Clinical trials: in Lesotho
Human Immunodeficiency Virus (HIV)
ComBaCaL HIV Prevention TwiCs
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- CoPrev (NCT07581600)
- Testing
- CoPrev model, Referral to the nearest responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Type 2 Diabetes Mellitus (DM)
Community-based, eHealth Supported Type 2 Diabetes Care by Lay Village Health Workers in Rural Lesotho
This cluster-randomized intervention is embedded in the ComBaCaL (Community-Based Chronic disease care Lesotho) cohort study (EKNZ ID AO_2022-00058, clinicaltrials.gov ID NCT05596773, Lesotho NH-REC ID 210-2022), a platform for…
- Trial name
- ComBaCaL DM (NCT05743387)
- Testing
- DM care package, Referral to the responsible health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- 252 people
- Sponsor
- University Hospital, Basel, Switzerland
HIV/AIDS
Characteristics and Outcomes of Patients Who Received Etravirine and/or Darunavir
The objectives of this data collection activity are to: 1. Describe the baseline demographics, clinical and laboratory profile of patients who ever received darunavir (DRV) and/or etravirine (ETR), at the time of initiation on…
- Trial name
- NewHorizon (NCT04194021)
- Where
- 5 sites in Cameroon, Eswatini and 3 more
- Volunteers
- 871 people, healthy volunteers welcome
- Sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
Tuberculosis, HIV Coinfection
Closing -TB GAPs - for People Living With HIV: TB Guidance for Adaptable Patient-Centered Service
Tuberculosis (TB) is the world's leading infectious cause of mortality and responsible for 1/3 of deaths in people living with human immunodeficiency virus (PLHIV).
- Conditions
- Tuberculosis, HIV Coinfection, Tuberculosis Infection
- Trial name
- TB_GAPS (NCT05342064)
- Testing
- patient-centered TB preventive therapy, TB preventive therapy adherence support
- Where
- 5 sites in Eswatini, Lesotho and 3 more
- Volunteers
- 6,500 people
- Sponsor
- Baylor College of Medicine
Non-communicable Diseases (NCDs)
Community-Based Chronic Disease Care in Rural Lesotho
This ComBaCaL cohort study is to assess the impact of community-based, lay-led chronic disease screening and care interventions in rural Lesotho.
- Trial name
- ComBaCaL (NCT05596773)
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- 17,500 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Arterial Hypertension
"Community-based, eHealth Supported Management of Cardiovascular Risk Factors by Lay Village Health Workers (ComBaCaL aHT TwiC 1 & ComBaCaL aHT TwiC 2)
ComBaCaL aHT TwiC 1 and aHT TwiC 2 are two cluster-randomized controlled trials that are identical in intervention, design and endpoints.
- Trial name
- NCT05684055
- Testing
- First-line antihypertensive single-pill combination (SPC), Standardized counselling and referral to the closest health facility
- Where
- 2 sites in Lesotho, Switzerland
- Volunteers
- 1,354 people
- Sponsor
- University Hospital, Basel, Switzerland
Tuberculosis
Tuberculosis Diagnostic Trial of CAD4TB Screening Alone Compared to CAD4TB Screening Combined With a CRP Triage Test, Both Followed by Confirmatory Xpert MTB/RIF Ultra in Communities of Lesotho and South Africa
According to WHO, about 40% of the incident TB cases in 2020 are either under-reported or under-diagnosed causing on one hand major health risks and on the other hand catastrophic financial consequences.
- Trial name
- NCT05526885
- Testing
- CAD4TB, POC-CRP, Xpert MTB/RIF Ultra
- Where
- 2 sites in Lesotho, South Africa
- Volunteers
- 20,000 people, healthy volunteers welcome
- Sponsor
- Klaus Reither
Pulmonary Tuberculosis, Tuberculosis Diagnosis
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
In the TB TRIAGE+ ACCURACY study, the accuracy of the following products will be determined: CAD4TB (Delft Imaging System, NL), a digital chest x-ray analysis software Afinion CRP assay (Alere Afinion, USA), which detects a…
- Conditions
- Pulmonary Tuberculosis, Tuberculosis Diagnosis, Covid-19, HIV
- Trial name
- TB TRIAGE+ (NCT04666311)
- Testing
- Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB, CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
- Where
- 2 sites in Lesotho, South Africa
- Volunteers
- 1,400 people
- Sponsor
- Klaus Reither
HIV-1-infection
Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance
This clinical trial will address the gap in published data on the effect of dolutegravir (DTG)-associated drug-resistant mutations on viral suppression among people remaining on DTG-based antiretroviral therapy.
- Trial name
- NCT06747507
- Testing
- Dolutegravir Pill, Darunavir+Ritonavir
- Where
- 9 sites in Kenya, Lesotho and 2 more
- Volunteers
- 392 people
- Sponsor
- University of Nairobi
HIV-1-infection
Investigating the Optimal Management of Dolutegravir Resistance
The goal of this study is to address the gap in published data on viral suppression among people meeting the criteria for virologic failure on dolutegravir (DTG)-based ART regimens without a change in regimen.
