Uterine fibroids affect 30%–77% of reproductive-age women and are a significant cause of infertility. Surgical myomectomies can restore fertility, but they often have limited and temporary benefits, with postoperative complications such as adhesions negatively impacting fertility. Existing medical therapies, such as oral contraceptives, gonadotropin hormone-releasing hormone (GnRH) analogues and GnRH antagonists, can manage fibroid symptoms but are not fertility friendly. This study addresses the pressing need for non-hormonal, non-surgical treatment options for women with fibroids desiring pregnancy. Previous preclinical and clinical studies have shown that epigallocatechin gallate (EGCG) effectively reduces uterine fibroid size. We hypothesise that EGCG from green tea extract will shrink fibroids, enhance endometrial quality and increase pregnancy likelihood. To investigate this hypothesis, we initiated a National Institute of Child Health and Human Development Confirm-funded trial to assess EGCG’s efficacy in treating women with fibroids and unexplained infertility.

This multicentre, prospective, interventional, randomised, double-blinded clinical trial aims to enrol 200 participants with fibroids and unexplained infertility undergoing intrauterine insemination (IUI). Participants will be randomly assigned in a 3:1 ratio to two groups: green tea extract (1650 mg daily) or a matched placebo, combined with clomiphene citrate-induced ovarian stimulation and timed IUI for up to four cycles. EGCG constitutes approximately 45% of the green tea extract. The primary outcome is the cumulative live birth rate, with secondary outcomes including conception rate, time to conception, miscarriage rate, change in fibroid volume and symptom severity scores and health-related quality of life questionnaire scores.

The FRIEND trial received approval from the Food and Drug adminstration (FDA) (investigational new drug number 150951), the central Institutional Review Board (IRB) at Johns Hopkins University and FRIEND-collaborative site local IRBs. The data will be disseminated at major conferences, published in peer-reviewed journals and support a large-scale clinical trial.

NCT05364008.

Increasing engagement in HIV care among people living with HIV, especially those from Black/African American and Hispanic/Latinx communities, is an urgent need. Mobility data that measure individuals’ movements over time in combination with sociostructural data (eg, crime, census) can potentially identify barriers and facilitators to HIV care engagement and can enhance public health surveillance and inform interventions.

The proposed work is a longitudinal observational cohort study aiming to enrol 400 Black/African American and Hispanic/Latinx individuals living with HIV in areas of the USA with high prevalence rates of HIV. Each participant will be asked to share at least 14 consecutive days of mobility data per month through the study app for 1 year and complete surveys at five time points (baseline, 3, 6, 9 and 12 months). The study app will collect Global Positioning System (GPS) data. These GPS data will be merged with other data sets containing information related to HIV care facilities, other healthcare, business and service locations, and sociostructural data. Machine learning and deep learning models will be used for data analysis to identify contextual predictors of HIV care engagement. The study includes interviews with stakeholders to evaluate the implementation and ethical concerns of using mobility data to increase engagement in HIV care. We seek to study the relationship between mobility patterns and HIV care engagement.

Ethical approval has been obtained from the Institutional Review Board of the University of California, Irvine (#20205923). Collected data will be deidentified and securely stored. Dissemination of findings will be done through presentations, posters and research papers while collaborating with other research teams.