More than awareness—taking action to address IPV as an SDOH in clinical trials
October is Intimate Partner Violence awareness month in the US. What can we do?
The social determinants of health (SDoH) are increasingly recognised as critical to understanding and improving patient outcomes. These determinants range from housing instability and limited access to education or transportation, to food insecurity and systemic inequities, and they exert a profound influence on health outcomes. Yet, one significant factor remains underassessed in clinical research: intimate partner violence (IPV).
IPV is a pervasive public health issue that transcends race, ethnicity, gender, and socioeconomic status. Despite its prevalence and well-documented impact on both physical and mental health, IPV is rarely considered in the design or execution of clinical trials. As the industry continues to prioritise equity in research, it is imperative to recognise IPV as a key SDoH and address its implications for participant recruitment, retention and outcomes.
IPV prevalence: A hidden reality in clinical trials
According to the Centers for Disease Control and Prevention (CDC), 41% of women and 26% of men in the United States experience IPV in their lifetime, including contact sexual violence, physical violence, or stalking with related impacts¹. Globally, the World Health Organization (WHO) estimates that 26% of women have experienced IPV². While IPV affects individuals of all genders, women are disproportionately impacted and there are variances in rates across geographic and demographic factors.
In contrast, only 5.1% of U.S. adults have participated in a clinical trial, based on a 2020 study using data from the National Institutes of Health³. Given the high prevalence of IPV, it is statistically likely that a significant proportion of clinical trial participants have experienced or are currently experiencing IPV. This reality necessitates a more intentional approach to trial design and participant support.
The health impact of IPV
IPV is anecdotally understood as having impacts on health. Studies in recent years confirm, with validated measurements, the wide range of detrimental effects on mental and physical wellbeing. Survivors are at increased risk for depression, anxiety, post-traumatic stress disorder (PTSD), self-harm, and sleep disturbances⁴. Physically, IPV is associated with chronic pain, somatic disorders, gynaecological issues, and a heightened risk of sexually transmitted infections⁵. Notably, IPV has also been linked to an increased risk of cardiovascular disease in women, a leading cause of mortality worldwide⁶.
These health outcomes can directly affect a participant’s ability to engage in and complete a clinical trial. Without appropriate support, individuals experiencing IPV may face significant barriers to participation, leading to higher attrition rates and skewed data that undermines the generalisability of trial results.
Reducing barriers to participation
To foster equitable participation, trial sponsors, CROs and sites must consider how IPV may influence a participant’s ability to enrol and remain in a study. Many of the same strategies used to address other SDoH, such as providing transportation or childcare support, can be adapted to meet the needs of IPV survivors.
- Revisiting inclusion and exclusion criteria: Rigid eligibility requirements may inadvertently exclude individuals affected by IPV that would benefit from the therapy within the clinical trial. Sponsors should critically assess whether each criterion is essential, ensuring that trials remain accessible to a broader and more representative population.
- Flexible, decentralised study visits: Survivors of IPV may face restrictions on their time, mobility, or autonomy due to coercive control that characterise IPV. Offering decentralised or virtual visits can reduce logistical burdens and empower participants to engage on their terms.
- Financial support: IPV often involves financial abuse or dependency. Providing stipends for travel, childcare, and other participation-related expenses can help mitigate financial barriers and promote retention.
Integrating IPV screening and support
While not typically part of clinical trial protocols, screening for IPV during patient intake can be a critical step in identifying participants who may need additional support. The US Preventive Services Task Force recommends routine IPV screening in primary care settings⁷. Extending this practice to clinical trials, when done sensitively and with appropriate training, can help connect participants to vital resources and improve their overall experience.
However, IPV screening is more complex than it may seem. Survivors may be reluctant to disclose abuse due to fear, stigma, or lack of recognition. Staff must be trained to approach these conversations with empathy, confidentiality and cultural competence. When IPV is identified, sites should be equipped to offer immediate referrals to support services and be able to maintain those services or communication channels throughout the trial.
Site-level support for deeper participant engagement
The most effective IPV interventions occur at the site level, where staff can build trust and respond to individual needs. Yet, many sites already face significant operational burdens. So how can we support sites so they can engage more deeply with participants that need them?
ICON Site Engagement has devised a more site-centric model to provide dedicated resources in the form of Site Engagement Liaisons (SELs) and Clinical Trial Liaisons (CTLs).
SELs provide tailored support to research sites, strengthening site relationships and helping them optimise patient recruitment, navigate study resources, and connect with local advocacy or community organisations. SELs can help sites identify the right resources for participants experiencing IPV and can help connect them once screened.
CTLs provide doctorate-level trained professionals who provide global scientific support through the development of peer-to-peer relationships with investigator teams. They’re a reliable, trusted field partner of scientific affairs, ensuring that scientific and ethical considerations—including those related to SDoH—are integrated into trial conduct.
Looking ahead: Building a more inclusive research ecosystem
As we observe IPV Awareness Month in the United States, the clinical research community has an opportunity to reflect on how trials can better serve all participants. Recognising IPV as a social determinant of health is not only a moral imperative but a scientific one. By addressing the unique barriers faced by survivors, we can improve trial accessibility, enhance data quality, and ultimately deliver more equitable healthcare solutions.
The path forward requires collaboration across sponsors, sites and community partners. It calls for thoughtful trial design, targeted support, and a commitment to meeting participants where they are. As we continue to evolve our approach to clinical research, we aim to leave no clinical trial participant or healthcare patient behind—especially those whose experiences are too often hidden in plain sight.
Connect with us to learn how we can work together to build trials that reflect the realities of all patients and deliver equitable health outcomes.
References
- U.S. Department of Health and Human Services. U.S. Playbook to Address Social Determinants of Health. November 2023.
- Centers for Disease Control and Prevention. Intimate Partner Violence. https://www.cdc.gov/intimate-partner-violence/about/index.html
- World Health Organization. Violence Info – Intimate Partner Violence. https://apps.who.int/violence-info/intimate-partner-violence
- Kontos EZ, Bennett GG, Viswanath K. Clinical trial participation in America: the roles of eHealth engagement and patient–provider communication. PLoS One. 2020;15(7):e0235694.
- Dillon G, Hussain R, Loxton D, Rahman S. Mental and physical health and intimate partner violence against women: a review of the literature. Int J Family Med. 2013;2013:313909.
- Ibid.
- Mason SM, Wright RJ, Hibert EN, Spiegelman D, Forman JP, Rich-Edwards JW. Intimate partner violence and incidence of hypertension in women. Ann Epidemiol. 2012;22(8):562–567.
- US Preventive Services Task Force. Screening for Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: US Preventive Services Task Force Final Recommendation Statement. JAMA Netw Open. 2024;7(1):e240786. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821812