We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study on Mhealth and Reproductive Health in Teens (SMART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02031575
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : August 18, 2016
Sponsor:
Collaborators:
Weiss Family Program Fund for Research in Development Economics
Harvard Lab for Economic Applications and Policy
Information provided by (Responsible Party):
Slawa Rokicki, Harvard University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Reproductive Health Behavioral: Interactive Treatment Behavioral: Basic Treatment Other: Control, comparator arm Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1419 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study on Mhealth and Reproductive Health in Teens
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2015
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]
  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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

  2. 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. 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.

  4. Cost effectiveness [ Time Frame: 3-6 months ]
    Assess whether the interactive treatment arm was cost effective compared to the basic treatment arm.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02031575


Locations
Layout table for location information
Ghana
Innovations for Poverty Action
Accra, Greater Accra, Ghana
Sponsors and Collaborators
Harvard University
Weiss Family Program Fund for Research in Development Economics
Harvard Lab for Economic Applications and Policy
Investigators
Layout table for investigator information
Principal Investigator: Slawa Rokicki, MS, BS Harvard University
Study Chair: Gunther Fink, PhD Harvard School of Public Health (HSPH)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Slawa Rokicki, PhD Candidate, Harvard University
ClinicalTrials.gov Identifier: NCT02031575    
Other Study ID Numbers: IRB13-1647
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Keywords provided by Slawa Rokicki, Harvard University:
Reproductive Health
Contraception
Public Health
 Sexual Health
Adolescents
Mobile Health