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A randomized stepped wedge trial of an intensive combination approach to roll back the HIV epidemic in Nigerian adolescents: iCARE Nigeria treatment support protocol.

Authors :
Taiwo BO
Kuhns LM
Omigbodun O
Awolude O
Kuti KM
Adetunji A
Berzins B
Janulis P
Akanmu S
Agbaji O
David AN
Akinbami A
Adekambi AF
Johnson AK
Okonkwor O
Oladeji BD
Cervantes M
Adewumi OM
Kapogiannis B
Garofalo R
Source :
PloS one [PLoS One] 2023 Jul 07; Vol. 18 (7), pp. e0274031. Date of Electronic Publication: 2023 Jul 07 (Print Publication: 2023).
Publication Year :
2023

Abstract

Background: Nigeria is one of six countries with half the global burden of youth living with HIV. Interventions to date have been inadequate as AIDS-related deaths in Nigeria's youth have remained unchanged in recent years. The iCARE Nigeria HIV treatment support intervention, a combination of peer navigation and SMS text message medication reminders to promote viral suppression, demonstrated initial efficacy and feasibility in a pilot trial among youth living with HIV in Nigeria. This paper describes the study protocol for the large-scale trial of the intervention.<br />Methods: The iCARE Nigeria-Treatment study is a randomized stepped wedge trial of a combination (peer navigation and text message reminder) intervention, delivered to youth over a period of 48 weeks to promote viral suppression. Youth receiving HIV treatment at six clinical sites in the North Central and South Western regions of Nigeria were recruited for participation. Eligibility criteria included registration as a patient at participating clinics, aged 15-24 years, on antiretroviral therapy for at least three months, ability to understand and read English, Hausa, Pidgin English, or Yoruba, and intent to remain a patient at the study site during the study period. The six clinic sites were divided into three clusters and randomized to a sequence of control and intervention periods for comparison. The primary outcome is plasma HIV-1 viral load suppression, defined as viral load ≤ 200 copies/mL, in the intervention period versus the control period at 48 weeks of intervention.<br />Discussion: Evidence-based interventions to promote viral load suppression among youth in Nigeria are needed. This study will determine efficacy of a combination intervention (peer navigation and text message reminder) and collect data on potential implementation barriers and facilitators to inform scale-up if efficacy is confirmed.<br />Trial Registration: ClinicalTrials.gov number, NCT04950153, retrospectively registered July 6, 2021, https://clinicaltrials.gov/.<br />Competing Interests: The authors have declared that no competing interests exist.<br /> (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Details

Language :
English
ISSN :
1932-6203
Volume :
18
Issue :
7
Database :
MEDLINE
Journal :
PloS one
Publication Type :
Academic Journal
Accession number :
37418498
Full Text :
https://doi.org/10.1371/journal.pone.0274031