Dataset Information

Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).

ABSTRACT: Women ages 16-29 utilizing family planning clinics for medical services experience higher rates of intimate partner violence (IPV) and reproductive coercion (RC) than their same-age peers, increasing risk for unintended pregnancy and related poor reproductive health outcomes. Brief interventions integrated into routine family planning care have shown promise in reducing risk for RC, but longer-term intervention effects on partner violence victimization, RC, and unintended pregnancy have not been examined.The 'Addressing Reproductive Coercion in Health Settings (ARCHES)' Intervention Study is a cluster randomized controlled trial evaluating the effectiveness of a brief, clinician-delivered universal education and counseling intervention to reduce IPV, RC and unintended pregnancy compared to standard-of-care in family planning clinic settings. The ARCHES intervention was refined based on formative research. Twenty five family planning clinics were randomized (in 17 clusters) to either a three hour training for all family planning clinic staff on how to deliver the ARCHES intervention or to a standard-of-care control condition. All women ages 16-29 seeking care in these family planning clinics were eligible to participate. Consenting clients use laptop computers to answer survey questions immediately prior to their clinic visit, a brief exit survey immediately after the clinic visit, a first follow up survey 12-20 weeks after the baseline visit (T2), and a final survey 12 months after the baseline (T3). Medical record chart review provides additional data about IPV and RC assessment and disclosure, sexual and reproductive health diagnoses, and health care utilization. Of 4009 women approached and determined to be eligible based on age (16-29 years old), 3687 (92 % participation) completed the baseline survey and were included in the sample.The ARCHES Intervention Study is a community-partnered study designed to provide arigorous assessment of the short (3-4 months) and long-term (12 months) effects of a brief, clinician-delivered universal education and counseling intervention to reduce IPC, RC and unintended pregnancy in family planning clinic settings. The trial features a cluster randomized controlled trial design, a comprehensive data collection schedule and a large sample size with excellent retention.ClinicialTrials.gov NCT01459458. Registered 10 October 2011.

SUBMITTER: Tancredi DJ

PROVIDER: S-EPMC4527212 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).

Tancredi Daniel J DJ Silverman Jay G JG Decker Michele R MR McCauley Heather L HL Anderson Heather A HA Jones Kelley A KA Ciaravino Samantha S Hicks Angela A Raible Claire C Zelazny Sarah S James Lisa L Miller Elizabeth E

BMC women's health 20150806

<h4>Background</h4>Women ages 16-29 utilizing family planning clinics for medical services experience higher rates of intimate partner violence (IPV) and reproductive coercion (RC) than their same-age peers, increasing risk for unintended pregnancy and related poor reproductive health outcomes. Brief interventions integrated into routine family planning care have shown promise in reducing risk for RC, but longer-term intervention effects on partner violence victimization, RC, and unintended preg ...[more]

PMID: 26245752

Similar Datasets

Project description:BackgroundSince 2013, the World Health Organization has recommended that reproductive coercion (RC) and intimate partner violence (IPV) be addressed within reproductive health services and, in 2018, the Lancet Commission on Sexual and Reproductive Health and Rights found that RC and IPV were significant contributors to unmet need for family planning (FP) and unintended pregnancy. In Kenya, the Ministry of Health (MOH) has made reduction of unintended pregnancy and gender-based violence a primary objective. Despite this need and guidance, no clinic-based intervention models outside of the U.S. (apart from the one described here) have demonstrated efficacy to improve FP use and reduce IPV or RC thereby reducing unintended pregnancy. ARCHES (Addressing Reproductive Coercion in Health Settings) is a brief, clinic-based intervention delivered by existing FP providers aiming to: (1) Increase women's ability to use FP without interference, (2) Provide a safe and supportive environment for IPV disclosure and referral to support services, and (3) Improve quality of FP counseling, including addressing RC and IPV. The objective of this study is to generate evidence on scaling integrated FP services (including FP, RC, and IPV) in public sector health facilities in Uasin Gishu county, Kenya via adaptation and implementation of ARCHES in partnership with the Kenya MOH.MethodsA cluster-randomized controlled trial paired with concurrent implementation science assessments will test effectiveness of the ARCHES model, adapted for scale by the Kenya MOH, in reducing unintended pregnancy. Female FP clients aged 15-49 years at selected sites will complete baseline surveys (immediately prior to receiving care), immediately post-visit exit surveys, and 6-month follow-up surveys. Provider surveys will assess changes in gender-equitable attitudes and self-efficacy to address violence reported by their clients. Costs associated with scaling ARCHES will be tracked and utilized in combination with results of the effectiveness trial to assess costs and cost-effectiveness relative to the standard of care.DiscussionThis study will provide evidence of the effectiveness of a facility-based intervention to address RC and IPV within public sector FP services at scale, as adapted and implemented in Uasin Gishu county, Kenya. Trial registration Trial registered on 28 September 2023 with clinicaltrials.gov NCT06059196.

