Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study

1. Joint United Nations Programme on HIV/AIDS. The gap report. Geneva: Joint United Nations Programme on HIV/AIDS; 2014.

2. Joint United Nations Programme on HIV/AIDS. Global report: UNAIDS report on the global AIDS epidemic 2013. Geneva: Joint United Nations Programme on HIV/AIDS; 2013.

3. Staveteig S, Wang S, Head S, Bradley S, Nybro E. Demographic patterns of HIV testing uptake in sub-Saharan Africa. DHS Comparative Reports No. 30. Calverton (Maryland): ICF International; 2013.

4. Morin SF, Khumalo-Sakutukwa G, Charlebois ED, Routh J, Fritz K, Lane T, et al. Removing barriers to knowing HIV status: same-day mobile HIV testing in Zimbabwe. J Acquir Immune Defic Syndr. 2006;41:218–224. 16394855

5. Angotti N, Bula A, Gaydosh L, Kimchi EZ, Thornton RL, Yeatman SE. Increasing the acceptability of HIV counseling and testing with three C’s: convenience, confidentiality and credibility. Soc Sci Med. 2009;68:2263–2270. doi: 10.1016/j.socscimed.2009.02.041 19375208

6. MacPherson P, Corbett EL, Makombe SD, van Oosterhout JJ, Manda E, Choko AT, et al. Determinants and consequences of failure of linkage to antiretroviral therapy at primary care level in Blantyre, Malawi: a prospective cohort study. PLoS ONE. 2012;7:e44794. doi: 10.1371/journal.pone.0044794 22984560

7. Choko AT, Desmond N, Webb EL, Chavula K, Napierala-Mavedzenge S, Gaydos CA, et al. 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:e1001102. doi: 10.1371/journal.pmed.1001102 21990966

8. Helleringer S, Kohler HP, Frimpong JA, Mkandawire J. Increasing uptake of HIV testing and counseling among the poorest in sub-Saharan countries through home-based service provision. J Acquir Immune Defic Syndr. 2009;51:185–193. doi: 10.1097/QAI.0b013e31819c1726 19352202

9. Suthar AB, Ford N, Bachanas PJ, Wong VJ, Rajan JS, Saltzman AK, et al. Towards universal voluntary HIV testing and counselling: a systematic review and meta-analysis of community-based approaches. PLoS Med. 2013;10:e1001496. doi: 10.1371/journal.pmed.1001496 23966838

10. MacPherson P, Lalloo DG, Webb EL, Maheswaran H, Choko AT, Makombe SD, et al. Effect of optional home initiation of HIV care following HIV self-testing on antiretroviral therapy initiation among adults in Malawi: a randomized clinical trial. JAMA. 2014;312:372–379. doi: 10.1001/jama.2014.6493 25038356

11. Wringe A, Cataldo F, Stevenson N, Fakoya A. Delivering comprehensive home-based care programmes for HIV: a review of lessons learned and challenges ahead in the era of antiretroviral therapy. Health Policy Plan. 2010;25:352–362. doi: 10.1093/heapol/czq005 20144935

12. Ganguli I, Bassett IV, Dong KL, Walensky RP. Home testing for HIV infection in resource-limited settings. Current HIV/AIDS Rep. 2009;6:217–223.

13. Spielberg F, Levine RO, Weaver M. Self-testing for HIV: a new option for HIV prevention? Lancet Infect Dis. 2004;4:640–646. doi: 10.1016/S1473-3099(04)01150-8 15451493

14. Joint United Nations Programme on HIV/AIDS. A short technical update on self-testing for HIV. Geneva: Joint United Nations Programme on HIV/AIDS; 2013. Available: http://www.unaids.org/en/media/unaids/contentassets/documents/unaidspublication/2014/JC2603_self-testing_en.pdf. Accessed 4 August 2015.

15. World Health Organization. Report on the first international symposium on self-testing for HIV: the legal, ethical, gender, human rights and public health implications of HIV self-testing scale-up. Geneva: World Health Organization; 2013.

