Violence, Domestic Clinical Trial
— ARCHESOfficial 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
NCT number | NCT03539315 |
Other study ID # | BD_01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 28, 2019 |
Est. completion date | January 15, 2021 |
Verified date | February 2020 |
Source | Ipas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2729 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bangladesh | Chittagong Medical College Hospital RHSTEP Clinic | Chittagong | |
Bangladesh | Dhaka Medical College Hospital RHSTEP Clinic | Dhaka | |
Bangladesh | Faridpur Medical College Hospital RHSTEP Clinic | Faridpur | |
Bangladesh | Rajshahi Medical College Hospital RHSTEP Clinic | Rajshahi | |
Bangladesh | Rangpur Medical College Hospital RHSTEP Clinic | Rangpur | |
Bangladesh | Sylhet Osmani Medical College Hospital RHSTEP Clinic | Sylhet |
Lead Sponsor | Collaborator |
---|---|
Ipas | Bangladesh Association for Prevention of Septic Abortion, Ipas Bangladesh, University of California, San Diego |
Bangladesh,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Reproductive coercion | 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. | Past 4 months | |
Secondary | Unsafe abortion | 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). | Past 12 months | |
Secondary | Unintended pregnancy | Proportion of women reporting that when they got pregnant, they did not want to get pregnant at that time. | Past 12 months |
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