Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: A cluster-randomized controlled health systems trial

1. The Joint United Nations Programme on HIV/AIDS. Ending AIDS: Progress Towards the 90-90-90 Targets. Geneva: Joint United Nations Programme on HIV/AIDS; 2017 [cited 2017 Aug 1]. Available from: http://www.unaids.org/sites/default/files/media_asset/Global_AIDS_update_2017_en.pdf

2. The Joint United Nations Programme on HIV/AIDS. 90–90–90—An ambitious treatment target to help end the AIDS epidemic. Geneva: Joint United Nations Programme on HIV/AIDS; 2017 [cited 2017 Nov 14]. Available from: http://www.unaids.org/en/resources/documents/2014/90-90-90

3. Donnell D, Baeten JM, Kiarie J, Thomas KK, Stevens W, Cohen CR, et al. Heterosexual HIV-1 transmission after initiation of antiretroviral therapy: a prospective cohort analysis. Lancet. 2010 Jun;375(9731):2092–8. doi: 10.1016/S0140-6736(10)60705-2 20537376

4. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States—2014; a clinical practice guideline. Atlanta, GA: Centers for Disease Control and Prevention; 2014 [cited 2017 Jul 7]. Available from: https://www.cdc.gov/hiv/pdf/prepguidelines2014.pdf

5. Fox MP, Rosen S. A new cascade of HIV care for the era of “treat all.” PLoS Med. 2017 Apr 11;14(4):e1002268. doi: 10.1371/journal.pmed.1002268 28399160

6. Iwuji C, Orne-Gliemann J, Balestre E. The impact of universal test and treat on HIV incidence in a rural South African population: ANRS 12249 TasP trial, 2012–2016. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa.

7. Haber N, Tanser F, Bor J, Naidu K, Mutevedzi T, Herbst K, et al. From HIV infection to therapeutic response: a population-based longitudinal HIV cascade-of-care study in KwaZulu-Natal, South Africa. Lancet HIV. 2017 May;4(5):e223–e230. doi: 10.1016/S2352-3018(16)30224-7

8. Nsanzimana S, Kanters S, Remera E, Forrest JI, Binagwaho A, Condo J, et al. HIV care continuum in Rwanda: a cross-sectional analysis of the national programme. Lancet HIV. 2015 May;2(5):e208–215. doi: 10.1016/S2352-3018(15)00024-7 26423003

9. 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 Nov 19;15(2):17383. doi: 10.7448/IAS.15.2.17383

10. 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 Aug 11;365(6):493–505. doi: 10.1056/NEJMoa1105243 21767103

11. Bunnell R, Mermin J, Cock KMD. HIV Prevention for a Threatened Continent: Implementing Positive Prevention in Africa. JAMA. 2006 Aug 16;296(7):855–8. doi: 10.1001/jama.296.7.855 16905790

12. Kennedy CE, Medley AM, Sweat MD, O’Reilly KR. Behavioural interventions for HIV positive prevention in developing countries: a systematic review and meta-analysis. Bull World Health Organ. 2010 Aug;88(8):615–23. doi: 10.2471/BLT.09.068213 20680127

13. The World Health Organization. Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV. Geneva: World Health Organization; 2015 [cited 2017 Nov 14]. Available from: http://www.who.int/hiv/pub/guidelines/earlyrelease-arv/en/

14. Baral S, Beyrer C, Muessig K, Poteat T, Wirtz AL, Decker MR, et al. Burden of HIV among female sex workers in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Infect Dis. 2012 Jul 1;12(7):538–49. doi: 10.1016/S1473-3099(12)70066-X 22424777

15. Shannon K, Strathdee SA, Goldenberg SM, Duff P, Mwangi P, Rusakova M, et al. Global epidemiology of HIV among female sex workers: influence of structural determinants. Lancet. 2015 Jan 3;385(9962):55–71. doi: 10.1016/S0140-6736(14)60931-4 25059947

16. The Joint United Nations Programme on HIV/AIDS. The Gap Report. Geneva: Joint United Nations Programme on HIV/AIDS; 2014 [cited 2017 Nov 14]. Available from: http://www.unaids.org/sites/default/files/media_asset/UNAIDS_Gap_report_en.pdf

17. The World Health Organization. Consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations. Geneva, Switzerland: World Health Organization; 2016 Update [cited 2017 Nov 14]. Available from: http://apps.who.int/iris/bitstream/10665/246200/1/9789241511124-eng.pdf

18. The World Health Organization. Consolidated Guidelines on HIV Testing Services; 5Cs: Consent, Confidentiatlity, Counseling, Correct Results and Connection. Geneva, Switzerland: World Health Organization; 2015 Jul.

