Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh

NCT ID: NCT03539315

Last Updated: 2021-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2729 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-28

Study Completion Date

2021-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary purpose of this research is to conduct a brief project to adapt and evaluate an evidence-based intervention model to address reproductive coercion and unintended pregnancy (ARCHES - Addressing Reproductive Coercion within Healthcare Settings) to the Bangladesh cultural context and for use with abortion clients (i.e., develop ARCHES Bangladesh) so as to provide initial assessment of acceptability, feasibility and effectiveness in this high-need LMIC context. Globally, addressing violence and coercion from male partners is considered key to reducing unintended pregnancy among adult and adolescent women. This has led to multiple efforts to integrate IPV screening and counseling in health settings, particularly in the context of family planning, across a range of middle and low-income countries. However, to date, no existing model addressing reproductive coercion has demonstrated reduction in risk for unintended pregnancy, either for Bangladesh or any other country.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. To conduct formative work to inform the adaptation of the ARCHES intervention to the Bangladesh context and for use with abortion clients.
2. To pilot the adapted intervention
3. 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.
4. To evaluate implementation of the ARCHES intervention using an implementation science approach.
5. To understand out of clinic abortion attempts and how these attempts interact with women's experiences of violence.
6. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Violence, Domestic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention: ARCHES

All women attending facilities assigned to the intervention arm receive the Addressing Reproductive Coercion within Healthcare Settings (ARCHES) intervention.

Group Type EXPERIMENTAL

ARCHES

Intervention Type BEHAVIORAL

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.

Control

All women attending facilities assigned to the control arm receive the standard of care (no intervention).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARCHES

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, San Diego

OTHER

Sponsor Role collaborator

Ipas Bangladesh

UNKNOWN

Sponsor Role collaborator

Bangladesh Association for Prevention of Septic Abortion

UNKNOWN

Sponsor Role collaborator

Ipas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Erin E Pearson, PhD

Role: PRINCIPAL_INVESTIGATOR

Ipas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chittagong Medical College Hospital RHSTEP Clinic

Chittagong, , Bangladesh

Site Status

Dhaka Medical College Hospital RHSTEP Clinic

Dhaka, , Bangladesh

Site Status

Faridpur Medical College Hospital RHSTEP Clinic

Farīdpur, , Bangladesh

Site Status

Rajshahi Medical College Hospital RHSTEP Clinic

Rajshahi, , Bangladesh

Site Status

Rangpur Medical College Hospital RHSTEP Clinic

Rangpur City, , Bangladesh

Site Status

Sylhet Osmani Medical College Hospital RHSTEP Clinic

Sylhet, , Bangladesh

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bangladesh

References

Explore related publications, articles, or registry entries linked to this study.

Pearson E, Paul D, Menzel J, Shakhider MAH, Konika RA, Uysal J, Silverman JG. Effectiveness of the Addressing Reproductive Coercion in Health Settings (ARCHES) intervention among abortion clients in Bangladesh: a cluster-randomized controlled trial. EClinicalMedicine. 2024 Jun 28;73:102699. doi: 10.1016/j.eclinm.2024.102699. eCollection 2024 Jul.

Reference Type DERIVED
PMID: 39040882 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BD_01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Consequences of Unwanted Pregnancy in Nepal
NCT03930576 ACTIVE_NOT_RECRUITING