Top

Published in:

01-07-2014 | Original Paper

HIV Self-Testing in Resource-Limited Settings: Regulatory and Policy Considerations

Authors: Vincent Wong, Cheryl Johnson, Elliot Cowan, Matthew Rosenthal, Rosanna Peeling, Maria Miralles, Anita Sands, Charlene Brown

Published in: AIDS and Behavior | Special Issue 4/2014

Abstract

HIV self-testing (HIVST) is an emerging HIV testing strategy intended to address challenges of increasing access to preliminary knowledge of serostatus. It offers the potential for tests and testing to reach more people than previously possible, including those who do not seek testing in facilities. With approval of an HIV self-test kit in the USA, increasing evidence from public pilot programs in sub-Saharan Africa showing high acceptability and feasibility, and evidence of the informal sale of rapid HIV test kits in the private sector, options for individuals to access HIV self-testing, as well as consumer-demand, appear to be increasing. More recently WHO and UNAIDS have explored self-testing as an option to achieving greater HIV testing coverage to support global treatment targets. However, for resource-limited settings, technological development, diagnostic device regulation and quality assurance policies are lagging behind. This commentary will examine regulatory and policy issues with HIVST, given its increased prominence as a potential part of the global HIV/AIDS response.

U.S. Department of State. PEPFAR blueprint: creating and AIDS-free generation. Washington DC, 2012.

WHO. Service delivery approaches to HIV testing and counseling (HTC): a strategic HTC programme framework. Geneva, 2012.

WHO. Handbook for improving HIV testing and counseling services. Geneva. 2011.

WHO. Global update on HIV treatment 2013: results, impact and opportunities. Geneva, 2013.

WHO. Supplement to the 2013 consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2014.

Ibitoye M, Frasca T, Giguere R, Carballo-Diéguez A. Home testing past, present and future: lessons learned and implications for HIV home tests. AIDS Behav. 2014;18(5):933–49.PubMedCrossRef

Global Harmonization Task Force. Principles of in vitro diagnostic (IVD) medical devices classification. Available from http://www.imdrf.org/docs/ghtf/archived/sg1/technical-docs/ghtf-sg1-n045r12-invitro-diagnostic-classification-070209.pdf (2007). Accessed 18 April 2014.

Pant Pai N, Sharma J, Shivkumar S, et al. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: a systematic review. PLoS Med. 2013;10(4):e1001414.PubMedCentralPubMedCrossRef

Napierala-Mavedzenge S, Baggeley R, Lo R, Corbett EL. HIV self-testing among health workers: a review of the literature and discussion of current practices, issues and options for increasing access to HIV testing in sub-Saharan Africa, 2011.

10.

Krause K, Subklew-Sehume F, Kenyon C, Colebunders R. Acceptability of HIV self-testing: a systematic literature review. BMC Public Health. 2013;13:735.PubMedCentralPubMedCrossRef

11.

Choko A, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, Makombe SD, Chunda T, Squire SB, French N, Mwapasa V, Corbett EL. The uptake and accuracy of oral kits for HIV self-testing in high HIV prevalence setting: a cross-sectional feasibility study in Blantyre, Malawi. PLoS Med. 2011;8(10):e1001102.PubMedCentralPubMedCrossRef

12.

Kalibala S, Tun W, Muraah W, et al. ‘Knowing myself first’: feasibility of self-testing among health workers in Kenya. Nairobi: Population Council; 2011.

13.

el Fuente L, Rosales-Statkus ME, Hoyos J, et al. Are participants in a street-based HIV testing program able to perform their own rapid test and interpret the results? PLoS ONE. 2012;7(10):e46555.PubMedCentralPubMedCrossRef

14.

WHO. Report on the first international symposium on self-testing for HIV: the legal, ethical, gender, human rights and public health implications of self-testing scale-up. Geneva, 2013. http://who.int/hiv/pub/vct/self_test/en/index.html.

15.

WHO. 2014. Draft Technical update: self-testing for HIV (forthcoming).

16.

MacPherson P, Lalloo D, Choko A, van Oosterhaut J, Thindwa D, Webb E, Squire B, Makombe S, Hayes R, Corbett E. Home assessment and initiation of ART following HIV self-testing: a cluster randomised trial to improve linkage to ART in Blantyre, Malawi. 20th Conference of Retroviruses and Opportunistic Infections (CROI). Oral LB95. 2013 Mar 3–6. Atlanta, Georgia.

17.

Corbett E. Accuracy of self-testing and linkage to care and treatment. Presented at: first international symposium on self-testing for HIV, 8–9 April 2013, Brocher Foundation, Geneva, Switzerland.

18.

Kumwenda M. Partnership dynamics and care-seeking trajectories among couples after HIV self-testing in Blantyre. Presented at: first international symposium on self-testing for HIV, 8–9 April 2013, Brocher Foundation, Geneva, Switzerland.

19.

Carballo-Diéguez A, Frasca T, Balan I, Ibitoye M, Dolezal C. Use of a rapid HIV home test prevents HIV exposure in a high risk sample of men who have sex with men. AIDS Behav. 2012;16(7):1753–60.PubMedCentralPubMedCrossRef

20.