19. The World Health Organization. Prevention and Treatment of HIV and Other Sexually Transmitted Infections for Sex Workers in Low- and Middle-Income Countries. Geneva, Switzerland: World Health Organization; 2012 Dec [cited 2017 Aug 19]. Available from: http://apps.who.int/iris/bitstream/10665/77745/1/9789241504744_eng.pdf

20. Schwartz S, Lambert A, Phaswana-Mafuya N, Kose Z, Mcingana M, Holland C, et al. Engagement in the HIV care cascade and barriers to antiretroviral therapy uptake among female sex workers in Port Elizabeth, South Africa: Findings from a respondent-driven sampling study. Sex Transm Infect. 2017 Jun;93(4):290–296. doi: 10.1136/sextrans-2016-052773

21. Cowan FM, Davey CB, Fearon E, Mushati P, Dirawo J, Cambiano V, et al. The HIV Care Cascade Among Female Sex Workers in Zimbabwe: Results of a Population-Based Survey From the Sisters Antiretroviral Therapy Programme for Prevention of HIV, an Integrated Response (SAPPH-IRe) Trial. J Acquir Immune Defic Syndr. 2017 Apr 1;74(4):375–82. doi: 10.1097/QAI.0000000000001255 27930599

22. Gupta S, Granich R. National HIV Care Continua for Key Populations: 2010 to 2016. J Int Assoc Provid AIDS Care JIAPAC. 2017 Mar 1;16(2):125–32. doi: 10.1177/2325957416686195 28090799

23. Chanda M, Perez-Brumer A, Ortblad K, Mwale M, Chongo S, Kamungoma N, et al. Barriers and facilitators to HIV testing among Zambia female sex workers in three transit hubs. AIDS Patient Care STDs. 2017 Jul;31(7):290–296. doi: 10.1089/apc.2017.0016 28581820

24. Wanyenze RK, Musinguzi G, Kiguli J, Nuwaha F, Mujisha G, Musinguzi J, et al. “When they know that you are a sex worker, you will be the last person to be treated”: Perceptions and experiences of female sex workers in accessing HIV services in Uganda. BMC Int Health Hum Rights. 2017 May 5;17(1):11. doi: 10.1186/s12914-017-0119-1 28476153

25. Lancaster KE, Cernigliaro D, Zulliger R, Fleming PF. HIV care and treatment experiences among female sex workers living with HIV in sub-Saharan Africa: A systematic review. Afr J AIDS Res AJAR. 2016 Dec;15(4):377–86. doi: 10.2989/16085906.2016.1255652 27974017

26. Lafort Y, Lessitala F, Candrinho B, Greener L, Greener R, Beksinska M, et al. Barriers to HIV and sexual and reproductive health care for female sex workers in Tete, Mozambique: results from a cross-sectional survey and focus group discussions. BMC Public Health. 2016;16:608. doi: 10.1186/s12889-016-3305-5 27440108

27. 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 Jul 1;57(1):126–38. doi: 10.1093/cid/cit156 23487385

28. Brown AN, Djimeu EW, Cameron DB. A Review of the Evidence of Harm from Self-Tests. AIDS Behav. 2014;18(Suppl 4):445–9.

29. Medley A, Kennedy C, O’Reilly K, Sweat M. Effectiveness of Peer Education Interventions for HIV Prevention in Developing Countries: A Systematic Review and Meta-Analysis. AIDS Educ Prev. 2009 Jun 1;21(3):181–206. doi: 10.1521/aeap.2009.21.3.181 19519235

30. George A, Blankenship KM. Peer Outreach Work as Economic Activity: Implications for HIV Prevention Interventions among Female Sex Workers. PLoS ONE. 2015 Mar 16;10(3):e0119729. doi: 10.1371/journal.pone.0119729 25775122

31. Luchters S, Chersich MF, Rinyiru A, Barasa M- S, King’ola N, Mandaliya K, et al. Impact of five years of peer-mediated interventions on sexual behavior and sexually transmitted infections among female sex workers in Mombasa, Kenya. BMC Public Health. 2008;8:143. doi: 10.1186/1471-2458-8-143 18445258

32. Ngugi EN, Wilson D, Sebstad J, Plummer FA, Moses S. Focused Peer-Mediated Educational Programs Among Female Sex Workers To Reduce Sexually Transmitted Disease And Human Immunodeficiency Virus Transmission In Kenya And Zimbabwe. J Infect Dis. 1996 Oct 1;174(Supplement_2):S240–7.

