Navigating 'ethics in practice': An ethnographic case study with young women living with HIV in Zambia.

While 'procedural ethics' provides essential frameworks for governing global health research, reflecting on 'ethics in practice' offers important insights into addressing ethically important moments that arise in everyday research. Particularly for ethnographic research, renowned for it's fluid and spontaneous nature, engaging with 'ethics in practice' has the potential to enhance research practice within global health. We provide a case study for such reflexivity, exploring 'ethics in practice' of ethnographic research with middle-income young women living with HIV in Lusaka, Zambia. We explore the ethical issues arising from the layered interaction of the population (young women), the disease under investigation (HIV), the method of study (ethnographic), and the setting (Zambia, a lower middle income country). We describe how we navigated five key practical ethical tensions that arose, namely the psycho-emotional benefits of the research, the negotiated researcher-participant relationship, protecting participants' HIV status, confidentiality and data ownership, and researcher obligations after the end of the research. We exemplify reflexive engagement with 'ethics in practice' and suggest that engaging with ethics in this way can make important contributions towards developing more adequate ethical guidelines and research practice in global public health

"The difference that makes a difference": highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa.

This paper explores contextual heterogeneity within a community randomised trial HPTN 071 (Population Effects of Antiretroviral Treatment to Reduce HIV Transmission) carried out in 21 study communities (12 Zambian, 9 South African). The trial evaluates the impact of a combination HIV prevention package (including household-based HIV counselling and testing and anti-retroviral treatment (ART) eligibility regardless of CD4-count) on HIV incidence. The selection, matching and randomisation of study communities relied on key epidemiological and demographic variables and community and stakeholder support. In 2013, following the selection of study communities, a "Broad Brush Survey" (BBS) approach was used to rapidly gather qualitative data on each study community, prior to the implementation of the trial intervention. First-year process indicator intervention data (2014-2015) were collected during the household-based intervention by community lay workers. Using an open/closed typology of urban communities (indicating more or less heterogeneity), this qualitative inquiry presents key features of 12 Zambian communities using a list of four meta-indicators (physical features, social organisation, networks and community narratives). These indicators are then compared with four intervention process indicators in a smaller set of four study communities. The process indicators selected for this analysis indicate response to the intervention (uptake) amongst adults. The BBS qualitative data are used to interpret patterns of similarity and variability in the process indicators across four communities. We found that meta-indicators of local context helped to interpret patterns of similarity and variability emerging across and within the four communities. Features especially significant for influencing heterogeneity in process indicators include proportion of middle-class residents, proximity to neighbouring communities and town centre, the scale of the informal economy, livelihood-linked mobility, presence of HIV stakeholders over time and commitment to community action. Future interdisciplinary analysis is needed to explore if these patterns of difference continue to hold up over the full intervention period and all intervention communities

'I will choose when to test, where I want to test': investigating young people's preferences for HIV self-testing in Malawi and Zimbabwe.

OBJECTIVES: The current study identifies young people's preferences for HIV self-testing (HIVST) delivery, determines the relative strength of preferences and explores underlying behaviors and perceptions to inform youth-friendly services in southern Africa. DESIGN: A mixed methods design was adopted in Malawi and Zimbabwe and includes focus group discussions, in-depth interviews and discrete choice experiments. METHODS: The current study was conducted during the formative phase of cluster-randomized trials of oral-fluid HIVST distribution. Young people aged 16-25 years were purposively selected for in-depth interviews (n = 15) in Malawi and 12 focus group discussions (n = 107) across countries. Representative samples of young people in both countries (n = 341) were administered discrete choice experiments on HIVST delivery, with data analyzed to estimate relative preferences. The qualitative results provided additional depth and were triangulated with the quantitative findings. RESULTS: There was strong concordance across methods and countries based on the three triangulation parameters: product, provider and service characteristics. HIVST was highly accepted by young people, if provided at no or very low cost. Young people expressed mixed views on oral-fluid tests, weighing perceived benefits with accuracy concerns. There was an expressed lack of trust in health providers and preference for lay community distributors. HIVST addressed youth-specific barriers to standard HIV testing, with home-based distribution considered convenient. Issues of autonomy, control, respect and confidentiality emerged as key qualitative themes. CONCLUSION: HIVST services can be optimized to reach young people if products are provided through home-based distribution and at low prices, with respect for them as autonomous individuals

Access to menstrual hygiene products through incentivised, community-based, peer-led sexual and reproductive health services before and during the COVID-19 pandemic: findings from the Yathu Yathu trial.

