Study on Mhealth and Reproductive Health in Teens (SMART)

August 17, 2016 updated by: Slawa Rokicki, Harvard University
The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate the effectiveness of using text messages to improve the knowledge, communication, and attitudes about reproductive health among female adolescents in Greater Accra senior high schools. Previous research as well as qualitative work conducted by the Investigators shows that there are significant gaps in knowledge about reproductive health including on topics of pregnancy, sexually transmitted diseases, and contraception among secondary school students in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually transmitted diseases. At the same time, phone ownership and use among young people has spread rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive Health (SMART) will seek to use mobile phone messages to increase awareness of these reproductive health issues among female adolescents in Accra. The objectives of SMART are to evaluate whether the messages can increase knowledge, increase communication, and improve attitudes towards reproductive health among adolescents in Greater Accra. By conducting a randomized controlled trial, we will be able to statistically evaluate if the messages have had any effect on improving outcomes for adolescents in the areas of knowledge, communication, and attitudes. This work can help guide future programs that can scale up this intervention and ultimately improve the health and wellbeing of adolescents across Ghana.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1419

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 Locations

  • Ghana
    • Greater Accra
      • Accra, Greater Accra, Ghana
        • Innovations for Poverty Action

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

14 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria (for treated and control subjects):

  • female
  • aged 14-24
  • secondary school student at day school

Exclusion Criteria (for treated and control subjects):

  • male
  • secondary school student at boarding school

Inclusion criteria (for spillover subjects):

  • aged 14-24
  • secondary school student at day school

Exclusion Criteria (for spillover subjects):

- secondary school student at boarding school

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basic Treatment
Sends messages to participants about reproductive health.
Behavioral: Basic Treatment
Mobile phone text messaging service about reproductive health
Experimental: Interactive Treatment
Sends multiple choice questions and receives texts message responses from participants with incentive for responding correctly
Behavioral: Interactive Treatment
Mobile phone text messaging service about reproductive health
Placebo Comparator: Control
Sends messages to students about malaria prevention and control.
Other: Control, comparator arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of Reproductive Health True/False Quiz of 20 questions
Time Frame: 5-6 months after baseline and then again 14-16 months after baseline
5-6 months after baseline and then again 14-16 months after baseline
Sexual behavior
Time Frame: 14-16 months after baseline
Assessed via a number of items: age at sexual debut, sex without a condom in the past year, pregnancy in the past year, ever had sex, use of condom at sexual debut, sex in the past year, used any contraception in the past year, used contraception at last sex, had an abortion
14-16 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication about reproductive health with family, friends, professional, and boyfriend
Time Frame: 3 months (asked 5-6 months after baseline and again 12-14 months after baseline)
Communication is assessed via questionnaire items that ask the participant how often the participant has communicated with family, friends, professional, and boyfriend over the past 3 months.
3 months (asked 5-6 months after baseline and again 12-14 months after baseline)
Attitudes about reproductive health as measured by 5-point Likert type scale
Time Frame: 5-6 months after baseline and asked again 12-14 months after baseline
Attitudes about reproductive health are measured via questionnaire items that ask participants about their attitudes about reproductive health. They respond via a 5-point Likert type scale.
5-6 months after baseline and asked again 12-14 months after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spillover effect
Time Frame: 3-6 months
Assess how much knowledge, communication, and attitudes spilled over to students in same school but not receiving any intervention
3-6 months
Process Measures
Time Frame: 3-6 months
Assess whether students liked the intervention, whether they used it, and other questions designed to understand whether the mobile service was useful from students' perspectives
3-6 months
Heterogeneous effects
Time Frame: 3-6 months
Assess whether treatment effects are heterogeneous along a number of dimensions: age (younger/older), category of school, and community connectedness.
3-6 months
Cost effectiveness
Time Frame: 3-6 months
Assess whether the interactive treatment arm was cost effective compared to the basic treatment arm.
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard University

Collaborators

Weiss Family Program Fund for Research in Development Economics
Harvard Lab for Economic Applications and Policy

Investigators

  • Principal Investigator: Slawa Rokicki, MS, BS, Harvard University
  • Study Chair: Gunther Fink, PhD, Harvard School of Public Health (HSPH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 7, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

August 18, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB13-1647

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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