Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study

Maureen Seguin, Catherine Dodds, Esther Mugweni, Lisa McDaid, Paul Flowers, Sonali Wayal, Ella Zomer, Peter Weatherburn, Ibidun Fakoya, Thomas Hartney, Lorraine McDonagh, Rachael Hunter, Ingrid Young, Shabana Khan, Nick Freemantle, Jabulani Chwaula, Memory Sachikonye, Jane Anderson, Surinder Singh, Eleni NastouliGreta Rait, Fiona Burns

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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.

Future work
Sexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities.

Study registration
This study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223.

Funding
The National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.
Original languageEnglish
JournalHealth Technology Assessment
Volume22
Issue number22
DOIs
Publication statusPublished - 1 May 2018

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HIV
Research
General Practice
Cost-Benefit Analysis
Butylated Hydroxyanisole
Economic Models
Community Health Services
Biomedical Technology Assessment
United States Public Health Service
Privacy
Delayed Diagnosis
National Institutes of Health (U.S.)
Focus Groups
Interviews
Technology
Morbidity
Delivery of Health Care
Costs and Cost Analysis
Mortality
Infection

Keywords

  • HIV testing
  • self-sampling kit
  • Africans

Cite this

Seguin, Maureen ; Dodds, Catherine ; Mugweni, Esther ; McDaid, Lisa ; Flowers, Paul ; Wayal, Sonali ; Zomer, Ella ; Weatherburn, Peter ; Fakoya, Ibidun ; Hartney, Thomas ; McDonagh, Lorraine ; Hunter, Rachael ; Young, Ingrid ; Khan, Shabana ; Freemantle, Nick ; Chwaula, Jabulani ; Sachikonye, Memory ; Anderson, Jane ; Singh, Surinder ; Nastouli, Eleni ; Rait, Greta ; Burns, Fiona. / Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study. In: Health Technology Assessment. 2018 ; Vol. 22, No. 22.
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abstract = "BackgroundTimely 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.ObjectivesTo 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).DesignA 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.SettingTwelve general practices and three community settings in London.Main outcome measureHIV SSK return rate.ResultsStage 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.LimitationsOwing 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.ConclusionsOur 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.Future workSexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities.Study registrationThis study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223.FundingThe National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.",
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Seguin, M, Dodds, C, Mugweni, E, McDaid, L, Flowers, P, Wayal, S, Zomer, E, Weatherburn, P, Fakoya, I, Hartney, T, McDonagh, L, Hunter, R, Young, I, Khan, S, Freemantle, N, Chwaula, J, Sachikonye, M, Anderson, J, Singh, S, Nastouli, E, Rait, G & Burns, F 2018, 'Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study', Health Technology Assessment, vol. 22, no. 22. https://doi.org/10.3310/hta22220

Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study. / Seguin, Maureen; Dodds, Catherine; Mugweni, Esther; McDaid, Lisa; Flowers, Paul; Wayal, Sonali; Zomer, Ella; Weatherburn, Peter; Fakoya, Ibidun; Hartney, Thomas; McDonagh, Lorraine; Hunter, Rachael; Young, Ingrid; Khan, Shabana; Freemantle, Nick; Chwaula, Jabulani; Sachikonye, Memory; Anderson, Jane; Singh, Surinder; Nastouli, Eleni; Rait, Greta; Burns, Fiona.

In: Health Technology Assessment, Vol. 22, No. 22, 01.05.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Self-sampling kits to increase HIV testing among black Africans in the UK: the HAUS mixed-methods study

AU - Seguin, Maureen

AU - Dodds, Catherine

AU - Mugweni, Esther

AU - McDaid, Lisa

AU - Flowers, Paul

AU - Wayal, Sonali

AU - Zomer, Ella

AU - Weatherburn, Peter

AU - Fakoya, Ibidun

AU - Hartney, Thomas

AU - McDonagh, Lorraine

AU - Hunter, Rachael

AU - Young, Ingrid

AU - Khan, Shabana

AU - Freemantle, Nick

AU - Chwaula, Jabulani

AU - Sachikonye, Memory

AU - Anderson, Jane

AU - Singh, Surinder

AU - Nastouli, Eleni

AU - Rait, Greta

AU - Burns, Fiona

N1 - Acceptance from VoR VoR permitted by journal Record used to test compliance logic for migration to 5.15.2 (changed pub date only - this changed compliance result as expected). ET 26/9/19 Pub date is 'May 2018' used 1-5-18 as VoR available to upload at 18-5-18. ET

PY - 2018/5/1

Y1 - 2018/5/1

N2 - BackgroundTimely 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.ObjectivesTo 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).DesignA 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.SettingTwelve general practices and three community settings in London.Main outcome measureHIV SSK return rate.ResultsStage 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.LimitationsOwing 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.ConclusionsOur 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.Future workSexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities.Study registrationThis study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223.FundingThe National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.

AB - BackgroundTimely 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.ObjectivesTo 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).DesignA 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.SettingTwelve general practices and three community settings in London.Main outcome measureHIV SSK return rate.ResultsStage 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.LimitationsOwing 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.ConclusionsOur 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.Future workSexual and public health services are increasingly utilising self-sampling technologies. However, alternative, user-friendly SSKs that meet user and provider preferences and UK regulatory requirements are needed, and additional research is required to understand clinical effectiveness and cost-effectiveness for black African communities.Study registrationThis study is registered as PROSPERO CRD42014010698 and Integrated Research Application System project identification 184223.FundingThe National Institute for Health Research Health Technology Assessment programme and the BHA for Equality in Health and Social Care.

KW - HIV testing

KW - self-sampling kit

KW - Africans

U2 - 10.3310/hta22220

DO - 10.3310/hta22220

M3 - Article

VL - 22

JO - Health Technology Assessment

JF - Health Technology Assessment

SN - 1366-5278

IS - 22

ER -