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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1419

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harvard University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Weiss Family Program Fund for Research in Development Economics
Harvard Lab for Economic Applications and Policy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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