Bavinton BR, Brown G, Hurley M, Bradley J, Keen P, Conway DP, Guy R, Grulich AE, Prestage G. Which gay men would increase their frequency of HIV testing with home self-testing? AIDS Behav. 2013;17(6):2084–92.PubMedCrossRef

21.

Greacen T, Friboulet D, Blachier A, Fugon L, Hefez S, Lorente N, Spire B. Internet-using men who have sex with men would be interested in accessing authorised HIV self-tests available for purchase online. AIDS Care. 2013;25(1):49–54.PubMedCrossRef

22.

Pant Pai N, Behlim T, Abrahams L, Vadnais C, Shivkumar S, et al. Will an unsupervised self-testing strategy for HIV work in health care workers of South Africa? a cross sectional pilot feasibility study. PLoS ONE. 2013;8(11):e79772.PubMedCentralPubMedCrossRef

23.

Dong M, Regina R, Hlongwane S, Ghebremichael M, Wilson D, Dong K. Can laypersons in high-prevalence South Africa perform an HIV self-test accurately? 20th International AIDS Conference, 2014 July 20–25, Melbourne, Australia. Abstract No. A-641-0087-10374.

24.

Nersesian P, Hülsmann M, Cloutier S, and Chintalova-Dallas R. Assessment of over-the-Counter HIV rapid test kits in Namibia. Arlington, VA. USAID AIDS Support and Technical Assistance Resources, AIDSTAR-One, Task Order 1. 2013. Available from: http://www.aidstar-one.com/sites/default/files/AIDSTAR-One_Report_Namibia_OTC_Rapid_Test_Kits.pdf.

25.

Strengthening Health Outcomes through the Private Sector. HIV testing by private health providers: evidence from 18 countries. Washington DC. Available from: http://www.shopsproject.org/resource-center/hiv-testing-by-private-health-providers-evidence-from-18-countries (2012). Accessed 4 Nov 2013.

26.

Sargent J, Johnson, J, Majorowski, M, Friedman, N, and Blazer, C. Private sector involvement in HIV service provision. Arlington, VA: USAID AIDS Support and Technical Assistance Resources, AIDSTAR-One Project, Task Order 1. Available from: http://www.aidstar-one.com/sites/default/files/AIDSTAR-One_Private_Sector_Tech_Brief_rev.pdf (2009). Accessed 4 Nov 2013.

27.

Richter M, Venter FD, Gray A. Home self-testing for HIV: AIDS exceptionalism gone wrong. South African Medical Journal. 2010;100(10).

28.

Muraranganda E. Govt probes HIV self-test kits. Namibian Sun. Available from: http://www.namibiansun.com/health/govt-probes-hiv-self-test-kits.54388 (2013). Accessed 26 June 2013.

29.

Anonymous. Home-testing kits for HIV now available amid concern. The Star. Available from: http://www.hst.org.za/news/home-testing-kits-hiv-now-available-amid-concern (2000). Accessed 4 Nov 2013.

30.

WHO, Pan-American Health Organization. A model regulatory program for medical devices: an international guide. Geneva, 2001. Available from: http://www1.paho.org/English/HSP/HSE/medical_devices.pdf. Accessed Nov 4, 2013.

31.

Australasian Society for HIV Medicine. 2012 National HIV testing policy v1.2. Surry Hills, Australia. 2012. http://testingportal.ashm.org.au/hiv/home-based-testing-in-australia.

32.

United States Food and Drug Administration. OraQuick^® In-home hiv test summary of safety and effectiveness. Washington DC. 2012. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM312534.pdf. Accessed Nov 4, 2013.

33.

Oraquick Technologies. Final advisory committee briefing materials: OraQuick^® In-Home HIV test. Available from: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/BloodProductsAdvisoryCommittee/UCM303652.pdf (2012). Accessed 4 Nov 2013.

34.

CDC. HIV surveillance—United States, 1981–2008. Morb Mortal Weekly Rep. 2011;60(21):689–693.

35.

US FDA. First rapid home-use HIV kit approved for self-testing. Available from: http://www.fda.gov/forconsumers/consumerupdates/ucm310545.htm (2013). Accessed 4 Nov 2013.

36.

Department of Public Health. Modernisation of HIV rules to better protect public. London. Available from: https://www.gov.uk/government/news/modernisation-of-hiv-rules-to-better-protect-public (2013). Accessed 4 Nov 2013.

37.

NY Daily News. France OKs home tests for HIV. Available from: http://www.nydailynews.com/life-style/health/france-oks-home-tests-hiv-article-1.1510008 (2013). Accessed 31 Jan 2014.

38.

WHO. Medical device regulation—global overview and guiding principles. Geneva, 2003.

39.

Peeling R. Update on regulatory harmonization of in vitro diagnostics in Africa. Presented at: Global HIV Diagnostics Working Group Meeting. Sep 2013, Geneva, Switzerland.

40.

