Perceived acceptability of self-administered topical therapy for cervical precancer treatment among women undergoing cervical cancer screening in Kenya.

Purpose: Innovative strategies are urgently needed to meet the World Health Organization's 2030 target of treating 90% of women with precancerous cervical lesions, especially in countries most affected by cervical cancer. We assessed the acceptability of self-administered intravaginal therapies for treating cervical precancer in women undergoing cervical cancer screening and precancer treatment in Kenya. Methods: We conducted a cross-sectional study among women aged 18 to 65 years undergoing cervical cancer screening or precancer treatment between January and October 2023 in Kisumu County, Kenya. Participants completed a questionnaire about their perceptions and perceived acceptability of self- or provider-administered topical therapies for cervical precancer treatment. Quantitative data were summarized using descriptive statistics. Results: A total of 379 questionnaires were completed. The median age of participants was 35 years (IQR 25-62), 62% had a primary education or less, and 71% earned $5 or less daily. All participants had been screened for cervical cancer, and 191 (51%) had received precancer treatment, primarily thermal ablation. Ninety-eight percent of participants were willing to use a self-administered intravaginal therapy for cervical precancer, if available. The majority, 91%, believed their male partner would support their use. Given a choice, 63% preferred self-admiration at home compared to provider-administration of a topical therapy in the clinic, citing time and cost savings. In multivariate analysis, married women were more likely to expect partner support for self-administration than single women. Participants preferred a therapy used less frequently but for a longer duration, compared to daily use therapy with a shorter duration of use. Conclusions: Self-administered intravaginal therapies for cervical precancer treatment are highly acceptable among women undergoing screening and precancer treatment in Kenya.

Comparing Cervical Cancer Screening Strategies in an Incarcerated Population.

Objective: To describe the prevalence of cervical intraepithelial neoplasia (CIN), high-risk human papillomavirus (hrHPV) infection, and cervical cancer in a high-risk, underscreened incarcerated population and to evaluate the performance of current cervical cancer screening options to detect cervical precancer (CIN 2/3) in this population. Study Design: Deidentified data were obtained from all cytological, hrHPV DNA, and histopathological testing of cervical biopsies performed on people incarcerated at the North Carolina Correctional Institute for Women between January 1, 2013, and December 31, 2020. These were linked to corresponding demographic data. The proportions of histopathological diagnoses of CIN2+ and CIN3+ immediately preceded by abnormal cytology testing or hrHPV testing were determined, and prevalence differences and 95% confidence intervals were calculated. Results: A total of 15,319 individuals incarcerated at the North Carolina Correctional Institute for Women had at least one cytology result during 2013-2020. Of these, 2,829 (18%) had abnormal cervical cytology, and 3,724 (24.3%) had positive hrHPV testing. The detection of CIN2+ was 95.9% by preceding abnormal cervical cytology, 89.9% by preceding positive hrHPV testing (p = 0.03), and 96.5% by preceding positive co-testing. The detection rate of CIN3+ was 96.6% by preceding abnormal cervical cytology, 90.8% by preceding positive hrHPV testing (p = 0.12), and 96.6% by positive co-testing. Conclusion: In our sample, primary cytology and co-testing detected CIN2+ at higher rates when compared with primary hrHPV testing. This reinforces that incarcerated populations do not fall into average-risk populations for which current cervical cancer screening options are designed, which should be considered when performing screening in this population.

"There is nothing that can prevent me from supporting her:" men's perspectives on their involvement and support of women's use of topical therapy for cervical precancer treatment in Kenya.

