Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents

Pregnancy in Adolescence Clinical Trial

Official title:

Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04198272
• Other study ID #: 2019-04-12145
• Status: Completed
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6078
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Adolescent Health
• Health Services Accessibility
• Pregnancy in Adolescence

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Rwanda	Society for Family Health	Kigali
Rwanda	Youth Development Labs	Kigali

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Berkeley	Society for Family Health, Rwanda, Youth Development Labs, Inc dba YLabs

Country where clinical trial is conducted

Rwanda, 

Outcome

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