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Thesis
Peer Reviewed

Optimizing the Delivery of HIV Pre-Exposure Prophylaxis (PrEP): An Evaluation of Risk Compensation, Disengagement, and the PrEP Cascade

UC San Francisco Electronic Theses and Dissertations (2017)

Introduction

To inform the optimal implementation of HIV pre-exposure prophylaxis (PrEP), we conducted three studies that evaluated serodisclosure, identified correlates of PrEP disengagement, and characterized the PrEP cascade of care.

Methods

Study 1 examined the association of PrEP use with participant non-disclosure and lack of knowledge of partner HIV status in the iPrEx Open Label Extension (OLE). Study 2 examined the effects of stimulant use and binge drinking (i.e., ≥5 drinks on one occasion) on PrEP disengagement in a nested case-cohort in OLE. PrEP disengagement was defined as failure to show for a follow-up visit or tenofovir drug levels <700fmol/punch. Study 3 characterized the PrEP cascade (i.e., seeking services, initiating PrEP, and retention in care) and identified predictors of non-retention among those who started PrEP in a clinic-based cohort of men who have sex with men in San Francisco.

Results

We analyzed data from 1,184 participants in Study 1. PrEP use was not significantly associated with non-disclosure or lack of knowledge of partner status in adjusted analyses (p-values≥.16). However, relationship characteristics were significantly associated with both outcomes. Of the 330 MSM and transgender women included in Study 2, 16% used stimulants and 22% reported binge drinking in the previous three months. Stimulant users had more than 5-fold greater odds of PrEP disengagement (adjusted odds ratio [aOR]=5.24, 95% CI [1.64-16.76]). Binge drinking was not significantly associated with PrEP disengagement after adjusting for stimulant use and baseline confounders (aOR=0.78 [0.33-1.88]). Of the 344 men who sought PrEP services in Study 3, 268 (78%) initiated PrEP. Cost was the most commonly cited reason for not starting. Among patients who initiated PrEP, cumulative incidence of non-retention at 13 months was 38%. Men with an STI diagnosis at enrollment had a 79% greater rate of non-retention (adjusted hazard ratio [aHR]=1.79 [1.06-3.01]).

Conclusion

We found no evidence to suggest that PrEP use is associated with non-disclosure or not knowing partner status. Comprehensive prevention approaches that enhance uptake, reduce stimulant use, and support PrEP adherence and persistence are needed to address the heightened risk of HIV infection of those who use stimulants and those with STI diagnoses.

Cover page: Optimizing the Delivery of HIV Pre-Exposure Prophylaxis (PrEP): An Evaluation of Risk Compensation, Disengagement, and the PrEP Cascade

Article
Peer Reviewed

HIV Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex with Men in a Community-Based Sexual Health Clinic.

UC San Francisco Previously Published Works (2018)

In a community-based clinic serving men who have sex with men in San Francisco, California, this study characterized key steps of the pre-exposure prophylaxis (PrEP) cascade and identified correlates of retention in care. In total, 344 patients were evaluated for PrEP. Three-fourths (78%) of those who sought PrEP services initiated PrEP. The overall cumulative incidence of discontinuing PrEP at 13 months was 38%. Men with a sexually transmitted infection (STI) were 44% less likely to be retained (adjusted hazard ratio [aHR] 0.56, 95% confidence interval [0.33-0.95]). Comprehensive retention efforts for men with STIs are crucial to optimize the benefits of PrEP.

Article
Peer Reviewed

HIV Pre-exposure Prophylaxis (PrEP) Uptake and Retention Among Men Who Have Sex with Men in a Community-Based Sexual Health Clinic

UC San Francisco Previously Published Works (2018)

In a community-based clinic serving men who have sex with men in San Francisco, California, this study characterized key steps of the pre-exposure prophylaxis (PrEP) cascade and identified correlates of retention in care. In total, 344 patients were evaluated for PrEP. Three-fourths (78%) of those who sought PrEP services initiated PrEP. The overall cumulative incidence of discontinuing PrEP at 13 months was 38%. Men with a sexually transmitted infection (STI) were 44% less likely to be retained (adjusted hazard ratio [aHR] 0.56, 95% confidence interval [0.33-0.95]). Comprehensive retention efforts for men with STIs are crucial to optimize the benefits of PrEP.

