Impact Evaluation of CyberRwanda: a Digital Health Intervention for Adolescents

NCT ID: NCT04198272

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6078 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-20

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy in Adolescence Adolescent Health Health Services Accessibility

Keywords

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Adolescent health Unintended pregnancy Global health Access to contraceptives

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Data analysts will be blind to intervention/control attribution

Study Groups

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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.

Group Type EXPERIMENTAL

CyberRwanda

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

CyberRwanda

Intervention Type BEHAVIORAL

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.

Control

Schools in this arm will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CyberRwanda

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Youth Development Labs, Inc dba YLabs

OTHER

Sponsor Role collaborator

Society for Family Health, Rwanda

UNKNOWN

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Sandra McCoy

Associate Professor in Residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra McCoy, PhD

Role: PRINCIPAL_INVESTIGATOR

UC Berkeley

Locations

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Society for Family Health

Kigali, , Rwanda

Site Status

Youth Development Labs

Kigali, , Rwanda

Site Status

Countries

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Rwanda

References

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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.

Reference Type BACKGROUND
PMID: 39179855 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37060934 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33187485 (View on PubMed)

Related Links

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https://osf.io/jmz4u

CyberRwanda analysis plan pre-registered on the Open Science Framework (May 2021)

Other Identifiers

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2019-04-12145

Identifier Type: -

Identifier Source: org_study_id