HIV-1 Incidence, Adherence, and Drug Resistance in Individuals Taking Daily Emtricitabine/Tenofovir Disoproxil Fumarate for HIV-1 Pre-Exposure Prophylaxis: Pooled Analysis From 72 Global Studies.

BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentration in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17,274 participants, there were 101 cases with new HIV-1 diagnosis (0.77 per 100 person-years; 95% CI 0.63-0.94). In 78 cases with resistance data, 18 (23%) had M184I or V, one (1.3%) had K65R, and three (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/week, respectively, and the corresponding incidence was 3.9 (95% CI 2.9-5.3), 0.24 (0.060-0.95), 0.27 (0.12-0.60), and 0.054 (0.008-0.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

PrEP Uptake and Methamphetamine Use Patterns in a 4-Year U.S. National Prospective Cohort Study of Sexual and Gender Minority People, 2017-2022.

Methamphetamine use is on the rise among sexual and gender minority people who have sex with men (SGMSM), escalating their HIV risk. Despite pre-exposure prophylaxis (PrEP) being an effective biomedical HIV prevention tool, its uptake in relation to methamphetamine use patterns in SGMSM has not been studied. In a U.S. cohort study from 2017 to 2022, 6,253 HIV-negative SGMSM indicated for but not using PrEP were followed for four years. Methamphetamine use was categorized (i.e., newly initiated, persistently used, never used, used but quit), and PrEP uptake assessed using generalized estimating equation (GEE), adjusted for attrition. Participants had a median age of 29, with 51.9% White, 11.1% Black, 24.5% Latinx, and 12.5% other races/ethnicities. Over the four years, PrEP use increased from 16.3 to 27.2%. GEE models identified risk factors including housing instability and food insecurity. In contrast, older age, health insurance, clinical indications, and prior PrEP use increased uptake. Notably, Latinx participants were more likely to use PrEP than Whites. Regarding methamphetamine use, those who newly initiated it were more likely to use PrEP compared to non-users. However, those who quit methamphetamine and those who persistently used it had PrEP usage rates comparable to those of non-users. Though PrEP uptake increased, it remained low in SGMSM. Methamphetamine use was associated with PrEP uptake. Healthcare providers should assess methamphetamine use for harm reduction. Prioritizing younger, uninsured SGMSM and addressing basic needs can enhance PrEP uptake and reduce HIV vulnerabilities.

Two Models for Increasing the Scope and Activities of Human Immunodeficiency Virus Partner Services Programs: Preliminary Findings From the Fast Track Project.

BACKGROUND: We sought to develop a novel strategy for expanding an existing human immunodeficiency virus (HIV) partner services (PS) model to provide comprehensive sexual health services, including sexually transmitted infection testing, a virtual telemedicine visit, and access to immediate start medication (antiretroviral treatment, preexposure or postexposure prophylaxis). Fast Track was a National Institutes of Health-funded implementation science trial in New York City to pilot and refine the new strategy, and examine its feasibility, acceptability, and impact. METHODS: Over the course of 1 year, health department staff collaborated with the academic research team to develop Fast Track protocols and workflows, create a cloud-based database to interview and track patients, and train disease intervention specialists to deliver the new program. The initial field-based program (Fast Track 1.0) was piloted March to December 2019. A modified telephone-based program (Fast Track 2.0) was developed in response to COVID-19 pandemic constraints and was piloted August 2020 to March 2021. RESULTS: These 2 pilots demonstrate the feasibility and acceptability of integrating comprehensive sexual health services into HIV PS programs. Disease intervention specialists were successfully trained to conduct comprehensive sexual health visits, and clients reported that the availability of comprehensive sexual health services made them more willing to engage with PS. Key lessons for scale-up include managing collaboration with a licensed provider, navigating technical and technological issues, and challenges in client engagement and retention. CONCLUSIONS: The success of this integrated strategy suggests that telehealth visits may be a critical gateway to care engagement for PS clients. This model is an innovative strategy for increasing engagement with HIV testing, prevention, and treatment for underserved populations.

Psychometric Evaluation and Predictive Validity of an Adapted Adherence Self-Efficacy Scale for PrEP.

