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Improving the HIV care cascade in Lesotho: Towards 90-90-90 - A research collaboration with the Ministry of Health

English title Improving the HIV care cascade in Lesotho: Towards 90-90-90 - A research collaboration with the Ministry of Health
Applicant Labhardt Niklaus
Number 160876
Funding scheme r4d (Swiss Programme for Research on Global Issues for Development)
Research institution Swiss Tropical and Public Health Institute Medical Services and Diagnostic Universität Basel
Institution of higher education University of Basel - BS
Main discipline Tropical Medicine
Start/End 01.03.2016 - 30.04.2019
Approved amount 502'785.80
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All Disciplines (2)

Discipline
Tropical Medicine
Infectious Diseases

Keywords (7)

UNAIDS 90-90-90 targets; resource-limited setting; antiretroviral therapy; HIV; Sub-Sahara Africa; Southern Africa; Lesotho

Lay Summary (German)

Lead
Verbesserung der HIV Behandlungskaskade: „In Richtung 90-90-90 in Lesotho - Eine Forschungszusammenarbeit mit dem Gesundheitsministerium“Das Projektteam besteht aus Partnern des Gesundheitsministeriums in Lesotho, der Entwicklungshilfeorganisation SolidarMed, dem Schweizerischen Tropen- und Public Health Institut und der Abteilung für Virologie des Instituts für Biomedizin der Universität Basel. Das Projekt beinhaltet mehrere Interventions-Studien, welche innovative Lösungsvorschläge zur erfolgreichen Umsetzung der UNAIDS 90-90-90 Strategie in Lesotho, einem armen HIV Hochprävalenzland, testen.
Lay summary

Hintergrund des Forschungsprojekts
Neue Studien haben gezeigt, dass bei Menschen mit HIV Infektion eine antiretrovirale Therapie so früh wie möglich begonnen werden sollte, um erstens das Risiko an AIDS zu erkranken zu verringern und, um zweitens die Ansteckung von HIV-negativen Geschlechtspartnern zu verhindern. Diese Erkenntnisse haben zur neuen sogenannten „90-90-90 Strategie“ geführt, welche UNAIDS bis 2020 umsetzen will:

  • 90% der HIV-Infizierten wissen von ihrer Infektion;
  • 90% der HIV-Infizierten die von Ihrer Infektion wissen beginnen moderne antiretrovirale Therapie;
  • bei 90% derer, die eine antiretrovirale Therapie beginnen, gelingt es, das HI Virus in ihrem Körper so zu kontrollieren, dass es im Blut nicht mehr nachweisbar ist (virale Suppression)

Diese „test-and-treat“ Strategie stellt arme Länder mit hohen HIV Raten vor sehr grosse technische, finanzielle, personelle und logistische Herausforderungen. Lesotho hat mit einer HIV-Rate von ca. 24% unter der erwachsenen Bevölkerung die zweithöchste Infektionsrate weltweit.

Konzept des Forschungsprojekts
Im Distrikt Butha-Buthe im Norden Lesothos werden zeitgleich drei prospektive randomisierte Studien durchgeführt: Der CASCADE-trial testet die Wirksamkeit eines niederschwelligen Angebots zur HIV Testung und Therapie (www.visibleimpact.org/projects/1197-cascade-trial). Der SAVIR-trial testet geeignete Interventionen zu einer besseren Medikamentenadhärenz bei Patienten, bei denen das HI-Virus trotz Therapie nicht supprimiert ist. Die dritte randomisierte Studie untersucht neue Ansätze für Patienten, bei denen es bereits unter der ersten Therapie zum Behandlungsversagen kommt. 

