Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in Bangladesh

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Using mHealth to Promote Post-Menstrual Regulation Contraceptive Uptake and Continuation in the Sylhet, Chittagong and Dhaka Regions of Bangladesh

Conditions
-----------------
Contraception, Post-abortion, Abortion

Intervention / Treatment
-----------------
* Behavioral: Mhealth intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mhealth intervention<br>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<br>* 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.<br>|
| No Intervention: Standard Care<br>Receives standard care which includes face to face post-MR family counselling and provision of existing hotline phone number. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of long acting and reversible contraceptive at 4 months | Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant) | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of long acting and reversible contraceptive at 2 weeks and 12 months | Proportion of subjects that self-report using a long acting and reversible contraceptive (coil or implant) | 2 weeks and 12 months | 
| Use of any modern method at 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) | 2 weeks, 4 months and 12 months | 
| Pregnancy | Proportion of subjects pregnant that self-report pregnancy at the time of follow-up | 4 months and 12 months | 
| Menstrual Regulation | Proportion of subjects that self report having had an MR procedure since baseline | 4 months and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Family Planning, Abortion, mHealth, Behaviour Change Communication, Menstrual Regulation, Postabortion, Bangladesh