BACKGROUND: Access to affordable and effective menstrual hygiene products (MHP) is critical to the menstrual health of adolescent girls and young women (AGYW). In this mixed-methods analysis, we use data from a programme delivering comprehensive sexual and reproductive health (SRH) services to describe access to MHP and how COVID-19-related closures affected access to MHP; we use qualitative data to understand AGYW's experience accessing products during the study. METHODS: Between September 2019-January 2021, we used data routinely collected from ten Yathu Yathu hubs offering community-based, peer-led SRH services to adolescents and young people aged 15-24. Hubs offered free MHP (primarily disposable pads) as a service. To incentivise service access, a "loyalty" card system was embedded within Yathu Yathu, allowing individuals to gain points for services accessed and redeem rewards using these points. Branded pads, tampons and reusable pads were among available rewards. We describe access to service pads and to reward MHP, and use logistic regression to investigate factors associated with accessing pads and reward products before (Sept 2019-March 2020) and after (July 2020-Jan 2021) COVID-19-related closures. Focus group discussions explored accessibility of offering MHP through hubs. RESULTS: Between September 2019-January 2021, 6374 AGYW made 34,116 hub visits to access an SRH service and/or redeem a reward. At 30% of these visits, AGYW accessed any MHP. Before COVID19-closures, an average of 17% of monthly visits were for freely-available disposable pads compared to 34% after hubs reopened (p < 0.001). Results were similar for reward visits. Overall, 63% of 6374 AGYW collected pads as a service at least once. Prior to COVID19-closures, AGYW aged 18-24 were more likely to access service pads than adolescents (15-17-years). After reopening, access was lower among older AGYW. Prior to hub closures, uptake of reward MHP was higher among AGYW with some secondary education but not after reopening. Discussions revealed that, for adolescents aged 15-19, COVID-19-related hub closures required reverting to using ineffective materials to manage menstruation. CONCLUSION: Availability of MHP through Yathu Yathu provided a large number of AGYW with access to these products. Hubs seemed particularly important for adolescent girls. Community-based, peer-led hubs should be considered as spaces to provide AGYW access to affordable and effective MHP

Regulation of HIV self-testing in Malawi, Zambia and Zimbabwe: a qualitative study with key stakeholders.

INTRODUCTION: HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries. METHODS: Between April and August 2016, we conducted semi-structured interviews in Malawi, Zambia and Zimbabwe to understand the relationships between different stakeholders on their perceptions of current and future HIVST regulation and the potential impact on implementation. We purposively sampled and interviewed 66 national-level key stakeholders from the Ministry of Health and the regulatory, laboratory, logistical, donor and non-governmental sectors. We used a thematic approach to analysis with an inductively developed common coding framework to allow inter-country comparison of emerging themes. RESULTS: In all countries, the national reference laboratory was monitoring the quality of HIVST kits entering the public sector. In Malawi, there was no legal mandate to regulate medical devices, in Zambia one regulatory body with a clear mandate had started developing regulations and in Zimbabwe the mandate to regulate was overlapping between two bodies. Stakeholders indicated that they had a poor understanding of the process and requirements for HIVST regulation, as well as lack of clarity and coordination between organizational roles. The need for good collaboration between sectors, a strong post-market surveillance model for HIVST and technical assistance to develop regulators capacity was noted as priorities. Key informants identified technical working groups as a potential way collaboration could be improved upon to accelerate the regulation of HIVST. CONCLUSION: Regulation of in vitro diagnostic devices, including HIVST, is now being recognized as important by regulators after a regional focus on pharmaceuticals. HIVST is providing an opportunity for each country to develop similar regulations to others in the region leading to a more coherent regulatory environment for the introduction of new devices

Ability to understand and correctly follow HIV self-test kit instructions for use: applying the cognitive interview technique in Malawi and Zambia.