Angestrebte Projektwirkung:

  • Das Projekt wird Wege aufzeigen, wie 90-90-90 in ähnlichen Settings der Region dauerhaft erreicht werden kann;
  • Fachliche Ausbildung von Spezialisten in Lesotho;
  • Dauerhafte Verbesserung der medizinischen Versorgung von HIV-infizierten Personen in der Projektregion
 
Direct link to Lay Summary Last update: 04.04.2016

Responsible applicant and co-applicants

Employees

Publications

Publication
SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa.
Amstutz Alain, Nsakala Bienvenu Lengo, Vanobberghen Fiona, Muhairwe Josephine, Glass Tracy Renée, Achieng Beatrice, Sepeka Mamorena, Tlali Katleho, Sao Lebohang, Thin Kyaw, Klimkait Thomas, Battegay Manuel, Labhardt Niklaus Daniel (2018), SESOTHO trial ("Switch Either near Suppression Or THOusand") - switch to second-line versus WHO-guided standard of care for unsuppressed patients on first-line ART with viremia below 1000 copies/mL: protocol of a multicenter, parallel-group, open-label, randomized clinical trial in Lesotho, Southern Africa., in BMC infectious diseases, 18(1), 76-76.
Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial.
Labhardt Niklaus D, Ringera Isaac, Lejone Thabo I, Klimkait Thomas, Muhairwe Josephine, Amstutz Alain, Glass Tracy R (2018), Effect of Offering Same-Day ART vs Usual Health Facility Referral During Home-Based HIV Testing on Linkage to Care and Viral Suppression Among Adults With HIV in Lesotho: The CASCADE Randomized Clinical Trial., in JAMA, E1.
The Treatment Cascade in Children With Unsuppressed Viral Load—A Reality Check in Rural Lesotho, Southern Africa
Lejone Thabo Ishmael, Ringera Isaac, Cheleboi Molisana, Wagner Sarah, Muhairwe Josephine, Klimkait Thomas, Labhardt Niklaus D. (2018), The Treatment Cascade in Children With Unsuppressed Viral Load—A Reality Check in Rural Lesotho, Southern Africa, in JAIDS Journal of Acquired Immune Deficiency Syndromes, 77(3), 250-256.
Importance of routine viral load monitoring: higher levels of resistance at ART failure in Uganda and Lesotho compared with Switzerland.
N Bachmann, von Braun A, ND Labhardt, C Kadelka, HF Günthard, C Sekaggya-Wiltshire, B Castelnuovo, A Kambugu, TI Lejone, J Böni, S Yerly, M Perreau, Study Swiss HIV Cohort (2018), Importance of routine viral load monitoring: higher levels of resistance at ART failure in Uganda and Lesotho compared with Switzerland., in The Journal of antimicrobial chemotherapy, 268-274.
When patients fail UNAIDS’ last 90 - the “failure cascade” beyond 90-90-90 in rural Lesotho, Southern Africa: a prospective cohort study
