsakala Bienvenu Lengo, Vanobberghen Fiona, Muhairwe Josephine, Glass Tracy Renée, Namane Tilo, Mpholo Tlali, Battegay Manuel, Klimkait Thomas, Labhardt Niklaus Daniel (2020), Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho, in PLOS Medicine, 17(9), e1003325-e1003325.
“If it is left, it becomes easy for me to get tested”: Use of oral self‐tests and community health workers to maximize the potential of home‐based HIV testing among adolescents in Lesotho
Amstutz Alain, Kopo Mathebe, Lejone Thabo I, Khesa Lefu, Kao Mpho, Muhairwe Josephine, Glass Tracy R, Labhardt Niklaus D (2020), “If it is left, it becomes easy for me to get tested”: Use of oral self‐tests and community health workers to maximize the potential of home‐based HIV testing among adolescents in Lesotho, in Journal of the International AIDS Society, 32.
Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial.
M Smit, A Marinosci, GJ Nicoletti, T Perneger, S Ragozzino, DO Andrey, M Stoeckle, F Jacquerioz, D Lebowitz, T Agoritsas, B Meyer, H Spechbach, A Calmy (2020), Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial., in BMJ open, 1-6.
Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania
Brown Jennifer Anne, Ringera Isaac, Luoga Ezekiel, Cheleboi Molisana, Kimera Namvua, Muhairwe Josephine, Kayembe Buntshi Paulin, Hlasoa Mosa Molapo, Kabundi Lorraine, Yav Ching Wey David, Mothobi Buoang, Thahane Lineo, Amstutz Alain, Bachmann Nadine, Mollel Getrud Joseph, Bresser Moniek, Glass Tracy Renée, Paris Daniel Henry, Klimkait Thomas, Weisser Maja, Labhardt Niklaus Daniel (2020), Genotype-Informed Versus Empiric Management Of VirEmia (GIVE MOVE): study protocol of an open-label randomised clinical trial in children and adolescents living with HIV in Lesotho and Tanzania, in BMC Infectious Diseases, 20(1), 0-11.
PEBRA trial - effect of a peer-educator coordinated preference-based ART service delivery model on viral suppression among adolescents and young adults living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho.
TI Lejone, M Kopo, N Bachmann, JA Brown, TR Glass, J Muhairwe, T Matsela, R Scherrer, L Chere, T Namane, ND Labhardt, A Amstutz (2020), PEBRA trial - effect of a peer-educator coordinated preference-based ART service delivery model on viral suppression among adolescents and young adults living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho., in BMC public health, 1-9.
Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho
Ford Nathan, Nsakala Bienvenu Lengo, Vanobberghen Fiona, Muhairwe Josephine, Glass Tracy Renée, Namane Tilo, Mpholo Tlali, Battegay Manuel, Klimkait Thomas, Labhardt Niklaus Daniel (2020), Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: An open-label randomized controlled trial in Lesotho, in PLoS Medicine, 1.
VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho
Amstutz Alain, Lejone Thabo Ishmael, Khesa Lefu, Muhairwe Josephine, Nsakala Bienvenu Lengo, Tlali Katleho, Bresser Moniek, Tediosi Fabrizio, Kopo Mathebe, Kao Mpho, Klimkait Thomas, Battegay Manuel, Glass Tracy Renée, Labhardt Niklaus Daniel (2019), VIBRA trial – Effect of village-based refill of ART following home-based same-day ART initiation vs clinic-based ART refill on viral suppression among individuals living with HIV: protocol of a cluster-randomized clinical trial in rural Lesotho, in Trials, 20(1), 522-522.
The HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho
Amstutz Alain, Lejone Thabo Ishmael, Khesa Lefu, Muhairwe Josephine, Nsakala Bienvenu Lengo, Tlali Katleho, Bresser Moniek, Vanobberghen Fiona, Kopo Mathebe, Kao Mpho, Klimkait Thomas, Battegay Manuel, Labhardt Niklaus Daniel, Glass Tracy Renée (2019), The HOSENG trial – Effect of the provision of oral self-testing for absent and refusing individuals during a door-to-door HIV-testing campaign on testing coverage: protocol of a cluster-randomized clinical trial in rural Lesotho, in Trials, 20(1), 496-496.
The viral load monitoring cascade in a resource-limited setting: A prospective multicentre cohort study after introduction of routine viral load monitoring in rural Lesotho
Glass Tracy Renee, Motaboli Lipontso, Nsakala Bienvenu, Lerotholi Malebanye, Vanobberghen Fiona, Amstutz Alain, Lejone Thabo Ishmael, Muhairwe Josephine, Klimkait Thomas, Labhardt Niklaus Daniel (2019), The viral load monitoring cascade in a resource-limited setting: A prospective multicentre cohort study after introduction of routine viral load monitoring in rural Lesotho, in PLOS ONE, 14(8), e0220337-e0220337.
Emtricitabine and lamivudine concentrations in saliva: a simple suitable test for treatment adherence
Courlet Perrine, Decosterd Laurent Arthur, Brown Jennifer Anne, Alves Saldanha Susana, Marzolini Catia, Cavassini Matthias, Stoeckle Marcel, Csajka Chantal, Labhardt Niklaus Daniel, Calmy Alexandra, Anagnostopoulos A, Battegay M, Bernasconi E, Böni J, Braun D L, Bucher H C, Calmy A, Cavassini M, Ciuffi A, Dollenmaier G, Egger M, Elzi L, Fehr J, Fellay J, et al. (2019), Emtricitabine and lamivudine concentrations in saliva: a simple suitable test for treatment adherence, in Journal of Antimicrobial Chemotherapy, 74(8), 2468-2470.
Engagement in Care, Viral Suppression, Drug Resistance, and Reasons for Nonengagement After Home-Based Same-Day Antiretroviral Therapy Initiation in Lesotho: A Two-Year Follow-up of the CASCADE Trial
Amstutz Alain, Brown Jennifer Anne, Ringera Isaac, Muhairwe Josephine, Lejone Thabo Ishmael, Klimkait Thomas, Glass Tracy Renée, Labhardt Niklaus Daniel (2019), Engagement in Care, Viral Suppression, Drug Resistance, and Reasons for Nonengagement After Home-Based Same-Day Antiretroviral Therapy Initiation in Lesotho: A Two-Year Follow-up of the CASCADE Trial, in Clinical Infectious Diseases, 20.

