The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria

Juliet Iwelunmor¹, Joseph D Tucker², Chisom Obiezu-Umeh³, Titilola Gbaja-Biamila⁴, David Oladele⁴, Ucheoma Nwaozuru⁵, Adesola Z Musa⁶, Collins O Airhihenbuwa⁷, Kathryn Muessig⁸, Nora Rosenberg⁸, Rhonda BeLue³, Hong Xian³, Donaldson F Conserve⁹, Jason J Ong¹⁰, Lei Zhang¹¹, Jamie Curley³, Susan Nkengasong¹², Stacey Mason³, Weiming Tang¹³, Barry Bayus¹⁴, Gbenga Ogedegbe¹⁵, Oliver Ezechi⁴

Affiliations

¹ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA. Electronic address: juliet.iwelunmor@slu.edu.
² Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
³ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA.
⁴ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA; Clinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
⁵ Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
⁶ Clinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
⁷ Heath Policy and Behavioral Sciences, School of Public Health, Georgia State University, Atlanta, GA, USA.
⁸ Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁹ Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
¹⁰ Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK; Central Clinical School, Monash University, Melbourne, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia.
¹¹ Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia.
¹² Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
¹³ Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁴ Kenan-Flagler Business School, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁵ Center for Healthful Behavior Change, Division of Health and Behavior, Department of Population Health, New York University School of Medicine, NY, New York, USA.

PMID: 34800699
PMCID: PMC9358609
DOI: 10.1016/j.cct.2021.106628

The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria

Juliet Iwelunmor et al. Contemp Clin Trials. 2022 Mar.

. 2022 Mar:114:106628.

doi: 10.1016/j.cct.2021.106628. Epub 2021 Nov 17.

Authors

Affiliations

¹ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA. Electronic address: juliet.iwelunmor@slu.edu.
² Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.
³ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA.
⁴ College for Public Health & Social Justice, Saint Louis University, Saint Louis, MO, USA; Clinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
⁵ Department of Implementation Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
⁶ Clinical Sciences Department, Nigerian Institute of Medical Research, Lagos, Nigeria.
⁷ Heath Policy and Behavioral Sciences, School of Public Health, Georgia State University, Atlanta, GA, USA.
⁸ Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁹ Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
¹⁰ Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK; Central Clinical School, Monash University, Melbourne, Australia; Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia.
¹¹ Melbourne Sexual Health Centre, Alfred Health, Melbourne, Australia.
¹² Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK.
¹³ Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁴ Kenan-Flagler Business School, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
¹⁵ Center for Healthful Behavior Change, Division of Health and Behavior, Department of Population Health, New York University School of Medicine, NY, New York, USA.

PMID: 34800699
PMCID: PMC9358609
DOI: 10.1016/j.cct.2021.106628

Abstract

Background: The World Health Organization recommends HIV self-testing (HIVST) as an additional approach to HIV testing and the Nigerian government is supportive of this policy recommendation. However, effectively increasing uptake and sustainability among Nigerian youth is unknown. The goal of this study is to conduct a full-powered type I hybrid effectiveness-implementation trial to test the effectiveness of youth-friendly implementation science strategies in increasing uptake and sustainability of HIVST led by and for Nigerian youth.

Methods: Our 4 Youth by Youth (4YBY) strategy combines four core elements: 1) HIVST bundle consisting of HIVST kits and photo verification system; 2) a participatory learning community; 3) peer to peer support and technical assistance; and 4) on-site supervision and performance feedback to improve uptake and sustainability of HIVST and enhance linkage to youth-friendly health clinics for confirmatory HIV testing where needed, sexually transmitted infection (STI) testing (i.e. syphilis, gonorrhea, chlamydia, and hepatitis, STI treatment, and PrEP referral. Utilizing a stepped-wedge, cluster-randomized controlled trial, a national cohort of youth aged 14-24 recruited from 32 local government areas across 14 states and four geo-political zones in Nigeria will receive the 4YBY implementation strategy. In addition, an economic evaluation will explore the incremental cost per quality adjusted life year gained.

Discussion: This study will add to the limited "how-to-do it literature" on implementation science strategies in a resource-limited setting targeting youth population traditionally underrepresented in implementation science literature. Study findings will also optimize uptake and sustainability of HIVST led by and for young people themselves.

Trial registration: This study is registered in ClinicalTrials.govNCT04710784 (on January 15, 2021).

Keywords: HIV; HIV self-testing; Nigeria; Participatory implementation strategies; Sexually transmitted infections; Stepped-wedge cluster-randomized controlled trial; Youth.

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Conflict of interest statement

Declaration of Competing Interest

All authors declare that they have no competing interests.

Figures

**Fig. 1.**
Study sites (LGA: Local Government Area).

**Fig. 2.**
Stepped-wedge study design and timeline.

**Fig. 3.**
4 Youth by Youth (4YBY) implementation strategies

See this image and copyright information in PMC

References

1. Kurth AE, Celum C, Baeten JM, Vermund SH, Wasserheit JN, Combination HIV prevention: significance, challenges, and opportunities, Curr. HIV/AIDS Reports 8 (1) (2011) 62–72. - PMC - PubMed
1. Guidelines on HIV Self-Testing and Partner Notification: Supplement to Consolidated Guidelines on HIV Testing Services, World Health Organization, Geneva, 2016. [Available from: https://www.ncbi.nlm.nih.gov/books/NBK401675/. - PubMed
1. UNICEF, HIV and AIDS in Adolescents: Turning the Tide Against AIDS will Require More Concentrated Focus on Adolescents and Young People, Available from, https://data.unicef.org/topic/adolescents/hiv-aids/, 2020.
1. Ajayi AI, Awopegba OE, Adeagbo OA, Ushie BA, Low coverage of HIV testing among adolescents and young adults in Nigeria: implication for achieving the UNAIDS first 95, PLoS One 15 (5) (2020), e0233368. - PMC - PubMed
1. Nwaozuru U, Iwelunmor J, Ong JJ, Salah S, Obiezu-Umeh C, Ezechi O, et al. , Preferences for HIV testing services among young people in Nigeria, BMC Health Serv. Res 19 (1) (2019) 1003. - PMC - PubMed

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The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria

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The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria

Authors

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Conflict of interest statement

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