16. 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;57:126–138. doi: 10.1093/cid/cit156 23487385

17. Pant Pai N, Sharma J, Shivkumar S, Pillay S, Vadnais C, Joseph L, et al. Supervised and unsupervised self-testing for HIV in high- and low-risk populations: a systematic review. PLoS Med. 2013;10:e1001414. doi: 10.1371/journal.pmed.1001414 23565066

18. Corbett E. Intensified HIV/TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care. ISRCTN02004005. London: ISRCTN Registry; 2012. 10.1186/ISRCTN02004005

19. MacQueen KM, McLellan E, Metzger DS, Kegeles S, Strauss RP, Scotti R, et al. What is community? An evidence-based definition for participatory public health. Am J Public Health. 2001;91:1929–1938. 11726368

20. World Health Organization. Guidelines for intensified tuberculosis case-finding and isoniazid preventive therapy for people living with HIV in resource-constrained setting. Geneva: World Health Organization; 2011.

21. van Rooyen H, Barnabas RV, Baeten JM, Phakathi Z, Joseph P, Krows M, et al. High HIV testing uptake and linkage to care in a novel program of home-based HIV counseling and testing with facilitated referral in KwaZulu-Natal, South Africa. J Acquir Immune Defic Syndr. 2013:64:e1–8. doi: 10.1097/QAI.0b013e31829b567d 23714740

22. Rao JNK, Scott AJ. The analysis of categorical data from complex sample surveys: Chi-squared tests for goodness of fit and independence in two-way tables. J Am Stat Assoc. 1981;76:221–230.

23. Rao JNK, Scott AJ. On chi-squared tests for multiway contingency tables with cell proportions estimated from survey data. Ann Stat. 1984;12:46–60.

24. Sterne JA, White IR, Carlin JB, Spratt M, Royston P, Kenward MG, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009;338:b2393. doi: 10.1136/bmj.b2393 19564179

25. Bland JM, Altman DG. Cronbach’s alpha. BMJ. 1997;314:572. 9055718

26. World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva: World Health Organization; 2014. Available: http://apps.who.int/iris/bitstream/10665/128048/1/9789241507431_eng.pdf?ua=1. Accessed 4 August 2015.

27. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, et al. Prevention of HIV-1 infection with early antiretroviral therapy. N Engl J Med. 2011;365:493–505. doi: 10.1056/NEJMoa1105243 21767103

28. Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet. 2007;369:657–666. doi: 10.1016/S0140-6736(07)60313-4 17321311

29. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363:2587–2599. doi: 10.1056/NEJMoa1011205 21091279

30. Weiser SD, Heisler M, Leiter K, Percy-de Korte F, Tlou S, DeMonner S, et al. Routine HIV testing in Botswana: a population-based study on attitudes, practices, and human rights concerns. PLoS Med. 2006;3:e261. doi: 10.1371/journal.pmed.0030261 16834458

31. Jurgensen M, Tuba M, Fylkesnes K, Blystad A. The burden of knowing: balancing benefits and barriers in HIV testing decisions. a qualitative study from Zambia. BMC Health Services Res. 2012;12:2. doi: 10.1186/1472-6963-12-2

32. Musheke M, Ntalasha H, Gari S, McKenzie O, Bond V, Martin-Hilber A, et al. A systematic review of qualitative findings on factors enabling and deterring uptake of HIV testing in sub-Saharan Africa. BMC Public Health. 2013;13:220. doi: 10.1186/1471-2458-13-220 23497196

33. Kwapong GD, Boateng D, Agyei-Baffour P, Addy EA. Health service barriers to HIV testing and counseling among pregnant women attending antenatal clinic; a cross-sectional study. BMC Health Services Res. 2014;14:267. doi: 10.1186/1472-6963-14-267

34. World Health Organization. Delivering HIV test results and messages for re-testing and counselling in adults. Geneva: World Health Organization; 2010. Available: http://whqlibdoc.who.int/publications/2010/9789241599115_eng.pdf. Accessed 4 August 2015.