Datasets

The viral load monitoring cascade in a resource-limited setting: a prospective multicentre cohort study after introduction of routine viral load monitoring in rural Lesotho

Author Glass, Tracy; Motaboli, Lipontso; Nsakala, Bienvenu; Lerotholi, Malebanye; Vanobberghen, Fiona; Amstutz, Alain; Lejone, Thabo; Muhairwe, Josephine; Klimkait, Thomas; Labhardt, Niklaus
Publication date 09.07.2019
Persistent Identifier (PID) 10.5281/zenodo.3274279
Repository Zenodo
Abstract
Anonymized dataset of publication

Switch to second-line versus continued first-line antiretroviral therapy for patients with low-level HIV-1 viremia: an open-label randomized controlled trial in Lesotho

Author Amstutz, Alain; Nsakala, Bienvenu; Vanobberghen, Fiona; Muhairwe, Josephine; Glass, Tracy; Namane, Tilo; Mpholo, Tlali; Battegay, Manuel; Klimkait, Thomas; Labhardt, Niklaus
Publication date 01.07.2020
Persistent Identifier (PID) 10.5281/zenodo.3953494
Repository Zenodo
Abstract
Pseudo-anonymized dataset

HOSENG trial – HOme-based oral SElf-testiNG for absent and refusing individuals during a door-to-door HIV testing campaign: a cluster randomised clinical trial in rural Lesotho

Author Amstutz, Alain; Lejone, Thao; Lefu, Khesa; Muhairwe, Josephine; Bresser, Moniek; Vanobberghen, Fiona; Kopo, Mathebe; Kao, Mpho; Nsakala, Bienvenu; Tlali, Katleho; Klimkait, Thomas; Labhardt, Niklaus; Glass, Tracy
Publication date 20.10.2020
Persistent Identifier (PID) 10.5281/zenodo.3961501
Repository Zenodo
Abstract
De-identified dataset

Offering ART refill through community health workers versus clinic-based follow-up after home-based same-day ART initiation in rural Lesotho: The VIBRA cluster-randomised clinical trial

Author Amstutz, Alain; Lejone, Thabo; Khesa, Lefu; Kopo, Mathebe; Kao, Mpho; Muhairwe, Josephine; Bresser, Moniek; Räber, Fabian; Klimkait, Thomas; Battegay, Manuel; Labhardt, Niklaus
Publication date 04.10.2021
Persistent Identifier (PID) 10.5281/zenodo.5547573
Repository Zenodo
Abstract
Deidentified dataset

Viral suppression after transition from nonnucleoside reverse transcriptase inhibitor‐ to dolutegravir‐based antiretroviral therapy: A prospective cohort study in Lesotho (DO‐REAL study)

Author Brown, Jennifer A.; Nsakala, Bienvenu L.; Mokhele, Kuena; Rakuoane, Itumeleng; Muhairwe, Josephine; Urda, Lorena; Amstutz, Alain; Tschumi, Nadine; Klimkait, Thomas; Labhardt, Niklaus D.
Publication date 10.10.2021
Persistent Identifier (PID) https://doi.org/10.1111/hiv.13189
Repository zenodo.org
Abstract
De-identified dataset.

