Mobile Technology for Improved Family Planning (MOTIF)

• 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: Marie Stopes International
• Collaborator: London School of Hygiene and Tropical Medicine
• Information provided by (Responsible Party): Marie Stopes International

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Supportive Care
• Conditions: Contraception; Post-abortion Family Planning; mHealth
• Intervention: Behavioral: Mobile phone-based intervention
• Enrollment: 500

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Mobile Phone-based Intervention	Standard Care
Arm/Group Description	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. 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.	Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
Period Title: 4 Month Follow up
Started	249	251
Completed	211	220
Not Completed	38	31
Period Title: 12 Month Follow up
Started	211	220
Completed	169	159
Not Completed	42	61

Baseline Characteristics

Arm/Group Title		Mobile Phone-based Intervention	Standard Care	Total
Arm/Group Description		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. 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.	Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.	Total of all reporting groups
Overall Number of Baseline Participants		249	251	500
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	249 participants	251 participants	500 participants
<25		88 35.3%	69 27.5%	157 31.4%
≥25		161 64.7%	182 72.5%	343 68.6%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	249 participants	251 participants	500 participants
	Female	249 100.0%	251 100.0%	500 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1. Primary Outcome

Title	Use of a Effective Contraceptive Method at Four-months Post-abortion
Description	Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mobile Phone-based Intervention	Standard Care
Arm/Group Description:	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. 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.	Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
Overall Number of Participants Analyzed	211	220
Measure Type: Number; Unit of Measure: participants
	135	101

2. Secondary Outcome

Title	Pregnancy
Description	[Not Specified]
Time Frame	4 months

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Repeat Abortion
Description	[Not Specified]
Time Frame	4 months

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Contraceptive Discontinuation
Description	[Not Specified]
Time Frame	4 months

Outcome Measure Data Not Reported

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Mobile Phone-based Intervention	Standard Care
Arm/Group Description	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. 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.	Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number.
All-Cause Mortality
	Mobile Phone-based Intervention	Standard Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Mobile Phone-based Intervention	Standard Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/249 (0.00%)	0/251 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Mobile Phone-based Intervention	Standard Care
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/249 (0.00%)	0/251 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Chris Smith
• Organization: London School of Hygiene and Tropical Medicine
• Phone: 07974562199
• EMail: christopher.smith@lshtm.ac.uk

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Review.

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.

• Responsible Party: Marie Stopes International
• ClinicalTrials.gov Identifier: NCT01823861
• Other Study ID Numbers: MarieStopes
• First Submitted: March 30, 2013
• First Posted: April 4, 2013
• Results First Submitted: March 2, 2020
• Results First Posted: March 16, 2020
• Last Update Posted: March 16, 2020