Article
Peer Reviewed

Trends in Referrals to a Pediatric Transgender Clinic

UC San Francisco Previously Published Works (2019)

Objectives

We characterized referral trends over time at a transgender clinic within an integrated health system in Northern California. We identified the transition-related requests of pediatric transgender and gender-nonconforming patients and evaluated differences in referrals by age group.

Methods

Medical records were analyzed for all patients <18 years of age in the Kaiser Permanente Northern California health system who were referred to a specialty transgender clinic between February 2015 and June 2018. Trends in treatment demand, demographic data, service requests, and surgical history were abstracted from medical charts and analyzed by using descriptive statistics.

Results

We identified 417 unique transgender and gender-nonconforming pediatric patients. The median age at time of referral was 15 years (range 3-17). Most (62%) identified on the masculine spectrum. Of the 203 patients with available ethnicity data, 68% were non-Hispanic. During the study period, the clinic received a total of 506 referrals with a significant increase over time (P < .001). Most referrals were for requests to start cross-sex hormones and/or blockers (34%), gender-affirming surgery (32%), and mental health (27%). Transition-related requests varied by age group: younger patients sought more mental health services, and older patients sought hormonal and surgical services. Eighty-nine patients underwent gender-affirming surgeries, mostly before age 18 and most frequently mastectomies (77%).

Conclusions

The increase in referrals supports the need for expanded and accessible health care services for this population. The transition-related care of patients in this large sample varied by age group, underscoring the need for an individualized approach to gender-affirming care.

Cover page: Trends in Referrals to a Pediatric Transgender Clinic

Article
Peer Reviewed

HIV Stigma and Its Associations with Longitudinal Health Outcomes Among Persons Living with HIV with a History of Unhealthy Alcohol Use

UC San Francisco Previously Published Works (2021)

This study examined the demographic and clinical correlates of HIV stigma and evaluated how HIV stigma was associated with physical and mental health outcomes one year later in a primary-care based cohort of persons living with HIV (PLHIV; N = 584). HIV stigma was measured using a modified Berger HIV stigma scale, which includes four subscales: (1) personalized stigma; (2) disclosure concerns; (3) negative self-image; and (4) concerns around public attitudes towards PLHIV. Physical and mental health were assessed using the 12-item short form survey (SF-12). Compared to whites, African Americans were more likely to have higher personalized stigma scores (adjusted prevalence ratio [aPR] 1.54 [95% confidence interval 1.10-2.15]), disclosure concerns (aPR 1.40 [1.03-1.92]), and concerns with public attitudes about PLHIV (aPR 1.61 [1.11-2.34]). Hispanic/Latinx participants were more likely to have concerns around public attitudes towards PLHIV (aPR 1.50 [1.11-2.02]) than whites. Compared to men, women were more likely to have higher negative self-image scores (aPR 1.50 [1.08-2.08]). Higher stigma scores were associated with poorer subsequent self-reported physical and mental health functional status. Our findings highlight the substantial need for addressing HIV stigma, particularly among minority subgroups.

Cover page: HIV Stigma and Its Associations with Longitudinal Health Outcomes Among Persons Living with HIV with a History of Unhealthy Alcohol Use

Article
Peer Reviewed

Skating on thin ice: stimulant use and sub‐optimal adherence to HIV pre‐exposure prophylaxis

UC San Francisco Previously Published Works (2018)

Introduction

Stimulant and heavy alcohol use are prevalent and associated with elevated risk for HIV seroconversion among men who have sex with men (MSM) and transgender women. In addition, each can pose difficulties for antiretroviral adherence among people living with HIV. Scant research has examined the associations of stimulant and heavy alcohol use with adherence to daily oral pre-exposure prophylaxis (PrEP) among MSM and transgender women. To address this gap in the literature, we evaluated the hypothesis that stimulant use and binge drinking are prospectively associated with sub-optimal PrEP adherence.

