Assessing the acceptability of, adherence to and preference for a dual prevention pill (DPP) for HIV and pregnancy prevention compared to oral pre-exposure prophylaxis (PrEP) and oral contraception taken separately: protocols for two randomised, controlled, cross-over studies in South Africa and Zimbabwe.

INTRODUCTION: Oral pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention method; however, uptake and persistence have been low among southern African women. A dual prevention pill (DPP) that combines PrEP with oral contraception (OC) may increase PrEP use and better meet women's sexual and reproductive health needs. We will gauge the DPP's acceptability in two cross-over clinical trials. METHODS AND ANALYSIS: PC952 (Zimbabwe) and PC953 (South Africa) will compare acceptability, adherence and preference for an over-encapsulated DPP versus PrEP and OCs taken separately. HIV-negative, non-pregnant cisgender females in Johannesburg, South Africa (n=96, 16-40 years) and Harare, Zimbabwe (n=30, 16-24 years) will be randomised 1:1 to the order of regimens-DPP or two separate tablets-each used for three 28-day cycles, followed by a 6-month choice period in South Africa. Monthly clinic visits include HIV and pregnancy testing; safety assessments and risk reduction and adherence counselling. We will assess adherence (monthly) based on tenofovir diphosphate drug levels in dried blood spots and by self-report. We will evaluate acceptability (monthly) and preference (end of cross-over) via computer-assisted self-interviewing and in-depth interviews with a subset of participants. Data collection started in September 2022 and ended in January 2024. ETHICS AND DISSEMINATION: PC952 was approved by the Ministry of Health and Child Care, Medical Research Council, Research Council and Medicines Control Authority of Zimbabwe; the Chitungwiza City Health Ethics Committee; and the Joint Research Ethics Committee for the University of Zimbabwe Faculty of Medicine and Health Sciences and Parirenyatwa Group of Hospitals. PC953 was approved by the South African Health Products Regulatory Authority and the University of the Witwatersrand's Human Research Ethics Committee. The Population Council IRB approved both studies. We will disseminate results in open-access journals, clinical trials registries, and at local and international meetings and conferences. TRIAL REGISTRATION NUMBERS: NCT04778514, NCT04778527.

Acceptability and Use of the Dapivirine Vaginal Ring and Daily Oral Pre-exposure Prophylaxis (PrEP) During Breastfeeding in South Africa, Malawi, Zimbabwe, and Uganda.

This study examines qualitative acceptability of the dapivirine vaginal ring (DVR) and oral daily pre-exposure prophylaxis (PrEP) among breastfeeding persons participating in Microbicide Trials Network 043/B-PROTECTED, a phase 3B safety and drug detectability study of DVR and oral PrEP in breastfeeding. A subsample of 52 participants were purposively sampled to participate in an in-depth interview (IDI). Breastfeeding participants found both study products to be acceptable, and easy to use. A common motivation for product use was to protect the baby from HIV, although participants' understanding of how the study drug would work to protect their babies was often unclear. While most participants did not report experiencing side effects, fears about side effects were common as both initial worries about how the study products would affect their health and the health of their baby, and increased anxiety that health issues experienced by them, or their baby were from the products.

The use of and need for data and information by health professionals supporting the delivery of palliative cancer care services in sub-Saharan Africa: A qualitative study.

PURPOSE: The ability to develop and evaluate approaches to the management of advanced cancer in sub-Saharan Africa is limited by the lack of local, reliable and valid data to ensure that practice is evidence-based, replicable and reflects the needs of the population served. METHODS: A secondary qualitative analysis of in-depth interviews with 59 health professionals delivering palliative cancer care in Nigeria, Uganda and Zimbabwe were conducted to determine the use and needs for data and information for patient care and service delivery. Framework analysis was used, informed by a conceptual model for data use in low and middle-income countries. RESULTS: Three meta-themes include: (1) Current practice in data gathering and use; (2) Gaps for capturing, storing information and supporting communication, and; (3) Needs and opportunities for data use. Deficits in current data access and use were identified, alongside targets for improving the quality, accessibility and utility of data to inform the development of palliative cancer care. CONCLUSIONS: The availability and use of relevant and reliable data relating to the current provision of palliative cancer care are requisite for the contextually appropriate and effective development of health services. The requirements and constraints articulated by participants can guide future development and optimisation of digital health approaches for palliative cancer care in the participating countries, with relevance to the wider sub-Saharan Africa region.

"From the Time You Start With them Until the Lord Calls You": A Qualitative Study on the Experiences and Expectations of People Living with Advanced Cancer Interacting With Palliative Care Services in Uganda, Nigeria and Zimbabwe.