- Trial name
- NCT06762054
- Testing
- Continue DTG-based antiretroviral therapy, Enhanced adherence counselling
- Where
- 9 sites in Kenya, Lesotho and 2 more
- Volunteers
- 6,600 people
- Sponsor
- University of Nairobi
HIV Infections
Viral Load Triggered ART Care in Lesotho
This cluster randomized clinical trial at 18 nurse-led rural health centers in Lesotho will test an automated differentiated service delivery model using viral load results, other clinical characteristics and participants'…
- Trial name
- VITAL (NCT04527874)
- Testing
- VITAL model
- Where
- 18 sites in Lesotho
- Volunteers
- 5,809 people
- Sponsor
- Swiss Tropical & Public Health Institute
Human Immunodeficiency Virus (HIV) Infection
Same-day Versus Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of Tuberculosis
SaDAPT is a pragmatic, randomized, therapeutic-use trial comparing two approaches ("ART first" versus "TB results first") for the timing of ART initiation in PLHIV with presumptive TB, but no signs of central nervous system (CNS)…
- Trial name
- SaDAPT (NCT05452616)
- Testing
- ART first- Therapeutic use trial, TB results first- Therapeutic use trial
- Where
- 2 sites in Lesotho, Malawi
- Volunteers
- 610 people
- Sponsor
- University Hospital, Basel, Switzerland
HIV Prevention
The CATALYST Study
The CATALYST study is an implementation study that will characterize and assess the implementation of an enhanced service delivery package providing informed choice of pre-exposure prophylaxis (PrEP) products among women at…
- Trial name
- NCT05937698
- Where
- 28 sites in Kenya, Lesotho and 3 more
- Volunteers
- 6,069 people, healthy volunteers welcome
- Sponsor
- FHI 360
Alcohol Use Disorder, Mild, Alcohol Use Disorder, Moderate
Substituting SMSs for Provider-delivered Care to Improve Alcohol Use Outcomes
The goal of this clinical trial is to test whether a technology-substituted intervention (mhGAP-Remote) derived from the World Health Organization's (WHO) Mental Health Gap Action Programme-Intervention Guide (mhGAP-IG) is…
- Trial name
- NCT05925270
- Testing
- mhGAP-Remote, mhGAP-Standard
- Where
- 3 sites in Lesotho
- Volunteers
- 255 people
- Sponsor
- University Hospital, Basel, Switzerland
Tuberculosis, Multidrug-Resistant, Infection, Bacterial
Evaluating Newly Approved Drugs for Multidrug-resistant TB
endTB Clinical Trial a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of five new, all-oral, shortened regimens for multidrug-resistant tuberculosis (MDR-TB).
- Conditions
- Tuberculosis, Multidrug-Resistant, Infection, Bacterial, Pulmonary Tuberculoses
- Trial name
- endTB (NCT02754765)
- Testing
- Bedaquiline, Delamanid, Clofazimine
- Where
- 12 sites in Georgia, India and 5 more
- Volunteers
- 754 people
- Sponsor
- Médecins Sans Frontières, France
Tuberculosis, Multidrug-Resistant, Tuberculosis
Evaluating Newly Approved Drugs in Combination Regimens for Multidrug-Resistant TB With Fluoroquinolone Resistance (endTB-Q)
endTB-Q Clinical Trial is a Phase III, randomized, controlled, open-label, non-inferiority, multi-country trial evaluating the efficacy and safety of two new, all-oral, shortened regimens for multidrug-resistant tuberculosis…
- Conditions
- Tuberculosis, Multidrug-Resistant, Tuberculosis, Pulmonary Tuberculoses, Mycobacterial Infections
- Trial name
- endTB-Q (NCT03896685)
- Testing
- Bedaquiline 100 MG, Delamanid 50 MG Oral Tablet, Clofazimine 100 MG Oral Capsule
- Where
- 10 sites in India, Kazakhstan and 4 more
- Volunteers
- 323 people
- Sponsor
- Médecins Sans Frontières, France
HIV
Tolerability of Lopinavir Versus Dolutegravir for Children and Adolescents Living With HIV
Dolutegravir-based antiretroviral therapy is set to be increasingly replace ritonavir-boosted lopinavir-based regimens for the treatment of paediatric HIV.
- Trial name
- LoDoCA (NCT05426421)
- Where
- Lesotho
- Volunteers
- 258 people
- Sponsor
- Swiss Tropical & Public Health Institute
Tuberculosis, Multidrug-Resistant, HIV
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens
This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru…
- Trial name
- STEM-TB (NCT05871489)
- Testing
- Bdq, Lzd, Lfx, Dlm, Cfz (9-12 months), Bdq, Lzd, Lfx, Cfz, Cs (9-12 months), Bdq, Lzd, Lfx, Z, Dlm (9-12 months)
- Where
- 3 sites in Kazakhstan, Lesotho and 1 more
- Volunteers
- 800 people
- Sponsor
- Harvard Medical School (HMS and HSDM)
Health Behavior, Motivation
Measuring Anticipated Attitudes and Behavior Towards a New Medical Treatment in Lesotho
The primary research objective is to examine how uncertainty towards a new medical treatment changes in patients when a partner (can be any close other, i.e.
- Conditions
- Health Behavior, Motivation, Health Care Utilization, Consumer Behavior
- Trial name
- NCT06246058
- Testing
- Partner support, Formal recruiter attire, Without Partner support
- Where
- Lesotho
- Volunteers
- 475 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
HIV-1-infection
Genotype-Informed Versus Empiric Management of VirEmia
HIV infection can be effectively controlled with antiretroviral therapy (ART). However, children and adolescents living with HIV and receiving ART suffer high rates of treatment failure, predominantly caused by suboptimal…
- Trial name
- GIVE MOVE (NCT04233242)
- Testing
- Clinical management informed by HIV-1 genotypic resistance testing
- Where
- 10 sites in Lesotho, Tanzania
- Volunteers
- 286 people
- Sponsor
- Swiss Tropical & Public Health Institute