Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents

Sponsor
University of California, Berkeley (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04198272
Collaborator
Youth Development Labs, Inc dba YLabs (Other), Society for Family Health, Rwanda (Other)
6,000
2
3
24.3
3000
123.6

Study Details

Study Description

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 six 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CyberRwanda
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda3-arm cluster randomized controlled trial, clusters are secondary schools in Rwanda
Masking:
Single (Outcomes Assessor)
Masking Description:
Data analysts will be blind to intervention/control attribution
Primary Purpose:
Prevention
Official Title:
Impact Evaluation of CyberRwanda: A Digital Health Intervention for Adolescents
Actual Study Start Date :
Feb 20, 2021
Anticipated Primary Completion Date :
Feb 20, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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 the following: -Peer facilitation of the CyberRwanda platform at the school-based cyber clubs that will house an online tablet with the educational components of CyberRwanda with a facilitator.

Behavioral: CyberRwanda
The CyberRwanda intervention consists of three primary components: 1. Guide to Teen Success: The CyberRwanda curriculum empowers youth to learn about FPRH and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. Ask Mutoni / Ask Ntwali: The Q&A platform answers questions and provides referrals to local youth-friendly services through 'Mutoni' and 'Ntwali,' virtual peer educators who provide evidence-based, teen-friendly information and signposting to clinics. 3. Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online and via SMS. The online and SMS clinic finder tool links youth clients to clinics for longer-acting methods. All participating pharmacies will be trained using the custom digital training game that supports them to give unbiased, nonjudgmental information and services.

Active Comparator: Self-service

Schools that are randomized to this arm will be exposed to the following components of the intervention: Availability of the fully functional online CyberRwanda web portal through school-based cyber clubs; SMS-based ordering of contraceptives and SMS-based FAQs Online (through web portal on computer or smartphone) ordering of contraceptives; Facility finder: A list of the closest health centers and pharmacies where youth can get contraceptives and other FPRH services; Promotion of the CyberRwanda program through school launch events; and Access to Youth Centers (1 per district) that will house tablets with the fully functional online CyberRwanda web portal

Behavioral: CyberRwanda
The CyberRwanda intervention consists of three primary components: 1. Guide to Teen Success: The CyberRwanda curriculum empowers youth to learn about FPRH and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. Ask Mutoni / Ask Ntwali: The Q&A platform answers questions and provides referrals to local youth-friendly services through 'Mutoni' and 'Ntwali,' virtual peer educators who provide evidence-based, teen-friendly information and signposting to clinics. 3. Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online and via SMS. The online and SMS clinic finder tool links youth clients to clinics for longer-acting methods. All participating pharmacies will be trained using the custom digital training game that supports them to give unbiased, nonjudgmental information and services.

No Intervention: Control

Schools in this arm will not receive any intervention

Outcome Measures

Primary Outcome Measures

  1. Uptake of a modern contraceptive method (age 15-19) [24 months]

    The proportion of sexually active 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 youth who are currently using a modern method of contraception at endline versus youth who are not using a modern method of contraception.

  2. Initiation of childbearing (age 15-19) [24 months]

    The proportion of youth who report having ever been pregnant or caused a pregnancy at endline (24 months), regardless of the pregnancy outcome. This outcome is expressed as a binary variable, defined as youth who report having ever been pregnant or caused a pregnancy versus youth who report never having been pregnant or having caused a pregnancy.

  3. HIV testing (age 12-19) [24months]

    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.

Secondary Outcome Measures

  1. FPRH Knowledge: % of youth (12-19) that understand the phases of a girl's menstrual cycle [24 months]

    The total number of youth (12-19) who can correctly identify a woman's fertile period, divided by the total number of youth.

  2. Behavioral Intentions: % of youth (15-19) who intend to use a modern contraceptive method in the next 12 months [24 months]

    The total number of youth (15-19), disaggregated by sex, who are very sure or sure that they will use contraception in the 12 months divided by the total number of youth who want to delay pregnancy.

  3. Self-efficacy Contraceptive Use: % of adolescents (15-19) who are confident that they could get their partner(s) to use contraceptives/condoms if they desired [24 months]

    The total number of youth (15-19) 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Attending a study school at baseline;

  • Between 12 and 19 years of age;

  • Assent to participate;

  • Parents have provided consent for their child to participate in the study; and

  • Willingness to provide valid contact information for study follow-up purposes.

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Society for Family Health Kigali Rwanda
2 Youth Development Labs Kigali Rwanda

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Sandra McCoy, PhD, UC Berkeley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sandra McCoy, Associate Professor in Residence, University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT04198272
Other Study ID Numbers:
  • 2019-04-12145
First Posted:
Dec 13, 2019
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sandra McCoy, Associate Professor in Residence, University of California, Berkeley

Study Results

No Results Posted as of May 17, 2022