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BMC Public Health
Published in: BMC Public Health 1/2022

Open Access 01-12-2022 | Hepatitis B Vaccination | Research

Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya

Authors: Elizabeth Mueni Mutisya, Vincent Muturi-Kioi, Andrew Abaasa, Delvin Nyasani, Rhoda W. Kabuti, Laura Lunani, Timothy Kotikot, Moses Mundia, Gaudensia Mutua, Geoffrey Ombati, Hannah Nduta, Matt A. Price, Joshua Kimani, Aggrey Omu Anzala

Published in: BMC Public Health | Issue 1/2022

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Abstract

Objective

To assess the feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya.

Background

HIV prevention trials require the inclusion of those at high risk of HIV infection and their informed decision to take part and remain in the clinical trial to the end is crucial. In Kenya key populations including men who have sex with men (MSM) and female sex workers (FSW) are, disproportionately, at high risk of HIV infection when compared to the general population. Few trials testing biomedical prevention products against HIV have enrolled Kenyan FSW and MSM.

Methods

We performed simulated vaccine efficacy trial (SiVET) using licensed hepatitis B vaccines as substitutes for a HIV vaccine candidate and included randomization for those immune to hep B. The SiVET was an observational study designed to mimic the rigors of a clinical trial; we assessed HIV risk, provided risk counselling and prevention tools and performed HIV testing at baseline and periodically until the end of the trial. MSM and FSW were enrolled at a ratio of 4:1. Volunteers were assigned to either hepatitis B vaccine or placebo.

Results

Recruitment took approximately 24 months between Sep 2015 and Sep 2017. Of the 368 volunteers screened, 250 (200 MSM and 50 FSW) were enrolled. Reasons for exclusion at screening included: being positive for HIV (n = 7), hepatitis (n = 14), other pre-existing medical conditions (n = 41), eligible but chose not to enrol (n = 47). Most of the volunteers adhered to study procedures and attended their study visits within the study window. These include volunteers who received the second vaccination 244 (98%), the third vaccination 228 (91%) and, the final study visit 217 (87%). The reasons volunteers discontinued from the study early included: relocation and loss to follow up (n = 14). A total of 8 cases of HIV infection were observed in 174.5 Person Years at Risk (PYAR), all among MSM, including 5 seroconversions identified at the last study visit, for a HIV incidence of 4.58 cases/ 100 PYAR, among MSM enrolled in the study.

