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Pregnancy in AdolescenceNCT04198272

Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents

A study testing CyberRwanda in people with Pregnancy in Adolescence and Adolescent Health, run by University of California, Berkeley at 2 sites in Rwanda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This protocol describes an evaluation of the CyberRwanda program, a digital health tool designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and family planning and reproductive health, more specifically. Read more about this study

Who is it for?
Ages 12 to 19 yearsHealthy volunteers can take part
What is being tested?
CyberRwanda
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,078 participants
Where
2 sitesRwanda
Study dates
20 Feb 2021to 31 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Attending a study school at baseline in secondary school levels S1 or S2;
  • Between 12 and 19 years of age;
  • If <18 years of age: Assent and parental consent to participate in the study;
  • If ≥ 18 years of age, informed consent to participate in the study;
  • Willingness to provide valid contact information for study follow-up purposes.

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Rwanda2 sites

  • Society for Family Health

    Kigali

  • Youth Development Labs

    Kigali

Other trials in Rwanda

About this study

This protocol describes an evaluation of the CyberRwanda program, a digital health tool designed with and for adolescents in Rwanda, with a focus on successful futures, broadly, and family planning and reproductive health, more specifically. CyberRwanda is a tablet-based system that provides information on family planning and reproductive health through a set of vignettes. The program also allows users to order and purchase contraceptives, with pick up at nearby participating pharmacies. The program will be implemented in schools in eight districts in Rwanda. The investigators will conduct a 3-arm, cluster, randomized controlled trial to evaluate the impact of CyberRwanda on three primary outcomes: uptake of a contraceptive method, initiation of childbearing, and HIV testing. The investigators will compare two implementation models (facilitated and self-service) to a control arm at the school (cluster) level. The study will enroll 60 schools (20 per arm) and 100 students per school, and follow students for 24 months.

Being tested
CyberRwanda
Keywords
Adolescent health, Unintended pregnancy, Global health, Access to contraceptives

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyberRwandaBehavioural

    The CyberRwanda intervention consists of three primary components: 1. STORIES: The CyberRwanda curriculum empowers youth to learn about family planning and reproductive health and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. LEARN: Q\&As and videos related to family planning and reproductive health. 3. SHOP: Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online. The online health facility finder tool links youth to health facilities for longer-acting methods. All participating pharmacies will be trained to give unbiased, nonjudgmental information and services.

Study groups in NCT04198272
Study groupRoleWhat they receive
FacilitatedExperimentalSchools that are randomized to this arm will be exposed to all of the components in the self-service version in addition to peer facilitation of the CyberRwanda platform at CyberRwanda clubs.
Receives: Behavioral: CyberRwanda
Self-serviceActive comparatorSchools that are randomized to this arm will be exposed to the following components of the intervention: * Self-guided access to the online CyberRwanda platform; and * Promotion of the CyberRwanda program through school launch events.
Receives: Behavioral: CyberRwanda
ControlNo interventionSchools in this arm will not receive any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uptake of a modern contraceptive method

    The proportion of female youth who report currently using a modern method of contraception at endline (24 months). The primary outcome is expressed as a binary variable, defined as female youth who are currently using a modern method of contraception at endline versus female youth who are not using a modern method of contraception.

    Measured: 24 months

  2. Initiation of childbearing

    The proportion of female youth who report having ever been pregnant at endline (24 months), regardless of the pregnancy outcome. This outcome is expressed as a binary variable, defined as female youth who report having ever been pregnant versus female youth who report never having been pregnant.

    Measured: 24 months

  3. HIV testing

    The proportion of youth who have ever had an HIV test at endline (24 months). This outcome is expressed as a binary variable, defined as youth who report having ever been tested for HIV versus youth who report never having tested for HIV.

    Measured: 24 months

Secondary outcomes (3)

  1. FPRH Knowledge: % of youth that understand the phases of a girl's menstrual cycle

    The total number of youth who can correctly identify a woman's fertile period, divided by the total number of youth.

    Measured: 24 months

  2. Behavioral Intentions: % of youth who intend to use a modern contraceptive method in the next 12 months

    The total number of youth, disaggregated by sex, who are very confident or confident that they will use contraception in the 12 months divided by the total number of youth who anticipate that they will have sexual intercourse in the next 12 months.

    Measured: 24 months

  3. Self-efficacy Contraceptive Use: % of adolescents who are confident that they could get their partner(s) to use contraceptives/condoms if they desired

    The total number of youth who state that they agree or strongly agree that they feel confident that they can negotiate contraception and condom use with their partners, divided by the total number of youth.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start20 Feb 2021
  3. Primary completion31 Aug 2023
  4. Study completion31 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6,078 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04198272
Sponsor's protocol ID
2019-04-12145
Status last verified
Feb 2024
First submitted
11 Dec 2019
Last updated
5 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hemono R, Gatare E, Kayitesi L, Hunter LA, Packel L, Ippoliti N, Cerecero-Garcia D, Contreras-Loya D, Gadsden P, Bautista-Arredondo S, Sayinzoga F, Mugisha M, Bertozzi SM, Hope R, McCoy SI. Effect of a digital school-based intervention on adolescent family planning and reproductive health in Rwanda: a cluster-randomized trial. Nat Med. 2024 Nov;30(11):3121-3128. doi: 10.1038/s41591-024-03205-1. Epub 2024 Aug 23.

    PubMed 39179855

  • Hemono R, Gatare E, Kayitesi L, Hunter LA, Kunesh J, Packel L, Hope R, McCoy SI. Measuring sexual behavior among in-school youth in Rwanda: a cross-sectional analysis of self-reported timing of first sex and correlates of early sexual debut. Ann Epidemiol. 2023 Jul;83:35-39.e1. doi: 10.1016/j.annepidem.2023.04.005. Epub 2023 Apr 14.

    PubMed 37060934

  • Nolan C, Packel L, Hope R, Levine J, Baringer L, Gatare E, Umubyeyi A, Sayinzoga F, Mugisha M, Turatsinze J, Naganza A, Idelson L, Bertozzi S, McCoy S. Design and impact evaluation of a digital reproductive health program in Rwanda using a cluster randomized design: study protocol. BMC Public Health. 2020 Nov 13;20(1):1701. doi: 10.1186/s12889-020-09746-7.

    PubMed 33187485

Questions about this trial

What is this clinical trial studying?

A study testing CyberRwanda in people with Pregnancy in Adolescence and Adolescent Health, run by University of California, Berkeley at 2 sites in Rwanda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uptake of a modern contraceptive method (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04198272, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.

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