- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05022277
Empowering Girls: Health-seeking Behavior, Staying in School, and Preventing Risky Sex
August 19, 2021 updated by: Young 1ove
Empowering Girls: Health-seeking Behavior, Staying in School and Preventing Risky Sex
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Noam Angrist, PhD
- Phone Number: +18572250117
- Email: nangrist@young1ove.org
Study Contact Backup
- Name: Claire Cullen, PhD
- Phone Number: +447562665937
- Email: ccullen@young1ove.org
Study Locations
-
-
-
Gaborone, Botswana
- Recruiting
- Young 1ove
-
Contact:
- Efua Bortsie
- Email: ebortsie@young1ove.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 25 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
|
|
EXPERIMENTAL: Phone-based intervention Plus SMS messages
|
Weekly health-related phone calls plus SMS messages are provided to adolescents.
|
EXPERIMENTAL: SMS messages only
|
Weekly health-related SMS messages are provided to adolescents.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Share of students that have been or are pregnant and/or have dropped out of school
Time Frame: ~6 months post-program
|
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
|
Share of students with the accurate belief that older partners have the highest risk of HIV compared to younger partners.
Time Frame: ~4 weeks post program
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Share of students reporting that they make the final decision in their life about visiting a Sexual and reproductive health clinic
Time Frame: ~4 weeks post program
|
Indicator variable from the survey question response
|
~4 weeks post program
|
Share of students reporting that if they or their partner were pregnant, they would tell the data collector
Time Frame: ~4 weeks post program
|
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
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Share of students disclosing personal information to the data collector in the open-ended question at the end of the survey.
Time Frame: ~4 weeks post program
|
~4 weeks post program
|
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'
Time Frame: ~4 weeks post program
|
~4 weeks post program
|
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?'
Time Frame: ~4 weeks post program
|
~4 weeks post program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Noam Angrist, PhD, University of Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 28, 2020
Primary Completion (ANTICIPATED)
October 20, 2021
Study Completion (ANTICIPATED)
October 20, 2021
Study Registration Dates
First Submitted
August 11, 2021
First Submitted That Met QC Criteria
August 19, 2021
First Posted (ACTUAL)
August 26, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 26, 2021
Last Update Submitted That Met QC Criteria
August 19, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- Y1HPDME2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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