Conclusion

Our findings suggest that it is possible to conduct HIV prevention trials among key populations in Nairobi with a good adherence to a vaccine efficacy trial schedule. Despite HIV prevention efforts, we also noted a high incidence of HIV infection. This demonstrates the need for effective HIV prevention products in these populations.
Literature
1.
Seage GR, Holte SE, Metzger D, Koblin BA, Gross M, Celum C, et al. Are US populations appropriate for trials of human immunodeficiency virus vaccine? The HIVNET vaccine preparedness study. Am J Epidemiol. 2001;153(7):619–27.CrossRef
2.
Djomand G, Metch B, Zorrilla CD, Donastorg Y, Casapia M, Villafana T, et al. The HVTN protocol 903 vaccine preparedness study: lessons learned in preparation for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr. 2008;48(1):82–9.CrossRef
3.
Hariton E, Locascio JJ. Randomised controlled trials – the gold standard for effectiveness research: study design: randomised controlled trials. BJOG: An International Journal of Obstetrics and Gynaecology. 2018;125(13):1716.CrossRef
4.
Sibbald B, Roland M. Why are randomised controlled trials important? Br Med J. 1998;316(7126):201.CrossRef
5.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. Consort 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239.CrossRef
6.
Price MA, Rida W, Mwangome M, Mutua G, Middelkoop K, Roux S, et al. Identifying at-risk populations in Kenya and South Africa: HIV incidence in cohorts of menwho report sex with men, sex workers, and youth. J Acquir Immune Defic Syndr. 2012;59(2):185–93.CrossRef
7.
Nabasumba SB, Lindan K, Abaasa A, Nalutaaya A, Nanvubya A, Price M, et al. Acceptance and adherence to a vaccination schedule in a sivet among adults in fishing communities of Lake Victoria. Uganda: AIDS Res Hum Retroviruses; 2018.
8.
Excler JL, Beyrer C. Human immunodeficiency virus vaccine development in developing countries: are efficacy trials feasible? J Hum Virol. 2000;3(4):193–214.
9.
De Bruyn G, Hudgens MG, Sullivan PS, Duerr AC. Participant retention in clinical trials of candidate HIV vaccines. J Acquir Immune Defic Syndr. 2005;39(4):499–501.CrossRef
10.
Jamieson D, Kellerman SE. The 90 90 90 strategy to end the HIV pandemic by 2030: can the supply chain handle it? J Int AIDS Soc. 2016;19(1):1–4.CrossRef
11.
12.
McKinnon LR, Gakii G, Juno JA, Izulla P, Munyao J, Ireri N, et al. High HIV risk in a cohort of male sex workers from Nairobi. Kenya Sex Transm Infect. 2014;90(3):237–42.CrossRef
13.
Sanders EJ, Okuku HS, Smith AD, Mwangome M, Wahome E, Fegan G, et al. High HIV-1 incidence, correlates of HIV-1 acquisition, and high viral loads following seroconversion among men who have sex with men in coastal Kenya. AIDS. 2013;27(3):437–46.CrossRef
14.
Mutisya EM, Mutua G, Nyasani D, Nduta H, Kabuti RW, Muturi-Kioi V, et al. Willingness to participate in future HIV vaccine trials among men who have sex with men and female sex workers living in Nairobi, Kenya. PLoS One. 2020;15(8):e0238028.CrossRef
15.
16.
17.
McKinnon LR, Izulla P, Nagelkerke N, Munyao J, Wanjiru T, Shaw SY, et al. Risk factors for HIV Acquisition in a Prospective Nairobi-Based Female sex Worker Cohort. AIDS Behav. 2015;19(12):2204–13.CrossRef
18.
Okal J, Geibel S, Muraguri N, Musyoki H, Tun W, Broz D, et al. Estimates of the size of key populations at risk for HIV infection: men who have sex with men, female sex workers and injecting drug users in Nairobi. Sex Transm Infect: Kenya; 2013.
19.
Key Population Mapping and Size Estimation in Selected Counties in Kenya: Phase 1 KEY FINDINGS NATIONAL AIDS AND STI CONTROL PROGRAMME (NASCOP).
20.
Esparza J. Future access to HIV vaccines: report from a WHO-UNAIDS consultation, Geneva, 2-3 October 2000. AIDS. 2001;15(7):W27–44.
21.
22.
Barresi P, Husnik M, Camacho M, Powell B, Gage R, LeBlanc D, et al. Recruitment of men who have sex with men for large HIV intervention trials: analysis of the explore study recruitment effort. AIDS Educ Prev. 2010;22(1):28–36.CrossRef
23.
Blatch-Jones AJ, Pek W, Kirkpatrick E, Ashton-Key M. Role of feasibility and pilot studies in randomised controlled trials: a crosssectional study. BMJ Open. 2018;8(9):e022233.CrossRef
24.
25.
Mayanja Y, Abaasa A, Namale G, Asiki G, Price MA, Kamali A. Factors associated with vaccination completion and retention among HIV negative female sex workers enrolled in a simulated vaccine efficacy trial in Kampala. Uganda BMC Infect Dis. 2019;19(1):1–10.