Purpose: Cervical cancer disproportionately impacts women in low- and middle-income countries (LMICs). The World Health Organization's (WHO) 90/70/90 strategy aims to eliminate cervical cancer by 2030 by increasing HPV vaccination coverage to 90%, screening 70% of eligible women, and effectively treating 90% of those with abnormal results by 2030, potentially preventing 62 million deaths in LMICs. LMICs, however, struggle with limited access to cervical precancer treatment, in part due to a lack of trained professionals and weak health systems. Effective non-surgical, self-administered, which have demonstrated efficacy in high-income countries, could bridge the treatment gap in LMICs and may be more scalable and cost-effective than provider-administered therapies. To inform feasibility studies in LMICs, data are needed on the role of male partners in influencing the acceptability and uptake of self-administered topical therapies, including their support of recommended abstinence and contraception guidelines associated with these therapies. Methods: Between November 2022 and April 2023, we conducted five focus group discussions (FGDs) with men aged 25 to 65 years in Kenya to explore their perspective and perceived support regarding their female partners using topical self-administered therapies for cervical precancer treatment. The FGDs were moderated by local qualitative research assistants and conducted in local languages, transcribed, coded, and analyzed using qualitative description. Results: Thirty-nine male participants meeting the eligibility criteria participated in five FGDs. The mean age of participants was 42.5 years. Most participants, 79.5%, had a female partner with a history of cervical precancer treatment, 5.1% did not, and 15.4% were unsure of their female partner's prior precancer treatment history. The study aimed to assess men's support of their female partners' use of topical therapies for treating cervical precancer. We find that male participants strongly express acceptance and willingness to support their wives or partners in using such therapies, if available. Reported supportive behavior included permitting the use of the therapies and support of maintaining abstinence during the recommended times. Additionally, participants desired male involvement in clinic and community-based education about topical therapies to facilitate widespread support. Conclusion: The use of self-administered topical therapies for cervical precancer treatment, if supported by efficacy studies in LMICs, may support achieving the WHO's 2030 goal of 90% treatment access. We find that with adequate education, men express overwhelming support of their female partner's use of topical therapies, including adherence to abstinence and contraception guidelines.

Men's perceptions and perceived acceptability of their female partner's use of self-administered intravaginal therapies for treatment of cervical precancer in Kenya.

Background: Cervical cancer continues to be a major health issue in low- and middle-income countries (LMICs). Despite increasing access to screening, access to precancer treatment remains a significant challenge in LMICs, highlighting a need for innovative, accessible, and resource-appropriate treatment approaches, including self-administered therapies. Methods: A cross-sectional mixed-methods study was conducted among men aged 25-65 with a current female partner in Kisumu County, Kenya. Participants were sequentially recruited and surveyed to evaluate their understanding of HPV and cervical cancer, their views on screening and treatment, and their attitudes toward self-administered therapies. Focus group discussions with a subset of the survey participants further explored their treatment preferences and perceptions. Results: Two hundred fourteen men participated in the survey, and 39 men participated in focus group discussions. The median age was 39 years, and 51% had a primary school education or less. Most (96%) were in a committed relationship, and 74% earned $10 or less daily. There was strong support for self-administered topical therapies, with 98% willing to support their partners using such treatments if available. Additionally, most participants were open to supporting necessary abstinence or condom use, though 76% believed their partners might hesitate to request condom use. When given an option, most preferred their partner to self-administer such therapies at home compared to provider administration at a health facility, citing convenience, cost-effectiveness, and privacy. Preferences varied between two potential therapies, 5-Fluorouracil (5FU) and Artesunate, based on their administration frequency, duration, and abstinence requirements. Qualitative findings largely supported the quantitative analysis. Conclusions: The study demonstrates strong support for self-administered topical therapies for cervical precancer among Kenyan men. Additional research on acceptability, feasibility, and efficacy in different LMICs could pave the way for these therapies to help bridge current cervical precancer treatment gaps in these settings.

Variations in Genes Encoding Human Papillomavirus Binding Receptors and Susceptibility to Cervical Precancer.

