Contemporary clinical trials · 2021
The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria.
Протокол клинического исследованияСтатьяПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Iwelunmor Juliet, Tucker Joseph D, Obiezu-Umeh Chisom, Gbaja-Biamila Titilola, Oladele David, Nwaozuru Ucheoma, Musa Adesola Z, Airhihenbuwa Collins O, Muessig Kathryn, Rosenberg Nora, BeLue Rhonda, Xian Hong, Conserve Donaldson F, Ong Jason J, Zhang Lei, Curley Jamie, Nkengasong Susan, Mason Stacey, Tang Weiming, Bayus Barry, Ogedegbe Gbenga, Ezechi Oliver
Аннотация
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).
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).