26.
Doshi M, Avery L, Kaddu RP, Gichuhi M, Gakii G, Du Plessis E, et al. Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials. BMC Public Health. 2017;17(1):469.CrossRef
27.
Chege W, Pals SL, Mclellan-Lemal E, Shinde S, Nyambura M, Otieno FO, et al. Baseline findings of an HIV incidence cohort study to prepare for future HIV prevention clinical trials in Kisumu. Kenya J Infect Dev Ctries. 2012;6(12):870–80.CrossRef
28.
Abaasa A, Asiki G, Price MA, Ruzagira E, Kibengo F, Bahemuka U, et al. Comparison of HIV incidence estimated in clinical trial and observational cohort settings in a high risk fishing population in Uganda: implications for sample size estimates. Vaccine. 2016;34(15):1778–85.CrossRef
29.
30.
National AIDS and STI control programme, Ministry of Health, Kenya. Guidelines for HIV Testing Services in Kenya. Nairobi; NASCOP; 2015.
31.
Ssetaala A, Nakiyingi-Miiro J, Asiimwe S, Nanvubya A, Mpendo J, Asiki G, et al. Recruitment and retention of women in fishing communities in HIV prevention research. Pan Afr Med J. 2015;21:1–10.CrossRef
32.
33.
Doshi M, Avery L, Kaddu RP, Gichuhi M, Gakii G, Du Plessis E, et al. Contextualizing willingness to participate: recommendations for engagement, recruitment & enrolment of Kenyan MSM in future HIV prevention trials. BMC Public Health. 2017;17(1):469.CrossRef
34.
Ruzagira E, Wandiembe S, Abaasa A, Levin J, Bwanika A, Bahemuka U, et al. Prevalence and incidence of HIV in a rural community-based HIV vaccine preparedness cohort in Masaka, Uganda. PLoS One. 2011;6(6):e20684.CrossRef
35.
Abaasa A, Todd J, Nash S, Mayanja Y, Kaleebu P, Fast PE, et al. Comparison of retention in observational cohorts and nested simulated HIV vaccine efficacy trials in the key populations in Uganda. BMC Med Res Methodol. 2020;20(1):1–12.CrossRef
36.
Kiwanuka N, Ssetaala A, Nalutaaya A, Mpendo J, Wambuzi M, Nanvubya A, et al. High incidence of HIV-1 infection in a general population of fishing communities around Lake Victoria, Uganda. PLoS One. 2014;9(5):e94932.CrossRef
37.
Bell ML, Kenward MG, Fairclough DL, Horton NJ. Differential dropout and bias in randomised controlled trials: when it matters and when it may not. BMJ. 2013;346:1–7.CrossRef
38.
Nunn AJ, Wagner HU, Kamali A, Kengeya-Kayondo JF, Mulder DW. Migration and HIV-1 seroprevalence in a rural Ugandan population. AIDS. 1995;9(5):503–6.CrossRef
39.
40.
Fakoya I, Álvarez-Del Arco D, Woode-Owusu M, Monge S, Rivero-Montesdeoca Y, Delpech V, et al. A systematic review of post-migration acquisition of HIV among migrants from countries with generalised HIV epidemics living in Europe: mplications for effectively managing HIV prevention programmes and. BMC Public Health. 2015;15:561.CrossRef
41.
Janes H, Donnell D, Gilbert PB, Brown ER, Nason M. Taking stock of the present and looking ahead: envisioning challenges in the design of future HIV prevention efficacy trials. The Lancet HIV. 2019;6(7):e475–82.CrossRef
42.
Janes H, Gilbert P, Buchbinder S, Kublin J, Sobieszczyk ME, Hammer SM. In pursuit of an HIV vaccine: designing efficacy trials in the context of partially effective nonvaccine prevention modalities. AIDS Res Hum Retrovir. 2013;29(11):1513–23.CrossRef
43.
Ruzagira E, Wandiembe S, Abaasa A, Bwanika AN, Bahemuka U, Amornkul P, et al. HIV incidence and risk factors for acquisition in HIV discordant couples in Masaka. Uganda: An hiv vaccine preparedness study. PLoS One; 2011.
44.
Buchbinder SP, Douglas JM, McKirnan DJ, Judson FN, Katz MH, MacQueen KM. Feasibility of human immunodeficiency virus vaccine trials in homosexual men in the United States: risk behavior, seroincidence, and willingness to participate. J Infect Dis. 1996;174(5):954–61.CrossRef
Metadata
Title
Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya
Authors
Elizabeth Mueni Mutisya
Vincent Muturi-Kioi
Andrew Abaasa
Delvin Nyasani
Rhoda W. Kabuti
Laura Lunani
Timothy Kotikot
Moses Mundia
Gaudensia Mutua
Geoffrey Ombati
Hannah Nduta
Matt A. Price
Joshua Kimani
Aggrey Omu Anzala
Publication date
01-12-2022
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2022
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-022-14875-2

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