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

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

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Abortion; Post-abortion
• Intervention / Treatment: Behavioral: Mhealth intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 972
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Chittagong, Bangladesh
    • Marie Stopes Bangladesh Maternity Clinic,
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Brahman Baria
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Chandpur, Comilla
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Chittagong 1
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Comilla
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Cox's Bazar
  • Chittagong, Bangladesh
    • Marie Stopes Clinic Shitakunda
  • Chittagong, Bangladesh
    • Marie Stopes Femi Maternity Clinic
  • Chittagong, Bangladesh
    • RHSTEP Bandarban Clinic
  • Chittagong, Bangladesh
    • RHSTEP Chittagong Medical College Hospital
  • Chittagong, Bangladesh
    • RHSTEP Clinic Khagrachhari
  • Chittagong, Bangladesh
    • RHSTEP Cox's Bazar Sadar Hospital
  • Chittagong, Bangladesh
    • RHSTEP Rangamati Sadar Hospital
  • Dhaka, Bangladesh
    • Faridpur Maternal and Child Welfare Centre
  • Dhaka, Bangladesh
    • Kishoreganj Maternal and Child Welfare Centre
  • Dhaka, Bangladesh
    • Manikganj Maternal and Child Welfare Centre
  • Dhaka, Bangladesh
    • Mari Stopes Clinic Manikgonj
  • Dhaka, Bangladesh
    • Marie Stopes Bashail Maternity Clinic
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Balurmath
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Gazipur
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Kallyanpur
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Kamrangirchar
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Madaripur
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Mymensingh
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Sherpur
  • Dhaka, Bangladesh
    • Marie Stopes Clinic Tongi
  • Dhaka, Bangladesh
    • Marie Stopes Kadamtali Maternity Clinic
  • Dhaka, Bangladesh
    • Marie Stopes Premium 1 Clinic
  • Dhaka, Bangladesh
    • Marie Stopes Premium 2 Clinic
  • Dhaka, Bangladesh
    • Marie Stopes Referal Clinic, Tangail
  • Dhaka, Bangladesh
    • Mohammapur Fertility Services and Training Centre
  • Dhaka, Bangladesh
    • RHSTEP Dhaka Medical College Hospital
  • Dhaka, Bangladesh
    • RHSTEP Faridpur Medical College Hospital
  • Dhaka, Bangladesh
    • RHSTEP Mymensingh Medical College Hospital
  • Dhaka, Bangladesh
    • RHSTEP Sir Salaimullh Medical College Hospital
  • Dhaka, Bangladesh
    • Rupganj UHC Health Unit
  • Sylhet, Bangladesh
    • Marie Stopes Clinic Chatak
  • Sylhet, Bangladesh
    • Marie Stopes Clinic Moulvi Bazar
  • Sylhet, Bangladesh
    • Marie Stopes Sylhet Maternity Clinic
  • Sylhet, Bangladesh
    • RHSTEP Sylhet OAG Osmani Medical College Hospital
  • Sylhet, Bangladesh
    • Shreemongol UHC Health Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

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

Collaborators and Investigators

• Sponsor: Marie Stopes International
• Collaborators: London School of Hygiene and Tropical Medicine; Ipas
• Investigators: Principal Investigator: Kathryn Anderson, PhD, Ipas; Principal Investigator: Sadid Nuremowla, PhD, Marie Stopes International

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
• Reiss K, Andersen K, Pearson E, Biswas K, Taleb F, Ngo TD, Hossain A, Barnard S, Smith C, Carpenter J, Menzel J, Footman K, Keenan K, Douthwaite M, Reena Y, Mahmood HR, Tabbassum T, Colombini M, Bacchus L, Church K. Unintended Consequences of mHealth Interactive Voice Messages Promoting Contraceptive Use After Menstrual Regulation in Bangladesh: Intimate Partner Violence Results From a Randomized Controlled Trial. Glob Health Sci Pract. 2019 Sep 26;7(3):386-403. doi: 10.9745/GHSP-D-19-00015. Print 2019 Sep.
• Reiss K, Andersen K, Barnard S, Ngo TD, Biswas K, Smith C, Carpenter J, Church K, Nuremowla S, Pearson E. Using automated voice messages linked to telephone counselling to increase post-menstrual regulation contraceptive uptake and continuation in Bangladesh: study protocol for a randomised controlled trial. BMC Public Health. 2017 Oct 3;17(1):769. doi: 10.1186/s12889-017-4703-z.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2015
• Primary Completion (Actual): July 15, 2016
• Study Completion (Actual): July 15, 2016

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: mHealth; Bangladesh; Family Planning; Abortion; Behaviour Change Communication; Menstrual Regulation; Postabortion
• Other Study ID Numbers: MSI-007-14