HIV self-testing (HIVST) is increasingly being sought and offered globally, yet there is limited information about the test features that will be required for an HIV self-test to be easy to use, acceptable to users, and feasible for manufacturers to produce. We conducted formative usability research with participants who were naïve to HIVST using five prototypes in Kenya, Malawi, and South Africa. The tests selected ranged from early-stage prototypes to commercially ready products and had a diverse set of features. A total of 150 lay users were video-recorded conducting unsupervised self-testing and interviewed to understand their opinions of the test. Participants did not receive a test result, but interpreted standardized result panels. This study demonstrated that users will refer to the instructions included with the test, but these can be confusing or difficult to follow. Errors were common, with less than 25 % of participants conducting all steps correctly and 47.3 % of participants performing multiple errors, particularly in sample collection and transfer. Participants also had difficulty interpreting results. To overcome these issues, the ideal HIV self-test requires pictorial instructions that are easy to understand, simple sample collection with integrated test components, fewer steps, and results that are easy to interpret.

IntroductionHIV self-testing (HIVST) has the potential to increase uptake of HIV testing among untested populations in sub-Saharan Africa and is on the brink of scale-up. However, it is unclear to what extent HIVST would be supported by stakeholders, what policy frameworks are in place and how variations between contexts might influence country-preparedness for scale-up. This qualitative study assessed the perceptions of HIVST among stakeholders in three sub-Saharan countries.MethodsFifty-four key informant interviews were conducted in Kenya (n=16), Malawi (n=26) and South Africa (n=12) with government policy makers, academics, activists, donors, procurement specialists, laboratory practitioners and health providers. A thematic analysis was conducted in each country and a common coding framework allowed for inter-country analysis to identify common and divergent themes across contexts.ResultsRespondents welcomed the idea of an accurate, easy-to-use, rapid HIV self-test which could increase testing across all populations. High-risk groups, such as men, Men who have sex with men (MSM), couples and young people in particular, could be targeted through a range of health facility and community-based distribution points. HIVST is already endorsed in Kenya, and political support for scale-up exists in South Africa and Malawi. However, several caveats remain. Further research, policy and ensuing guidelines should consider how to regulate, market and distribute HIVST, ensure quality assurance of tests and human rights, and critically, link testing to appropriate support and treatment services. Low literacy levels in some target groups would also need context-specific consideration before scale up. World Health Organization (WHO) policy and regulatory frameworks are needed to guide the process in those areas which are new or specific to self-testing.ConclusionsStakeholders in three HIV endemic sub-Saharan countries felt that HIVST will be an important complement to existing community and facility-based testing approaches if accompanied by the same essential components of any HIV testing service, including access to accurate information and linkages to care. While there is an increasingly positive global policy environment regarding HIVST, several implementation and social challenges limit scale-up. There is a need for further research to provide contextual and operational evidence that addresses concerns and contributes to normative WHO guidance.

Background and objectivesThis study explores the perceptions of a wide range of stakeholders in Malawi towards the mental health impact of intimate partner violence (IPV) and the capacity of health services for addressing these.DesignIn-depth interviews (IDIs) and focus group discussions (FGDs) were conducted in three areas of Blantyre district, and in two additional districts. A total of 10 FGDs, 1 small group, and 14 IDIs with health care providers; 18 FGDs and 1 small group with male and female, urban and rural community members; 7 IDIs with female survivors; and 26 key informant interviews and 1 small group with government ministry staff, donors, gender-based violence service providers, religious institutions, and police were conducted. A thematic framework analysis method was applied to emerging themes.ResultsThe significant mental health impact of IPV was mentioned by all participants and formal care seeking was thought to be impeded by social pressures to resolve conflict, and fear of judgemental attitudes. Providers felt inadequately prepared to handle the psychosocial and mental health consequences of IPV; this was complicated by staff shortages, a lack of clarity on the mandate of the health sector, as well as confusion over the definition and need for ‘counselling’. Referral options to other sectors for mental health support were perceived as limited but the restructuring of the Ministry of Health to cover violence prevention, mental health, and alcohol and drug misuse under a single unit provides an opportunity.ConclusionDespite widespread recognition of the burden of IPV-associated mental health problems in Malawi, there is limited capacity to support affected individuals at community or health sector level. Participants highlighted potential entry points to health services as well as local and national opportunities for interventions that are culturally appropriate and are built on local structures and resilience.

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.

37 Background: Cancer of the cervix is one of the reproductive cancers that are claiming the lives of women worldwide, and Malawi has not been spared. Of the 16 countries with the highest incidence of cervical cancer in Africa, Malawi has been rated the highest, with an incidence of 75.9. Being a reproductive disease, male involvement is critical as men control approximately 95% of sexual relationships in Malawi, but their role in cervical cancer prevention is not known. This study was carried out to investigate the knowledge and practices of married men regarding cervical cancer and screening. Methods: A cross-sectional study recruited 396 married men. Collected data were analyzed by using SPSS for Windows version 16 (SPSS, Chicago, IL). Results: The majority of respondents were not knowledgeable about cervical cancer and cervical cancer screening, as 84.1% did not know the cause, nor did 88.9% know the signs or symptoms of cervical cancer. Only 4% of respondents knew the risk factors, whereas 75.5% had no knowledge. On prevention, 76.5% had no knowledge, and 68.2 % had some knowledge on cervical cancer treatment. Almost all respondents (99%) said they would encourage their spouses to undergo screening, and 71.7 % said that men, as heads of families, are responsible for deciding whether their spouse should access screening services or not. Conclusion: Men have a stake in taking part in cervical cancer prevention. This is a window of opportunity that the Ministry of Health can use to develop strategies that are tailored toward men to participate fully in cervical cancer prevention to reduce its burden. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST No COIs from either author.