Despite advances in the physiotherapy management of low back pain (LBP) worldwide, studies indicate that there is a large variation in the quality of physiotherapy management for LBP in Nigeria. This clinical trial aims to evaluate the implementation of individualised physiotherapy for chronic LBP in Nigeria using the Specific Treatment Of Problems of the Spine (STOPS) approach.

This will be an implementation clinical trial using a non-randomised, prospective, sequential comparison design. One hundred and fifty-four participants with chronic LBP will be recruited at one hospital in Nigeria. In phase I, participants will receive 11 sessions of usual physiotherapy care. In phase II, consenting physiotherapists will undergo training in the implementation of the STOPS treatment approach, led by the original Australian developers. In phase III, participants will receive 11 sessions of individualised physiotherapy using the STOPS approach. Patient evaluation in phases I and III will be measured at baseline and at 5, 10, 26 and 52 weeks, and will evaluate the clinical outcomes (including primary outcomes of pain intensity measured with a 0–10 Numerical Rating Scale, and activity limitation measured via the Oswestry) and cost-effectiveness from the healthcare perspective (incremental healthcare costs relative to incremental quality adjusted life-years gained on the EuroQOL-5D-5L). Physiotherapist outcomes will include confidence in treating LBP and implementation behaviour measured at the start of phase I and at the end of phases I, II and III. Implementation feasibility and qualitative analysis of patient and physiotherapist experiences will also be explored.

The trial has been approved by the Human Research Ethics Committees of La Trobe University, Australia (HEC22278) and Federal Medical Centre (FMC) Nguru, Yobe State, Nigeria (FMC/N/CL.SERV/355/VOL IV/131). The study results will be shared through peer-reviewed journals and conferences.

PACTR202305707317550.

Tuberculosis (TB) remains a significant public health challenge in many African communities, where underreporting and underdiagnosis are prevalent due to barriers in accessing care and inadequate diagnostic tools. This is particularly concerning in hard-to-reach areas with a high burden of TB/HIV co-infection, where missed or delayed diagnoses exacerbate disease transmission, increase mortality and lead to severe economic and health consequences. To address these challenges, it is crucial to evaluate innovative, cost-effective, community-based screening strategies that can improve early detection and linkage to care.

We conduct a prospective, community-based, diagnostic, pragmatic trial in communities of the Butha Buthe District in Lesotho and the Greater Edendale area of Msunduzi Municipality, KwaZulu-Natal in South Africa to compare two strategies for population-based TB screening: computer-aided detection (CAD) technology alone (CAD4TBv7 approach) versus CAD combined with point-of-care C reactive protein (CRP) testing (CAD4TBv7-CRP approach). Following a chest X-ray, CAD produces an abnormality score, which indicates the likelihood of TB. Score thresholds informing the screening logic for both approaches were determined based on the WHO’s target product profile for a TB screening test. CAD scores above a threshold prespecified for the CAD4TBv7 approach indicate confirmatory testing for TB (Xpert MTB/RIF Ultra). For the CAD4TBv7-CRP approach, a CAD score within a predefined window requires the conduct of the second screening test, CRP, while a score above the respective upper threshold is followed by Xpert MTB/RIF Ultra. A CRP result above the selected cut-off also requires a confirmatory TB test. Participants with CAD scores below the (lower) threshold and those with CRP levels below the cut-off are considered screen-negative. The trial aims to compare the yield of detected TB cases and cost-effectiveness between two screening approaches by applying a paired screen-positive design. 20 000 adult participants will be enrolled and will receive a posterior anterior digital chest X-ray which is analysed by CAD software.

The protocol was approved by National Health Research Ethics Committee in Lesotho (NH-REC, ID52-2022), the Human Sciences Research Council Research Ethics Committee (HSRC REC, REC 2/23/09/20) and the Provincial Health Research Committee of the Department of Health of KwaZulu-Natal (KZ_202209_022) in South Africa and from the Swiss Ethics Committee Northwest and Central Switzerland (EKNZ, AO_2022–00044). This manuscript is based on protocol V.4.0, 19 January 2024. Trial findings will be disseminated through peer-reviewed publications, conference presentations and through communication offices of the consortium partners and the project’s website (https://tbtriage.com/).

ClinicalTrials.gov (NCT05526885), South African National Clinical Trials Register (SANCTR; DOH-27-092022-8096).