BACKGROUND: Cervical cancer oncogenesis starts with human papillomavirus (HPV) cell entry after binding to host cell surface receptors; however, the mechanism is not fully known. We examined polymorphisms in receptor genes hypothesized to be necessary for HPV cell entry and assessed their associations with clinical progression to precancer. METHODS: African American women (N = 1,728) from the MACS/WIHS Combined Cohort Study were included. Two case-control study designs were used-cases with histology-based precancer (CIN3+) and controls without; and cases with cytology-based precancer [high-grade squamous intraepithelial lesions (HSIL)] and controls without. SNPs in candidate genes (SDC1, SDC2, SDC3, SDC4, GPC1, GPC2, GPC3, GPC4, GPC5, GPC6, and ITGA6) were genotyped using an Illumina Omni2.5-quad beadchip. Logistic regression was used to assess the associations in all participants and by HPV genotypes, after adjusting for age, human immunodeficiency virus serostatus, CD4 T cells, and three principal components for ancestry. RESULTS: Minor alleles in SNPs rs77122854 (SDC3), rs73971695, rs79336862 (ITGA6), rs57528020, rs201337456, rs11987725 (SDC2), rs115880588, rs115738853, and rs9301825 (GPC5) were associated with increased odds of both CIN3+ and HSIL, whereas, rs35927186 (GPC5) was found to decrease the odds for both outcomes (P value ≤ 0.01). Among those infected with Alpha-9 HPV types, rs722377 (SDC3), rs16860468, rs2356798 (ITGA6), rs11987725 (SDC2), and rs3848051 (GPC5) were associated with increased odds of both precancer outcomes. CONCLUSIONS: Polymorphisms in genes that encode binding receptors for HPV cell entry may play a role in cervical precancer progression. IMPACT: Our findings are hypothesis generating and support further exploration of mechanisms of HPV entry genes that may help prevent progression to cervical precancer.

Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.

OBJECTIVES: To determine the feasibility (as measured by tolerability and safety) and efficacy of topical 5-fluorouracil (5-FU) and imiquimod for the treatment of cervical intraepithelial neoplasia (CIN) 2/3. METHODS: This pilot prospective study was conducted in women aged 18-45 years with p16+ CIN 2/3. Participants underwent an 8-week alternating regimen of self-applied 5% 5-FU on weeks 1, 3, 5, and 7 and physician-applied imiquimod on weeks 2, 4, 6, and 8. Adverse events (AEs) were collected by symptom diary and clinical exam. Feasibility was measured by tolerability and safety (AEs) of the study intervention. Tolerability was assessed as the number of participants able to apply 50% or more of the treatment doses. The safety outcome was calculated as the number of participants who experienced "specified AEs" defined as possibly, probably, or definitely related grade 2 or worse AE or grade 1 genital AEs (blisters, ulcerations, or pustules) lasting more than 5 days. The efficacy of the intervention was determined by histology and high-risk human papillomavirus (hrHPV) testing was done after treatment. RESULTS: The median age of the 13 participants was 27 ± 2.9 years. Eleven (84.61%) participants applied 50% or more of the treatment. All participants reported grade 1 AEs; 6 (46.15%) reported grade 2 AEs; and 0 reported grade 3/4 AEs. Three (23.08%) participants had specified AEs. Histologic regression to normal or CIN 1 among those completing 50% or more of the treatment doses was observed in 10 (90.91%) participants, and 7 (63.63%) tested negative for hr-HPV at the end of the study. CONCLUSIONS: Topical treatment for CIN 2/3 with 5-FU/imiquimod is feasible, with preliminary evidence of efficacy. Topical therapies need further investigation as adjuncts or alternatives to surgical therapy for CIN 2/3.

Breastfeeding Among People With Human Immunodeficiency Virus in North America: A Multisite Study.

