Group | International HIV and Chronic Disease Care

Globally, the number of people suffering from chronic conditions such as HIV and non-communicable diseases is growing. How to provide these people with sustainable, cost-effective high-quality care in resource-limited settings is a key question in global health. Our group contributes evidence through clinical, epidemiological, molecular biological and implementation research in sub-Saharan Africa. The main focus of our activities is on HIV in Lesotho, where we have conducted several randomized clinical trials. Past and current randomized clinical trials address community-based HIV testing and care, improvement of the cascade of care, differentiated service delivery models and management of treatment failure in persons living with HIV in sub-Saharan Africa.

In Lesotho, projects are developed and conducted jointly with strong national partners including the Ministry of Health of Lesotho and SolidarMed, Partnerships for Health.

While the focus of our group’s activities remains on HIV in Lesotho, we are currently broadening our scope through expansion to project sites in South Africa and Tanzania and new additional research fields involving other conditions, such as high blood pressure, tuberculosis and mental health.

Niklaus Labhardt

Prof. Dr. Niklaus Labhardt, MD, DTM&H, MIH

Group Leader
n.labhardt@swisstph.ch

GET ON

In rural Lesotho, a lot of people need to walk hours to reach one of the few health facilities, because there is no transport or they can’t afford it. Thus, people living with HIV remain undiagnosed or do not start and continue their treatment. Scalable community-based HIV services are part of the solution.
The GET ON project entails two cluster-randomized trials, HOSENG trial and VIBRA trial, addressing community-based HIV testing and care. HOSENG assesses oral HIV self-testing during a door-to-door testing campaign. VIBRA investigates antiretroviral therapy start at home and HIV medication pick-up in the village. Read more

GIVE MOVE

HIV mutates rapidly and if unsuppressed, can become resistant to a patient’s therapy, eventually causing AIDS. Resistance testing can determine which drugs will work for a particular patient; however, access to this costly diagnostic tool is extremely low in most resource-limited settings. Children and adolescents with HIV have poorer treatment outcomes than adults and are particularly vulnerable to delays in finding a functioning drug combination.
GIVE MOVE is a multi-country (Lesotho, Tanzania) randomized clinical trial assessing if rapid resistance testing at the first measurement of an unsuppressed viral load improves health outcomes for children and adolescents living with HIV. Read more

VITAL

There is a need to develop and validate new models of care delivery that ensure sustainable provision of good quality care to the increasing number of people living with HIV who take antiretroviral therapy. VITAL is a large cluster randomized trial (18 clinics with over 5’000 participants) conducted in Lesotho. Nine intervention clinics implement an automated differentiated service delivery model that uses viral load results and other clinical characteristics, sub-population needs and participants’ and providers’ preference to automatically triage participants into groups requiring different levels of attention and care. Innovatively, the whole differentiation is done automatically using an innovative database with integrated management algorithms that are communicated to health care workers’ tablets and patients’ cell phones. Read more

DO-REAL

While people living with HIV can have normal life expectancy thanks to antiretroviral therapy, many suffer severe side effects from their daily medication. Dolutegravir is an antiretroviral drug that, when used in two- or three-drug combinations, causes fewer side-effects and has better health outcomes than other drug combinations that have been used in low- and middle-income countries. Based on the favorable safety and efficacy profile of Dolutegravir, most low- and middle-income countries are now changing patients to Dolutegravir containing regimens. As millions of patients across Africa are currently being moved to Dolutegravir-based regimens, concerns remain regarding the residual risk of drug resistance and side effects. DO-REAL is a prospective observational study on the roll-out of Dolutegravir in Lesotho, focusing on virological outcomes and psychological side-effects. Read more

PEBRA

In Lesotho, every second adolescent living with HIV is failing antiretroviral therapy. Too many drop out of care at their health facility. In collaboration with peer-educators, young people living with HIV, clinicians and IT developers we designed PEBRApp – an application for peer-educators who work at the health facilities. The peer-educators will deliver health services for their peers according to personal needs and preferences. PEBRApp helps them to coordinate and keep track of every adolescent in their care.
 
PEBRA is a cluster-randomized trial at 20 health facilities in 3 districts in Lesotho in order to assess PEBRApp in partnership with two local NGOs and the Ministry of Health. Recruitment started end of 2019. Read more

SESOTHO

This randomized controlled trial started recruiting in 2017. For patients who do not achieve virus suppression on first-line antiretroviral therapy, the SESOTHO trial assesses new criteria for switching patients to second-line therapy using a lower threshold for viral load.

