- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04198272
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
Status
Completed
Intervention / Treatment
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
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-
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Kigali, Rwanda
- Society for Family Health
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Kigali, Rwanda
- Youth Development Labs
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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.
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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.
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Active Comparator: Self-service
Schools that are randomized to this arm will be exposed to the following components of the intervention:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Uptake of a modern contraceptive method
Time Frame: 24 months
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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.
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24 months
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Initiation of childbearing
Time Frame: 24 months
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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.
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24 months
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HIV testing
Time Frame: 24 months
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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.
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24 months
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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
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The total number of youth who can correctly identify a woman's fertile period, divided by the total number of youth.
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24 months
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Behavioral Intentions: % of youth who intend to use a modern contraceptive method in the next 12 months
Time Frame: 24 months
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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.
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24 months
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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
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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.
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24 months
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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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