Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Apr:127:107123.
doi: 10.1016/j.cct.2023.107123. Epub 2023 Feb 20.

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

Lisa L Abuogi  1 , Jayne Lewis Kulzer  2 , Eliud Akama  3 , Thomas A Odeny  4 , Ingrid Eshun-Wilson  5 , Maya Petersen  6 , Starley B Shade  7 , Lina M Montoya  8 , Laura K Beres  9 , Sarah Iguna  3 , Harriet F Adhiambo  3 , Joseph Osoro  3 , Isaya Opondo  3 , Norton Sang  3 , Zachary Kwena  3 , Elizabeth A Bukusi  3 , Elvin H Geng  5
Affiliations

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

Lisa L Abuogi et al. Contemp Clin Trials. 2023 Apr.

Abstract

Background: Adolescents and young adults living with HIV (AYAH) aged 14-24 years 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 AYAH pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYAH in Kenya.

Methods: Using a SMART design, we will randomize 880 AYAH 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: This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYAH at 24 months post-enrollment and assess the cost-effectiveness of successful strategies.

Discussion: The study utilizes promising interventions tailored to AYAH while optimizing resources by intensifying services only for those AYAH 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 AYAH in Africa.

Trial registration: Clinicaltrials.govNCT04432571, registered June 16, 2020.

Keywords: Adolescents; HIV; Retention; Viral suppression; Youth.

PubMed Disclaimer

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no competing interests.

Figures

Figure 1.
Figure 1.
Adapt for Adolescents study design Study aims
Figure 2.
Figure 2.
Adapt for Adolescents flow diagram *Participants who meet criteria for re-randomization at enrollment will be immediately re-randomized to Stage 2.
Fig. 3.
Fig. 3.
An adaptive strategy for preventing and treating lapses of retention in HIV care for adolescents study measures and timepoints.
Fig. 3.
Fig. 3.
An adaptive strategy for preventing and treating lapses of retention in HIV care for adolescents study measures and timepoints.
See this image and copyright information in PMC

References

    1. Slogrove AL, Mahy M, Armstrong A, Davies MA. Living and dying to be counted: What we know about the epidemiology of the global adolescent HIV epidemic. J Int AIDS Soc 2017;20(Suppl 3):21520. - PMC - PubMed
    1. Joint United Nations Programme on HIV/AIDS (UNAIDS). In Danger: UNAIDS Global AIDS Update 2022. In: UNAIDS, editor. Geneva, Switzerland: 2022.
    1. Petersen M, Balzer L, Kwarsiima D, Sang N, Chamie G, Ayieko J, et al. Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa. JAMA : the journal of the American Medical Association 2017;317(21):2196–206. - PMC - PubMed
    1. Ryscavage PA, Anderson EJ, Sutton SH, Reddy S, Taiwo B. Clinical outcomes of adolescents and young adults in adult HIV care. JAIDS Journal of Acquired Immune Deficiency Syndromes 2011;58(2):193–7. - PubMed
    1. Wong VJ, Murray KR, Phelps BR, Vermund SH, McCarraher DR. Adolescents, young people, and the 90–90-90 goals: a call to improve HIV testing and linkage to treatment. AIDS 2017;31 Suppl 3:S191–S4. - PMC - PubMed

Publication types

Associated data