Overview

This trial is active, not recruiting.

Conditions contraception, post-abortion, abortion
Treatment mhealth intervention
Sponsor Marie Stopes International
Collaborator Ipas
Start date December 2015
End date March 2016
Trial size 969 participants
Trial identifier NCT02579785, MSI-007-14

Summary

The purpose of this study is to assess whether a mobile phone intervention can be effectively used to improve post menstrual regulation contraceptive uptake and continuation in Bangladesh.

The study will consist of two phases: Phase I: A formative phase to understand barriers to post-abortion contraceptive uptake and continuation and the content and modality of messages most appropriate for women in the study areas; and Phase II: An RCT will be conducted to test the effectiveness of the mHealth intervention developed during the formative phase on contraceptive use.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose health services research
Arm
(Experimental)
Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number. Also receives Mobile phone based intervention for post-abortion contraceptive uptake.
mhealth intervention
A series of ten automated interactive voice messages will be delivered to the participant's mobile phone over a period of 4 months. Messages will be targeted to the method of contraception the participant is using (no-method, condoms, pills, injectable, implant, copper coil). Messages will support uptake of contraception among no-method users. Messages will support existing users to continue their method and to use it correctly and will also encourage participants who are not happy with their method to switch to a different method. All messages will end with five options: Press 1 to repeat the message, press 2 to listen to recorded information about methods of contraception, press 3 to speak to a counsellor, press 4 to tell me you're fine, press 5 to stop receiving these messages.
(No Intervention)
Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number.

Primary Outcomes

Measure
Use of long acting and reversible contraceptive at 4 months
time frame: 4 months

Secondary Outcomes

Measure
Use of long acting and reversible contraceptive at 2 weeks and 12 months
time frame: 2 weeks and 12 months
Use of any modern method at 2 weeks, 4 months and 12 months
time frame: 2 weeks, 4 months and 12 months
Pregnancy
time frame: 4 months and 12 months
Menstrual Regulation
time frame: 4 months and 12 months

Eligibility Criteria

Female participants from 18 years up to 49 years old.

Inclusion Criteria: - Received menstrual regulation services using Manual Vacuum Aspiration (MVA) or Medical Abortion (MA) - Have a personal mobile telephone - Agree to receive messages on mobile about family planning - Provide informed consent for participation Exclusion Criteria: - Received anaesthesia for their MVA procedure - Intend to become pregnant within the next six months - Intend to use, or for partner to use, a permanent method of contraception (i.e. sterilisation) within the next six months

Additional Information

Official title Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh
Principal investigator Kathryn Anderson, PhD
Description The proposed study aims to develop and evaluate a mHealth intervention to promote post-abortion contraceptive uptake and continuation among menstrual regulation clients in the Sylhet, Chittagong and Dhaka regions of Bangladesh. The aim of the formative phase of the study is to develop an interactive two-way messaging service for post-MR clients. The messaging service will deliver information relating to the women's contraceptive method of choice as well as information about other modern contraceptive methods. This part of the study will focus on determining the modality, content, timing, language and acceptability of messaging services for post menstrual regulation clients. The aim of the RCT phase is to measure the effect of mHealth on uptake or switching to long-acting reversible contraceptives at the 4 month and 12 month follow ups. The investigators expect mHealth to have a positive effect on uptake and a negative effect on discontinuation rates of contraceptive users.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Marie Stopes International.