- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03539315
Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh (ARCHES)
Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention to Improve Reproductive Autonomy and Reproductive Health Among Abortion Clients in Bangladesh
Study Overview
Detailed Description
Reproductive coercion and partner violence are associated with unwanted pregnancy and abortion globally. In Bangladesh, women reporting partner violence are more likely to access abortion outside the health system and less likely to access post-abortion contraception, especially if accompanied to the clinic by their partner, which suggests additional intervention is needed to support clients' reproductive autonomy and ultimately their ability to safely control their fertility. ARCHES (Addressing Reproductive Coercion in HEalth Settings) is a clinic-based harm reduction intervention that empowers women to implement strategies that mitigate the impact of reproductive coercion on their reproductive health. ARCHES has been shown to reduce reproductive coercion among family planning clients in the U.S., but it has not previously been used in Asia or specifically with MR/PAC clients. This study seeks to adapt the ARCHES intervention for use with MR/PAC clients in Bangladesh and to test its effectiveness through a cluster randomized controlled trial. Overall, this study is expected to result in 1) evidence of the effectiveness of the adapted ARCHES intervention in increasing contraceptive use and reducing reproductive coercion, and ultimately in reducing the risk for future unintended pregnancy and unsafe abortion, and 2) evidence on the elements required for successful implementation in high volume MR/PAC clinics.
The aims of this study are:
- To conduct formative work to inform the adaptation of the ARCHES intervention to the Bangladesh context and for use with abortion clients.
- To pilot the adapted intervention
- To test the effect of the adapted ARCHES intervention on uninterrupted contraceptive use and reproductive coercion, and ultimately reduction in future unintended pregnancy and unsafe abortion, among abortion clients in Bangladesh.
- To evaluate implementation of the ARCHES intervention using an implementation science approach.
- To understand out of clinic abortion attempts and how these attempts interact with women's experiences of violence.
- To assess structural, community-related, and cultural barriers to accessing MR, methods of self-induced abortion, and abortion care received prior to presenting for MR/PAC.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chittagong, Bangladesh
- Chittagong Medical College Hospital RHSTEP Clinic
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Dhaka, Bangladesh
- Dhaka Medical College Hospital RHSTEP Clinic
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Farīdpur, Bangladesh
- Faridpur Medical College Hospital RHSTEP Clinic
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Rajshahi, Bangladesh
- Rajshahi Medical College Hospital RHSTEP Clinic
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Rangpur, Bangladesh
- Rangpur Medical College Hospital RHSTEP Clinic
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Sylhet, Bangladesh
- Sylhet Osmani Medical College Hospital RHSTEP Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Woman receiving MR or PAC services during the evaluation phase in all 6 selected RHSTEP clinics
- Age 18-49
- Able to provide a safe phone number at which they can be contacted for study follow-up
- Not being accompanied to the clinic by a person (e.g. spouse, family member) who refuses to allow her to be spoken to privately by the provider and/or research assistant
- Able to provide informed consent
- Able to communicate in Bangla
- Not planning on moving out of the area in the coming year
Exclusion Criteria:
- Woman not receiving MR or PAC services during the evaluation phase in the 6 selected RHSTEP clinics
- Not age 18-49
- Unable to provide a safe phone number for follow-up
- Accompanied to the clinic by a person (e.g. spouse, family member) who refuses to allow her to be spoken to privately by the provider and/or research assistant
- Unable to provide informed consent
- Unable to communicate in Bangla
- Planning on moving out of the area in the coming year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention: ARCHES
All women attending facilities assigned to the intervention arm receive the Addressing Reproductive Coercion within Healthcare Settings (ARCHES) intervention.
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Addressing Reproductive Coercion within Healthcare Settings (ARCHES) is a clinic-based intervention developed in the U.S., and involves training existing health providers to identify RC and IPV during standard family planning clinic-based counselling interactions.
The intervention seeks to empower women with harm reduction strategies that minimize their risk for unintended pregnancy by offering a wide range of contraceptive options, providing counseling on correct and consistent use of contraception, and counseling on contraceptive methods that are difficult for a male partner to detect or block such as injectables or IUDs.
ARCHES also facilitates access to violence support and counselling services by connecting women with community-based IPV services.
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No Intervention: Control
All women attending facilities assigned to the control arm receive the standard of care (no intervention).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modern contraceptive use without interruption or partner interference
Time Frame: Past 4 months
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Proportion of women reporting use of a modern contraceptive method (pills, condoms, injectables, IUD, implant, sterilization) without reported interruption or partner interference such as contraceptive sabotage.
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Past 4 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reproductive coercion
Time Frame: Past 4 months
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Proportion of women reporting reproductive coercion.
A reproductive coercion metric for Bangladesh is currently under development.
Reproductive coercion metrics used in other settings include indicators such as contraceptive sabotage, a husband or family member preventing a woman from accessing contraception, and pressure for her to become pregnant when she does not wish to be pregnant.
This description will be replaced with the reproductive coercion metric developed for Bangladesh when it is available.
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Past 4 months
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Unsafe abortion
Time Frame: Past 12 months
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Proportion of women reporting accessing unsafe abortion services, including an unsafe provider (provider who is untrained or unauthorized to provide abortion services) or using an unsafe method of abortion (a method that is not a WHO-approved uterine evacuation method).
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Past 12 months
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Unintended pregnancy
Time Frame: Past 12 months
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Proportion of women reporting that when they got pregnant, they did not want to get pregnant at that time.
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Past 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Erin E Pearson, PhD, Ipas
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BD_01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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