Trial results are expected in the second half of 2020. Read more

CASCADE

The CASCADE trial was the first randomized trial assessing whether the offer of same-day ART initiation improves treatment outcomes in persons testing positive during home-based HIV testing. It showed that same-day home-based ART initiation improves linkage to and retention in care, as well as viral suppression compared to clinic referral after home-based HIV testing. This trial informed the World Health Organization’s recommendation to offer same-day ART to all persons testing HIV positive who do not have any contraindications and who feel ready to start.

Trial registration: clinicaltrials.gov/ct2/show/NCT02692027

Published study protocol: https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-016-2972-6

Publication in JAMA: jamanetwork.com/journals/jama/fullarticle/2674479

Publication of 24-month results in CID: academic.oup.com/cid/advance-article/doi/10.1093/cid/ciz1126/5645287

SolidarMed

  • Josephine Muhairwe – Country Director SolidarMed Lesotho
  • Ravi Gupta – Project Manager & Local Principal Investigator coArtHA
  • Bienvenu L. Nsakala – Clinical Advisor & Study Physician & Study Manager DO-REAL
  • Thabo I. Lejone – Research Fellow
  • Isaac Ringera – Senior Clinical Mentor & Study Manager GIVE MOVE
  • Lefu Khesa – Community ART Nurse GET ON
  • Mathebe Kopo – VITAL Study Coordinator
  • Mpho J. Kao – VITAL Study Assistant
  • Mashaete Kamele – Study Manager TB Triage+
  • Buoang Mothobi – Data Clerk & Quality Assurance Officer & Local Study Monitor
  • Lipontso Motaboli – VITAL Database Manager & Local Study Monitor
  • Nana Molise – Research Quality Officer & Local Study Monitor
  • Katleho Tlali – Laboratory Technologist
  • Motseki Malikalike – Laboratory Technologist 

Baylor College of Medicine Children’s Foundation Lesotho

  • Lineo Thahane – Executive Director
  • Bunthi P. Kayembe – Deputy Medical Director
  • Mosa M. Hlasoa – Program Manager

Sentebale Lesotho

  • Tebatso Matsela

Technify/T4A

  • Tlotliso Mafantiri

Laboratory of Seboche Mission Hospital

  • Molisana Cheleboi – Head of Laboratory

Ministry of Health of Lesotho

  • Malebanye D. Lerotholi – National Laboratory Information Systems Officer
  • Tapiwa Tarumbiswa – HIV/AIDS Manager
  • Mathaha Makoea – Research Coordination Unit

Chronic Disease Clinic in Ifakara

  • Ezekiel Luoga – Physician & Clinical Research Officer & Local Principal Investigator GIVE MOVE
  • Getrud J. Mollel – Physician & Research Scientist

Molecular Virology Group, Department of Biomedicine, University of Basel

·         Thomas Klimkait – Group Leader

Department of Infectious Diseases and Hospital Epidemiology, University Hospital Basel

  • Manuel Battegay – Head of Department
  • Maja Weisser – Sponsor/Chief Investigator coArtHA

VisibleSolutions

  • Nico Schefer - Cofounder
  • Niklaus Holbro - Cofounder

Life4me+

  • Alex Schneider – CEO

Clinical TB Group at Swiss TPH

  • Klaus Reither – Group Leader & Head of Unit

Statistics and Data Management Group at Swiss TPH

  • Tracy Glass – Group Leader
  • Fiona Vanobberghen – Senior Scientific Collaborator
  • Moniek Bresser – Scientific Collaborator

Clinical Operations Unit at Swiss TPH

  • Elisabeth Reus – Head of Unit
  • Sonja Bernhard – Group Leader

Amstutz A et al. Engagement in care, viral suppression, drug resistance and reasons for non-engagement after home-based same-day ART initiation in Lesotho: a two-year follow-up of the CASCADE trial. Clin Infect Dis. 2019(In press). DOI: 10.1093/cid/ciz1126

Amstutz A et al. 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. Trials. 2019;20:522. DOI: 10.1186/s13063-019-3510-5

Amstutz A et al. 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. Trials. 2019;20:496. DOI: 10.1186/s13063-019-3469-2

Labhardt N.D et al. Effect and cost of two successive home visits to increase HIV testing coverage: a prospective study in Lesotho, Southern Africa. BMC Public Health. 2019;19:1441. DOI: 10.1186/s12889-019-7784-z

Amstutz A et al. 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, r. BMC Infect Dis. 2018;18:76. DOI: 10.1186/s12879-018-2979-y

Labhardt N.D et al. 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. JAMA. 2018;319(11):1103-1112. DOI: 10.1001/jama.2018.1818