Impact Evaluation of CyberRwanda: a Digital Health Intervention for Adolescents

NCT04198272 | Completed

• 1 other identifier: 2019-04-12145
• Study Type: interventional
• Target: 6,078
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Pregnancy in Adolescence; Adolescent Health; Health Services Accessibility

Keywords

Adolescent health; Unintended pregnancy; Global health; Access to contraceptives

Outcome Measures

Primary Outcomes (3)

• 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.

  24 months

• 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.

  24 months

• 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.

  24 months

Secondary Outcomes (3)

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

  24 months

• Behavioral Intentions: % of youth who intend to use a modern contraceptive method 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

  24 months

Study Arms (3)

Facilitated

EXPERIMENTAL

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.

Behavioral: CyberRwanda

Self-service

ACTIVE COMPARATOR

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.

Behavioral: CyberRwanda

Control

NO INTERVENTION

Schools in this arm will not receive any intervention.

Interventions

CyberRwanda 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.

Facilitated; Self-service

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of California, Berkeley: lead
• Youth Development Labs, Inc dba YLabs: collaborator
• Society for Family Health, Rwanda: collaborator

Study Sites (2)

Society for Family Health

Kigali, Rwanda

Location

Youth Development Labs

Kigali, Rwanda

Location

Related Publications (3)

• 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.

  PMID: 39179855 BACKGROUND

• 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.

  PMID: 37060934 DERIVED

• 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.

  PMID: 33187485 DERIVED

Related Links

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

Study Officials

• Sandra McCoy, PhD

  UC Berkeley

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysts will be blind to intervention/control attribution
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Residence

Model Details: 3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: February 20, 2021
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

RW (2)