Collaboration

Group / person Country
Types of collaboration
Molecular Virology Group, Department Biomedicine, Basel Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
SolidarMed-supported clinics in Lesotho (districts of Butha-Buthe and Mokhotlong) Lesotho (Africa)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel
Chronic Disease Clinic Ifakara Tanzania (Africa)
- in-depth/constructive exchanges on approaches, methods or results
- Publication
- Research Infrastructure
- Exchange of personnel

Communication with the public

Communication Title Media Place Year
Media relations: print media, online media Omikron und HIV: Wenn Menschen zu Brutstätten für neue Coronavirus-Varianten werden NZZ German-speaking Switzerland 2021
Media relations: print media, online media In Conversation With… Mathebe Kopo and Alain Amstutz The Lancet Podcasts International 2020
Media relations: radio, television Echo der Zeit SRF German-speaking Switzerland 2019

Associated projects

Number Title Start Funding scheme
205053 Assessing the feasibility, safety and effectiveness of offering same-day antiretroviral therapy to persons with HIV and presumptive tuberculosis: A collaborative multi-country research project in sub-Sahara Africa 01.01.2022 Project funding
196251 Efficacy of same day chemoprophylaxis for exposed asymptomatic individuals exposed to SARS-CoV-2 in Switzerland: a pragmatic open-label cluster randomized trial (COPEP-trial) 01.06.2020 Special Call on Coronaviruses
160876 Improving the HIV care cascade in Lesotho: Towards 90-90-90 - A research collaboration with the Ministry of Health 01.03.2016 r4d (Swiss Programme for Research on Global Issues for Development)

Abstract

Background and rationale:With the Public Health Approach, over the last decade, the World Health Organization promoted standardized and simplified HIV care allowing scale-up of antiretroviral therapy (ART) provision even in very under-resourced health systems. This approach succeeded in a massive increase of people receiving ART in Sub-Saharan Africa. However, despite substantial progress, HIV/AIDS remains a leading cause of morbidity and death in Sub-Saharan Africa. Further progress towards ending the AIDS epidemic is challenged by several factors: (i) scaling up ART provision among “hard-to-reach” populations, (ii) maintaining the rising numbers of patients on ART in under-resourced health care facilities while international funding support decreases, (iii) preventing and adapting to emerging resistance of HIV to current drugs, (iv) improving outcomes among children and adolescents taking ART. To meet the above-listed challenges, continuing the “one size fits all” approach will not be sufficient, and refining the public health approach through differentiated care models (DCM) will be required. “Differentiated care” is the term describing the adjustment of treatment programs to a patient’s individual needs and prognosis. DCMs have the potential to improve patient outcomes as well as cost-effectiveness through better allocation of resources. However, to date the data on DCMs at larger scale are scarce and generating evidence through randomized trials in differentiated care represents an urgent requirement. Aim of the Project:This project entails four pragmatic randomized trials (RCT) aiming to test innovative new DCMs in real-life settings and assess relevant endpoints of clinical response/outcome, virological control as well as the cost-effectiveness of interventions. The DCMs tested all make use of new and innovative technologies and - if successful - have the potential to be integrated into future guidelines and policies. All RCTs will be conducted in Lesotho, Southern Africa. RCT-4 will additionally include sites in Tanzania.Planned Studies:RCT-1: HOSENG trial: “Home-based testing plus self-testing to improve HIV diagnosis coverage in rural Lesotho” - an open-label cluster randomized trial. Including 100 clusters with >10’000 individuals, this trial assesses if combining home-based HIV testing with dispensing of oral self-test kits to household members absent during home-based HIV testing is an effective approach to reach high testing coverage in remote rural hard-to-reach settings.RCT-2: VIBRA trial: “Village-based refill of ART after same-day ART start vs a clinic-based ART provision to HIV-positive individuals not on ART after home-based HIV testing” - an open-label cluster randomized trial in rural Lesotho. This trial aims at improving linkage to care, initiation of and retention on ART to achieve viral suppression in individuals newly diagnosed with HIV during home-based testing in remote rural settings. It is the first trial to test a DCM using village-health-worker based ART-care right from diagnosis.RCT-3: VITAL trial: “Viral load triggered ART care in Lesotho” - an open-label cluster-randomized trial. The proposed DCM called “VITAL model” uses an innovative database that groups patients on ART automatically into different follow-up algorithms depending on their last viral load result, clinical condition and preference, and informs patients automatically about their viral load results via SMS. Grading intensity of follow-up according to viral load result shall allow to optimize resource-allocation in HIV care and improve patient-outcomes. Sending results via SMS directly to patients shall promote treatment literacy.RCT-4: GIVES-MOVE trial: “Genotype-Informed Versus Empiric Management Of VirEmia” in children and adolescents: an open-label randomized trial. This will be the first trial to test if management informed by genotypic resistance testing improves outcomes of children and adolescents with treatment failure while taking ART, and if this will be cost-effective. It will be conducted simultaneously in Lesotho and Tanzania.The studies listed above will be conducted in close collaboration with:-SolidarMed, Swiss Organization for Health in Africa (www.solidarmed.ch)-Ministry of Health of Lesotho-Molecular Virology of the Department of Biomedicine, Haus Petersplatz, University of Basel-Department of Global Health, University of Washington, United States-Ifakara Health Institute, Tanzania (RCT-4)
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