Methods

We analysed data from participants in a nested case-cohort in the iPrEx open label extension. Stimulant use (i.e. powder cocaine, crack-cocaine, cocaine paste, methamphetamine, cathinone) and binge drinking (i.e. ≥5 drinks in a single day) in the last 30 days were assessed. Baseline urine was tested for stimulants using immunoassays to reduce misclassification. Sub-optimal adherence was defined as tenofovir drug concentrations in dried blood spots less than 700 fmol per punch, indicative of less than four doses per week. We tested the prospective association of stimulant use and binge drinking with sub-optimal adherence at the 4-week follow-up visit.

Results and discussion

Data from 330 participants were analysed. The majority of the participants were MSM (89%) with a median age at baseline of 29 years (interquartile range 24 to 39). Approximately 16% (52/330) used stimulants and 22% (72/330) reported binge drinking in the last 30 days. Stimulant users had fivefold greater odds of sub-optimal PrEP adherence compared to non-users in adjusted analysis (adjusted odds ratio [aOR] 5.04; [95% CI 1.35 to 18.78]). Self-reported binge drinking was not significantly associated with sub-optimal adherence after adjusting for stimulant use and baseline confounders (aOR 1.16 [0.49 to 2.73]). Depressive symptoms, being transgender, and number of sex partners were also not significantly associated with sub-optimal PrEP adherence (p > 0.05).

Conclusions

Stimulant use is a risk factor for sub-optimal PrEP adherence in the month following PrEP initiation. Comprehensive prevention approaches that reduce stimulant use may optimize PrEP adherence. Creating adherence plans that specifically address PrEP dosing in the context of ongoing stimulant use should also be considered.

Cover page: Skating on thin ice: stimulant use and sub‐optimal adherence to HIV pre‐exposure prophylaxis

Article
Peer Reviewed

Early Adopters of Event-driven Human Immunodeficiency Virus Pre-exposure Prophylaxis in a Large Healthcare System in San Francisco

UC San Francisco Previously Published Works (2020)

Among 279 patients within a large healthcare system in San Francisco, event-driven HIV pre-exposure prophylaxis using a 2-1-1 regimen was a desirable alternative to daily dosing. Problems with adherence, planning sex in advance, or side effects were infrequent (13.9%). We found no new HIV infections over 136 person-years of follow-up.

Cover page: Early Adopters of Event-driven Human Immunodeficiency Virus Pre-exposure Prophylaxis in a Large Healthcare System in San Francisco

Article
Peer Reviewed

The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions

UC San Francisco Previously Published Works (2022)

Objective

The HIV preexposure prophylaxis optimization intervention (PrEP-OI) study evaluated the efficacy of a panel management intervention using PrEP coordinators and a web-based panel management tool to support healthcare providers in optimizing PrEP prescription and ongoing PrEP care.

Design

The PrEP-OI study was a stepped-wedge randomized clinical trial conducted across 10 San Francisco Department of Public Health primary care sites between November 2018 and September 2019. Each month, clinics one-by-one initiated PrEP-OI in random order until all sites received the intervention by the study team.

Methods

The primary outcome was the number of PrEP prescriptions per month. Secondary outcomes compared pre- and postintervention periods on whether PrEP was discussed and whether PrEP-related counseling (e.g., HIV risk assessment, risk reduction counseling, PrEP initiation/continuation assessment) was conducted. Prescription and clinical data were abstracted from the electronic health records. We calculated incidence rate ratios (IRR) and risk ratios (RR) to estimate the intervention effect on primary and secondary outcomes.

Results

The number of PrEP prescriptions across clinics increased from 1.85/month (standard deviation [SD] = 2.55) preintervention to 2.44/month (SD = 3.44) postintervention (IRR = 1.34; 95% confidence interval [CI] = 1.05-1.73; P = 0.021). PrEP-related discussions during clinic visits (RR = 1.13; 95% CI = 1.04-1.22; P = 0.004), HIV risk assessment (RR = 1.40; 95% CI = 1.14-1.72; P = 0.001), and risk reduction counseling (RR = 1.16; 95% CI = 1.03-1.30; P = 0.011) increased from the pre- to the postintervention period. Assessment of PrEP initiation/continuation increased over time during the postintervention period (RR = 1.05; 95% CI = 0.99-1.11; P = 0.100).

