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

NCT03539315 | Completed

• 1 other identifier: BD_01
• Study Type: interventional
• Target: 2,729
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Violence, Domestic

Outcome Measures

Primary Outcomes (1)

• Modern contraceptive use without interruption or partner interference

  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.

  Past 4 months

Secondary Outcomes (3)

• Reproductive coercion

  Past 4 months

• Unsafe abortion

  Past 12 months

• Unintended pregnancy

  Past 12 months

Study Arms (2)

Intervention: ARCHES

EXPERIMENTAL

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

Behavioral: ARCHES

Control

NO INTERVENTION

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

Interventions

ARCHES 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.

Intervention: ARCHES

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Woman receiving abortion services
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipas: lead
• University of California, San Diego: collaborator
• Ipas Bangladesh: collaborator
• Bangladesh Association for Prevention of Septic Abortion: collaborator

Study Sites (6)

Chittagong Medical College Hospital RHSTEP Clinic

Chittagong, Bangladesh

Location

Dhaka Medical College Hospital RHSTEP Clinic

Dhaka, Bangladesh

Location

Faridpur Medical College Hospital RHSTEP Clinic

Farīdpur, Bangladesh

Location

Rajshahi Medical College Hospital RHSTEP Clinic

Rajshahi, Bangladesh

Location

Rangpur Medical College Hospital RHSTEP Clinic

Rangpur City, Bangladesh

Location

Sylhet Osmani Medical College Hospital RHSTEP Clinic

Sylhet, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 39040882 DERIVED

MeSH Terms

Interventions

cpsf4 protein, zebrafish

Study Officials

• Erin E Pearson, PhD

  Ipas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 29, 2018
• Study Start: January 28, 2019
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: September 5, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (6)