Condition category
Not Applicable
Date applied
15/03/2018
Date assigned
29/05/2018
Last edited
13/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
There is a high unmet need for sexual and reproductive health (SRH) information and services for youth (defined as between the ages of 15 and 24) worldwide. However, financial, cultural, social, and legal considerations often impede youth accessing SRH resources. There are efforts in place to make facility-based services and health providers ‘youth-friendly’; however, a welcoming facility environment alone may not be enough to entice young people to enter and access the information and services available to them.

Creating demand among youth in need of SRH resources for those youth-friendly services requires an enabling environment. Innovative solutions have been used to create this enabling environment, including the use of mobile phone technology to engage and inform youth around SRH issues. These approaches offer significant advantages, including the wide availability of mobile phones within this age group and the discretion these devices offer.

Despite the apparent good fit between SRH and mobile phones, the evidence base supporting mobile health approaches is still underdeveloped due to limited rigorous research to assess impact. As the number of mobile health interventions increase, so does the need to demonstrate the coverage, impact, and cost effectiveness of mobile phone strategies to deliver high quality SRH information and drive appropriate use of SRH services.

Following a formative stage centred on the iterative refinement and finalization of a repository of SRH messages targeted towards youth (conducted in 2015-2016), this trial will seek to assess the effect of on-demand SRH information, delivered via SMS, on dispelling myths and misconceptions around contraception for young people in Peru (youth aged 13-17) and Kenya (youth aged 18-24).

Who can participate?
Youth aged 13 to 17 years of age (Peru), youth aged 18 to 24 years of age (Kenya)

What does the study involve?
Participants will either receive access to on-demand information via SMS, followed by weekly quizzes (any quiz answer receives free airtime) or pushed SMS (varies by site) and invitation to participate in a quiz at the end of the week (again, any answer receives free airtime); or no intervention.

What are the possible benefits and risks of participating?

Benefits include participants being able to access validated sexual and reproductive health information (via messages developed by fellow young people) on a broad array of SRH topics, in communities where access to such information for these age groups is often extremely difficult. Intervention participants will have full access to ARMADILLO message content and at the end of the intervention and follow-up period, the full ARMADILLO system will be made available to all study participants (including Arm 3 and control participants). Risks to participation are minimal, but might consist of participants being uncomfortable with message content or a friend, partner, or family member seeing the messages without a participant’s permission.

Where is the study run from?
1.International Centre for Reproductive Health (Kenya)
2.Universidad Peruana Cayetano Heredia (Peru)

When is the study starting and how long is it expected to run for?
April 2016 to July 2018

Who is funding the study?
UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (Switzerland)

Who is the main contact?
Ms Lianne Gonsalves (scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Ms Lianne Gonsalves

ORCID ID

http://orcid.org/0000-0003-2409-5043

Contact details

World Health Organization
Avenue Appia 20
Geneva
1201
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

A65892b

Study information

Scientific title

Adolescent/Youth Reproductive Mobile Access and Delivery Initiative for Love and Life Outcomes (ARMADILLO) protocol for research trial evaluating youth learning and information retention following delivery of SRH information via mobile phones.

Acronym

ARMADILLO

Study hypothesis

Youth given access to ARMADILLO’s targeted SRH information on-demand through their mobile phones will be more knowledgeable about contraception and better able to dispel contraception myths and misconceptions than those without access to ARMADILLO.

Ethics approval

WHO Research Ethics Review Committee

Study design

Randomised controlled trial. This is an three-armed, 'open-label' trial. Following a baseline survey, the intervention period lasts seven weeks after which participants complete an endline survey. An additional follow-up assessment is done eight weeks after endline.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Sexual and reproductive health

Intervention

The three arms consist of: 1) intervention: participants receive access to on-demand information via SMS, followed by weekly quizzes (any quiz answer receives free airtime); 2) intervention-lite: pushed SMS (varies by site) and invitation to participate in a quiz at the end of the week (again, any answer receives free airtime); and 3) control: no intervention.

ARMADILLO as an intervention (arm 1) consists of an automated, interactive, and on-demand SMS platform that will provide essential facts and address common misconceptions about a full range of SRH issues pertinent to youth, including puberty, relationships, sex, pregnancy, HIV and STIs, and contraception. The ARMADILLO system will be available to users at no charge.

Each site will implement a three armed trial, with intervention and control arms. An additional third arm 'intervention-lite' will vary by country: Peru will test the delivery of this intervention via pushed-messages (rather than 'pull' on-demand messages), while in Kenya, youth will receive only the SRH domain as a prompt. Intervention and intervention-lite arms in both countries will have weekly quizzes where participants receive free airtime for any response. All arms will be free for participants to engage with.

This study utilizes an open, individually-randomized, three-arm comparative design with eligible participants (from a randomly selected list of eligible households) randomized in a 1:1:1 allocation ratio to intervention, control or Arm 3. The randomization of participants to each arm was completed by a tool developed using Node.js and docker.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Myths and misconceptions of contraception, as determined by a questionnaire about contraception administered by a researcher, with answers collected on a mobile phone, measured at baseline, at the end of the intervention (seven weeks), and eight weeks following the end of the intervention (15 weeks from baseline).The questionnaire uses a series of multiple choice and/or true/false questions which are combined into one large survey (with 40+ questions, most of which also have sub-questions).

Secondary outcome measures

1. Knowledge of contraception
2. Knowledge of puberty, anatomy and sexuality
3. Knowledge of HIV/AIDs and its transmission
4.Knowledge of attitude around engaging in sex (with self and others)
5. Attitudes around intimate partner violence
6. Previous behaviour around sex and contraception use

The following outcome measures are measured using a questionnaire, with answers collected on a mobile phone. Measured at baseline, at the end of the intervention (seven weeks), and eight weeks following the end of the intervention (15 weeks from baseline).The questionnaire uses a series of multiple choice and/or true/false questions which are combined into one large survey (with 40+ questions, most of which also have sub-questions).

Overall trial start date

01/04/2016

Overall trial end date

01/07/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Eligibility criteria for the general ARMADILLO study is as follows:
1.Youth between the ages of 13-24 (age range narrowed as needed for each site);
2.Literate
3.Have their own mobile phone (meaning it is primarily in their possession, and they control when and with whom they share access) and report regular use
4.Have a mobile phone with them at the time of recruitment
5.Report current use of text messaging

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

1476

Participant exclusion criteria

Those that do not meet the eligibility criteria

Recruitment start date

15/01/2018

Recruitment end date

18/03/2018

Locations

Countries of recruitment

Kenya, Peru

Trial participating centre

International Centre for Reproductive Health - Kenya
Mombasa
80103
Kenya

Trial participating centre

Universidad Peruana Cayetano Heredia
Lima
15102
Peru

Sponsor information

Organisation

UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Sponsor details

Avenue Appia 20
Geneva
1211
Switzerland
+41 (0)22 791 2970
agh-info@who.intx

Sponsor type

Other

Website

http://www.who.int/reproductivehealth/about_us/en/

Funders

Funder type

Not defined

Funder name

UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Plan to publish protocol: 15/07/2018
Regional and national level results dissemination to Ministry of Health partners in each site: 15/08/2018
Planned publication of results in high-impact peer reviewed journal

Intention to publish date

01/06/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29996854

Publication citations

Additional files

Editorial Notes

13/07/2018: Publication reference added.