Adherence to and sustainment of HIV pre-exposure prophylaxis (PrEP) are critical to its effectiveness. Adherence self-efficacy, i.e., confidence in one's ability to adhere to a particular medication, is a key psychological determinant of health behavior that strongly predicts HIV treatment adherence but has been understudied in PrEP research. This paper describes the psychometric evaluation and validation of the PrEP Adherence Self-Efficacy Scale (PrEP-ASES), adapted from the previously validated HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Data are drawn from two studies conducted at a community health center, one focused on gay and bisexual cisgender men and the other on transgender women. Factor analyses support a one-factor score (eigenvalue = 6.78) that explained 75.3% of the variance, with good test-retest reliability (rs > 0.40). In both studies, higher PrEP-ASES scores were associated with PrEP uptake, adherence, and sustainment. Findings support the utility of the PrEP-ASES in research and suggest the importance of addressing self-efficacy in PrEP programs and services.

The Long-Acting Cabotegravir Tail as an Implementation Challenge: Planning for Safe Discontinuation.

The long-acting feature of cabotegravir, an integrase-inhibitor highly effective in preventing acquisition of HIV in adolescents and adults, is both its greatest strength and a challenge to its implementation. Cab-LA is administered at 8-week intervals (after an initial loading dose) but has a long, variable drug "tail" that may leave users vulnerable to future drug resistance if they contract HIV during this critical period. The potential for cab-LA to meaningfully contribute to ending the HIV Epidemic is hindered by, among other factors, limited resources to guide patients and providers on how to safely discontinue injections. We suggest three key strategies to overcome this specific challenge: (1) Comprehensive patient education and counseling about the drug tail; (2) Training and coaching PrEP care teams, including clinical and non-clinical staff, on communication around the tail; (3) Adherence support strategies, including monitoring of cabotegravir drug levels after discontinuation, for a personalized medicine approach to safe discontinuation.

Intersectional stigma and gender non-affirmation hinder HIV care engagement among transgender women living with HIV in India.

Among transgender women living with HIV (TGWLH) in India, little is understood about the mechanisms through which multiple intersecting stigmas impact HIV care engagement, or intervention strategies that might mitigate this impact. We conducted focus groups with TGWLH (N = 30) in three Indian cities and analysed data using theoretical frameworks related to HIV stigma, gender affirmation, and syndemics. Findings revealed that enacted and anticipated stigma due to transgender identity, HIV, or sex work status, and lack of gender affirmation (e.g., misgendering) in healthcare settings delayed ART initiation and promoted care disengagement. Having supportive physicians and counsellors within ART centres and peer outreach workers facilitated ART initiation, adherence, and retention. Findings also revealed that HIV stigma within TGW communities led to concealment of HIV status or syndemic conditions such as depression and alcohol use, thereby affecting care engagement. However, the TGW community itself was also described as a resilience resource, offering emotional, psychological and tangible support that decreased the impact of discrimination on care engagement. HIV care engagement efforts among Indian TGWLH could be strengthened by reducing intersecting stigmas in healthcare settings and within TGW communities, providing gender-affirming and culturally competent healthcare, addressing psychosocial syndemic conditions, and strengthening support within transgender communities.

Exploring Factors Affecting Patient-Provider Interactions and Healthcare Engagement Among a Diverse Sample of Women Who Have Sex with Women in New York City.

Women who have sex with women (WSW) have lower rates of engagement in health care and preventive screenings than women who have sex exclusively with men. Existing literature provides limited insight into how intersecting and overlapping identities, such as race, ethnicity, sexual orientation, gender identity, and identities related to gender expression, may shape individuals' experiences within health care. We conducted qualitative interviews in New York City with 30 people who identified as women, reported sex with people who identify as women, were age 18-65, and were diverse in race, ethnicity, and sexual orientation and gender identity. The semi-structured questionnaire asked participants about positive and negative healthcare experiences to elicit what could encourage or prevent seeking care, with a focus on provider-related factors. Factors that led to positive healthcare experiences included having a provider who was knowledgeable about LGBTQ experience and health and who affirmed their sexuality, gender identity, and other intersecting identities. Factors that contributed to negative healthcare experiences included poor interactions with providers, and providers' perceived heteronormativity and lack of awareness of WSW healthcare needs. WSW of different races, ethnicities, sexual orientations, and gender identities seek validating healthcare experiences that acknowledge and affirm their identities. We present a visual summary of the main thematic factors that contributed to positive and negative WSW healthcare experiences. Increasing access to care requires training providers on how to engage WSW patients, including WSW of diverse race/ethnicity and gender identity and expression.

