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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05022277
Other study ID # Y1HPDME2021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 28, 2020
Est. completion date October 20, 2021

Study information

Verified date August 2021
Source Young 1ove
Contact Noam Angrist, PhD
Phone +18572250117
Email nangrist@young1ove.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships. The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date October 20, 2021
Est. primary completion date October 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 25 Years
Eligibility Inclusion Criteria: - Adolescent who provided their phone number to Young 1ove staff when prompted by their school; or their siblings/ other adolescents living in the same household. - Parents and students consented to participate. Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Low tech health SMS messages
Weekly health-related SMS messages are provided to adolescents.
Low tech health Phone + SMS messages
Weekly health-related phone calls plus SMS messages are provided to adolescents.

Locations

Country Name City State
Botswana Young 1ove Gaborone

Sponsors (2)

Lead Sponsor Collaborator
Young 1ove University of Oxford

Country where clinical trial is conducted

Botswana, 

Outcome

Type Measure Description Time frame Safety issue
Other Share of students disclosing personal information to the data collector in the open-ended question at the end of the survey. ~4 weeks post program
Other Share of female students reporting that they agree or strongly agree with the statement 'If I don't want to hold hands with a guy, I can comfortably refuse to do it' ~4 weeks post program
Other Share of students listing known support services when asked 'If a friend experienced dating difficulties or violence, do you know any organizations, services or phone numbers you could suggest she contact to get some help if she wanted?' ~4 weeks post program
Primary Share of students that have been or are pregnant and/or have dropped out of school These two outcomes (using school administrative data on whether students have dropped out of school and were pregnant) will be combined into a composite variable equal to 1 if the student has become pregnant and/or has dropped out of school. ~6 months post-program
Primary Share of students with the accurate belief that older partners have the highest risk of HIV compared to younger partners. Indicator variable from the survey question wording: "Who do you think has the highest risk of infecting you with HIV?" ~4 weeks post program
Secondary Share of students reporting that they make the final decision in their life about visiting a Sexual and reproductive health clinic Indicator variable from the survey question response ~4 weeks post program
Secondary Share of students reporting that if they or their partner were pregnant, they would tell the data collector Indicator variable coded 1 if student answered likely or very likely to 'If you were pregnant, how likely would you be to tell me?' ~4 weeks post program
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