Clinical trial NCT04198272: Impact Evaluation of CyberRwanda: a Digital Health Intervention for Adolescents
Official title: Impact Evaluation of CyberRwanda: a Digital Health Intervention for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Adolescent Health
Health Services Accessibility
Keywords: Adolescent health
Unintended pregnancy
Global health
Access to contraceptives
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Youth Development Labs, Inc dba YLabs
name: Society for Family Health, Rwanda
First posted: 2019-12-13
Enrollment: 6078
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda
Primary purpose: PREVENTION

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Uptake of a modern contraceptive method
timeFrame: 24 months
measure: Initiation of childbearing
timeFrame: 24 months
measure: HIV testing
timeFrame: 24 months
Secondary outcomes:
measure: FPRH Knowledge: % of youth that understand the phases of a girl's menstrual cycle
timeFrame: 24 months
measure: Behavioral Intentions: % of youth who intend to use a modern contraceptive method in the next 12 months
timeFrame: 24 months
measure: Self-efficacy Contraceptive Use: % of adolescents who are confident that they could get their partner(s) to use contraceptives/condoms if they desired
timeFrame: 24 months
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Society for Family Health
city: Kigali
country: Rwanda
facility: Youth Development Labs
Study officials:
affiliation: UC Berkeley
name: Sandra McCoy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.