The 4 Youth by Youth (4YBY) pragmatic trial to enhance HIV self-testing uptake and sustainability: Study protocol in Nigeria.
HIV
HIV self-testing
Nigeria
Participatory implementation strategies
Sexually transmitted infections
Stepped-wedge cluster-randomized controlled trial
Youth
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
03 2022
03 2022
Historique:
received:
30
06
2021
revised:
11
11
2021
accepted:
14
11
2021
pubmed:
21
11
2021
medline:
1
4
2022
entrez:
20
11
2021
Statut:
ppublish
Résumé
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. 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. 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. This study is registered in ClinicalTrials.govNCT04710784 (on January 15, 2021).
Sections du résumé
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).
Identifiants
pubmed: 34800699
pii: S1551-7144(21)00364-5
doi: 10.1016/j.cct.2021.106628
pmc: PMC9358609
mid: NIHMS1819569
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04710784']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106628Subventions
Organisme : NICHD NIH HHS
ID : UG3 HD096929
Pays : United States
Organisme : NICHD NIH HHS
ID : UH3 HD096929
Pays : United States
Informations de copyright
Copyright © 2021. Published by Elsevier Inc.
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