Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh
|ClinicalTrials.gov Identifier: NCT02579785|
Recruitment Status : Unknown
Verified May 2016 by Marie Stopes International.
Recruitment status was: Active, not recruiting
First Posted : October 20, 2015
Last Update Posted : May 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception Post-abortion Abortion||Behavioral: Mhealth intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||969 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Health Services Research|
|Official Title:||Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||May 2017|
Experimental: mhealth intervention
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.
Behavioral: 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: Standard Care
Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number.
- Use of long acting and reversible contraceptive at 4 months [ Time Frame: 4 months ]Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)
- Use of long acting and reversible contraceptive at 2 weeks and 12 months [ Time Frame: 2 weeks and 12 months ]Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant)
- Use of any modern method at 2 weeks, 4 months and 12 months [ Time Frame: 2 weeks, 4 months and 12 months ]The proportion of subjects that self report using any effective modern contraceptive method: Modern contraceptive methods are defined according to the WHO as those associated with <10% 12 month pregnancy rates (WHO, 2011)
- Pregnancy [ Time Frame: 4 months and 12 months ]Proportion of subjects pregnant that self-report pregnancy at the time of follow-up
- Menstrual Regulation [ Time Frame: 4 months and 12 months ]Proportion of subjects that self report having had an MR procedure since baseline
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02579785
|Principal Investigator:||Kathryn Anderson, PhD||Ipas|
|Principal Investigator:||Sadid Nuremowla, PhD||Marie Stopes International|