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Mobile Technology for Improved Family Planning (MOTIF)

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: NCT01823861
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Marie Stopes International

Tracking Information
First Submitted Date  ICMJE March 30, 2013
First Posted Date  ICMJE April 4, 2013
Results First Submitted Date  ICMJE March 2, 2020
Results First Posted Date  ICMJE March 16, 2020
Last Update Posted Date March 16, 2020
Study Start Date  ICMJE May 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
Use of a Effective Contraceptive Method at Four-months Post-abortion [ Time Frame: 4 months ]
Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2013)
Use of a reliable contraceptive method at four-months post-abortion [ Time Frame: 4 months ]
Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • Pregnancy [ Time Frame: 4 months ]
  • Repeat Abortion [ Time Frame: 4 months ]
  • Contraceptive Discontinuation [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2013)
  • Pregnancy [ Time Frame: 4 months ]
  • Repeat abortion [ Time Frame: 4 months ]
  • Contraceptive discontinuation [ Time Frame: 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mobile Technology for Improved Family Planning
Official Title  ICMJE Not Provided
Brief Summary

An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia.

The study seeks to address the research question: does a PAFP mHealth intervention increase use of contraception in Cambodia? STUDY RESULTS: http://www.who.int/bulletin/online_first/en/

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Contraception
  • Post-abortion Family Planning
  • mHealth
Intervention  ICMJE Behavioral: Mobile phone-based intervention
Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.
Study Arms  ICMJE
  • Experimental: Mobile phone-based intervention
    Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message.
    Intervention: Behavioral: Mobile phone-based intervention
  • No Intervention: Standard care
    Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2013)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Client attending for abortion
  • Client does not want to have a child at the current time
  • Client aged 18 or over
  • Client owns a mobile phone
  • Client willing to receive simple voice messages relating to contraception from Marie Stopes in Khmer language

Exclusion Criteria:

  • Not meeting inclusion criteria
  • Declined to participate
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cambodia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823861
Other Study ID Numbers  ICMJE MarieStopes
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marie Stopes International
Study Sponsor  ICMJE Marie Stopes International
Collaborators  ICMJE London School of Hygiene and Tropical Medicine
Investigators  ICMJE Not Provided
PRS Account Marie Stopes International
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP