TY - JOUR
T1 - The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability
T2 - Study protocol in Nigeria
AU - Iwelunmor, Juliet
AU - Tucker, Joseph D.
AU - Obiezu-Umeh, Chisom
AU - Gbaja-Biamila, Titilola
AU - Oladele, David
AU - Nwaozuru, Ucheoma
AU - Musa, Adesola Z.
AU - Airhihenbuwa, Collins O.
AU - Muessig, Kathryn
AU - Rosenberg, Nora
AU - BeLue, Rhonda
AU - Xian, Hong
AU - Conserve, Donaldson F.
AU - Ong, Jason J.
AU - Zhang, Lei
AU - Curley, Jamie
AU - Nkengasong, Susan
AU - Mason, Stacey
AU - Tang, Weiming
AU - Bayus, Barry
AU - Ogedegbe, Gbenga
AU - Ezechi, Oliver
N1 - Publisher Copyright:
© 2021
PY - 2022/3
Y1 - 2022/3
N2 - 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.gov NCT04710784 (on January 15, 2021).
AB - 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.gov NCT04710784 (on January 15, 2021).
KW - HIV
KW - HIV self-testing
KW - Nigeria
KW - Participatory implementation strategies
KW - Sexually transmitted infections
KW - Stepped-wedge cluster-randomized controlled trial
KW - Youth
KW - Humans
KW - HIV Infections/diagnosis
KW - Randomized Controlled Trials as Topic
KW - Young Adult
KW - HIV Testing
KW - Motivation
KW - Adolescent
KW - Self-Testing
KW - Adult
UR - http://www.scopus.com/inward/record.url?scp=85123316623&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85123316623&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2021.106628
DO - 10.1016/j.cct.2021.106628
M3 - Article
C2 - 34800699
AN - SCOPUS:85123316623
SN - 1551-7144
VL - 114
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106628
ER -