Abstract
Background: Timely diagnosis of human immunodeficiency virus (HIV) enables access to antiretroviral treatment, which reduces mortality, morbidity and further transmission in people living with HIV. In the UK, late diagnosis among black African people persists. Novel methods to enhance HIV testing in this population are needed. Objectives: To develop a self-sampling kit (SSK) intervention to increase HIV testing among black Africans, using existing community and health-care settings (stage 1) and to assess the feasibility for a Phase III evaluation (stage 2). Design: A two-stage, mixed-methods design. Stage 1 involved a systematic literature review, focus groups and interviews with key stakeholders and black Africans. Data obtained provided the theoretical base for intervention development and operationalisation. Stage 2 was a prospective, non-randomised study of a provider-initiated, HIV SSK distribution intervention targeted at black Africans. The intervention was assessed for cost-effectiveness. A process evaluation explored feasibility, acceptability and fidelity. Setting: Twelve general practices and three community settings in London. Main outcome measure: HIV SSK return rate. Results: Stage 1 - the systematic review revealed support for HIV SSKs, but with scant evidence on their use and clinical effectiveness among black Africans. Although the qualitative findings supported SSK distribution in settings already used by black Africans, concerns were raised about the complexity of the SSK and the acceptability of targeting. These findings were used to develop a theoretically informed intervention. Stage 2 - of the 349 eligible people approached, 125 (35.8%) agreed to participate. Data from 119 were included in the analysis; 54.5% (65/119) of those who took a kit returned a sample; 83.1% of tests returned were HIV negative; and 16.9% were not processed, because of insufficient samples. Process evaluation showed the time pressures of the research process to be a significant barrier to feasibility. Other major barriers were difficulties with the SSK itself and ethnic targeting in general practice settings. The convenience and privacy associated with the SSK were described as beneficial aspects, and those who used the kit mostly found the intervention to be acceptable. Research governance delays prevented implementation in Glasgow. Limitations: Owing to the study failing to recruit adequate numbers (the intended sample was 1200 participants), we were unable to evaluate the clinical effectiveness of SSKs in increasing HIV testing in black African people. No samples were reactive, so we were unable to assess pathways to confirmatory testing and linkage to care. Conclusions: Our findings indicate that, although aspects of the intervention were acceptable, ethnic targeting and the SSK itself were problematic, and scale-up of the intervention to a Phase III trial was not feasible. The preliminary economic model suggests that, for the acceptance rate and test return seen in the trial, the SSK is potentially a cost-effective way to identify new infections of HIV.
| Original language | English |
|---|---|
| Number of pages | 192 |
| Journal | Health Technology Assessment |
| Volume | 22 |
| Issue number | 22 |
| DOIs | |
| Publication status | Published - 31 May 2018 |
Funding
1Research Department, Infection & Population Health, University College London, London, UK 2Sigma Research, London School of Hygiene & Tropical Medicine, London, UK 3MRC/CSO Social and Public Health Sciences Unit, University of Glasgow, Glasgow, UK 4School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK 5Research Department, Primary Care and Population Health, University College London, London, UK 6National Institute for Health Research Health Protection Research Unit in Blood Borne and Sexually Transmitted Infections, University College London, London, UK 7Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK 8PRIMENT Clinical Trials Unit, Primary Care and Population Health, University College London, London, UK 9BHA for Equality in Health and Social Care, Leeds, UK 10UK Community Advisory Board, London, UK 11Centre for the Study of Sexual Health and HIV, Homerton University Hospital NHS Foundation Trust, London, UK 12Virology Department, University College London Hospitals NHS Foundation Trust, London, UK 13Royal Free London NHS Foundation Trust, London, UK Declared competing interests of authors: Fiona Burns reports grants from the National Institute for Health Research (NIHR) for other projects during the conduct of the study, and personal fees and other from Gilead Sciences Ltd (London, UK), outside the submitted work. Rachael Hunter reports grants from the NIHR Health Technology Assessment (HTA) programme for other projects, during the conduct of the study. Ibidun Fakoya reports a grant from NIHR for another project, during the conduct of the study. Eleni Nastouli reports personal fees from Roche (Burgess Hill, UK), grants from Viiv Healthcare (London, UK), grants from the European Union (H2020) and personal fees from NIHR, outside the submitted work. Lisa McDaid reports grants from the NIHR HTA programme for other projects, during the conduct of the study. Jane Anderson reports grants and personal fees from Gilead Sciences Ltd, and personal fees from ViiV Healthcare, Merck Sharp & Dohme Limited (Hoddesdon, UK), Bristol-Myers Squibb (Uxbridge, UK), Jansen-Cilag Limited (High Wycombe, UK) and AbbVie (Maidenhead, UK), outside the submitted work. The research reported in this issue of the journal was funded by the HTA programme as project number 12/138/02. The contractual start date was in June 2014. The draft report began editorial review in October 2016 and was accepted for publication in June 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report. This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. © Queen ’s Printer and Controller of HMSO 2018. This work was produced by Seguin et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Funding for this study was provided by the Health Technology Assessment programme of the National Institute for Health Research, and the BHA for Equality in Health and Social Care. This report presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health
Keywords
- HIV testing
- antiretroviral treatment
- black Africans in the UK
