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

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

Study Contact Backup

Study Locations

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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