UNIverse - Public Research Portal

Projects & Collaborations

4 found

Show per page

Project cover

SaDAPT: Same-day vs Rapid ART Initiation in HIV-positive Individuals Presenting With Symptoms of TB

Research Networks of the University of Basel | 2 Project Members

SaDAPT is a randomized controlled trial in Lesotho and Malawi investigating when to start antiretroviral therapy in persons testing positive for HIV and simultaneously showing symptoms of a possible TB infection.
Rapid, if possible same-day initiation (SDI) of antiretroviral therapy (ART) is recommended for all persons living with HIV (PLHIV) without contraindication who are ready to start treatment. A possible contraindication to initiating ART is the presence of an untreated tuberculosis (TB) infection as it increases the risk of TB-associated immune reconstitution inflammatory syndrome (TB-IRIS) after ART initiation. In case of TB symptoms (presumptive TB), previous guidelines recommended to postpone ART initiation until investigations for active TB infection have been completed to avoid initiating ART in presence of untreated TB and thus reduce the risk of TB-IRIS. However, the 2021 guidelines of the World Health Organization (WHO) changed to recommending rapid or SDI even in case of TB symptoms without awaiting results of TB diagnostic tests based on the assumption that TB tests often unnecessarily delay ART initiation increasing the risk for pre-ART attrition from care while the clinical relevance of TB-IRIS outside the central nervous system remains unclear. To date, there is no conclusive evidence about whether SDI of ART or TB test results should be prioritized in PLHIV with presumptive TB.
SaDAPT is a two arm, individually randomized, pragmatic trial comparing two approaches for the timing of ART initiation in PLHIV with presumptive TB (“ART first” versus “TB results first”). PLHIV in Lesotho and Malawi, aged 12 years and older (re)initiating ART who have at least one of TB symptom (cough, fever, night sweats or weight loss) and who do not have signs of meningitis are eligible. Participants in the “ART first” arm will be offered SDI of ART while those in the “TB results first” arm will be offered ART only after results of TB tests are available.
We hypothesize that the “ART first” approach is safe and non-inferior to the “TB results first” approach with regard to HIV viral suppression (<400 copies/ml) six months after enrollment. Secondary outcomes include retention in care and adverse events consistent with TB-IRIS.
Trial registration: The trial has been registered on clinicaltrials.gov (NCT05452616; July 11 2022).

Project cover

ComBaCaL: Community-based Chronic Care Lesotho

Research Networks of the University of Basel | 11 Project Members

Community-based Chronic Care Lesotho is a five-year implementation research project addressing chronic disease care in remote villages in rural Lesotho. In a cohort of over 100 villages we assess through cluster-randomized trials within cohorts (TwiCs) different innovative models where ehealth assisted lay community health workers provide care for hypertension, diabetes and HIV.

Project cover

Hair Salon Project

Research Project | 17 Project Members

In settings such as Lesotho, where young women face enormous HIV and sexual and reproductive health (SRH) challenges, novel and accessible spaces to complement traditional health facilities are urgently needed. HIV- and pregnancy-related complications are still the leading cause of death among young women in high HIV prevalence settings in Southern Africa.

Hair salons may offer a safe, accessible, trusted community space to engage young women and address barriers related to HIV/SRH.

In a first step, we concluded an innovative cross-sectional survey – co-designed and conducted in collaboration with citizen scientists – and gathered data among 100 hair stylists and 300 clients across Lesotho. The findings were complemented by qualitative research, narrative storytelling and a video documentary.

In a next step, we are designing and implementing a pilot to evaluate a first HIV/SRH service intervention at a few hair salons in Lesotho.

Project cover

Trials within Cohorts (TwiCs)

Research Project | 5 Project Members

Innovative Trial Design: Overcoming some of the problems common to traditional Randomized Clinical Trials

Trials within Cohorts (TwiCs) are a randomized trial design in which a trial is set up and conducted within an existing or newly started cohort. In a cohort that uses the TwiCs approach a group of participants with a particular condition of interest may agree to regular data collection and observation – and to random assignment into a future intervention. Once an intervention is trialed, only the cohort participants who have been assigned to the intervention group will be informed of their role as the trial group and an additional consent will be obtained. The control group receives the standard treatment according to the cohort procedures. Because of the multi-staged consent process, which differs from classic randomized controlled trials, TwiCs may better mimic clinical practice and improve recruitment of study participants. However, TwiCs-specific ethical, statistical and methodological challenges need to be addressed.

Since Juli 2024 we are implementing the TwiCs in the main centers of the Swiss HIV Cohort Study (SHCS). The SHCS, established in 1988 is a multicenter, prospective, nationwide, observational cohort study with around 10’000 active participants.

In parallel, we have implemented the TwiCs design in the ComBaCaL cohort, a large-scale general population-based cohort in two districts of Lesotho, in Southern Africa. Using the design, we evaluate several community-led decentralised models of care for hypertension, diabetes and HIV.