33. Shahmanesh M, Patel V, Mabey D, Cowan F. Effectiveness of interventions for the prevention of HIV and other sexually transmitted infections in female sex workers in resource poor setting: a systematic review. Trop Med Int Health. 2008 May 1;13(5):659–79. doi: 10.1111/j.1365-3156.2008.02040.x 18266784

34. Pai NP, 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 Apr 2;10(4):e1001414. doi: 10.1371/journal.pmed.1001414 23565066

35. Krause J, Subklew-Sehume F, Kenyon C, Colebunders R. Acceptability of HIV self-testing: a systematic literature review. BMC Public Health. 2013 Aug 8;13(1):735.

36. Mokgatle MM, Madiba S. High Acceptability of HIV Self-Testing among Technical Vocational Education and Training College Students in Gauteng and North West Province: What Are the Implications for the Scale Up in South Africa? PLoS ONE. 2017 Jan 31;12(1):e0169765. doi: 10.1371/journal.pone.0169765 28141858

37. Zerbe A, DiCarlo A, Mantell J, Remien R, Morris D, Frederix K, et al. Acceptability and uptake of home-baed HIV self-testing in Lesotho. Conference on Retroviruses and Opportunistic Infections; February 23-26, 2015; Seattle, USA.

38. Figueroa C, Johnson C, Verster A, Baggaley R. Attitudes and Acceptability on HIV Self-testing Among Key Populations: A Literature Review. AIDS Behav. 2015 Jun 9;19(11): 1–17, 1949–65.

39. Pérez GM, Cox V, Ellman T, Moore A, Patten G, Shroufi A, et al. “I Know that I Do Have HIV but Nobody Saw Me”: Oral HIV Self-Testing in an Informal Settlement in South Africa. PLoS ONE. 2016 Apr 4;11(4):e0152653. doi: 10.1371/journal.pone.0152653 27044006

40. 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 Jul;18 Suppl 4:S396–404.

41. Brown W, Carballo-Diéguez A, John RM, Schnall R. Information, Motivation, and Behavioral Skills of High-Risk Young Adults to Use the HIV Self-Test. AIDS Behav. 2016 Sep 1;20(9):2000–9. doi: 10.1007/s10461-016-1309-x 26885813

42. Mugo PM, Micheni M, Shangala J, Hussein MH, Graham SM, Wit TFR de, et al. Uptake and Acceptability of Oral HIV Self-Testing among Community Pharmacy Clients in Kenya: A Feasibility Study. PLoS ONE. 2017 Jan 26;12(1):e0170868. doi: 10.1371/journal.pone.0170868 28125699

43. Choko AT, MacPherson P, Webb EL, Willey BA, Feasy H, Sambakunsi R, et al. 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. PLoS Med. 2015 Sep;12(9):e1001873. doi: 10.1371/journal.pmed.1001873 26348035

44. 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 Oct 4;8(10):e1001102. doi: 10.1371/journal.pmed.1001102 21990966

45. Ayles H, Floyd S, Mulubwa C, Hensen B, Schaap A, Phiri B, et al. Increasing knowledge of HIV status among men: a cluster-randomised trial of community-based distribution of oral HIV self-test kits nested in four HPTN 071 communities in Zambia. 9th IAS Conference on HIV Science; July 23-26, 2017; Paris, France; 2017 [cited 2017 Nov 14]. Available from: http://programme.ias2017.org/Abstract/Abstract/5600

46. Gichangi A, Wambua J, Gohole A, Mutwiwa S, Njogu R, Bazant E. Provision of oral HIV self-test kits triples uptake of HIV testing among male partners of antenatal care clients: results of a randomized trial in Kenya. 21st International AIDS Conference; July 18-22, 2016; Durban, South Africa.

47. Masters SH, Agot K, Obonyo B, Mavedzenge SN, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166 27824882

48. Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266–274. doi: 10.1016/S2352-3018(16)00041-2 27240789

49. Johnson CC, Kennedy C, Fonner V, Siegfried N, Figueroa C, Dalal S, et al. Examining the effects of HIV self-testing compared to standard HIV testing services: a systematic review and meta-analysis. J Int AIDS Soc. 2017 May 15;20(1):21594. doi: 10.7448/IAS.20.1.21594

50. Wang Z, Lau J, Ip M, Ho S, Mo P, Latkin C, et al. A randomized controlled trial evaluating efficacy of promoting a home-based HIV self-testing with online counseling on increasing HIV testing among men who have sex with men. AIDS Behav. 2017 Aug. doi: 10.1007/s10461-017-1887-2. [Epub ahead of print] 28831616

51. Wang Z, Lau J, Ip M, Ho S. A randomized controlled trial evaluating the efficacy of promoting HIV self-testing and online real-time counseling on increasing HIV testing among men who have sex with men in Hong Kong. International Congress of Behavioral Medicine. December 7–10, 2016. Melbourne, Australia.

52. Katz D, Golden M, Hughes J, Farquhar C, Stekler J. HIV self-testing increases HIV testing frequency among high-risk men who have sex with men: a randomized controlled trial. IAS 2015. 8th Conference on HIV Pathogenesis, Treatment and Prevention. July 19–22, 2015. Vancouver, Canada. Abstract MOPDC0103.

53. Jamil MS, Prestage G, Fairley CK, Grulich AE, Smith KS, Chen M, et al. Effect of availability of HIV self-testing on HIV testing frequency in gay and bisexual men at high risk of infection (FORTH): a waiting-list randomised controlled trial. Lancet HIV. 2017 Jun;4(6):e241–50. doi: 10.1016/S2352-3018(17)30023-1 28219619

54. Chanda MM, Ortblad KF, Mwale M, Chongo S, Kanchele C, Kamungoma N, et al. (2017) HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial. PLoS Med 14(11):e1002442. doi: 10.1371/journal.pmed.1002442

55. Centers for Disease Control and Prevention. The Crane Survey: Female sex workers (FSW) in Kampala. Entebbe: Centers for Disease Control and Prevention; 2009 Dec [cited 2017 Mar 28]. Available from: https://docs.google.com/viewer?a=v&pid=sites&srcid=ZGVmYXVsdGRvbWFpbnxjcmFuZXN1cnZleXxneDo3NzE4MjNjM2YwYzRkY2E4

56. The Joint United Nations Programme on HIV/AIDS. Global AIDS Update 2016. Geneva: Joint United Nations Programme on HIV/AIDS; 2016 [cited 2017 Nov 14]. Available from: http://www.unaids.org/sites/default/files/media_asset/global-AIDS-update-2016_en.pdf

57. The Ugandan Ministry of Health. MARPI—Most at Risk Populations Initiatives. [cited 2017 Apr 27]. Available from: http://www.marpi.org/marpi/about_us

58. HIV self-testing research and policy hub: Uganda. 2017 [cited 2017 Jun 7]. Available from: http://hivst.org/policy/uganda

59. The Ugandan Ministry of Health. Consolidated Guidelines for Prevention and Treatment of HIV in Uganda. Kampala, Uganda: Ugandan Ministry of Health; 2016 Dec.

60. The World Bank Group. PPP conversion factor, GDP (LCU per international $). Washington, DC: World Bank; 2017 [cited 2017 Sep 28]. Available from: https://data.worldbank.org/indicator/PA.NUS.PPP

61. Kang M, Ragan BG, Park J-H. Issues in Outcomes Research: An Overview of Randomization Techniques for Clinical Trials. J Athl Train. 2008 Mar 1;43(2):215–21. doi: 10.4085/1062-6050-43.2.215 18345348

62. Hemming K, Marsh J. A menu-driven facility for sample-size calculations in cluster randomized controlled trials. Stata J. 2013;13(1):114–35.