35. Rosen S, Fox MP. Retention in HIV care between testing and treatment in sub-Saharan Africa: a systematic review. PLoS Med. 2011;8:e1001056. doi: 10.1371/journal.pmed.1001056 21811403

36. Kranzer K, Govindasamy D, Ford N, Johnston V, Lawn SD. Quantifying and addressing losses along the continuum of care for people living with HIV infection in sub-Saharan Africa: a systematic review. J Int AIDS Soc. 2012;15:17383. doi: 10.7448/IAS.15.2.17383 23199799

37. Hallett TB, Eaton JW. A side door into care cascade for HIV-infected patients? J Acquir Immune Defic Syndr. 2013;63 Suppl 2:S228–S232. doi: 10.1097/QAI.0b013e318298721b 23764640

38. Thirumurthy H, Masters SH, Rao S, Bronson MA, Lanham M, Omanga E, et al. Effect of providing conditional economic compensation on uptake of voluntary medical male circumcision in Kenya: a randomized clinical trial. JAMA. 2014;312:703–711. doi: 10.1001/jama.2014.9087 25042290

39. Cambiano V, Mavedzenge SN, Phillips A. Modelling the potential population impact and cost-effectiveness of self-testing for HIV: evaluation of data requirements. AIDS Behav. 2014;18 Suppl 4:S450–S458. doi: 10.1007/s10461-014-0824-x 24957978

40. Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, et al. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial. PLoS Med. 2014;11:e1001768. doi: 10.1371/journal.pmed.1001768 25513807

41. Namakhoma I, Bongololo G, Bello G, Nyirenda L, Phoya A, Phiri S, et al. Negotiating multiple barriers: health workers’ access to counselling, testing and treatment in Malawi. AIDS Care. 2010;22 Suppl 1:68–76. doi: 10.1080/09540121003607241 20680862

42. Wachira J, Kimaiyo S, Ndege S, Mamlin J, Braitstein P. What is the impact of home-based HIV counseling and testing on the clinical status of newly enrolled adults in a large HIV care program in Western Kenya? Clin Infect Dis. 2012;54:275–281. doi: 10.1093/cid/cir789 22156847

43. May M, Boulle A, Phiri S, Messou E, Myer L, Wood R, et al. Prognosis of patients with HIV-1 infection starting antiretroviral therapy in sub-Saharan Africa: a collaborative analysis of scale-up programmes. Lancet. 2010;376:449–457. doi: 10.1016/S0140-6736(10)60666-6 20638120

44. Leisegang R, Cleary S, Hislop M, Davidse A, Regensberg L, Little F, et al. Early and late direct costs in a Southern African antiretroviral treatment programme: a retrospective cohort analysis. PLoS Med. 2009;6:e1000189. doi: 10.1371/journal.pmed.1000189 19956658

45. Shanks L, Klarkowski D, O’Brien DP. False positive HIV diagnoses in resource limited settings: operational lessons learned for HIV programmes. PLoS ONE. 2013;8:e59906. doi: 10.1371/journal.pone.0059906 23527284

46. Jafa K, Patel P, MacKellar DA, Sullivan PS, Delaney KP, Sides TL, et al. Investigation of false positive results with an oral fluid rapid HIV-1/2 antibody test. PLoS ONE. 2007;2:e185. 17268576

47. Food and Drug Administration Blood Products Advisory Committee. OraSure Technologies: final advisory committee briefing materials—available for public release. OraQuick In-Home HIV Test. Washington (District of Columbia): Food and Drug Administration Blood Products Advisory Committee; 2012. Available: http://www.fda.gov/downloads/Adviso…uctsAdvisoryCommittee/UCM303652.pdf. Accessed 4 August 2015.

48. US Food and Drug Administration. OraQuick In-Home HIV Test: summary of safety and effectiveness. Available: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/PremarketApprovalsPMAs/UCM312534.pdf. Accessed 1 June 2014.

49. Kumwenda M, Munthali A, Phiri M, Mwale D, Gutteberg T, MacPherson E, et al. Factors shaping initial decision-making to self-test amongst cohabiting couples in urban Blantyre, Malawi. AIDS Behav. 2014;18 Suppl 4:S396–S404. doi: 10.1007/s10461-014-0817-9 24929834

50. Obermeyer CM, Verhulst C, Asmar K, MATCH study group. Could you have said no? A mixed-methods investigation of consent to HIV tests in four African countries. J Int AIDS Soc. 2014;17:18898. doi: 10.7448/IAS.17.1.18898 24647205

51. Musheke M, Bond V, Merten S. Couple experiences of provider-initiated couple HIV testing in an antenatal clinic in Lusaka, Zambia: lessons for policy and practice. BMC Health Serv Res. 2013;13:97. doi: 10.1186/1472-6963-13-97 23496926