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Fibroids and unexplained infertility treatment with epigallocatechin gallate: a natural compound in green tea (FRIEND) - protocol for a randomised placebo-controlled US multicentre clinical trial of EGCG to improve fertility in women with uterine fibroids

Por: Al-Hendy · A. · Segars · J. H. · Taylor · H. S. · Gonzalez · F. · Siblini · H. · Zamah · M. · Alkelani · H. · Singh · B. · Flores · V. A. · Christman · G. M. · Johnson · J. J. · Huang · H. · Zhang · H.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT05364008.

Avoidance of healthcare service use and correlates among HIV-positive patients in Vietnam: a cross-sectional study

Por: Nguyen · H. L. T. · Bui · T. M. · Dam · V. A. T. · Nguyen · T. T. · Nguyen · H. T. · Zeng · G. M. · Bradley · D. · Nguyen · Q. N. · Ngo · T. V. · Latkin · C. A. · Ho · R. C. · Ho · C. S.
Objective

The prevention of HIV/AIDS is not making sufficient progress. The slow reduction of HIV/AIDS infections needs to prioritise hesitancy towards service utilisation, including treatment duration, social support and social stigma. This study investigates HIV-positive patients’ avoidance of healthcare services and its correlates.

Design

A cross-sectional study.

Setting

The secondary data analysis used cross-sectional data from a randomised controlled intervention, examining the effectiveness of HIV-assisted smartphone applications in the treatment of HIV/AIDS patients in the Bach Mai and Ha Dong clinics in Hanoi.

Methods

Simple random sampling was used to identify 495 eligible patients. Two-tailed 2, Mann-Whitney, multivariate logistic and ordered logistic regression models were performed.

Primary and secondary outcome measures

The main study outcome was the patients’ healthcare avoidance and frequency of healthcare avoidance. The association of individual characteristics, social and behavioural determinants of HIV patients’ usage of health services was also determined based on the collected data using structured questionnaires.

Results

Nearly half of the participants avoid health service use (47.3%), while 30.7% rarely avoid health service use. Duration of antiretroviral therapy and initial CD4 cell count were negatively associated with avoidance of health services and frequency of health service avoidance. Similarly, those with the middle and highest income were more likely to avoid health services compared with those with the lowest income. People having health problems avoided health service use more frequently (OR 1.47, 95% CI 1.35 to 1.61).

Conclusions

Our study’s findings identify characteristics of significance in relation to health service avoidance and utilisation among HIV-positive patients. The results highlighted the need to improve satisfaction, adherence and utilisation of treatment. Moreover, identifying ways to address or incorporate those social determinants in new policy may also help the treatment of HIV/AIDS and strategically allocate funding in the changing financial and political climate of Vietnam.

Trial registration number

Thai Clinical Trials Registry TCTR20220928003.

Long COVID in long-term care: a rapid realist review

Por: Fyffe · I. · Sorensen · J. · Carroll · S. · MacPhee · M. · Andrews-Paul · A. · Crooks · V. A. · Freeman · S. · Davison · K. · Walls · J. · Berndt · A. · Shams · B. · Sivan · M. · Mithani · A.
Objectives

The goals of this rapid realist review were to ask: (a) what are the key mechanisms that drive successful interventions for long COVID in long-term care (LTC) and (b) what are the critical contexts that determine whether the mechanisms produce the intended outcomes?

Design

Rapid realist review.

Data sources

Medline, CINAHL, Embase, PsycINFO and Web of Science for peer-reviewed literature and Google for grey literature were searched up to 23 February 2023.

Eligibility criteria

We included sources focused on interventions, persons in LTC, long COVID or post-acute phase at least 4 weeks following initial COVID-19 infection and ones that had a connection with source materials.

Data extraction and synthesis

Three independent reviewers searched, screened and coded studies. Two independent moderators resolved conflicts. A data extraction tool organised relevant data into context-mechanism-outcome configurations using realist methodology. Twenty-one sources provided 51 intervention data excerpts used to develop our programme theory. Synthesised findings were presented to a reference group and expert panel for confirmatory purposes.

Results

Fifteen peer-reviewed articles and six grey literature sources were eligible for inclusion. Eleven context-mechanism-outcome configurations identify those contextual factors and underlying mechanisms associated with desired outcomes, such as clinical care processes and policies that ensure timely access to requisite resources for quality care delivery, and resident-centred assessments and care planning to address resident preferences and needs. The underlying mechanisms associated with enhanced outcomes for LTC long COVID survivors were: awareness, accountability, vigilance and empathetic listening.

Conclusions

Although the LTC sector struggles with organisational capacity issues, they should be aware that comprehensively assessing and monitoring COVID-19 survivors and providing timely interventions to those with long COVID is imperative. This is due to the greater care needs of residents with long COVID, and coordinated efficient care is required to optimise their quality of life.

Use of social media in recruiting young people to mental health research: a scoping review

Por: Smith · M. V. A. · Grohmann · D. · Trivedi · D.
Objectives

This review explored the literature on the use of social media in recruiting young people, aged 13–18 years, to mental health research. It aimed to identify barriers and facilitators to recruitment and strategies to improve participation in future research.

Design

Scoping review.

Data sources

Articles published between January 2011 and February 2023 were searched for on PubMed, Scopus, Medline (via EBSCOhost) and Cochrane Library databases.

Eligibility criteria

Studies that outlined social media as a recruitment method and recruited participants aged 13–18 years.

Data extraction and synthesis

Data was extracted by two reviewers independently and cross-checked by a third reviewer. Data on study design, aims, participants, recruitment methods and findings related specifically to social media as a recruitment tool were collected.

Results

24 journal articles met the inclusion criteria. Studies were predominantly surveys (n=13) conducted in the USA (n=16) recruiting via Facebook (n=16) and/or Instagram (n=14). Only nine of the included articles provided a summary of success and reviewed the efficacy of social media recruitment for young people in mental health research. Type of advertisement, the language used, time of day and the use of keywords were all found to be factors that may influence the success of recruitment through social media; however, as these are based on findings from a small number of studies, such potential influences require further investigation.

Conclusion

Social media recruitment can be a successful method for recruiting young people to mental health research. Further research is needed into recruiting socioeconomically marginalised groups using this method, as well as the effectiveness of new social media platforms.

Registration

Open Science Framework Registry (https://osf.io/mak75/).

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