BACKGROUND: In North American countries, national guidelines have strongly recommended formula over breastmilk for people with human immunodeficiency virus (HIV) because of concern for HIV transmission. However, data from resource-limited settings suggest the risk is <1% among virally suppressed people. Information regarding breastfeeding experience in high-resource settings is lacking. METHODS: A retrospective multisite study was performed for individuals with HIV who breastfed during 2014-2022 in the United States (8 sites) and Canada (3 sites). Descriptive statistics were used for data analysis. RESULTS: Among the 72 cases reported, most had been diagnosed with HIV and were on antiretroviral therapy prior to the index pregnancy and had undetectable viral loads at delivery. Most commonly reported reasons for choosing to breastfeed were health benefits, community expectations, and parent-child bonding. Median duration of breastfeeding was 24 weeks (range, 1 day to 72 weeks). Regimens for infant prophylaxis and protocols for testing of infants and birthing parents varied widely among institutions. No neonatal transmissions occurred among the 94% of infants for whom results were available ≥6 weeks after weaning. CONCLUSIONS: This study describes the largest cohort to date of people with HIV who breastfed in North America. Findings demonstrate high variability among institutions in policies, infant prophylaxis, and infant and parental testing practices. The study describes challenges in weighing the potential risks of transmission with personal and community factors. Finally, this study highlights the relatively small numbers of patients with HIV who chose to breastfeed at any 1 location, and the need for further multisite studies to identify best care practices.

Evaluating situational judgment test use and diversity in admissions at a southern US medical school.

INTRODUCTION: Situational judgment tests have been adopted by medical schools to assess decision-making and ethical characteristics of applicants. These tests are hypothesized to positively affect diversity in admissions by serving as a noncognitive metric of evaluation. The purpose of this study was to evaluate the performance of the Computer-based Assessment for Sampling Personal Characteristics (CASPer) scores in relation to admissions interview evaluations. METHODS: This was a cohort study of applicants interviewing at a public school of medicine in the southeastern United States in 2018 and 2019. Applicants took the CASPer test prior to their interview day. In-person interviews consisted of a traditional interview and multiple-mini-interview (MMI) stations. Between subjects, analyses were used to compare scores from traditional interviews, MMIs, and CASPer across race, ethnicity, and gender. RESULTS: 1,237 applicants were interviewed (2018: n = 608; 2019: n = 629). Fifty-seven percent identified as female. Self-identified race/ethnicity included 758 White, 118 Black or African-American, 296 Asian, 20 Native American or Alaskan Native, 1 Native Hawaiian or Other Pacific Islander, and 44 No response; 87 applicants identified as Hispanic. Black or African-American, Native American or Alaskan Native, and Hispanic applicants had significantly lower CASPer scores than other applicants. Statistically significant differences in CASPer percentiles were identified for gender and race; however, between subjects, comparisons were not significant. CONCLUSIONS: The CASPer test showed disparate scores across racial and ethnic groups in this cohort study and may not contribute to minimizing bias in medical school admissions.

Single-center serological surveillance of SARS-CoV-2 in pregnant patients presenting to labor and delivery.

OBJECTIVE: To measure maternal/fetal SARS-CoV-2 antibody levels. METHODS: A prospective observational study of eligible parturients admitted to the hospital for infant delivery was conducted between April and September 2020. SARS-CoV-2 antibody levels were measured in maternal and umbilical cord specimens using an in-house ELISA based on the receptor-binding domain (RBD) of the spike protein. Among SARS-CoV-2 seropositive patients, spike RBD antibody isotypes (IgG, IgM, and IgA) and ACE2 inhibiting antibodies were measured. RESULTS: In total, 402 mothers were enrolled and spike RBD antibodies in 388 pregnancies were measured (336 maternal and 52 cord specimens). Of them, 19 were positive (15 maternal, 4 cord) resulting in a seroprevalence estimate of 4.8% (95% confidence interval 2.9-7.4). Of the 15 positive maternal specimens, all had cord blood tested. Of the 15 paired specimens, 14 (93.3%) were concordant. Four of the 15 pairs were from symptomatic mothers, and all four showed high spike-ACE2 blocking antibody levels, compared to only 3 of 11 (27.3%) from asymptomatic mothers. CONCLUSION: A variable antibody response to SARS-CoV-2 in pregnancy among asymptomatic infections compared to symptomatic infections was found, the significance of which is unknown. Although transfer of transplacental neutralizing antibodies occurred, additional research is needed to determine how long maternal antibodies can protect the infant against SARS-CoV-2 infection.

Attitudes on breast feeding among persons with HIV who have given birth and their perceptions of coercion during counseling on safe infant feeding practices.

Persons with HIV can receive mixed messages about the safety of breastfeeding. We sought to assess if they felt coerced to formula feed when counseled about practices to reduce HIV transmission. Persons with HIV who had given birth were eligible to complete a survey to describe their experiences with infant feeding counseling and if they felt coerced to formula feed. An Iowa Infant Feeding Attitude Scale (IIFAS) assessed attitudes towards breastfeeding. Qualitative analyses were performed on narrative responses. One hundred surveys were collected from sites in Georgia, North Carolina, Pennsylvania, and South Carolina. The mean IIFAS score (n, 85) was 47 (SD 9.2), suggesting relatively favorable attitudes toward breastfeeding. Thirteen persons reported feeling coerced to formula feed. When controlling for choosing to give any breast milk, persons with any college education were more likely to report feeling coerced (aOR 9.8 [95% CI 1.8-52.5]). Qualitative analyses revealed three themes: perceiving breastfeeding as unsafe, engaging in shared decision-making, and resisting advice to formula feed. Persons with HIV desire to be counseled about safe infant feeding practices and have their questions answered without judgement. We highlight experiences of persons with HIV that reflect a need for a nuanced approach to infant feeding counseling.

"There is nothing that can prevent me from supporting her:" Men's perspectives on their involvement and support of women's use of topical therapy for cervical precancer treatment in Kenya.

Purpose: Cervical cancer disproportionately impacts women in low- and middle-income countries (LMICs). The World Health Organization's (WHO) 90/70/90 strategy aims to eliminate cervical cancer by 2030 by increasing HPV vaccination coverage to 90%, screening 70% of eligible women, and effectively treating 90% of those with abnormal results by 2030, potentially preventing 62 million deaths in LMICs. LMICs, however, struggle with limited access to cervical precancer treatment, in part due to a lack of trained professionals and weak health systems. Effective non-surgical, self-administered, which have demonstrated efficacy in high-income countries, could bridge the treatment gap in LMICs and may be more scalable and cost-effective than provider-administered therapies. To inform feasibility studies in LMICs, data are needed on the role of male partners in influencing the acceptability and uptake of self-administered topical therapies, including their support of recommended abstinence and contraception guidelines associated with these therapies. Methods: Between November 2022 and April 2023, we conducted five focus group discussions (FGDs) with men aged 25 to 65 years in Kenya to explore their perspective and perceived support regarding their female partners using topical self-administered therapies for cervical precancer treatment. The FGDs were moderated by local qualitative research assistants and conducted in local languages, transcribed, coded, and analyzed using qualitative description. Results: Male participants in the FGDs strongly expressed acceptance and willingness to support their wives or partners in using topical therapies for cervical precancer treatment, if available. Reported supportive behavior included permitting the use of the therapies and support of maintaining abstinence during the recommended times. Additionally, participants desired male involvement in clinic and community-based education about topical therapies to facilitate widespread support. Conclusion: The use of self-administered topical therapies for cervical precancer treatment, if supported by efficacy studies in LMICs, may support achieving the WHO's 2030 goal of 90% treatment access. We find that with adequate education, men express overwhelming support of their female partner's use of topical therapies, including adherence to abstinence and contraception guidelines.

Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial.

Background: Women living with HIV (WLWH), the majority of whom live in low- and middle-income countries (LMICs), are at higher risk of cervical precancer, known as cervical intraepithelial neoplasia (CIN), and are up to six times more likely to get cervical cancer. Current CIN treatment methods, primarily ablation or excision, have high treatment failure rates among WLWH, up to 30% for CIN grade 2 or 3 (CIN2/3) at 24 months following ablation. Without strong follow-up many WLWH with treatment failure are at risk of developing invasive cervical cancer, highlighting the urgent need for improved CIN treatment methods. Prior studies in high-income countries (HICs) have demonstrated that 5-Fluorouracil (5-FU) cream, an antimetabolite drug that is easily accessible in LMICs, can be used intravaginally as adjuvant therapy following primary CIN2/3 treatment in WLWH to reduce CIN2/3 recurrence. While the safety, acceptability, and efficacy of self-administered 5-FU for cervical precancer treatment has been demonstrated in HICs, it has not been studied among WLWH in LMICs who bear the greatest burden of cervical cancer. Methods: We are conducting a Phase I pilot study investigating the feasibility of using 5-FU cream as an adjuvant, self-administered intravaginal therapy following cervical intraepithelial neoplasia grade 2/3 (CIN2/3) treatment among WLWH in Kenya (ClinicalTrials.gov NCT05362955). Twelve participants will be enrolled in this single-arm study. Participants will self-administer 2g of 5% 5-FU cream intravaginally every other week for eight applications. The primary objective is to determine safety, defined as the type, frequency, and severity of adverse events (AEs) using a standardized grading scale. The secondary objectives are uptake, tolerability, adherence, and acceptability. Results: There are no results at this time as this is an ongoing study. Discussion: To achieve the World Health Organization (WHO) 90/70/90 global cervical cancer elimination goals, which include 90% of women with cervical precancer adequately treated by 2030, it is essential to employ innovative and resource-appropriate strategies to improve cervical precancer treatment among WLWH. The use of 5-FU as adjuvant therapy following current screen & treat programs may be a feasible and scalable strategy to optimize outcomes in this high-risk group. This clinical trial will provide important feasibility data to inform future randomized efficacy trials in LMICs. Trial registration: ClinicalTrials.gov identifier: NCT05362955.

Human papillomavirus vaccination and cervical cancer risk.

Persistent human papillomavirus infection is the central cause of cervical cancer, the leading cause of cancer death among women worldwide. Clear evidence from both randomized trials and population based studies shows that vaccination against human papillomavirus reduces the incidence of cervical pre-cancer. These data suggest that the vaccine reduces the incidence of cervical cancer. However, human papillomavirus vaccine coverage is inadequate in all countries, especially in low and middle income countries where disease burden is highest. Supply side strategies to improve coverage include increasing the availability of low cost vaccines, school located delivery, single dose vaccine schedules, and development of vaccines that do not need refrigeration. Demand side strategies include enhancing provider recommendations, correcting misinformation, and public awareness campaigns. The near elimination of cervical cancer is achievable through increased uptake of human papillomavirus vaccination and efforts to increase screening for cervical cancer, especially when enacted to reduce disparities in across the world.

Perception of coercion during contraceptive counseling among individuals with HIV.

OBJECTIVE: Historically, individuals with HIV have reported feeling coerced during contraceptive counseling or experienced forced sterilization. The purpose of this study was to assess perceptions of coercion related to counseling and influence on postpartum contraceptive choice among individuals with HIV. METHODS: This is a mixed methods study conducted in Georgia, North Carolina, Pennsylvania, and South Carolina between March 2020 and June 2021. Participants completed a survey to assess their experiences with contraception counseling and perceived coercion. An Interpersonal Quality of Family Planning (IQFP) care score was calculated to assess quality of counseling. Qualitative analyses were performed on narrative responses. Bivariate and regression analyses were used to evaluate factors associated with perceived coercion and IQFP scores. RESULTS: 100 surveys were collected. The median age of respondents was 29 (IQR 24-35). The median IQFP score was 53 (IQR 44-55) and 45 % of individuals had a maximum IQFP score of 55. Most individuals (96 %) report that a provider "did a good job" explaining contraceptive options and 26 % report their provider's preference affected their contraceptive choice to some degree. Few (11 %) respondents felt pressured to use long-acting reversible contraception postpartum. This perceived coercion was more likely when a provider suggested a specific contraceptive method, aOR 6.1 [95 % CI 1.1-33.1] and such specific provider suggestions were reported by one-third of respondents. CONCLUSION: While perceived coercion was reported by few individuals with HIV, it was strongly associated with the provider making a specific method suggestion. Disproportionate provider influence in the final contraceptive decision occurred in one-quarter of individuals. More research is needed to discern to what extent provider preference compromises patient autonomy in shared decision-making.

