Group | International HIV and Chronic Disease Care
Tuberculosis is the most common cause of death in people with HIV. If persons with HIV/TB co-infection are started on antiretroviral therapy (ART) without first starting TB treatment, this can lead to possibly severe immune reconstitution syndrome (IRIS). Delaying ART on the other hand increases risk for HIV-associated complications and further HIV transmission. To date, there is no scientific evidence for this difficult balancing act and accordingly no clear treatment guidelines. The SaDAPT (Same-Day ART in persons with HIV and Presumptive Tuberculosis) study, a randomized controlled clinical trial in Lesotho and Malawi, is investigating the question of when ART in persons tested positive for HIV should be started when they simultaneously show symptoms of a possible TB infection. This project is funded by the Swiss National Science Foundation. Read more
In many sub-Saharan African countries, including Lesotho, non-communicable diseases (NCDs) such as diabetes and hypertension have overtaken infectious diseases as the major burden of disease. ComBaCaL (Community Based chronic disease Care Lesotho) is a multidisciplinary implementation research programme that aims to tackle NCDs in Lesotho, building on long-term experience in HIV/AIDS chronic disease care. ComBaCaL will train lay health workers (LHWs) to provide NCD prevention, screening and diagnosis and will evaluate in a large-scale randomized trial, which aspects of NCD care can safely and effectively be shifted to LHWs. A locally developed eHealth application with smart clinical algorithms will assist the LHWs, allow supervision by clinic staff, and efficiently link the data to the health facility. Read more
The SESOTHO trial was the first published randomized trial that assessed whether a regimen switch is beneficial for patients with a persisting low level of HIV in their blood stream. The findings encourage the threshold for virologic failure to be lowered below 1000 copies/mL in the upcoming WHO guidelines.
Read the trial study published in September 2020 in PLOS Medicine.
In rural Lesotho, 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 entailed two large-scale cluster-randomized trials in over 150 villages: HOSENG trial and VIBRA trial.
HOSENG assessed secondary distribution of oral HIV self-tests during a door-to-door testing campaign. This testing approach improved HIV testing coverage in the study area by 21% and was particularly successful among men, migrant workers and adolescents. The results were published in the Lancet HIV. The costing analysis demonstrated that the cost per person tested was lower in the intervention group than in the standard of care group.
VIBRA investigated HIV medication pick-up in the village, coordinated by a village health worker, directly after treatment start at home. The results published in the PLOS Medicine show that this approach did not lead to better outcomes than medication pick-up at the clinic and rather raised concerns.
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
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. 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
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
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
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
- 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
- Lineo Thahane – Executive Director
- Bunthi P. Kayembe – Deputy Medical Director
- Mosa M. Hlasoa – Program Manager
- Tebatso Matsela
- Tlotliso Mafantiri
- Molisana Cheleboi – Head of Laboratory
- Malebanye D. Lerotholi – National Laboratory Information Systems Officer
- Tapiwa Tarumbiswa – HIV/AIDS Manager
- Mathaha Makoea – Research Coordination Unit
- Lebohang Sao - District Health Manager Butha-Buthe
- Kabelo Matjeane - District Health Manager Mokhotlong
- Madavida Mphunyane – NCD Progamme Manager & ComBaCaL Steering Committee Member
- Moelo Ramahlele – Director Mental Health Services & ComBaCaL Steering Committee Member
- Ezekiel Luoga – Physician & Clinical Research Officer & Local Principal Investigator GIVE MOVE
- Getrud J. Mollel – Physician & Research Scientist
· Thomas Klimkait – Group Leader
- Manuel Battegay – Head of Department
- Maja Weisser – Sponsor/Chief Investigator coArtHA
- Nico Schefer - Cofounder
- Niklaus Holbro - Cofounder
- Alex Schneider – CEO
Motjelo Naleli – Senior Lecturer & ComBaCaL Steering Committee Member
Gerhard Schwabe – Group Leader
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
- Nikki Rommers – Scientific Collaborator
- Elisabeth Reus – Head of Unit
- Sonja Bernhard – Group Leader