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
Randomized Controlled Trial
. 2018 Jul 11;15(1):126.
doi: 10.1186/s12978-018-0568-6.

Protocol of an open, three-arm, individually randomized trial assessing the effect of delivering sexual and reproductive health information to young people (aged 13-24) in Kenya and Peru via mobile phones: adolescent/youth reproductive mobile access and delivery initiative for love and life outcomes (ARMADILLO) study stage 2

Lianne Gonsalves  1 , Michelle J Hindin  2 , Angela Bayer  3 , Cesar P Carcamo  3 , Peter Gichangi  4   5   6 , Ndema Habib  7 , Jefferson Mwaisaka  4 , Lale Say  7
Affiliations
Free PMC article
Randomized Controlled Trial

Protocol of an open, three-arm, individually randomized trial assessing the effect of delivering sexual and reproductive health information to young people (aged 13-24) in Kenya and Peru via mobile phones: adolescent/youth reproductive mobile access and delivery initiative for love and life outcomes (ARMADILLO) study stage 2

Lianne Gonsalves et al. Reprod Health. .
Free PMC article

Abstract
in English, Spanish

Background: Young people face special challenges to accessing needed sexual and reproductive health (SRH) information and support. With high penetration and access, mobile phones provide a new channel for reaching young people, but there is little evidence around the impact of digital interventions on improving health outcomes. The Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) study will assess the effect of an intervention providing SRH information to young people via text message on their mobile phones in Kenya and Peru. This protocol details an open, individually-randomized, three-arm trial lasting seven weeks to assess the effect of the ARMADILLO intervention on dispelling myths and misconceptions related to contraception. A secondary objective is to determine whether youth given access to SRH information via text message can accurately retain that information.

Methods: Following a household enumeration, one eligible youth per household will be randomly selected for participation and randomized by computer into one of the three arms. Intervention arm participants will receive access to ARMADILLO content, control participants will receive no information, and 'Arm 3' participant interactions will vary by site: in Kenya, they will be alerted to various SRH domains and encouraged to learn on their own; in Peru, they will receive key content from each domain with the option to learn more if they wish. Participants will complete multiple-choice questionnaires administered by data collectors at baseline (prior to randomization), at intervention-period end (after week seven), and eight weeks after timing out of the intervention period.

Discussion: Part of the Sustainable Development Goal commitment towards ensuring healthy lives and promoting well-being for all at all ages includes a commitment to 'ensuring universal access to sexual health and reproductive health-care services, including for family planning, information and education'. If proven to be effective, interventions like ARMADILLO can bridge an important gap towards achieving universal access to SRH information and education for an otherwise difficult-to-reach group.

Trial registration: This trial was retrospectively registered with the ISRCTN Registry and assigned registration number ISRCTN85156148 on 29 May, 2018.

Antecedentes: Las personas jóvenes se enfrentan a desafíos únicos en cuanto a acceso a información y apoyo en temas de salud sexual y reproductiva (SSR). Debido a su elevada penetración y acceso, los teléfonos celulares brindan un nuevo canal para acceder a los jóvenes. Sin embargo, existe poca evidencia sobre el impacto de las intervenciones digitales en la mejora de los resultados de salud. La investigación ARMADILLO (Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes en inglés y Uso de celulares para mejorar resultados de amor y vida en adolescentes y jóvenes en español) evaluará el efecto de una intervención que brinda información sobre SSR a jóvenes mediante mensajes de texto a sus celulares en Kenia y Perú. Este protocolo detalla un ensayo abierto de tres brazos aleatorizado a nivel individual que dura siete semanas y evalúa el efecto de la intervención ARMADILLO para disipar los mitos e ideas equivocadas relacionadas a los métodos anticonceptivos. Un objetivo secundario es determinar si los jóvenes que tienen acceso a información sobre SSR vía mensaje de texto pueden retener esa información de manera precisa.

Métodos: Posterior a una enumeración de hogares, una persona joven por cada hogar será seleccionada al azar para ser participante y será randomizada por computadora en uno de los tres brazos. Los participantes del brazo intervención recibirán acceso a los contenidos de ARMADILLO, los participantes del brazo control no recibirán ninguna información, y los participantes del ‘brazo 3’ variarán según la sede: en Kenia, serán alertados sobre diversos dominios de SSR y animados a aprender más por su cuenta; en Perú, recibirán contenidos claves de cada dominio con la opción de aprender más si desean. Los participantes completarán encuestas de opción múltiple administradas por encuestadores durante la línea basal (antes de ser randomizados), al final de la intervención (después de la semana 7), y ocho semanas después de terminar la intervención.

Discusión: Parte del compromiso de los Objetivos de Desarrollo Sostenible hacia garantizar una vida sana y promover el bienestar para todos en todas las edades incluye un compromiso a ‘garantizar el acceso universal a los servicios de salud sexual y reproductiva, incluidos los de planificación de la familia, información y educación’. Si se prueba su efectividad, intervenciones como ARMADILLO podrían tender un puente sobre una brecha importante hacia el logro del acceso universal a información y educación en SSR para un grupo que es difícil de alcanzar de otra manera.

Registro del Ensayo: Este ensayo se registró de manera retrospectiva con el Registro ISRCTN y fue asignado el número de registro ISRCTN85156148 el 29 de mayo, 2018.

Keywords: Adolescent; Intervention; Low-income countries; Middle-income countries; Sexual and reproductive health; Youth; mHealth.

PubMed Disclaimer

Conflict of interest statement

Ethics approval and consent to participate

This study (protocol ID, A65892b) underwent ethics review and obtained approval from the WHO Research Ethics Review Committee (ERC). Ethics approval was also locally obtained from Institutional Review Boards of the Universidad Peruana Cayetano Heredia as well as the University of Nairobi/Kenyatta National Hospital.

All participants will provide their written, informed consent to participate in this study. In Peru, where participants are under 18 years of age, parents will provide written informed consent and the adolescent participants will provide their written, informed assent.

Consent for publication

N/A.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Theoretical model of contraceptive use patterns among adolescents
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. UNFPA . Adolescent and youth demographics : a brief overview. 2010. pp. 4–5.
    1. Patton GC, Coffey C, Sawyer SM, Viner RM, Haller DM, Bose K, Vos T, Ferguson J, Mathers CD. Global patterns of mortality in young people: a systematic analysis of population health data. Lancet. 2009;374:881–892. doi: 10.1016/S0140-6736(09)60741-8. - DOI - PubMed
    1. Shah IH, Ahman E. Unsafe abortion differentials in 2008 by age and developing country region: high burden among young women. Reproductive Health Matters. 2012;20(39):169–173. doi: 10.1016/S0968-8080(12)39598-0. - DOI - PubMed
    1. Gore FM, Bloem PJN, Patton GC, Ferguson J, Joseph V, Coffey C, Sawyer SM, Mathers CD. Global burden of disease in young people aged 10–24 years: a systematic analysis. Lancet. 2011;377:2093–2102. doi: 10.1016/S0140-6736(11)60512-6. - DOI - PubMed
    1. Chandra-Mouli VM, McCarraher DR, Phillips SJ, Williamson NE, Hainsworth G. Contraception for adolescents in low and middle income countries: needs, barriers, and access. Reprod Health. 2014;11(1):1. doi: 10.1186/1742-4755-11-1. - DOI - PMC - PubMed

Publication types