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Randomised controlled community trial assessing efficacy of the AWACAN-ED public toolkit to improve cancer symptom awareness and intention to seek help in South Africa and Zimbabwe: study protocol

Por: Scott · S. · Lurgain · J. G. · Day · S. · Guzha · B. T. · Pazukhina · E. · Arendse · K. D. · Govender · S. · Chirenje · M. · Sills · V. A. · Harries · J. · Jacobs · R. · Moodley · J. · Walter · F. M.
Introduction

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

Methods and analysis

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethics and dissemination

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

Trial registration number

PACTR202505475803308.

Swallowing prehabilitation for people with head and neck cancer: a pilot cluster-randomised feasibility trial of the SIP SMART intervention

Por: Govender · R. · Wang · J. · Marston · L. · Pizzo · E. · Taylor · S. · Nazareth · I.
Objectives

To assess the feasibility of delivering the swallowing prehabilitation intervention known as Swallowing Intervention Package: Self-Monitoring, Assessment and Rehabilitation Training (SIP SMART) within the National Health Service (NHS) head and neck cancer care pathway.

Design

Two-arm cluster-randomised pilot trial: SIP SMART2 trial.

Setting and participants

Adults newly diagnosed with stage II–IV head and neck cancer receiving curative treatment within a multidisciplinary team who agree to participate.

Interventions

Six hospitals were randomised. Trained clinicians at the intervention sites delivered the manualised SIP SMART intervention, while standard care was provided at care as usual (CAU) sites. The intervention included two 45-minute consultations incorporating an X-ray swallow assessment, tailored exercises/advice and specific behaviour change strategies while CAU involved a single consultation of information giving and provision of a generic exercise sheet.

Outcomes

Study outcomes related to feasibility of the cluster-randomised design, recruitment of both sites and patients and completeness of clinical and health economic data collected at baseline, 4 weeks, 12 weeks and 24 weeks after treatment.

Results

12 hospitals expressed interest and six were randomised (50%) and provided data to the point of study completion. Patient recruitment across all sites (n=76) reached the target, although two sites fell short of their individual targets. The proportion of people with HNC recruited versus those eligible for each arm was 39% (95% CI 29 to 49) for SIP SMART group and 55% (95% CI 43 to 66) for CAU. The end point data at 24 weeks were completed for 50% (95% CI 33 to 67) for SIP SMART and 78% (95% CI 62 to 89) for CAU. Adherence to the intervention was above 50% at all time points. No harms related to the intervention were reported.

Conclusions

It is feasible to deliver the SIP SMART intervention embedded within the NHS cancer care pathway using a cluster-randomised design. A future trial will be optimised for efficiency in set-up and follow-up data collection based on these findings and learnings from the accompanying process evaluation study.

Trial registration number

ISRCTN12377415.

Prevalence and determinants of unsuppressed HIV viral loads among children and adolescents living with HIV on antiretroviral therapy in Lubumbashi, Democratic Republic of the Congo: a retrospective cross-sectional study

Por: Mukuku · O. · Govender · K. · Wembonyama · S. O.
Background

Despite global improvements in antiretroviral therapy (ART) access for children and adolescents living with HIV (CALHIV), a significant proportion continue to experience unsuppressed viral load (USVL). Limited studies focus on the factors contributing to USVL among CALHIV in the Democratic Republic of the Congo (DRC), especially in the context of evolving treatment landscapes. Understanding these determinants is crucial for enhancing ART outcomes.

Objective

This study aimed to determine the prevalence of USVL and identify factors associated with USVL among CALHIV receiving ART in Lubumbashi, DRC.

Design

A multicentre retrospective cross-sectional study was conducted. Data were gathered using an observational checklist based on assessing patient file data and entered into Microsoft Excel. Analysis was performed using STATA V.16. Variables with a p value of 0.20 from the bivariable analysis were included in a multivariable logistic regression model, and significant variables (p

Setting and participants

The study was conducted at 21 HIV care clinics in Lubumbashi from June to September 2024. It included 847 CALHIV aged 0–19 years who had been on ART for at least 6 months and had at least one available VL result.

Primary outcome measure

The rate of USVL among CALHIV, defined as achieving a VL below 1000 copies/mL, in those who had been on ART for at least 6 months.

Results

The prevalence of USVL among CALHIV was 24.68% (209/847; 95% CI: 21.89% to 27.69%). Multivariable logistic regression analysis revealed that CALHIV with married caregivers were more likely to have USVL (adjsuted OR, aOR=2.4; 95% CI: 1.2 to 5.0). Other factors associated with USVL included horizontal HIV transmission (aOR=2.3; 95% CI: 1.0 to 5.2), advanced WHO clinical stages (aOR=3.5; 95% CI: 1.0 to 13.7), poor/fair ART adherence (aOR=107.8; 95% CI: 50.3 to 231.1) and ART-induced side effects (aOR=3.8; 95% CI: 1.9 to 7.9).

Conclusions

The high rate of USVL among CALHIV in Lubumbashi highlights the need to strengthen ART adherence support, manage treatment side effects and improve early diagnosis and follow-up, particularly for those infected through horizontal transmission or presenting with advanced clinical stages. Special attention should also be given to caregiver-related factors, including marital status, which may influence treatment outcomes.

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