Strategies for enhancing the representation of women in clinical trials: an evidence map.

BACKGROUND: Equitable sex- and gender-based representation in clinical trials is an essential step to ensuring evidence-based care for women. While multi-institutional actions have led to significant improvements in the inclusion of women in trials, inequity persists in areas like sex-neutral cancers and cardiovascular disease. We sought to identify strategies described or evaluated to boost the inclusion of women in clinical trials. METHODS: We used evidence mapping methodology to examine the breadth of relevant literature. We developed an a priori protocol and followed reporting guidance from the Preferred Reporting Items for Systematic Reviews and Meta-Analysis where applicable. We searched MEDLINE® (via PubMed) and EMBASE (via Elsevier) databases from inception through April 4, 2023, and used standardized procedures incorporating duplication and data verification. We included articles that described strategies to improve the recruitment and retention of women in clinical trials. RESULTS: We identified 122 articles describing recruitment and retention strategies for 136 trials (377,595 women). Only one article distinguished between the sex and gender identity of participants, and none defined their use of the terms such as "women" or "female". The majority of articles (95%) described recruitment for only women, and 64% were conducted in the USA. Ninety-two articles (75%) described strategies in the context of sex-specific conditions (e.g., gynecologic diagnosis). The majority of included articles evaluated a behavioral intervention (52%), with 23% evaluating pharmacologic interventions and 4% invasive interventions. The most common trial phase for reported strategies was during outreach to potential participants (116 articles), followed by intervention delivery (76), enrollment (40), outcomes assessment (21), analysis and interpretation (3), and dissemination (4). We describe specific types of strategies within each of these phases. CONCLUSIONS: Most of the existing literature describing strategies to improve the inclusion of women draws from trials for sex-specific conditions and is largely related to outreach to potential participants. There is little information about how and if studies have attempted to proportionally increase the inclusion of women in trials with both men and women or those focused on invasive and pharmacologic interventions. Future work in this area should focus on how to increase the participation of women in mixed-sex studies and on those areas with remaining inequities in trial participation.

The influence of healthcare financing on cardiovascular disease prevention in people living with HIV.

BACKGROUND: People living with HIV are diagnosed with age-related chronic health conditions, including cardiovascular disease, at higher than expected rates. Medical management of these chronic health conditions frequently occur in HIV specialty clinics by providers trained in general internal medicine, family medicine, or infectious disease. In recent years, changes in the healthcare financing for people living with HIV in the U.S. has been dynamic due to changes in the Affordable Care Act. There is little evidence examining how healthcare financing characteristics shape primary and secondary cardiovascular disease prevention among people living with HIV. Our objective was to examine the perspectives of people living with HIV and their healthcare providers on how healthcare financing influences cardiovascular disease prevention. METHODS: As part of the EXTRA-CVD study, we conducted in-depth, semi-structured interviews with 51 people living with HIV and 34 multidisciplinary healthcare providers and at three U.S. HIV clinics in Ohio and North Carolina from October 2018 to March 2019. Thematic analysis using Template Analysis techniques was used to examine healthcare financing barriers and enablers of cardiovascular disease prevention in people living with HIV. RESULTS: Three themes emerged across sites and disciplines (1): healthcare payers substantially shape preventative cardiovascular care in HIV clinics (2); physician compensation tied to relative value units disincentivizes cardiovascular disease prevention efforts by HIV providers; and (3) grant-based services enable tailored cardiovascular disease prevention, but sustainability is limited by sponsor priorities. CONCLUSIONS: With HIV now a chronic disease, there is a growing need for HIV-specific cardiovascular disease prevention; however, healthcare financing complicates effective delivery of this preventative care. It is important to understand the effects of evolving payer models on patient and healthcare provider behavior. Additional systematic investigation of these models will help HIV specialty clinics implement cardiovascular disease prevention within a dynamic reimbursement landscape. TRIAL REGISTRATION: Clinical Trial Registration Number: NCT03643705 .

A qualitative study of perceived barriers to hepatitis C care among people who did not attend appointments in the non-urban US South.

BACKGROUND: Most people diagnosed with hepatitis C virus (HCV) have not linked to care, despite the availability of safe and effective treatment. We aimed to understand why people diagnosed with HCV have not pursued care in the non-urban Southern United States. METHODS: We conducted a survey and semi-structured interview with participants referred to an HCV clinic who did not attend an appointment between 2014 and 2018. Our clinic is located in a non-urban region of Virginia at a university hospital. Qualitative data collection was guided by the Health Belief Model (HBM). Data was analyzed using qualitative content analysis to identify key factors influencing patient perceptions regarding HCV and pursuit of care. RESULTS: Over half of previously referred patients (N = 200) could not be reached by phone. Eleven participants enrolled, including 7 men and 4 women. Based on survey responses, unreliable transportation, unstable housing, substance use, and lack of insurance were common. Participants demonstrated good knowledge of HCV disease, complications, and treatment. On qualitative analysis of semi-structured interviews, final themes emerged from within and between HBM constructs. Emerging themes influencing patient perceptions included (1) structural barriers, (2) stigma, (3) prior experiences of HCV disease and treatment, (4) discordance between the recognized severity of HCV and expected impacts on one's own health, and (5) patient-provider relationship. Substance use was not identified to be a barrier to care. CONCLUSIONS: Participants perceived individual and structural barriers to linking to care. A strong HCV knowledge base was not sufficient to motivate pursuit of care. Efforts to improve linkage to care must address barriers at multiple levels, and system-level changes are needed. As the majority of previously referred patients could not be contacted by phone, current approaches to patient engagement are not effective for reaching these populations. Expansion of HCV care to primary care settings with an established patient-provider relationship or co-located treatment within substance use treatment programs may serve to increase access to HCV treatment.