CONTEXT: A challenge facing the provision of palliative care in sub-Saharan Africa is a means of increasing coverage of services whilst maintaining quality. Developing an evidence base that reflects patients' experiences and expectations of palliative care services, the context within which services are provided, and the approaches adopted by services in caring for patients, could facilitate and inform the planning and development of patient-centered and responsive services. OBJECTIVES: To explore the experiences and expectations of palliative care for people living with advanced cancer in Nigeria, Uganda, and Zimbabwe. METHODS: A secondary qualitative analysis of in-depth interviews with 62 people with advanced cancer in Nigeria, Uganda, and Zimbabwe. Framework approach to thematic analysis of transcripts was adopted, focusing on patients' experiences and expectations when interacting with palliative care services, aligning reporting with the COnsolidated criteria for REporting Qualitative research (COREQ). RESULTS: Four main themes were generated from the analysis: 1) Condition and community as drivers of a multidimensional burden when living with advanced cancer; 2) The expectations and endeavors of palliative care to ameliorate the impact of cancer on physical, psychological and basic needs; 3) Processes and preferences for interacting and communicating with palliative care services, and; 4) Restoration of hope in the context of limited resources. CONCLUSION: Wide-ranging physical, psychological, social and financial impacts on participants were outlined. These concerns were largely met with compassionate and responsive care in the context of constrained resources. Study findings can inform evolving notions of patient-centred care for serious illnesses in the participating countries.

Patient experiences of living with cancer before interaction with palliative care services in Zimbabwe: A qualitative secondary data analysis.

OBJECTIVE: Cancer patients in Zimbabwe typically access health services with advanced disease, limiting treatment choices and lessening the likelihood of positive treatment outcomes. We outline experiences of patients with advanced cancer prior to interaction with palliative care services to identify targets for future intervention development to enhance care delivery in Zimbabwe. METHODS: Participants were purposively sampled adult patients with advanced cancer. We adopted a thematic approach to guide a qualitative secondary data analysis exploring factors influencing support sought by participants, external factors influencing decision making across the disease trajectory and the process for seeking and accessing palliative care. RESULTS: Participants reported fragmented and uncoordinated care, from initial symptom experience and throughout disease progression. A recurring notion of disjuncture was present through participants' experiences of gaps, breaks and discontinuity across the disease trajectory. Each step had a beginning and end without clear routes for transition with movement between steps as a result of happenstance or informal encounters. CONCLUSION: Targets for intervention development at the patient and family level exist that may reduce the disjuncture currently experienced between need and care provision. A holistic response that incorporates engagement with policy actors is critical to addressing prominent financial constraints for patients.

Data and information needs of policymakers for palliative cancer care: a multi-country qualitative study.

BACKGROUND: Despite regional efforts to address concerns regarding the burden of advanced cancer in Africa, urgent attention is still required. Widespread issues include late symptom presentation, inaccessibility of palliative care services, limited resources, poor data quality, disparity in data availability, and lack of stakeholder engagement. One way of helping to address these issues is by understanding and meeting the data and information needs of policymakers in palliative cancer care. AIMS: To explore the views of policymakers regarding data availability, data gaps and preferred data formats to support policy and decision making for palliative cancer care in Nigeria, Uganda and Zimbabwe. METHODS: A secondary analysis of interview data collected as part of a cross-sectional qualitative study that aimed to explore the data and information needs of patients, policymakers and caregivers in Nigeria, Uganda and Zimbabwe. Framework analysis, guided by the MEASURE evaluation framework, was used to qualitatively analyse the data. RESULTS: Twenty-six policymakers were recruited. The policymakers data and information concerns are aligned to the MEASURE evaluation framework of data and information use and include; assessing and improving data use (e.g. low prioritisation of cancer); identifying and engaging the data user (e.g. data processes); improving data quality (e.g. manual data collection processes); improving data availability (e.g. the accessibility of data); identifying information needs (e.g. what is 'need to know'?); capacity building in core competencies (e.g. skills gaps); strengthening organisational data demand and use (e.g. policy frameworks); monitoring, evaluating and communicating of data demand and use (e.g. trustworthiness of data). CONCLUSIONS: We present evidence of data sources, challenges to their access and use, guidance on data needs for policymakers, and opportunities for better engagement between data producers, brokers and users. This framework of evidence should inform the development of strategies to improve data access and use for policy and decision making to improve palliative cancer services in participating countries with relevance to the wider region.

Stakeholder perspectives and requirements to guide the development of digital technology for palliative cancer services: a multi-country, cross-sectional, qualitative study in Nigeria, Uganda and Zimbabwe.

