NCT01823861

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/

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

1.6 years

First QC Date

March 30, 2013

Results QC Date

March 2, 2020

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Use of a Effective Contraceptive Method at Four-months Post-abortion

    Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.

    4 months

Secondary Outcomes (3)

  • Pregnancy

    4 months

  • Repeat Abortion

    4 months

  • Contraceptive Discontinuation

    4 months

Study Arms (2)

Mobile phone-based intervention

EXPERIMENTAL

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.

Behavioral: Mobile phone-based intervention

Standard care

NO INTERVENTION

Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.

Interventions

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.

Mobile phone-based intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Declined to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie Stopes International

Phnom Penh, Cambodia

Location

Related Publications (6)

  • Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, Machiyama K, Slaymaker E, Warnock R, McCarthy O, Free C. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015 Dec 1;93(12):842-50A. doi: 10.2471/BLT.15.160267. Epub 2015 Oct 15.

  • Hill J, McGinn J, Cairns J, Free C, Smith C. A Mobile Phone-Based Support Intervention to Increase Use of Postabortion Family Planning in Cambodia: Cost-Effectiveness Evaluation. JMIR Mhealth Uhealth. 2020 Feb 25;8(2):e16276. doi: 10.2196/16276.

  • Smith C, Edwards P, Free C. Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Reprod Health. 2018 Mar 15;15(1):50. doi: 10.1186/s12978-018-0494-7.

  • Smith C, Jarvis C, Free C. Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Trials. 2017 Dec 1;18(1):577. doi: 10.1186/s13063-017-2316-6.

  • Smith C, Ngo TD, Edwards P, Free C. MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. Trials. 2014 Nov 12;15:440. doi: 10.1186/1745-6215-15-440.

  • Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Khut K, Edwards P, Rathavy T, Free C. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. Trials. 2013 Dec 12;14:427. doi: 10.1186/1745-6215-14-427.

Results Point of Contact

Title
Dr. Chris Smith
Organization
London School of Hygiene and Tropical Medicine

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 4, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 16, 2020

Results First Posted

March 16, 2020

Record last verified: 2020-03

Locations