Labhardt Niklaus Daniel, Ringera Isaac, Lejone Thabo Ishmael, Cheleboi Molisana, Wagner Sarah, Muhairwe Josephine, Klimkait Thomas (2017), When patients fail UNAIDS’ last 90 - the “failure cascade” beyond 90-90-90 in rural Lesotho, Southern Africa: a prospective cohort study, in Journal of the International AIDS Society, 20(1), 21803-21803.
Metabolic syndrome in patients on first-line antiretroviral therapy containing zidovudine or tenofovir in rural Lesotho, Southern Africa.
Labhardt ND, Müller UF, Ringera I, Ehmer J, Motlatsi MM, Pfeiffer K, Hobbins MA, Muhairwe JA, Muser J, Hatz C (2017), Metabolic syndrome in patients on first-line antiretroviral therapy containing zidovudine or tenofovir in rural Lesotho, Southern Africa., in Trop Med Int Health, 725-733.
"The first 90": how close can we get with home-based HIV testing? First results from recruitment for the CASCADE trial in rural Lesotho
Labhardt N.D. Ringera I. Lejone T.I. Muhairwe J. Fritz C. Klimkait T. & Glass T.R. (2016), "The first 90": how close can we get with home-based HIV testing? First results from recruitment for the CASCADE trial in rural Lesotho, in HIV Congress Glasgow, GlasgowAbstracts of the HIV Glasgow supplement, Journal of the International AIDS Society, 19 (Suppl 7), Switzerland.
Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial).
Labhardt Niklaus Daniel, Ringera Isaac, Lejone Thabo Ishmael, Masethothi Phofu, Thaanyane T'sepang, Kamele Mashaete, Gupta Ravi Shankar, Thin Kyaw, Cerutti Bernard, Klimkait Thomas, Fritz Christiane, Glass Tracy Renée (2016), Same day ART initiation versus clinic-based pre-ART assessment and counselling for individuals newly tested HIV-positive during community-based HIV testing in rural Lesotho - a randomized controlled trial (CASCADE trial)., in BMC public health, 16, 329-329.
Alcohol use and depression: link with adherence and viral suppression in adult patients on antiretroviral therapy in rural Lesotho, Southern Africa: a cross-sectional study.
Cerutti B, Broers B, Masetsibi M, Faturiyele O, Toti-Mokoteli L, Motlatsi M, Bader J, Klimkait T, Labhardt ND (2016), Alcohol use and depression: link with adherence and viral suppression in adult patients on antiretroviral therapy in rural Lesotho, Southern Africa: a cross-sectional study., in BMC Public Health, 1-7.
Should viral load thresholds be lowered?: Revisiting the WHO definition for virologic failure in patients on antiretroviral therapy in resource-limited settings.
Labhardt ND, Bader J, Lejone TI, Ringera I, Hobbins MA, Fritz C, Ehmer J, Cerutti B, Puga D, Klimkait T (2016), Should viral load thresholds be lowered?: Revisiting the WHO definition for virologic failure in patients on antiretroviral therapy in resource-limited settings., in Medicine (Baltimore), 1-7.

Collaboration

Group / person Country
Types of collaboration
University of Geneva Switzerland (Europe)
- in-depth/constructive exchanges on approaches, methods or results
- Publication

Scientific events

Active participation

Title Type of contribution Title of article or contribution Date Place Persons involved
Conference on Retroviruses and Opportunistic Infections (CROI) Poster CASCADE trial: 24 month outcomes after same-day home-based ART inititation 04.03.2019 Seattle, United States of America Lejone Thabo Ismael; Klimkait Thomas; Labhardt Niklaus; Jans-Glass Tracy; Ringera Isaac;
Technical consultation on HIV linkage Talk given at a conference Community-based ART initiation – Experience from Lesotho 03.03.2019 Seattle, United States of America Labhardt Niklaus;
Think Tank on Future Directions for HIV Service Delivery Talk given at a conference Same-day Community ART Initiation 08.11.2018 Addis Abeba, Ethiopia Lejone Thabo Ismael;
Conference on Retroviruses and Opportunistic Infections (CROI) Talk given at a conference SAME-DAY ART INITIATION AFTER HOME-BASED HIV TESTING: A RANDOMIZED CONTROLLED TRIAL 06.03.2018 Boston, United States of America Labhardt Niklaus; Lejone Thabo Ismael; Ringera Isaac; Jans-Glass Tracy; Klimkait Thomas;
16 European AIDS Conference 2017 Poster PE24/3: Same-day ART initiation improves linkage to care and viral suppression after home-based HIV testing campaigns in rural Lesotho: An open-label randomized controlled trial (CASCADE-trial) 25.10.2017 Milan, Italy Labhardt Niklaus; Vanobberghen Fiona; Lejone Thabo Ismael; Fritz Christiane; Jans-Glass Tracy;
16 European AIDS Conference 2017 Poster PE9/32: The Cascade from a High Viral Load to Switch to Second-line Therapy among Adults: Implementation of Routine Viral Load Monitoring in Rural Lesotho 25.10.2017 Milan, Italy Ringera Isaac; Labhardt Niklaus; Vanobberghen Fiona; Fritz Christiane; Lejone Thabo Ismael; Klimkait Thomas; Jans-Glass Tracy;
16 European AIDS Conference 2017 Poster PE20/4: High Rates of Paediatric Treatment Failure and Poor Management of Children with Unsuppressed Viral Load: A Reality-Check in a Cohort in Rural Lesotho. 25.10.2017 Milan, Italy Labhardt Niklaus; Jans-Glass Tracy; Vanobberghen Fiona; Lejone Thabo Ismael; Fritz Christiane; Ringera Isaac; Klimkait Thomas;
2017 90-90-90 Targets Workshop; pre-conference IAS Paris Talk given at a conference Same-Day ART: Avoiding the HIV Diagnosis-Treatment Gap 22.07.2017 Paris, France Lejone Thabo Ismael;
21st AIDS conference 2016 in Durban, South Africa Poster The treatment cascade of children with unsuppressed viral load - a reality check in rural Lesotho, Southern Africa. TUPEB111 16.07.2017 Durban, South Africa Klimkait Thomas; Lejone Thabo Ismael; Vanobberghen Fiona; Labhardt Niklaus; Fritz Christiane; Ringera Isaac; Jans-Glass Tracy;
21st AIDS conference 2016 in Durban, South Africa Poster Leaks in the HIV treatment failure cascade: the reality in rural Lesotho. TUPEB077 16.07.2017 Durban, South Africa Klimkait Thomas; Vanobberghen Fiona; Jans-Glass Tracy; Labhardt Niklaus; Ringera Isaac; Lejone Thabo Ismael;
12th International Conference on HIV Treatment and Prevention Adherence Talk given at a conference Same-Day Home-Based ART Start in Lesotho: Lessons from the Field 04.06.2017 Florida, United States of America Jans-Glass Tracy;
MMS/aidsfocus.ch conference 2017: HIV Test and Treat: Are the 90 - 90 - 90 targets set for 2020 within reach? Talk given at a conference 90-90-90 - Yes, but how? Implementation strategies for resource-limited high-prevalence settings 10.05.2017 Bern, Switzerland Labhardt Niklaus;
HIV Conference Glasgow 2016 Poster "The first 90": how close can we get with home-based HIV testing? First results from recruitment for the CASCADE trial in rural Lesotho 23.10.2016 Glasgow, Great Britain and Northern Ireland Labhardt Niklaus;


Knowledge transfer events



Self-organised

Title Date Place
Health Research Forum of the Ministry of Health of Lesotho 31.03.2017 Maseru, Lesotho

Communication with the public

Communication Title Media Place Year
Media relations: print media, online media Die Therapie beginnt in der Hütte NZZ German-speaking Switzerland 2018
Video/Film HIV-Tests zuhause - Studie in Lesotho, Afrika International 2018
Media relations: radio, television Interview Youtube International 2018
Media relations: print media, online media Same-day treatment start improves retention in care and viral suppression in Lesotho aidsmap International 2018
Media relations: print media, online media Starting ART at home improves HIV care in Africa HEALIO: Infectious Disease News International 2018
New media (web, blogs, podcasts, news feeds etc.) Dank Forschungspartnerschaft näher an den UNAIDS Zielen - Niklaus Labhardt in Interview www.aidsfocus.ch German-speaking Switzerland International 2016
Media relations: radio, television Von Tür zu Tür im Kampf gegen AIDS SRF Tagesschau German-speaking Switzerland 2016

Awards

Title Year
Stiftung Pfizer Forschungspreis 2019; Bereich: Infektiologie, Rheumatologie und Immunologie; https://www.pfizerforschungspreis.ch/de/preisträgerinnen 2019
1st Price "clinical research in infectious diseases" of the Swiss Society for Infectious Diseases (SSI Award) http://www.safe-id.ch/about-us/awards/awards.html 2018

