Clinical trial NCT03539315: Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Domestic
Lead sponsor: Ipas
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
name: Ipas Bangladesh
name: Bangladesh Association for Prevention of Septic Abortion
First posted: 2018-05-29
Enrollment: 2729
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modern contraceptive use without interruption or partner interference
timeFrame: Past 4 months
Secondary outcomes:
measure: Reproductive coercion
timeFrame: Past 4 months
measure: Unsafe abortion
timeFrame: Past 12 months
measure: Unintended pregnancy
timeFrame: Past 12 months
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College Hospital RHSTEP Clinic
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College Hospital RHSTEP Clinic
city: Farīdpur
country: Bangladesh
facility: Faridpur Medical College Hospital RHSTEP Clinic
city: Rajshahi
country: Bangladesh
facility: Rajshahi Medical College Hospital RHSTEP Clinic
city: Rangpur
country: Bangladesh
facility: Rangpur Medical College Hospital RHSTEP Clinic
city: Sylhet
country: Bangladesh
facility: Sylhet Osmani Medical College Hospital RHSTEP Clinic
Study officials:
affiliation: Ipas
name: Erin E Pearson, PhD
role: PRINCIPAL_INVESTIGATOR
References: