Validation of a claims-based algorithm to identify pre-exposure prophylaxis indications for tenofovir disoproxil fumarate/emtricitabine prescriptions, United States, 2012-2014: algorithm validation by medical records review.

BACKGROUND: To monitor the use of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) and related medicines for pre-exposure prophylaxis (PrEP) as HIV prevention using commercial pharmacy data, it is necessary to determine whether TDF/FTC prescriptions are used for PrEP, or for some other clinical indication. OBJECTIVE: To validate an algorithm to distinguish the use of TDF/FTC for HIV prevention or infectious disease treatment. METHODS: An algorithm was developed to identify whether TDF/FTC prescriptions were for PrEP or for other indications from large-scale administrative databases. The algorithm identifies TDF/FTC prescriptions, and then excludes patients with International Classification of Diseases (ICD)-9 diagnostic codes, medications or procedures that suggest indications other than for PrEP (e.g., documentation of HIV infection, chronic hepatitis B (CHB), or use of TDF/FTC for post-exposure prophylaxis (PEP)). For evaluation, we collected data by clinician assessment of medical records for patients with TDF/FTC, and compared the assessed indication identified by the clinician review with the assessed indication identified by the algorithm. The algorithm was then applied and evaluated in a large urban community-based sexual health clinic. RESULTS: The PrEP algorithm demonstrated high sensitivity and moderate specificity (99.6%, 49.6%) in the electronic medical record database, and high sensitivity and specificity (99%, 87%) in data from the urban community health clinic. CONCLUSIONS: The PrEP algorithm classified the indication for PrEP in most subjects treated with TDF/FTC with sufficient accuracy to be useful for surveillance purposes. The methods described can serve as a basis for developing a robust and evolving case definition for antiretroviral prescriptions for HIV prevention purposes. CLINICALTRIAL: None required.

PA experiences in clinical trials.

OBJECTIVE: Physician associate/assistant (PA) experience in clinical trials is poorly documented in medical literature. This survey aimed to describe the characteristics and experiences of PAs in clinical trial research. METHODS: We performed descriptive analyses of data gathered in 2022 by the American Academy of Physician Associates and published in the organization's annual Salary Report, specifically of respondents who indicated experience in traditional and/or decentralized clinical trials. RESULTS: About 73% of PAs eligible for the clinical trials survey indicated they were either involved in clinical trials or had been involved in the past and were interested in working in clinical trials in the future. PAs often serve in subinvestigator roles and perform various clinical trial tasks regardless of previous research experience. CONCLUSIONS: PAs working in clinical trials demonstrated broad responsibilities and skills in the research setting. They leveraged benefits to working in clinical trials despite institutional barriers. Clinical research may fit into numerous PAs' practices and let them contribute to medical advancements.

Lipid profiles and hypertriglyceridemia among transgender and gender diverse adults on gender-affirming hormone therapy.

BACKGROUND: The effects of gender-affirming hormone therapy on lipid profiles among transgender adults have been inconsistent and incompletely characterized. OBJECTIVE: To longitudinally assess changes to lipid profiles following hormone therapy and to establish prevalence rates of hyperlipidemia/low HDL-cholesterol. METHODS: This longitudinal study followed lipid profiles of 366 transgender and gender-diverse adult patients (170 transfeminine and 196 transmasculine; mean age, 28 years) in Washington DC USA. Lipid profiles were measured at baseline and at multiple follow-up clinical visits up to 57 months after the initiation of hormone therapy. RESULTS: Within 2-10 months of starting gender-affirming hormone therapy, mean levels of HDL-cholesterol decreased by 16% in transmasculine individuals and increased by 11% in transfeminine individuals. Over the study, mean triglyceride levels increased by 26-37% in the transmasculine group. Over the study, the prevalence of moderate hypertriglyceridemia (175-499 mg/dL) ranged from 11 to 32% in the transfeminine group and 6-19% in the transmasculine group. Severe hypertriglyceridemia (≥500 mg/dL) was only observed in one individual. On hormone therapy, 24-30% of the transfeminine group had a HDL-cholesterol < 50 mg/dL and 16-24% of the transmasculine group had a HDL-cholesterol < 40 mg/dL. LDL-cholesterol levels ≥160 mg/dL were rare among both groups. CONCLUSIONS: In a gender-diverse population on hormone therapy, low HDL-cholesterol and moderate hypertriglyceridemia were relatively common. HDL-cholesterol decreased with testosterone therapy and increased with a combination of oral estrogen and spironolactone. Testosterone use was associated with an increase in triglycerides. Our data support the recommendation to routinely monitor lipid profiles in gender-diverse patients on GAHT.

Reproductive intentions among HIV-negative gay and bisexual men initiating pre-exposure prophylaxis in the Sustainable Health Center Implementation pre-exposure prophylaxis pilot study, 2014-2016.

INTRODUCTION: We assessed reproductive intentions and associated characteristics among men enrolled in the Sustainable Health Center Implementation pre-exposure prophylaxis (PrEP) Pilot (SHIPP) Study. METHODS: We analyzed baseline data from 1275 men who self-identified as gay or bisexual and participated in the SHIPP study. SHIPP was a cohort study of PrEP implementation in five community health centers in Chicago, Jackson, Philadelphia, and Washington, D.C. conducted from 2014 to 2016. Participants completed audio computer-assisted self-interviews querying intentions to have a child in the future. We estimated the association between participants' reproductive intentions and their characteristics using Poisson regression models. RESULTS: Approximately 47% of participants indicated their intentions to have a child. Black/non-Hispanic (aPR = 1.40; 95% CI: 1.10-1.78) and other/non-Hispanic participants (aPR = 1.40; 95% CI: 1.01-1.93) were more likely to report intentions to have a child than white/non-Hispanic participants. Participants were less likely to report intentions to have children as age increased (18-29 years, reference group; 30-39 years, aPR = 0.80, 95% CI: 0.64-0.99; 40-49 years, aPR = 0.49, 95% CI: 0.33-0.72; 50+ years, aPR = 0.07, 95% CI: 0.02-0.21). CONCLUSIONS: Clinicians offering PrEP to black and other/non-Hispanic gay and bisexual men should assess their reproductive intentions as family-planning counseling may be an opportunity to introduce PrEP to HIV-negative gay and bisexual men.

Blood Pressure Effects of Gender-Affirming Hormone Therapy in Transgender and Gender-Diverse Adults.

[Figure: see text].

Transgender and Nontrans Patients Do Not Receive Statistically Different Quality Primary Care at Whitman-Walker Health, 2008-2016.

Purpose: Washington, DC, has the highest prevalence of transgender persons in the United States at 2.8%. Transgender persons in DC have lower income, less stable housing, and more HIV infection than nontrans persons. Data are scarce regarding primary care quality among trans persons. We provide a detailed analysis of transgender patients at Whitman-Walker Health, an HIV- and LGBT-focused community health center. Methods: We performed a retrospective electronic medical record review of transgender patients ≥18 years of age from 2008 to 2016, evaluating demographic factors, HIV status, gender-affirming care, and primary care quality indicators. Results: Of 20,097 patients, 1822 (9.0%) self-identify as transgender (62.9% trans female and 37.2% trans male), and 18,275 were nontransgender. Transgender patients are more likely to be young, white, HIV negative, and reside outside Washington, DC, than nontrans patients. Transgender patients are more likely to engage in primary care and have a similar likelihood of mammogram and colonoscopy screening than nontrans patients. Trans males are more likely to be privately insured, have lower rates of HIV testing than nontrans patients, and have higher rates of cervical Pap smears than cis females. Trans females have a high prevalence of HIV infection (26.6%). Conclusion: This is the largest single-center U.S. transgender cohort to date. Over a quarter of trans females are HIV positive, consistent with a national prevalence of 27.7%. Transgender and nontrans patients do not receive statistically different quality of primary care. Trans patients' high engagement in primary care may result from providing hormone therapy and primary care within a single provider visit.

Incidence of Venous Thromboembolism in Transgender Women Receiving Oral Estradiol.

INTRODUCTION: One of the most serious known adverse effects of feminizing cross-sex hormone therapy (CSHT) is venous thromboembolism (VTE); however, no study has assessed the incidence of VTE from the hormone therapies used in the United States because previous publications on this topic have originated in Europe. CSHT in the United States typically includes estradiol with the antiandrogen spironolactone, whereas in Europe estradiol is prescribed with the progestin cyproterone acetate. AIM: To estimate the incidence of VTE from the standard feminizing CSHTs used in the United States. METHODS: A retrospective chart review of transgender women who had been prescribed oral estradiol at a District of Columbia community health center was performed. MAIN OUTCOME MEASURE: The primary outcomes of interest were deep vein thrombosis or pulmonary emboli. RESULTS: From January 1, 2008 through March 31, 2016, 676 transgender women received oral estradiol-based CSHT for a total of 1,286 years of hormone treatment and a mean of 1.9 years of CSHT per patient. Only one individual, or 0.15% of the population, sustained a VTE, for an incidence of 7.8 events per 10,000 person-years. CONCLUSION: There was a low incidence of VTE in this population of transgender women receiving oral estradiol.