Title: Feasibility and acceptability of home sampling kits to increase the uptake of HIV testing among black Africans in the United Kingdom: The Haus study.
Funder: Department of Health (England)

Abstract: Design: We propose a two stage mixed-method design.Health technology being assessed: An HIV home sampling kit (HSK) collection device for use with a lab-based screening test for HIV. Stage I Aim: To develop an HSK-based intervention to increase the provision and uptake of HIV testing among black Africans using existing community and healthcare provision.Specific objectives:1.Clarify barriers and facilitators to provision access and use of HIV HSK by black Africans in primary care pharmacies and community outreach2.Determine appropriate HSK-based intervention models for different settings3.Determine control population and robust HIV result management pathways4.Develop intervention manuals to enable intervention deliverySettings: •London and Glasgow. •Primary care pharmacies and community outreach programsTarget populations: •Black African adults.•GPs pharmacists and community based organisations in contact with black African communities.•HIV prevention & HIV care service providers and commissioners.Exclusion criteria •People younger than 18 years•People who cannot give informed consentMethods:Literature review: A systematic review of self-testing for HIV was published in Apr 2013 (review period Jan 2000 to Oct 2012). We will update this review by reviewing studies and practices related to HSK utility uptake barriers implementation feasibility and acceptability published since October 2012. We will use standard criteria (CONSORT STROBE and CASP) to assess study quality. Focus Group Discussions: We will conduct focus group discussions (FGD) with stakeholders and the target population to inform the development of interventions. FGD will examine views towards HSK rationales for selecting potential settings and key features of implementation. We will conduct six FGD with Black African people (3 per city). Purposive sampling will be used to ensure diversity in age gender African region of origin time in the UK and service use. Six FGD will be conducted with service providers (primary care staff Pharmacists and community workers) (3 per city). All participants will be compensated for their time.Thematic analysis of FGD data will inform kit selection and development of HSK distribution procedures (the interventions) to be implemented. It is likely that two intervention models will be proposed for Phase II evaluation in both Glasgow and London. Interviews: Once the interventions are formulated 8 additional stakeholder interviews will check the acceptability of procedures. HIV specialists will be consulted to ensure result management and linkage to care pathways are robust. Outcome measures: •Acceptability of HSK intervention to potential users and providers by setting.•Barriers to i) uptake of HSK by potential users and ii) offer of HSK by providers.Outputs: An intervention manual that specifies procedures for targeted distribution of HSKs in two community settings including training pathways for HIV result management and linkage into specialist care and strategies for cost evaluation.Stage II Aim: To conduct a phase II evaluation of selected HSK distribution models to assess feasibility appropriateness of settings and optimal intervention design for future phase III evaluation.Settings: These will be determined through the formative research conducted in Stage I. Ideally two diverse types of settings will be used in London and Glasgow.Target populations: •Black African people without diagnosed HIV 18 years of age or older and able to provide informed consent•GPs and/or pharmacists and/or community based services in contact with black African communities as identified in Stage I as suitable for delivery of HIV HSK interventions.Methods: Training & recruitment: Staff will be trained on site by the research team and a nurse specialist to recruit eligible black Africans between March 1st 2015 and 30th July 2015. Informed consent will be obtained from all participants. Sample size: We have assumed a return rate of 50%. Distribution of 400 test kits in each setting will enable a precision rate of ±5% should the return rate be lower or higher with a fixed sample size the size of the standard error will be smaller and the resulting confidence intervals narrower. As we envisage testing the intervention in two settings in two cities a total of 1600 HSK will be distributed. Data collection: Quantitative and qualitative research will be used to answer the research questions (see subsequent Research plan). The MRC complex intervention guidance will inform our evaluation. Acceptability and feasibility data collection result management cost data and process evaluation will be undertaken.Economic analysis: We will collect economic costs and outcomes of HSKs to calculate the cost per HSK distributed and cost per HIV positive result. We will assess the feasibility of developing a life-time decision analytical model to assess the cost-effectiveness of HSK compared to standard care.Outcome measures: Primary outcome: HIV HSK return rateSecondary outcomes: 1.Point of delivery outcomes:•Acceptability of intervention including rationales for accepting or refusing a HSK•Acceptability and feasibility of intervention among specified service providers2.Data collection outcomes:•Demonstration that intervention and services incorporates sufficient capacity to successfully record the numbers of: people offered HSK accepting HSK and returning HSK•Feasibility of collecting correct contact details enabling follow-up reminders and communication of results3.Pathway to care outcome measures:•Proportion of those whose samples are reactive who: a) are informed of results in person and b) who attend for confirmatory testing4.Overarching outcome measures:•Cost per person kit distributed and cost per HIV diagnosis per setting•Attrition rates and loss to follow up•Confirmatory testing proportion of those receiving an HIV positive diagnoses and clinical stage at diagnosis•Feasibility and sensitivity of outcome measures (testing behavioural and economic) for a definitive trial.Outputs: A report detailing the feasibility of a phase III trial and intervention manual


Research activity codes: 4.3 INFLUENCES AND IMPACT;4.4 POPULATION SCREENING
Health categories: INFECTION