Preston C, Valdez ML, Bond K. Strengthening medical product regulation in low and middle income countries. PloS Med. 2012;9(10):e1001327.PubMedCentralPubMedCrossRef

41.

WHO. National regulatory agency for medical devices (map). Available from: http://gamapserver.who.int/mapLibrary/Files/Maps/Global_DIM_Indicator3_20110211.PNG (2011). Accessed 4 Nov 2013.

42.

WHO. Increasing access to diagnostics through technology transfer and local production. Geneva, 2011.

43.

National AIDS and STD Control Programme. National guidelines for HIV testing and counseling in Kenya. Nairobi. Available from: http://www.ilo.org/wcmsp5/groups/public/—ed_protect/—protrav/—ilo_aids/documents/legaldocument/wcms_127533.pdf (2008). Accessed 31 Oct 2013.

44.

South African HIV Clinicians Society, Treatment Action Campaign. Joint statement on HIV testing and counselling, Johannesburg. Available from: http://www.sahivsoc.org/newsroom/society-news (2012). Accessed 31 Oct 2013.

45.

WHO. Effective medicines regulation: ensuring safety, efficacy and quality. Policy Perspectives on Medicines No. 7. Available from: http://whqlibdoc.who.int/hq/2003/WHO_EDM_2003.2.pdf (2003). Accessed 4 Nov 2013.

46.

Pan African Harmonization Working Party on Medical Devices and Diagnostics. Available from: http://pahwp.org/index.html (2014). Accessed 18 April 2018.

47.

WHO. WHO Prequalification of Diagnostics Programme. Available from: http://www.who.int/diagnostics_laboratory/evaluations/en/ (2014). Accessed 18 April 2014

48.

USAID. HIV rapid test kits approval and technical guidance. Available from: http://www.usaid.gov/sites/default/files/documents/1864/GuidanceHIVRTKs.pdf (2013). Accessed 18 April 2014.

49.

Study Group 1, Global Harmonization Task Force. Principles of conformity assessment for medical devices. Available from: http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n78-2012-conformity-assessment-medical-devices-121102.pdf (2012). Accessed 31 Jan 2014.

50.

WHO. Assessment of medicines regulatory systems in sub-Saharan African countries. Available from: http://www.who.int/healthsystems/Assessment26African_countries.pdf (2010). Accessed 14 April 2014.

51.

WHO. Health Policy. Available from: http://www.who.int/topics/health_policy/en/ (2013). Accessed 14 April 2014.

52.

Australian Government Department of Health and Aging. National HIV testing policy: home based testing in Australia. Available from: http://testingportal.ashm.org.au/hiv/home-based-testing-in-australia (2012). Accessed 18 April 2014.

53.

Hong Kong Department of Health. Knowing about HIV Antibody Test. Available from: http://www.info.gov.hk/aids/english/hotline/testing_question.htm#d2 (2013). Accessed 31 Jan 2014.

54.

WHO, UNAIDS, UNICEF. Global HIV response epidemic: update and health sector progress towards Universal Access, Progress Report. Geneva, 2011.

55.

Napierala-Mavedzenge S, Baggaley R, Corbett EL. A review of self-testing for HIV: research and policy priorities in a new era of HIV prevention. Clin Infect Dis. 2013;57(1):126–38.PubMedCentralPubMedCrossRef

56.

Katz D, Cassels S, Stekler J. Replacing clinic-based tests with home-use tests may increase HIV prevalence among Seattle men who have sex with men: evidence from a mathematical model. Sex Transm Dis. 2014;41(1):2–9.PubMedCentralPubMedCrossRef

Title: HIV Self-Testing in Resource-Limited Settings: Regulatory and Policy Considerations
Authors: Vincent Wong
Cheryl Johnson
Elliot Cowan
Matthew Rosenthal
Rosanna Peeling
Maria Miralles
Anita Sands
Charlene Brown
Publication date: 01-07-2014
Publisher: Springer US
Published in: AIDS and Behavior / Issue Special Issue 4/2014
Print ISSN: 1090-7165
Electronic ISSN: 1573-3254
DOI: https://doi.org/10.1007/s10461-014-0825-9

ACC 2024 Congress Coverage

Heart Failure Video

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

HIV Self-Testing in Resource-Limited Settings: Regulatory and Policy Considerations

Abstract

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Special Issue 4/2014

What Should the Ideal HIV Self-Test Look Like? A Usability Study of Test Prototypes in Unsupervised HIV Self-Testing in Kenya, Malawi, and South Africa

A Review of the Evidence of Harm from Self-Tests

Realizing the Potential for HIV Self-Testing

Factors Shaping Initial Decision-Making to Self-test Amongst Cohabiting Couples in Urban Blantyre, Malawi

Factors Associated with Acceptability of HIV Self-Testing Among Health Care Workers in Kenya

Modelling the Potential Population Impact and Cost-Effectiveness of Self-Testing for HIV: Evaluation of Data Requirements

ACC 2024 Congress Coverage

Year in Review: Heart failure and cardiomyopathies

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

Incentivised to exercise

New intervention for STEMI-related cardiogenic shock

» View more highlights on the ACC 2024 congress hub page