INTRODUCTION: The ability to achieve an accurate test result and interpret it correctly is critical to the impact and effectiveness of HIV self-testing (HIVST). Simple and easy-to-use devices, instructions for use (IFU) and other support tools have been shown to be key to good performance in sub-Saharan Africa and may be highly contextual. The objective of this study was to explore the utility of cognitive interviewing in optimizing the local understanding of manufacturers' IFUs to achieve an accurate HIVST result. METHODS: Functionally literate and antiretroviral therapy-naive participants were purposefully selected between May 2016 and June 2017 to represent intended users of HIV self-tests from urban and rural areas in Malawi and Zambia. Participants were asked to follow IFUs for HIVST. We then conducted cognitive interviews and observed participants while they attempted to complete the HIVST steps using a structured guide, which mirrored the steps in the IFU. Qualitative data were analysed using a thematic approach. RESULTS: Of a total of 61 participants, many successfully performed most steps in the IFU. Some had difficulties in understanding these and made errors, which could have led to incorrect test results, such as incorrect use of buffer and reading the results prematurely. Participants with lower levels of literacy and inexperience with standard pictorial images were more likely to struggle with IFUs. Difficulties tended to be more pronounced among those in rural settings. Ambiguous terms and translations in the IFU, unfamiliar images and symbols, and unclear order of the steps to be followed were most commonly linked to errors and lower comprehension among participants. Feedback was provided to the manufacturer on the findings, which resulted in further optimization of IFUs. CONCLUSIONS: Cognitive interviewing identifies local difficulties in conducting HIVST from manufacturer-translated IFUs. It is a useful and practical methodology to optimize IFUs and make them more understandable

Broad Brush Surveys: a rapid qualitative assessment approach for water and sanitation infrastructure in urban sub-Saharan cities

Introduction: Broad Brush Surveys (BBS) are a rapid, qualitative assessment approach using four meta-indicators -physical features, social organization, social networks and community narratives - to gauge how local context interfaces with service/intervention options, implementation and uptake. Methods: In 2021, responding to rapid urbanization and the accompanying need for water and sanitation services, BBS was innovatively applied by social scientists and engineers to assess water and sanitation infrastructure, both formal and informal, in two African cities - Lusaka and Cape Town. In four urban communities, identified with local stakeholders, BBS data collection included: four mapping group discussions with local stakeholders (participants = 24); eight transect walks/drives; 60 structured observations of water and sanitation options, transport depots, health facilities, weekends, nights, rainy days; seven mixed gender focus group discussions (FGDs) with older and young residents (participants = 86); 21 key-informant interviews (KII, participants = 21). Results: Findings were rapidly summarized into community profiles, including narrative reports, maps and posters, and first discussed with community stakeholders, then at national/provincial levels. The meta-indicator framework and set sequence of qualitative activities allowed the detail on water and sanitation to gradually emerge. For example, the mapping discussion identified water sources considered a risk for waterborne infections, further observed in the transect walks and then structured observations, which compared their relative condition and social interactions and what local residents narrated about them. FGDs and KIIs elaborated on the control of these sources, with nuanced detail, including hidden sources and the use of different water sources for different activities also emerging. Discussion: We demonstrated that despite some limitations, BBS provided useful insight to systems and social processes surrounding formal and informal water and sanitation infrastructure in and across designated urban areas. Furthermore, BBS had the potential to galvanize local action to improve infrastructure, and illuminated the value of informal options in service delivery

Value and limitations of broad brush surveys used in community-randomized trials in Southern Africa