Considerations for the Design of Pre-exposure Prophylaxis (PrEP) Interventions for Women: Lessons Learned from the Implementation of a Novel PrEP Intervention.

Pre-exposure prophylaxis (PrEP) uptake among women in the United States has been low. To increase uptake, we developed a peer outreach and navigation PrEP intervention. Semi-structured qualitative interviews with 32 cisgender women and 3 transgender women were conducted to assess the intervention. We used a thematic approach to identify barriers to, and facilitators of the intervention. Facilitators included interest in PrEP, offer of health and social services, the intervention's women-focused approach, and peer outreach and navigation. Barriers were perceived HIV risk, concerns about medication side effects or interactions, housing insecurity and travel, co-occurring health-related conditions, and caregiving responsibilities. We recommend that future interventions consider packaging PrEP in local community settings, such as syringe exchange programs; include services such as food and housing assistance; use peers to recruit and educate women; integrate a culturally appropriate women's focus; and consider providing same-day PrEP.

A Pilot Study to Evaluate a Novel Pre-exposure Prophylaxis Peer Outreach and Navigation Intervention for Women at High Risk for HIV Infection.

Pre-exposure prophylaxis (PrEP) uptake remains woefully low among U.S. women at high risk for HIV acquisition. We evaluated a pilot intervention which involved Peers providing brief PrEP education and counseling at mobile syringe exchange sites and at sex worker and syringe exchange drop-in centers followed by navigation to PrEP care. Peers recruited English-proficient, self-identified women (i.e., cisgender and transgender women and persons with other transfeminine identities) over a 3-month period and delivered the intervention to 52 HIV-negative/status unknown participants. Thirty-eight participants (73.1%) reported PrEP interest, 27 (51.9%) accepted the offer of a PrEP appointment, 13 (25.0%) scheduled a PrEP appointment, 3 (5.8%) attended an initial PrEP appointment, and none were prescribed PrEP. We found a gap between PrEP interest and connecting women to PrEP care. Further study is needed to understand this gap, including exploring innovative approaches to delivering PrEP care to women at highest risk for HIV.

Sexual goals and perceptions of goal congruence in individuals' PrEP adoption decisions: A mixed-methods study of gay and bisexual men who are in primary relationships.

BACKGROUND: Although health goals are recognized as a central feature of health behavior theories, the relational context through which goals are conceptualized is often overlooked. Interdependence theory represents a valuable framework for understanding goals in the adoption of health behaviors, such as pre-exposure prophylaxis (PrEP), among gay and bisexual men in primary relationships. PURPOSE: We examined the content and focus of men's sexual health goals, as well as whether goal content, goal focus, or perceptions of goal congruence with a primary partner were related to PrEP adoption among gay and bisexual men in primary relationships. METHODS: Mixed-methods data were collected from a PrEP demonstration project from 145 HIV-negative gay and bisexual men in primary relationships. Participants reported their sexual health goals and completed measures of perceptions of goal congruence, relationship factors, and sociodemographic factors. RESULTS: Three main goal content categories were identified: prevention, satisfaction, and intimacy. In expressing these goals, participants framed them with either a self-focus or a relationship-focus. Men in serodiscordant relationships reported more intimacy goals and greater perceptions of goal congruence. There were no differences in goal content or focus by sexual agreement. In the multivariable logistic regression model, perceived goal congruence was associated with PrEP adoption, over and above covariates. CONCLUSIONS: Intimate relationships play a significant role in the formation of health-related goals. Goal content, focus, and perceived congruence with partners may represent important targets for HIV prevention interventions for gay and bisexual men in primary relationships, especially in the context of PrEP.

Predictors of PrEP Uptake Among Patients with Equivalent Access.

Increasing PrEP adoption for eligible individuals is critical, but limited research has examined individual-level factors that might be amenable to educational or behavioral intervention. Using data from a PrEP demonstration project conducted at a community health center, we examined differences in behavioral and psychosocial factors between patients offered PrEP who chose to accept it and those who declined. In a multivariable model, the odds of accepting PrEP were higher among those with an HIV-positive main partner, greater risk behavior in the past 3 months, and higher HIV risk perception. PrEP adoption was positively associated with PrEP adherence self-efficacy and negatively associated with perceived sensitivity to medicines. These psychological variables were associated with measures of PrEP- and HIV-related stigma. In the multivariable model, there were no differences in PrEP adoption by demographic factors or socioeconomic status. Data suggest that patients' decisions about PrEP uptake may be impacted not only by objective and subjective HIV risk, but also by psychological variables such as stigma beliefs, medication beliefs, and self-efficacy.

