Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents

February 9, 2024 updated by: Sandra McCoy, University of California, Berkeley
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

6078

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Kigali, Rwanda
        • Society for Family Health
      • Kigali, Rwanda
        • Youth Development Labs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Facilitated
Schools 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.
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.
Active Comparator: Self-service

Schools 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.
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.
No Intervention: Control
Schools in this arm will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of a modern contraceptive method
Time Frame: 24 months
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.
24 months
Initiation of childbearing
Time Frame: 24 months
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.
24 months
HIV testing
Time Frame: 24 months
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FPRH Knowledge: % of youth that understand the phases of a girl's menstrual cycle
Time Frame: 24 months
The total number of youth who can correctly identify a woman's fertile period, divided by the total number of youth.
24 months
Behavioral Intentions: % of youth who intend to use a modern contraceptive method in the next 12 months
Time Frame: 24 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.
24 months
Self-efficacy Contraceptive Use: % of adolescents who are confident that they could get their partner(s) to use contraceptives/condoms if they desired
Time Frame: 24 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sandra McCoy, PhD, UC Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

December 11, 2019

First Submitted That Met QC Criteria

December 11, 2019

First Posted (Actual)

December 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-04-12145

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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