We describe and reflect on a rapid qualitative survey approach called “Broad Brush Survey” (BBS) used in six community-randomized trials (CRTs)/studies in Zambia and South Africa (2004–2018) to document, compare, classify, and communicate community features systematically for public health and multidisciplinary research ends. BBS is based on a set sequence of participatory qualitative methods and fieldwork carried out prior to a CRT intervention and/or research by social scientists to generate rapid community profiles using four key indicators: physical features, social organization, networks, and community narratives. Profiling makes apparent similarities and differences, enabling comparison across communities and can be facilitated by an ideal model of open-closed systems. Findings have provided practical outputs (e.g., community profiles) and academic opportunities (e.g., community typologies). The BBS approach enables complex social landscapes to be incorporated in CRTs. This method has proven to be useful, adaptable and to have multidisciplinary appeal

Demographics of sources of HIV-1 transmission in Zambia: a molecular epidemiology analysis in the HPTN 071 PopART study

BACKGROUND: In the last decade, universally available antiretroviral therapy (ART) has led to greatly improved health and survival of people living with HIV in sub-Saharan Africa, but new infections continue to appear. The design of effective prevention strategies requires the demographic characterisation of individuals acting as sources of infection, which is the aim of this study. METHODS: Between 2014 and 2018, the HPTN 071 PopART study was conducted to quantify the public health benefits of ART. Viral samples from 7124 study participants in Zambia were deep-sequenced as part of HPTN 071-02 PopART Phylogenetics, an ancillary study. We used these sequences to identify likely transmission pairs. After demographic weighting of the recipients in these pairs to match the overall HIV-positive population, we analysed the demographic characteristics of the sources to better understand transmission in the general population. FINDINGS: We identified a total of 300 likely transmission pairs. 178 (59·4%) were male to female, with 130 (95% CI 110-150; 43·3%) from males aged 25-40 years. Overall, men transmitted 2·09-fold (2·06-2·29) more infections per capita than women, a ratio peaking at 5·87 (2·78-15·8) in the 35-39 years source age group. 40 (26-57; 13·2%) transmissions linked individuals from different communities in the trial. Of 288 sources with recorded information on drug resistance mutations, 52 (38-69; 18·1%) carried viruses resistant to first-line ART. INTERPRETATION: HIV-1 transmission in the HPTN 071 study communities comes from a wide range of age and sex groups, and there is no outsized contribution to new infections from importation or drug resistance mutations. Men aged 25-39 years, underserved by current treatment and prevention services, should be prioritised for HIV testing and ART. FUNDING: National Institute of Allergy and Infectious Diseases, US President's Emergency Plan for AIDS Relief, International Initiative for Impact Evaluation, Bill & Melinda Gates Foundation, National Institute on Drug Abuse, and National Institute of Mental Health

Preferences for linkage to HIV care services following a reactive self-test: discrete choice experiments in Malawi and Zambia.

OBJECTIVES: The current research identifies key drivers of demand for linkage into care following a reactive HIV self-test result in Malawi and Zambia. Preferences are explored among the general population and key groups such as HIV-positive individuals and adolescents. DESIGN: We used discrete choice experiments (DCEs) embedded in representative household surveys to quantify the relative strength of preferences for various HIV services characteristics. METHODS: The DCE was designed on the basis of a literature review and qualitative studies. Data were collected within a survey (Malawi n = 553, Zambia n = 388), pooled across country and analysed using mixed logit models. Preference heterogeneity was explored by country, age, sex, wealth, HIV status and belief that HIV treatment is effective. RESULTS: DCE results were largely consistent across countries. Major barriers for linkage were fee-based testing and long wait for testing. Community-based confirmatory testing, that is at the participant's or counsellor's home, was preferred to facility-based confirmation. Providing separated waiting areas for HIV services at health facilities and mobile clinics was positively viewed in Malawi but not in Zambia. Active support for linkage was less important to respondents than other attributes. Preference heterogeneity was identified: overall, adolescents were more willing to seek care than adults, whereas HIV-positive participants were more likely to link at health facilities with separate HIV services. CONCLUSION: Populations in Malawi and in Zambia were responsive to low-cost, HIV care services with short waiting time provided either at the community or privately at health facilities. Hard-to-reach groups could be encouraged to link to care with targeted support