Conclusions

A panel management intervention using PrEP coordinators and a web-based panel management tool increased PrEP prescribing and improved PrEP-related counseling in safety-net primary care clinics.

Cover page: The effect of an HIV preexposure prophylaxis panel management strategy to increase preexposure prophylaxis prescriptions

Creative Commons 'BY' version 4.0 license

Article
Peer Reviewed

Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data

UC Davis Previously Published Works (2020)

In a sample of people with HIV (PWH) enrolled in an alcohol intervention trial and followed for 12 months, we examined the association of changes in days (i.e., decrease, increase, no change [reference]) of unhealthy drinking (consuming ≥ 4/≥ 5 drinks for women/men) with antiretroviral therapy adherence (≥ 95% adherent), viral suppression (HIV RNA < 75 copies/mL), condomless sex with HIV-negative/unknown status partners, and dual-risk outcome (HIV RNA ≥ 75 copies/mL plus condomless sex). The sample included 566 PWH (96.8% male; 63.1% White; 93.9% HIV RNA < 75 copies/mL) who completed baseline, 6-, and 12-month assessments. Decrease in days of unhealthy drinking was associated with increased likelihood of viral suppression (odds ratio [OR] 3.78; 95% confidence interval [CI] 1.06, 13.51, P = .04) versus no change. Increase in days of unhealthy drinking was associated with increased likelihood of condomless sex (OR 3.13; 95% CI 1.60, 6.12, P < .001). Neither increase nor decrease were associated with adherence or dual-risk outcome. On a continuous scale, for each increase by 1 day of unhealthy drinking in the prior month, the odds of being 95% adherent decreased by 6% (OR 0.94, 95% CI 0.88, 1.00, P = 0.04).

Cover page: Changes in Days of Unhealthy Alcohol Use and Antiretroviral Therapy Adherence, HIV RNA Levels, and Condomless Sex: A Secondary Analysis of Clinical Trial Data

Article
Peer Reviewed

Gender-Affirming Mastectomy Trends and Surgical Outcomes in Adolescents

UC San Francisco Previously Published Works (2022)

Background

There are over 150,000 transgender adolescents in the United States, yet research on outcomes following gender-affirming mastectomy in this age group is limited. We evaluated gender-affirming mastectomy incidence, as well as postoperative complications, including regret, in adolescents within our integrated health care system.

Methods

Gender-affirming mastectomies performed from January 1, 2013 - July 31, 2020 in adolescents 12-17 years of age at the time of referral were identified. The incidence of gender-affirming mastectomy was calculated by dividing the number of patients undergoing these procedures by the number of adolescents assigned female at birth ages 12-17 within our system at the beginning of each year and amount of follow-up time within that year. Demographic information, clinical characteristics (comorbidities, mental health history, testosterone use), surgical technique, and complications, including mention of regret, of patients who underwent surgery were summarized. Patients with and without complications were compared to evaluate for differences in demographic or clinical characteristics using chi-squared tests.

Results

The incidence of gender-affirming mastectomy increased 13-fold (3.7 to 47.7 per 100,000 person-years) during the study period. Of the 209 patients who underwent surgery, the median age at referral was 16 years (range 12-17) and the most common technique was double-incision (85%). For patients with greater than 1-year follow-up (n=137, 65.6%), at least one complication was found in 7.3% (n=10), which included hematoma (3.6%), infection (2.9%), hypertrophic scars requiring steroid injection (2.9%), seroma (0.7%), and suture granuloma (0.7%); 10.9 % underwent revision (n=15). There were no statistically significant differences in patient demographics and clinical characteristics between those with and without complications (p>0.05). Two patients (0.95%) had documented postoperative regret but neither underwent reversal surgery at follow-up of 3 and 7 years postoperatively.

Conclusion

Between 2013-2020, we observed a marked increase in gender-affirming mastectomies in adolescents. The prevalence of surgical complications was low and of over 200 adolescents who underwent surgery, only two expressed regret, neither of which underwent a reversal operation. Our study provides useful and positive guidance for adolescent patients, their families, and providers regarding favorable outcomes with gender-affirming mastectomy.

Cover page: Gender-Affirming Mastectomy Trends and Surgical Outcomes in Adolescents