Use-inspired outputs

Software

Name Year


Associated projects

Number Title Start Funding scheme
181355 Evidence-based Differentiated Care for HIV in South-Eastern Africa: Shaping the post 2020 agenda 01.01.2019 Eccellenza

Abstract

Background: Despite enormous progress in the last decade, HIV/AIDS remains the most important cause of morbidity and mortality in most countries of Southern Africa and a central contributor to economic underdevelopment and poverty in many societies. The 2014 UNAIDS “90-90-90” targets for 2020 represent an important step towards an AIDS-free generation by 2030. The targets emphasize the importance of antiretroviral therapy (ART) to prolong the life of people living with HIV and as the most effective preventative measure for reducing the spread of new infections through better virus control. The three key targets of “90-90-90” are:-90% of all people living with HIV will know their HIV status. -90% of all people with diagnosed HIV infection receive treatment. -90% of all people receiving therapy will have their virus suppressedThis project represents a collaboration between the Research Coordination Unit (RCU) of the Ministry of Health (MoH) of Lesotho, the District Health Management Team (DHMT) of Butha-Buthe, SolidarMed (Lesotho-based Swiss organization for health in Africa), the Swiss Tropical and Public Health Institute (SwissTPH) and the Molecular Virology unit at the Department of Biomedicine (DBM) of the University of Basel. The project combines epidemiological, operational and clinical research to address key questions related to reaching 90-90-90 targets in rural Lesotho, a country with the second-highest HIV prevalence in the world, high transmission rates and low ART coverage. Methods:The proposed project is planned in Butha-Buthe district, Northern Lesotho, involving 2 hospitals and 10 health centers. As a crucial first step, the project has established the technical basis for the intended studies. As part of Lesotho’s national viral load (VL) roll-out plan, the country’s first decentralized VL monitoring platform was installed in the district laboratory of Butha-Buthe by the end of October 2015. Local laboratory personnel was trained and audited to roll out routine VL monitoring in the district of Butha-Buthe from 2016 onwards. Two randomized controlled trials (RCTs) and additional observational studies are planned within the proposed project.RCT-1 (CASCADE-trial; NCT02692027, www.visibleimpact.org/projects/1197-cascade-trial) addresses the care-cascade from HIV-test to linkage to care to retention in care and achievement of viral suppression in the era of test-and-treat. Individuals who are newly tested HIV-positive during home-based HIV testing and counseling (HTC) are randomized into 2 groups. The control group provides standard of care with post-test counseling and a referral letter for enrolment in pre-ART care at the nearest facility. In the intervention-group, baseline laboratory testing and adherence counseling is provided after a positive HIV test at the participant’s home with the option to start ART on the same day. The first primary endpoint is linkage to care at the facility within 3 months. The secondary endpoint is retention in care and viral suppression 12 months after HIV diagnosis. This trial has two nested observational studies. The first examines HTC-coverage achieved through home-based HTC while recruiting trial-participants. The second examines glucose- and lipid-profiles pre-ART and after ART initiation. This trial has started on 22nd of February 2016 (https://visibleimpact.org/projects/1197-cascade-trial).RCT-2 (SAVIR-trial): A culturally adapted, short, standardized adherence intervention for patients on ART with unsuppressed VL will be rolled out to the facilities in the district using a step-wedged design with the primary endpoint of VL re-suppression at follow-up determination.Establishing routine viral load monitoring will be linked to a database, a plasma-bank and introduction of genotypic sequencing in the district. This will allow observational studies on roll-out of viral load monitoring, treatment failure, switch to second-line ART and HIV resistance. Based on these observational data, a protocol for a third RCT will be elaborated by end of 2016. This RCT will address challenges identified in the field of treatment failure and switch to second-line ART.The projects aims at an impact at the following levels 1) Sustainable improvement of HIV care in the district; 2) Capacity building and strengthening among health professionals at district and national level; 3) Generation of evidence for future national and international guidelines and policies
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