Project description:BackgroundReproductive coercion (RC) and intimate partner violence (IPV) are prevalent forms of gender-based violence (GBV) associated with reduced female control over contraceptive use and subsequent unintended pregnancy. Although the World Health Organization has recommended the identification and support of GBV survivors within health services, few clinic-based models have been shown to reduce IPV or RC, particularly in low or middle-income countries (LMICs). To date, clinic-based GBV interventions have not been shown to reduce RC or unintended pregnancy in LMIC settings.InterventionARCHES (Addressing Reproductive Coercion in Health Settings) is a single-session, clinic-based model delivered within routine contraceptive counseling that has been demonstrated to reduce RC in the United States. ARCHES was adapted to the Kenyan context via a participatory process to reduce GBV and unintended pregnancy among women and girls seeking contraceptive services in this setting. Core elements of ARCHES include enhanced contraceptive counseling that addresses RC, opportunity for patient disclosure of RC and IPV (and subsequent warm referral to local services), and provision of a palm-sized educational booklet.MethodsA matched-pair cluster control trial is being conducted to assess whether the ARCHES intervention (treatment condition), as compared to standard-of-care contraceptive counseling (control condition), reduces RC and IPV, and improves contraceptive outcomes for woman and girls of reproductive age (15 to 49 years) seeking contraceptive services from community-based clinics in Nairobi, Kenya. All six clinics were assigned to intervention-control pairs based on similarities in patient volume and demographics, physical structure and neighborhood context. Survey data will be collected from patients immediately prior to their clinic visit (baseline, T1), immediately after their clinic visit (exit), and at 3- and 6-months post-visit (T2 and T3, respectively).DiscussionThis study is the first to assess the efficacy of an adaptation of the ARCHES model to reduce GBV and improve reproductive health outside of the U.S., and one of only a small number of controlled trials to assess reductions in GBV associated with a clinic-based program in an LMIC context. Evidence from this trial will inform health system efforts to reduce GBV, and to enhance female contraceptive control and reproductive health in Kenya and globally.Trial registrationRegistered May 23, 2018 - ClinicalTrials.gov, NCT03534401. Unique Protocol ID: 170084.

Project description:ObjectiveWe assessed the effectiveness of a provider-delivered intervention targeting reproductive coercion, an important factor in unintended pregnancy.Study designWe randomized 25 family planning clinics (17 clusters) to deliver an education/counseling intervention or usual care. Reproductive coercion and partner violence victimization at 1 year follow-up were primary outcomes. Unintended pregnancy, recognition of sexual and reproductive coercion, self-efficacy to use and use of harm reduction behaviors to reduce victimization and contraception nonuse, and knowledge and use of partner violence resources were secondary outcomes. Analyses included all available data using an intention-to-treat approach.ResultsAmong 4009 females ages 16 to 29 years seeking care, 3687 completed a baseline survey prior to clinic visit from October 2011 to November 2012; 3017 provided data at 12-20weeks post-baseline (T2) and 2926 at 12months post-baseline (T3) (79% retention). Intervention effects were not significant for reproductive coercion [adjusted risk ratio (ARR) 1.50 (95% confidence interval 0.95-2.35)] or partner violence [ARR 1.07 (0.84-1.38)]. Intervention participants reported improved knowledge of partner violence resources [ARR 4.25 (3.29-5.50)] and self-efficacy to enact harm reduction behaviors [adjusted mean difference 0.06 (0.02-0.10)]. In time point-specific models which included moderating effects of exposure to reproductive coercion at baseline, a higher reproductive coercion score at baseline was associated with a decrease in reproductive coercion 1 year later (T3). Use and sharing of the domestic violence hotline number also increased.ConclusionThis brief clinic intervention did not reduce partner violence victimization. The intervention enhanced two outcomes that may increase safety for women, specifically awareness of partner violence resources and self-efficacy to enact harm reduction behaviors. It also appeared to reduce reproductive coercion among women experiencing multiple forms of such abuse.