PrEP Stigma: Implicit and Explicit Drivers of Disparity.

PURPOSE OF REVIEW: Despite its promise as an HIV prevention strategy, PrEP uptake remains slow, especially among highest priority populations. One factor that may be impeding implementation and driving disparities is PrEP-related stigma. This paper reviews the role of PrEP-related stigma in PrEP access, adherence, and persistence and examines its antecedents and consequences. RECENT FINDINGS: Although PrEP stigma is often experienced at the community level (i.e., by potential and current users), it can be reinforced and even amplified by public health programs, policy, and research. PrEP stigma disproportionately impacts disadvantaged groups and impedes scalability by influencing behavior of both patients and providers. Reducing PrEP stigma and its negative impact on the epidemic requires a significant shift in perspective, language, and programs. Such a shift is necessary to ensure broader reach of PrEP as a prevention strategy and improve its utilization by the individuals who need it most.

Lessons for Patient Education Around Long-Acting Injectable PrEP: Findings from a Mixed-Method Study of Phase II Trial Participants.

This study aimed to identify patients' physical and psychosocial experiences of an investigational long-acting injectable PrEP product to aid in the development of patient and provider education materials. Twenty-eight participants of a Phase 2 safety, tolerability, and acceptability study of long-acting integrase inhibitor cabotegravir (CAB-LA) were interviewed on their physical and psychosocial experiences of the injections. Five themes emerged through a framework analysis on these interview transcripts: (1) injection-related pain is highly variable across individuals; (2) pain is more impactful after the injections than during; (3) patient anxiety is critical, but does not determine the experience of injections and decreases over time; (4) intimacy and awkwardness of gluteal injections impacts patients' experiences; (5) patient education and care strategies can mitigate the above factors. These findings can inform further sociobehavioral research within Phase 3 efficacy trials of CAB-LA, as well as patient education and provider guidance for future injectable PrEP products.

A Community-Based Randomized Trial of Hepatitis B Screening Among High-Risk Vietnamese Americans.

OBJECTIVES: To evaluate the effectiveness of a community-based liver cancer prevention program on hepatitis B virus (HBV) screening among low-income, underserved Vietnamese Americans at high risk. METHODS: We conducted a cluster randomized trial involving 36 Vietnamese community-based organizations and 2337 participants in Pennsylvania, New Jersey, and New York City between 2009 and 2014. We randomly assigned 18 community-based organizations to a community-based multilevel HBV screening intervention (n = 1131). We randomly assigned the remaining 18 community-based organizations to a general cancer education program (n = 1206), which included information about HBV-related liver cancer prevention. We assessed HBV screening rates at 6-month follow-up. RESULTS: Intervention participants were significantly more likely to have undergone HBV screening (88.1%) than were control group participants (4.6%). In a Cochran-Mantel-Haenszel analysis, the intervention effect on screening outcomes remained statistically significant after adjustment for demographic and health care access variables, including income, having health insurance, having a regular health provider, and English proficiency. CONCLUSIONS: A community-based, culturally appropriate, multilevel HBV screening intervention effectively increases screening rates in a high-risk, hard-to-reach Vietnamese American population.

Demographic Differences in PrEP-Related Stereotypes: Implications for Implementation.

Qualitative interviews about pre-exposure prophylaxis (PrEP) stereotypes were conducted with a subsample of 160 MSM who participated in a PrEP messaging study. Negative stereotypes about PrEP users were identified by 80 % of participants. Two types of stereotypes were most common: PrEP users are HIV-infected (and lying about it), and PrEP users are promiscuous and resistant to condom use. Participants' identification of these stereotype categories differed significantly by demographic factors (i.e., race/ethnicity, education). Expanding access to PrEP requires recognizing potential differences in the experience or anticipation of PrEP-related stereotypes that might impact willingness to discuss PrEP with providers, friends, or partners.

The Importance of Sexual History Taking for PrEP Comprehension Among Young People of Color.

