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

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. 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.

Addressing the Know-Do Gap in Adolescent HIV: Framing and Measuring Implementation Determinants, Outcomes, and Strategies in the AHISA Network

“…For example, the Sauti Ya Vijana scale protocol [28] included the CFIR framework to evaluate barriers and facilitators to implementation and the FRAME to evaluate intervention adaptations, expanding IS activities from those included in the earlier pilot [26,27]. Additionally, almost all AHISA-related protocols dated 2020-2021 included a formal IS frameworks (CFIR, RE-AIM, FRAME, Proctor) [23,28,46,48], whereas most protocols dated 2017-2019 did not. This extended use of IS frameworks among AHISA team research projects demonstrates progress towards achieving the AHISA goal of building implementation science capacity among adolescent HIV researchers in high HIV-burden African countries [12].…”

“…Across AHISA, 26 studies incorporated one or more implementation strategies and 21 studies developed and tested a strategy. For example, the 3P study developed and tested a conditional financial incentive based on PrEP drug levels to motivate adherence [41], while the iCARE study developed and tested a combination demand creation and service provision implementation strategy that included personalized interactive SMS support and peer navigation [46]. Seven studies engaged in adapting an EBI; 3 only adapted an EBI while 4 adapted and tested an EBI.…”