INTRODUCTION: Coverage of palliative care in low and middle-income countries is very limited, and global projections suggest large increases in need. Novel approaches are needed to achieve the palliative care goals of Universal Health Coverage. This study aimed to identify stakeholders' data and information needs and the role of digital technologies to improve access to and delivery of palliative care for people with advanced cancer in Nigeria, Uganda and Zimbabwe. METHODS: We conducted a multi-country cross-sectional qualitative study in sub-Saharan Africa. In-depth qualitative stakeholder interviews were conducted with N = 195 participants across Nigeria, Uganda and Zimbabwe (advanced cancer patients n = 62, informal caregivers n = 48, health care professionals n = 59, policymakers n = 26). Verbatim transcripts were subjected to deductive and inductive framework analysis to identify stakeholders needs and their preferences for digital technology in supporting the capture, transfer and use of patient-level data to improve delivery of palliative care. RESULTS: Our coding framework identified four main themes: i) acceptability of digital technology; ii) current context of technology use; iii) current vision for digital technology to support health and palliative care, and; iv) digital technologies for the generation, reporting and receipt of data. Digital heath is an acceptable approach, stakeholders support the use of secure data systems, and patients welcome improved communication with providers. There are varying preferences for how and when digital technologies should be utilised as part of palliative cancer care provision, including for increasing timely patient access to trained palliative care providers and the triaging of contact from patients. CONCLUSION: We identified design and practical challenges to optimise potential for success in developing digital health approaches to improve access to and enhance the delivery of palliative cancer care in Nigeria, Uganda and Zimbabwe. Synthesis of findings identified 15 requirements to guide the development of digital health approaches that can support the attainment of global health palliative care policy goals.

The role, impact, and support of informal caregivers in the delivery of palliative care for patients with advanced cancer: A multi-country qualitative study.

BACKGROUND: Cancer is increasing in its prevalence in sub-Saharan Africa. Informal caregivers are key to supporting engagement and interaction with palliative care services, but limited literature on their role impedes development of supportive interventions. AIM: We aimed to understand the role, impact, and support of informal caregivers of patients with advanced cancer when interacting with palliative care services in Nigeria, Uganda, and Zimbabwe. DESIGN: Secondary analysis of qualitative interview transcripts. The dataset was assessed for fit and relevance and framework approach was used. SETTING/PARTICIPANTS: Interview transcripts of informal caregivers included participants aged over 18 years of age recruited from palliative care services across participating countries. RESULTS: A total of 48 transcripts were analyzed. Mean age was 37 (range 19-75) with equal numbers of men and women. Five themes emerged from the data: (1) caregivers are coordinators of emotional, practical, and health service matters; (2) caregiving comes at a personal social and financial cost; (3) practical and emotional support received and required; (4) experience of interacting and liaising with palliative care services; and (5) barriers and recommendations relating to the involvement of palliative care. CONCLUSIONS: The role of informal caregivers is multi-faceted, with participants reporting taking care of the majority of medical, physical, financial, and emotional needs of the care recipient, often in the face of sacrifices relating to employment, finances, and their own health and social life. Efforts to develop comprehensive cancer control plans in sub-Saharan Africa must take account of the increasing evidence of informal caregiver needs.

Understanding data and information needs for palliative cancer care to inform digital health intervention development in Nigeria, Uganda and Zimbabwe: protocol for a multicountry qualitative study.

INTRODUCTION: Palliative care is a clinically and cost-effective component of cancer services in sub-Saharan Africa (SSA). Despite the significant need for palliative cancer care in SSA, coverage remains inadequate. The exploration of digital health approaches could support increases in the quality and reach of palliative cancer care services in SSA. However, there is currently a lack of any theoretical underpinning or data to understand stakeholder drivers for digital health components in this context. This project addresses this gap through engaging with key stakeholders to determine data and information needs that could be supported through digital health interventions. METHODS AND ANALYSIS: This is a multicountry, cross-sectional, qualitative study conducted in Nigeria, Uganda and Zimbabwe. In-depth interviews will be conducted in patients with advanced cancer (n=20), caregivers (n=15), health professionals (n=20) and policy-makers (n=10) in each of the three participating countries. Data from a total of 195 interviews will transcribed verbatim and translated into English before being imported into NVivo software for deductive framework analysis. The analysis will seek to understand the acceptability and define mechanisms of patient-level data capture and usage via digital technologies. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Institutional Review Boards of University of Leeds (Ref: MREC 18-032), Research Council of Zimbabwe (Ref: 03507), Medical Research Council of Zimbabwe (Ref: MRCZ/A/2421), Uganda Cancer Institute (Ref: 19-2018), Uganda National Council of Science and Technology (Ref: HS325ES) and College of Medicine University of Lagos (Ref: HREC/15/04/2015). The project seeks to determine optimal mechanisms for the design and development of subsequent digital health interventions to support development, access to, and delivery of palliative cancer care in SSA. Dissemination of these findings will occur through newsletters and press releases, conference presentations, peer-reviewed journals and social media. TRIAL REGISTRATION NUMBER: ISRCTN15727711.