63. Montori VM, Guyatt GH. Intention-to-treat principle. CMAJ Can Med Assoc J. 2001 Nov 13;165(10):1339–41.

64. Gupta SK. Intention-to-treat concept: A review. Perspect Clin Res. 2011;2(3):109–12. doi: 10.4103/2229-3485.83221 21897887

65. Ranganathan P, Pramesh CS, Aggarwal R. Common pitfalls in statistical analysis: Intention-to-treat versus per-protocol analysis. Perspect Clin Res. 2016;7(3):144–6. doi: 10.4103/2229-3485.184823 27453832

66. Zou G. A modified poisson regression approach to prospective studies with binary data. Am J Epidemiol. 2004 Apr 1;159(7):702–6. 15033648

67. Ngure K, Heffron R, Mugo N, Thomson KA, Irungu E, Njuguna N, et al. Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya. J Int AIDS Soc. 2017 10;20(1):21234. doi: 10.7448/IAS.20.1.21234 28362073

68. Suntharasamai P, Martin M, Choopanya K, Vanichseni S, Sangkum U, Tararut P, et al. Assessment of Oral Fluid HIV Test Performance in an HIV Pre-Exposure Prophylaxis Trial in Bangkok, Thailand. PLoS ONE. 2015 Dec 30;10(12):e0145859. doi: 10.1371/journal.pone.0145859 26717405

69. Southern African HIV Clinicians Society. South African HIV Self-Testing Policy and Guidance Considerations: A supplement to the National HIV Testing Services Policy 2016. Johannesburg, South Africa: Southern African HIV Clinicians Society, 2017.

70. The Kenyan Ministry of Health. The Kenya HIV Testing Services Guidelines. Nairobi, Kenya: Kenyan Ministry of Health; 2015 Oct.

71. HIVST.org. Policy: HIV self-testing research and policy hub. HIVST.org. 2017 [cited 2017 Aug 20]. Available from: http://www.hivst.org/policy

72. Asiimwe S, Oloya J, Song X, Whalen CC. Accuracy of Un-supervised Versus Provider-Supervised Self-administered HIV Testing in Uganda: A Randomized Implementation Trial. AIDS Behav. 2014 Apr 2;18(12):2477–84. doi: 10.1007/s10461-014-0765-4 24691923

73. Kurth AE, Cleland CM, Chhun N, Sidle JE, Were E, Naanyu V, et al. Accuracy and Acceptability of Oral Fluid HIV Self-Testing in a General Adult Population in Kenya. AIDS Behav. 2016;20:870–9. doi: 10.1007/s10461-015-1213-9 26438487

74. Arem H, Nakyanjo N, Kagaayi J, Mulamba J, Nakigozi G, Serwadda D, et al. Peer health workers and AIDS care in Rakai, Uganda: a mixed methods operations research evaluation of a cluster-randomized trial. AIDS Patient Care STDs. 2011 Dec;25(12):719–24. doi: 10.1089/apc.2010.0349 21391828

75. Chang LW, Kagaayi J, Nakigozi G, Ssempijja V, Packer AH, Serwadda D, et al. Effect of peer health workers on AIDS care in Rakai, Uganda: a cluster-randomized trial. PLoS ONE. 2010 Jun 2;5(6):e10923. doi: 10.1371/journal.pone.0010923 20532194

76. Kipp W, Konde-Lule J, Saunders LD, Alibhai A, Houston S, Rubaale T, et al. Results of a community-based antiretroviral treatment program for HIV-1 infection in Western Uganda. Curr HIV Res. 2010 Mar;8(2):179–85. 20163349

77. Iwuji CC, Orne-Gliemann J, Larmarange J, Okesola N, Tanser F, Thiebaut R, et al. Uptake of Home-Based HIV Testing, Linkage to Care, and Community Attitudes about ART in Rural KwaZulu-Natal, South Africa: Descriptive Results from the First Phase of the ANRS 12249 TasP Cluster-Randomised Trial. PLoS Med. 2016 Aug;13(8):e1002107. doi: 10.1371/journal.pmed.1002107 27504637

78. Bassett IV, Wilson D, Taaffe J, Freedberg KA. Financial incentives to improve progression through the HIV treatment cascade. Curr Opin HIV AIDS. 2015 Nov;10(6):451–63. doi: 10.1097/COH.0000000000000196 26371461

79. Govindasamy D, Meghij J, Negussi EK, Baggaley RC, Ford N, Kranzer K. Interventions to improve or facilitate linkage to or retention in pre-ART (HIV) care and initiation of ART in low- and middle-income settings–a systematic review. J Int AIDS Soc. 2014 Aug 1;17(1). Available from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4122816/