Project description:IntroductionReproductive coercion (RC) describes behaviours that interfere with an individual's reproductive autonomy and decision-making. RC can be a form of intimate partner violence and overlaps with other forms of gender-based violence, such as sexual violence. Health settings are well placed to identify and intervene to support patients experiencing RC, however, the lack of conceptual clarity on RC means that health providers are not easily able to identify those at risk of experiencing RC. To facilitate appropriate identification and development of interventions, there is a need to understand the risk factors related to experiencing RC and associated health consequences.AimTo assess the current scope of evidence in relation to risk factors and health consequences of experiencing RC.Methods and analysisEligible articles for inclusion in the scoping review will be original peer-reviewed literature that describe risk factors and health consequences of any type of RC. Studies on humans published in English since 2010 will be included. The proposed scoping review will be conducted in accordance with the JBI Methodology. This protocol is reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. Five electronic databases, OVID Medline, CINAHL, Scopus, PsychINFO and Embase, will be searched for relevant literature from 1 January 2010 to 23 January 2023. Two reviewers will individually screen and review articles for eligibility, and conflicts will be resolved by a third reviewer. Data will be charted and reported using a tool developed for the purpose of this review.Ethics and disseminationFindings will be disseminated in publications and presentations to relevant stakeholders. Ethical approval is not required as data from publicly available literature sources will be used. Available evidence will be mapped across the breadth of eligible studies to identify associated risk factors and health consequences of RC.

Project description:BackgroundPerinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support.MethodsThis study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm.DiscussionThis manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.Trial registrationClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.

Project description:The Building on Existing Tools to Improve Chronic Disease Prevention and Screening (BETTER) cluster randomized trial in primary care settings demonstrated a 30% improvement in adherence to evidence-based Chronic Disease Prevention and Screening (CDPS) activities. CDPS activities included healthy activities, lifestyle modifications, and screening tests. We present a protocol for the adaptation of BETTER to a public health setting, and testing the adaptation in a cluster randomized trial (BETTER HEALTH: Durham) among low income neighbourhoods in Durham Region, Ontario (Canada).The BETTER intervention consists of a personalized prevention visit between a participant and a prevention practitioner, which is focused on the participant's eligible CDPS activities, and uses Brief Action Planning, to empower the participant to set achievable short-term goals.Durham aims to establish that the BETTER intervention can be adapted and proven effective among 40-64 year old residents of low income areas when provided in the community by public health nurses trained as prevention practitioners. Focus groups and key informant interviews among stakeholders and eligible residents of low income areas will inform the adaptation, along with feedback from the trial's Community Advisory Committee. We have created a sampling frame of 16 clusters composed of census dissemination areas in the lowest urban quintile of median household income, and will sample 10 clusters to be randomly allocated to immediate intervention or six month wait list control. Accounting for the clustered design effect, the trial will have 80% power to detect an absolute 30% difference in the primary outcome, a composite score of completed eligible CDPS actions six months after enrollment. The prevention practitioner will attempt to link participants without a primary care provider (PCP) to a local PCP. The implementation of BETTER HEALTH: Durham will be evaluated by focus groups and key informant interviews.The effectiveness of BETTER HEALTH: Durham will be tested for delivery in low income neighbourhoods by a public health department.NCT03052959, registered February 10, 2017.

Project description:Increasing modern contraceptive use and gender equity are major foci of the recently ratified Sustainable Development Goals for 2030 and the Government of India. Coercion and sabotage by husbands and in-laws to inhibit women's access, initiation, continuation, and successful use of modern contraception methods (i.e., reproductive coercion) may contribute to low usage rates and unintended pregnancy in India; however, little is known about the extent of this problem. The current study assesses the prevalence of reproductive coercion, both husband and in-law perpetrated, among a large population-based sample. Data were collected from currently married women of reproductive age (15-49 years; N?=?1770) across 49 districts of Uttar Pradesh as part of an evaluation of a broad effort to improve the public health system in the state. Dependent variables included modern contraceptive use in the past 12 months, unintended pregnancy, and pregnancy termination. Independent variables included ever experiencing reproductive coercion (RC) by a current husband or in-laws and lifetime experience of physical and sexual intimate partner violence (IPV) by a current husband. Approximately 1 in 8 (12%) women reported ever experiencing RC from their current husbands or in-laws; 42% of these women reported RC by husbands only, 48% reported RC by in-laws only, and 10% reported RC by both husbands and in-laws. Among women experiencing RC, more than one-third (36%) reported that their most recent pregnancy was unintended; these women had 4 to 5 times greater odds of unintended pregnancy and a more than 5 times decreased likelihood of recent use of modern contraceptives than women not experiencing RC, after accounting for effects of demographics and physical and sexual IPV. Scalable and sustainable interventions in both clinical and community settings are needed to reduce RC, a potentially key factor in effective strategies for improving women's reproductive autonomy and health in India and globally.

Dataset Information

Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).

Publications

Cluster randomized controlled trial protocol: addressing reproductive coercion in health settings (ARCHES).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets