Violence, DomesticARCHESNCT03539315
Adaptation and Testing of the Addressing Reproductive Coercion in HEalth Settings (ARCHES) Intervention in Bangladesh
A study testing ARCHES in people with Violence, Domestic, run by Ipas at 6 sites in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Violence, Domestic
- What is being tested?
- ARCHES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,729 participants
- Where
- 6 sitesBangladesh
- Study dates
- 28 Jan 2019to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Bangladesh6 sites
Chittagong Medical College Hospital RHSTEP Clinic
Chittagong
Dhaka Medical College Hospital RHSTEP Clinic
Dhaka
Faridpur Medical College Hospital RHSTEP Clinic
Farīdpur
Rajshahi Medical College Hospital RHSTEP Clinic
Rajshahi
Rangpur Medical College Hospital RHSTEP Clinic
Rangpur City
Sylhet Osmani Medical College Hospital RHSTEP Clinic
Sylhet
About this study
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
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.
Read the 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.
- Conditions
- Violence, Domestic
- Being tested
- ARCHES
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARCHESBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: ARCHES | Experimental | All women attending facilities assigned to the intervention arm receive the Addressing Reproductive Coercion within Healthcare Settings (ARCHES) intervention. Receives: Behavioral: ARCHES |
| Control | No intervention | All women attending facilities assigned to the control arm receive the standard of care (no intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Past 4 months
Secondary outcomes (3)
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.
Measured: Past 4 months
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).
Measured: Past 12 months
Unintended pregnancy
Proportion of women reporting that when they got pregnant, they did not want to get pregnant at that time.
Measured: Past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start28 Jan 2019
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Violence, DomesticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,729 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipas
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Ipas Bangladesh, Bangladesh Association for Prevention of Septic Abortion
- Responsible party
- Sponsor
- Investigators
- Erin E Pearson, PhD, Principal investigator, Ipas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539315
- Sponsor's protocol ID
- BD_01
- Acronym
- ARCHES
- Status last verified
- Feb 2020
- First submitted
- 14 May 2018
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39040882
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03539315
- Acronym / sponsor ID
- ARCHES / BD_01
- Conditions
- Violence, Domestic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,729 participants (actual)
- Lead sponsor
- IpasUniversity, hospital or other
- Collaborators
- University of California, San Diego, Ipas Bangladesh, Bangladesh Association for Prevention of Septic Abortion
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention: ARCHES | Experimental | Behavioral: ARCHESAll women attending facilities assigned to the intervention arm receive the Addressing Reproductive Coercion within Healthcare Settings (ARCHES) intervention. |
| Control | No intervention | –All women attending facilities assigned to the control arm receive the standard of care (no intervention). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARCHESAddressing 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. | Behavioural | Intervention: ARCHES |
Primary outcome
Modern contraceptive use without interruption or partner interference
Time frame: Past 4 months
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.
3 secondary outcomes
Reproductive coercion
Time frame: Past 4 months
Unsafe abortion
Time frame: Past 12 months
Unintended pregnancy
Time frame: Past 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Derived from this study: PubMed 39040882Pearson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erin E Pearson, PhD principal investigator
Ipas
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARCHES in people with Violence, Domestic, run by Ipas at 6 sites in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modern contraceptive use without interruption or partner interference (time frame: Past 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03539315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.