Premature and early menopause among US women with or at risk for HIV.

OBJECTIVE: Little is known about the prevalence and treatment of premature and early menopause among people with HIV. We described premature and early menopause and subsequent hormonal treatment in a longitudinal cohort of women living with or at risk for HIV in the US. METHODS: Data from the Women's Interagency HIV Study between 2008 and 2020 were analyzed to describe premature and early menopause among cohort participants under the age of 51. RESULTS: Of 3,059 eligible women during the study period, 1% (n = 35) underwent premature menopause before age 41, 3% (n = 101) underwent menopause between ages 41 and 46, and 21% (n = 442) underwent menopause between ages 46 and 50, inclusive. Of participants who experienced menopause before age 41, between age 41 and 45, and between ages 46 and 50, 51%, 24%, and 7% (respectively) received either menopausal hormone therapy or hormonal contraception. CONCLUSION: These findings suggest that disparities in receipt of recommended hormone therapy for premature and early menopause may contribute, in part, to evident health disparities, such as cardiovascular disease, osteoporosis, and overall mortality. They also suggest a substantial need for education among people experiencing early menopause and their providers, with the goal of improving access to hormone therapy based on guidelines to address health disparities and minimize future health consequences.

The Association Between HIV Status, Estradiol, and Sex Hormone Binding Globulin Among Premenopausal Women in the Women's Interagency HIV Study.

Background: Characterizing estradiol among women with HIV may have implications for breast cancer and cardiovascular disease risk but has not been adequately explored. We quantified differences in total (E2), free (FE2) estradiol, and sex hormone binding globulin (SHBG) by HIV and viral suppression status. Methods: Women from a substudy (2003-2006) within the Women's Interagency HIV Study (IRB approved at each participating site) were included if they reported: a period in the last six months, were not pregnant/breastfeeding, no oophorectomy, and no exogenous hormone use in the prior year. Serum was collected on days 2-4 of the menstrual cycle. We assessed differences in biomarkers at 25th, 50th, and 75th percentiles by HIV and viral suppression status using weighted quantile regression. Results: Among 643 women (68% with HIV) median age was 37 years. All E2 percentiles were significantly (p < 0.05) lower in women with suppressed viral load versus women without HIV (4-10 pg/mL). The 25th and 50th percentile of E2 were 4-5 pg/mL lower in women with unsuppressed viral load compared to women without HIV (p < 0.05). The 25th and 50th percentile of SHBG was significantly higher in women with unsuppressed viral load compared to women without HIV (10 and 12 nmol/L, respectively). There were no consistent differences in estradiol or SHBG by suppression status. Conclusions: There were no differences in FE2 but significantly lower E2 and higher SHBG among women with HIV versus without HIV. Further research is merited in a large contemporary sample to clarify the clinical implications of these findings.

Associations between HIV, antiretroviral therapy and preterm birth in the US Women's Interagency HIV Study, 1995-2018: a prospective cohort.

OBJECTIVE: To evaluate the associations of HIV infection with preterm birth (PTB), and of HIV antiretroviral therapy (ART) with PTB. METHODS: We analysed singleton live-born pregnancies among women from 1995 to 2019 in the Women's Interagency HIV Study, a prospective cohort of US women with, or at risk for, HIV. The primary exposures were HIV status and ART use before delivery [none, monotherapy or dual therapy, or highly active antiretroviral therapy (HAART)]. The primary outcome was PTB < 34 weeks, and, secondarily, < 28 and < 37 weeks. We analysed self-reported birth data, and separately modelled the associations between HIV and PTB, and between ART and PTB, among women with HIV. We used modified Poisson regression, and adjusted for age, race, parity, tobacco use and delivery year, and, when modelling the impact of ART, duration from HIV diagnosis to delivery, nadir CD4 count, and pre-pregnancy viral load and CD4 count. RESULTS: We analysed 488 singleton deliveries (56% exposed to HIV) to 383 women. The risk of PTB < 34 weeks was similar among women with and without HIV, but the risk of PTB < 37 weeks was higher [32% vs. 23%; adjusted risk ratio (aRR) = 1.43; 95% confidence interval (CI): 1.07-1.91] among women with HIV. The risk of PTB < 34 weeks was lower among women with HIV receiving HAART than among those receiving no ART (7% vs. 26%; aRR:0.19; 95% CI: 0.08-0.44). The associations between HAART and PTB < 28 and < 37 weeks were similar. CONCLUSIONS: Antiretroviral therapy exposure was associated with a decreased risk of PTB among a US cohort of women with HIV. Given the growing concerns about ART and adverse pregnancy outcomes, this finding that ART may be protective for PTB is reassuring.

Pregnant Individuals' Views on Fetal Tissue Research in the United States.

OBJECTIVE: Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. METHODS: We conducted a secondary analysis of data from two separate, broader qualitative studies. Pregnant and recently pregnant individuals (N=79) from clinical sites at the University of North Carolina at Chapel Hill, Johns Hopkins University, and Massachusetts General Hospital were interviewed individually using a semi-structured guide addressing a range of issues related to infectious disease research and pregnancy, including the acceptability of fetal tissue research. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: Among this sample of predominantly Black (61%), reproductive-aged pregnant and recently pregnant participants, the majority (72%) generally supported fetal tissue research. The following three themes were identified: choice, respect, and meaning. Respondents discussed the deeply personal nature of decisions surrounding fetal tissue research, emphasizing the importance of informed consent and respect for the person's emotional state when approaching for consent. The ways in which participants regarded how to respectfully handle fetal tissue also shaped views about the acceptability of donation, both for and against. For many participants, fetal tissue donation to research represented one way of ascribing meaning to pregnancy termination or loss. CONCLUSION: Among this diverse sample of pregnant and recently pregnant individuals, most were supportive of fetal tissue donation for research. A better understanding of pregnant individuals' views on this topic may lead to policies and practices that are congruent with the needs and values of people facing decisions regarding the disposition of fetal remains.

Efforts to Recruit Medical Students From Rural Counties: A Model to Evaluate Recruitment Efforts.

Background Over the past 40 years, the physician supply of North Carolina (NC) grew faster than the total population. However, the distribution of physicians between urban and rural areas increased, with many more physicians in urban areas. In rural counties, access to care and health disparities remain concerning. As a result, the medical school implemented pipeline programs to recruit more rural students. This study investigates the results of these recruitment efforts. Methodology Descriptive analyses were conducted to compare the number and percentage of rural and urban students from NC who applied, interviewed, and were accepted to the University of North Carolina's School of Medicine (UNC SOM). The likely pool of rural applicants was based on the number of college-educated 18-34-year-olds by county. Results Roughly 10.9% of NC's population of college-educated 18-34-year-olds live in rural counties. Between 2017 and 2019, 9.3% (n = 225) of UNC SOM applicants were from a rural county. An increase of just 14 additional rural applicants annually would bring the proportion of rural UNC SOM applicants in alignment with the potential applicant pool in rural NC counties. Conclusions Our model of analysis successfully calculated the impact of recruitment efforts to achieve proportional parity in the medical school class with the rural population of the state. Addressing rural physician workforce needs will require multiple strategies that affect different parts of the medical education and healthcare systems, including boosting college completion rates in rural areas. This model of analysis can also be applied to other pipeline programs to document the success of the recruitment efforts.