Adapt for Adolescents: Protocol for a Sequential Multiple Assignment Randomized Trial to Improve Retention and Viral Suppression Among Adolescents and Young Adults Living with HIV in Kenya

Abstract

Background: Adolescents and young adults (AYA) aged 14-24 years living with HIV in Africa experience substantially higher rates of virological failure and HIV-related mortality than adults.  We propose to utilize developmentally appropriate interventions with high potential for effectiveness, tailored by AYA pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYA living with HIV in Kenya.

Methods: Using a SMART design, we will randomize 880 AYA with HIV in Kisumu, Kenya to either youth-centered education and counseling (standard of care) or electronic peer navigation in which a peer provides support, information, and counseling via phone and automated monthly text messages.  Those with a lapse in engagement (defined as either a missed clinic visit by > 14 days or HIV viral load > 1000 copies/ml) will be randomized a second time to one of three higher-intensity re-engagement interventions: (1) standard of care outreach and intensified counseling; (2) conditional cash transfers; and (3) in-person peer navigation. This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYA with HIV at 24 months post-enrollment and assess the cost-effectiveness of successful strategies.

Discussion: The study utilizes promising interventions tailored to AYA with HIV while optimizing resources by intensifying services only for those AYA who need more support.  Findings from this innovative study will offer evidence for public health programming to end the HIV epidemic as a public health threat for AYA in Africa.

Note:
Funding Declaration: National Institute or Nursing Research, National Institutes of Health R01NR018801

Conflict of Interests: The authors declare that they have no competing interests

Ethical Approval: Ethical approval for this study has been obtained from all relevant Institutional Review Boards (IRBs). In the US, Washington University in St. Louis (IRB #202006141) is the single IRB of record and has reviewed and approved this study protocol, with the University of Colorado Denver and University of California San Francisco relying on Washington University in St. Louis. In Kenya, the protocol was reviewed by Kenya Medical Research Institute’s (KEMRI) Scientific and Ethics Review Unit (SERU) (#3986). Protocol version 5.0 May 20, 2022. Eligible participants 18 years of age and older will undergo written informed consent. Caregiver consent and participant assent will be obtained for those less than 18 years of age and not emancipated (e.g., married or a parent).

Trial Registration: Clinicaltrials.gov NCT04432571, registered June 16, 2020.

Keywords: HIV, adolescents, youth, retention, viral suppression