Despite demonstrated efficacy, uptake of pre-exposure prophylaxis (PrEP) remains low, especially among highest priority populations. This study examined four PrEP messaging factors hypothesized to impact comprehension of PrEP educational information: (1) modality (video versus in-person message delivery); (2) frame (risk versus health focus); (3) specificity (gist versus verbatim efficacy information); and (4) sexual history (administered either before or after PrEP education). We examined message comprehension among 157 young people of color (YPoC) eligible for PrEP, using a series of multiple choice questions. Overall, 65.6 % (n = 103) got all message comprehension questions correct. In multivariate analyses, engaging in a sexual history before receiving PrEP education was associated with increased odds of message comprehension (aOR 2.23; 95 % CI 1.06-4.72). This effect was even stronger among those who received PrEP education via video (aOR 3.53; 95 % CI 1.16-10.81) compared to via health educator. This research underscores the importance of sexual history-taking as part of PrEP education and clinical practice for YPoC, and suggests that engaging patients in a sexual history prior to providing them with PrEP education may be key to increasing comprehension.

Psychometric evaluation of the Condom Barriers and Motivations Scale (CBMS).

The Condom Barriers and Motivations Scale (CBMS) was developed to measure four distinct categories of barriers and motives to condom use, including: risk reduction motivations, pleasure reduction barriers, intimacy interference barriers, and partner pressure barriers. The CBMS is a 16-item scale with four items that correspond to each of these subscales. The CBMS was tested in two samples of gay and bisexual men. Results support the reliability and validity of the scale and its structure. Results also indicate that CBMS subscales are distinct from general measures of sexual wellbeing, personality factors, or relationship quality (i.e., discriminant validity) and are associated with self-reported condom use with different partner types (i.e., construct validity). The CBMS can be helpful in better understanding the dynamics of condom use in the context of pre-exposure prophylaxis decision-making, and can shed light on innovative approaches to enhance condom use as part of comprehensive HIV prevention and sexual health goals.

New to New York: Ecological and Psychological Predictors of Health Among Recently Arrived Young Adult Gay and Bisexual Urban Migrants.

BACKGROUND: Young gay and bisexual men might move to urban enclaves to escape homophobic environments and achieve greater sexual and social freedom, yet little is known about the health risks that these young migrants face. PURPOSE: Drawing on recent qualitative depictions of gay and bisexual men's urban ecologies and psychological research on motivation and goal pursuit, we investigated migration-related motivations, experiences, health risks, and their associations among young gay and bisexual men in New York City. METHOD: Gay and bisexual men (n = 273; ages 18-29) who had moved to New York City within the past 12 months completed an online survey regarding their hometowns, new urban experiences, migration motivations, and health risks. RESULTS: Not having a college degree, HIV infection, hometown stigma, within-US migration, and moving to outside a gay-dense neighborhood were associated with moving to escape stress; hometown structural stigma and domestic migration were associated with moving for opportunity. Migrating from larger US-based hometowns, having recently arrived, and moving for opportunity predicted HIV transmission risk. Social isolation predicted lower drug use but more mental health problems. Higher income predicted lower HIV and mental health risk but higher alcohol risk. Hometown interpersonal discrimination predicted all health risks, but hometown structural stigma protected against drug risk. CONCLUSION: Findings offer a comprehensive picture of young gay and bisexual male migrants' experiences and health risks and help build a theory of high-risk migration. Results can inform structural- and individual-level interventions to support the health of this sizeable and vulnerable segment of the urban population.

Demographic Predictors of Event-Level Associations between Alcohol Consumption and Sexual Behavior.

Alcohol consumption is associated with sexual behavior and outcomes, though research indicates a variety of moderating factors, including demographic characteristics. To better target interventions aimed at alcohol-related sexual risk behavior, our analyses simultaneously examine demographic predictors of both day- and event-level associations between alcohol consumption and sexual behavior in a sample of young adults (N = 301) who are sexually active and consume alcohol. Young adults (aged 18-29) recruited using time-space sampling and incentivized snowball sampling completed a survey and a timeline follow-back calendar reporting alcohol consumption and sexual behavior in the past 30 days. On a given day, a greater number of drinks consumed was associated with higher likelihood of sex occurring, particularly for women and single participants. During a given sexual event, number of drinks consumed was not associated with condom use, nor did any demographic predictors predict that association. Findings highlight associations between alcohol and sexual behavior, though not between alcohol and sexual risk behavior, highlighting the need for additional research exploring the complex role of alcohol in sexual risk behavior and the need to develop prevention efforts to minimize the role of alcohol in the initiation of sexual encounters.