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

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. 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. 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. Trial registration [ClinicalTrials.gov][1] number, NCT 04950153, retrospectively registered July 6, 2021, . ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT 04950153 ### Funding Statement This publication was supported by funding from the Eunice Kennedy Shriver National Institute of Child Health & Human Development (https://www.nichd.nih.gov) of the National Institutes of Health under Award Number UH3HD096920. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health under award number UH3HD096920 to BT and RG. The funding source has no role in the original design of this study, analysis and interpretation of data, or decision to submit results. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This protocol has been approved by the Institutional Review Boards of Northwestern University (STU00214317-CR0001), Ann & Robert H. Lurie Children’s Hospital of Chicago, College of Medicine, University of Ibadan/University College Hospital Lagos State University Teaching Hospital, Lagos University Teaching Hospital, Nigerian Institute of Medical Research Jos University Teaching Hospital and Olabisi Onabanjo University Teaching Hospital respectively, with a waiver of parental permission for participation of minors (aged 16-17). Current protocol version: March 11, 2022. Any modifications to the protocol are submitted to and approved by the IRBs of Record prior to implementation. Spontaneously reported adverse events and unintended effects of the trial are tracked by the study Principal Investigators and reported to the IRBs of Record. Study participants complete a written informed assent or consent process prior to participation in research activities. This study is monitored by a Data Safety and Monitoring Board (DSMB), the composition of which may be obtained from the study Principal Investigator at the lead institution. The trial will be suspended or stopped if recommended by the DSMB and the study investigators, in consultation with the study sponsor, determine that, in their clinical opinion, there are risks to participants for continuation. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Not Applicable No datasets were generated or analyzed during the current study. All relevant data from this study will be made available upon study completion. No datasets were generated or analyzed during the current study. All relevant data from this study will be made available upon study completion. [1]: http://ClinicalTrials.gov