Study on Mhealth and Reproductive Health in Teens (SMART)

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT02031575
First received: January 7, 2014
Last updated: August 9, 2014
Last verified: August 2014
  Purpose

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 Intervention
Reproductive Health
Behavioral: Interactive Treatment
Behavioral: Basic Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Study on Mhealth and Reproductive Health in Teens

Resource links provided by NLM:


Further study details as provided by Harvard University:

Primary Outcome Measures:
  • Knowledge of Reproductive Health True/False Quiz of 20 questions [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Communication about reproductive health with family, friends, professional, and boyfriend [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.

  • Attitudes about reproductive health as measured by 5-point Likert type scale [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    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:
  • Spillover effect [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Assess how much knowledge, communication, and attitudes spilled over to students in same school but not receiving any intervention

  • Process Measures [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    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

  • Heterogeneous effects [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Assess whether treatment effects are heterogeneous along a number of dimensions: age (younger/older), category of school, and community connectedness.

  • Cost effectiveness [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
    Assess whether the interactive treatment arm was cost effective compared to the basic treatment arm.


Enrollment: 1419
Study Start Date: January 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   14 Years to 24 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031575

Locations
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
Principal Investigator: Slawa Rokicki, MS, BS Harvard University
Study Chair: Gunther Fink, PhD Harvard School of Public Health
  More Information

No publications provided

Responsible Party: Slawa Rokicki, PhD Candidate, Harvard University
ClinicalTrials.gov Identifier: NCT02031575     History of Changes
Other Study ID Numbers: IRB13-1647
Study First Received: January 7, 2014
Last Updated: August 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Harvard University:
Reproductive Health
Contraception
Public Health
Sexual Health
Adolescents
Mobile Health

ClinicalTrials.gov processed this record on August 21, 2014