INTRODUCTION
MSF is providing cervical cancer screening in Blantyre and Chiradzulu districts in Southern Malawi in the catchment area of 10 health centres. Improved screening strategies under diverse recruitment models are introduced to increase HPV screening coverage at health centres and with outreach activities.
METHODS
Under PAVE study, self-collected vaginal swabs are tested by an isothermal amplification PCR assay followed byvisual inspection, imaging, and histological assessment for HPV +ve women. Women living <5km from health centers are recruited opportunistically during routine visits. After HPV test, they are advised either to wait onsite (test-and-wait model) or called back in two days’ time (test-and-call model) for triage and treatment visit.Women living>10km from health centers are offered HPV test, triage, and treatment in community settings by outreach teams (mobile-clinic model). A fourth model for women living 5-10km from a health center with HPV testing in their communities followed by a triage and treatment visit at respective health centers (mobile-lab model) is not yet implemented.
RESULTS
As of April 2024, over 2000 women have undergone HPV screening across all active sites. Key insights from the experience are focused at: i)streamlining patient flow during opportunistic recruitment at health centers,ii)improving HPV results communication, iii)effectively tracing women back for triage and treatment visits using phone and community based tracing, iv)ensuring provision of stable internet for effective and real time data collection and synchronization, v)reducing gaps in logistics and quality assurances at HPV lab particularly in mobile lab setup, vi)ensuring real-time quality histopathology review of cervical biopsies for case management,and vii)continuous monitoring of patients and data flow to ensure quality of screening, compliance, and effective case management.
CONCLUSIONS
Diverse HPV-based screening strategies are key to achieve good screening coverage, and subsequently reducethe cervical cancer morbidity and mortality in southern Malawi.
INTRODUCTION
Since November 2019, Medecins Sans Frontieres (MSF) and the Malawian Ministry of Health have provided a comprehensive range of cervical cancer care services. Initially, all consultations, pathological diagnoses, chemotherapy, surgery, and patient support activities were centralized at the tertiary hospital. To address the overwhelming surge in demand for these services, an innovative decentralisation approach was introduced to alleviate the workload and enhance patient care quality.
METHODS
The decentralization strategy involves triaging patients at the district level and categorizing them by type of lesion (Fig 1). Patients with early or locally advanced cancer, as well as those in need of palliative chemotherapy, are referred to the tertiary hospital for further evaluation and treatment. Those with premalignant lesions or advanced cancer are treated at the district level by trained surgical and palliative care teams. Quality is ensured through provision of medications, equipment and allowances, as well as monthly mentoring sessions for about 120 providers.
RESULTS
During the first months of comprehensive care provision, the number of palliative consultations at the tertiary hospital increased way above the threshold of 150 manageable consultations. Using the new decentralized system from August 2021, 818 palliative patients were referred to 45 palliative sites at district level, leading to a reduction in monthly consultations at central level from a high of 226 (2021) to a high of only 134 (2023) (Fig 2). Among the new patients presenting at the tertiary hospital, an average of 45% presented with benign or pre-malignant lesions. Therefore, from July 2023, 561 women started to be biopsied and managed at their district hospitals instead of the tertiary level.
CONCLUSIONS
It is feasible to provide a comprehensive package of cervical cancer care in low resource settings without overburdening services when a decentralization strategy is used to ensure manageable workload and high quality of care.
Trypanosoma brucei rhodesiense human African trypanosomiasis (r-HAT), the zoonotic, acute form of sleeping sickness in eastern Africa, is lethal if untreated. Today, only one arsenic- based, neurotoxic drug, melarsoprol, is available for treatment of the advanced meningo-encephalitic stage. A new oral treatment would simplify HAT elimination as proposed by WHO. Fexinidazole was recommended by the European Medicines Agency (EMA) in 2018 as the first oral treatment for Trypanosoma brucei gambiense HAT, but it was not yet evaluated for r-HAT.
METHODS
This single-arm clinical trial, sponsored by DNDi, began in October 2019 and tested fexinidazole treatment in patients with r-HAT as an alternative to existing treatment in Malawi and Uganda. Patients (aged ≥6 years) with both stages of the disease were recruited up to the target of 34 patients with stage 2 disease evaluable at the end of hospitalization. Patients were hospitalised during the 10 days of treatment and followed up to 12 months after hospital discharge. The primary outcome was r-HAT-related or treatment-related fatality at the end of hospitalisation in patients with stage 2 disease and was compared with an unacceptable fatality rate of 8.5%, a threshold defined according to results from a previous clinical trial with melarsoprol. This trial is registered with ClinicalTrials.gov, NCT03974178.
RESULTS
45 patients received treatment between 1 October 2019 and 28 November 2021 (35 [78%] had stage 2 disease and ten [22%] stage 1, 31 [69%] were male and 14 [31%] female, with median age of 24 years). The primary efficacy result of the clinical trial, analysed among the 34 evaluable patients, was achieved, with no r-HAT-related or treatment-related deaths during hospitalisation (0.0%, 95% CI 0.0–8.4), compared with a benchmark of 8.5% lethality attributable to melarsoprol. Safety was acceptable, with no severe adverse events related to fexinidazole; and one patient relapsed.
CONCLUSION
Fexinidazole, an oral treatment, was shown to be a good alternative to existing injectable and toxic drugs. Results were submitted for EMA regulatory review in preparation for use in endemic countries, and a positive scientific opinion was received in December 2023 to extend the indication of fexinidazole for the treatment of r-HAT. Fexinidazole is expected to be deployed in 2024 as a new r-HAT therapeutic.
The key lessons learned from this implementation were:
▸ Schedule all adolescents on the same day(s); preferably during out-of-school hours.
▸ Ensure disclosure is a repeated and ongoing process and not an on/off one.
▸ Maintain close collaboration between clinicians and counsellors to continuously transmit information to the changing and evolving concerns of teens.
▸ Organize sessions by age band, separating the pre-pubescent adolescents from older ones. Full HIV disclosure is recommended before integrating the adolescents into group activities.
▸ Include sexual and reproductive health in the package of care. Health workers and peers must be trained to address the specific concerns of adolescents.
▸ Recognize peers are an important asset to conveying messages and sharing positive experiences. While peers are useful actors in the management of teens, they should not be solely responsible for managing the cases of adolescents failing on treatment.
▸ Perform a viral load (VL) every six months for this vulnerable age group. Point-of-care VL, with same-day results, permits a rapid management of the unsuppressed patients, and requires logistic organization in rural contexts.
▸ Utilize a multidisciplinary team – clinicians, counsellors, psychologists, social workers, and peers – to address the complex situations faced by some adolescents.