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.

Gay and Bisexual Men's Perceptions about a Potential HIV Vaccine within a Post-COVID-19 Era: A Qualitative Study.

To end the HIV epidemic, there is need for targeted strategies to reduce HIV incidence for those most vulnerable, including an HIV vaccine. This study seeks to understand the perceptions that non-PrEP using gay and bisexual men and other men who have sex with men (GBMSM) have about a potential HIV vaccine, while contextualizing their perspectives within the context of heightened vaccine hesitancy that has emerged since the COVID-19 pandemic. Between March and May of 2022, GBMSM (N = 20) participated in in-depth interviews, which assessed their perceptions about an HIV vaccine. Interviews were analysed using a codebook approach to thematic analysis. We oversampled for those unvaccinated against COVID-19 as a proxy for vaccine hesitation. Participants expressed a range of enthusiastic support, cautious optimism and skepticism when presented with the possibility of an HIV vaccine. Factors that drove willingness to receive an HIV vaccine included community-oriented altruism, individualized risk-benefit assessment, and/or the perception that a vaccine could provide a beneficial shift in sexual experiences. Participants also expressed hesitations about receiving an HIV vaccine, including concerns about potential side-effects and efficacy, as well as mistrust in the vaccine development process. Notably, participants often evaluated the vaccine in comparison to PrEP and condoms. Participants offered specific insights into information they would like to receive about an HIV and where/how they would like to receive it. Our findings can help inform future HIV vaccine implementation efforts by offering insights into the factors that motivate and deter GBMSM to receive an HIV vaccine.

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.

Predictors of Event-Driven Regimen Choice in Current PrEP Users and Sexual Behavior Characteristics of MSM Receiving Sexual Health Services in New York City.

While daily PrEP is undeniably effective, broad-based adoption remains low. Non-daily PrEP modalities, like event-driven PrEP (ED PrEP), offer an efficient way to deliver PrEP's protection to priority populations. We carried out an at-home survey with patients receiving sexual health services in a LGBTQ-clinic in New York (n = 147). Participants answered questions on ED PrEP awareness and preferences, sexual behavior, and sexual preparatory practices. Only 50% of our sample were aware of ED PrEP, about 30% met eligibility for ED PrEP, and 35% chose ED PrEP as a good HIV prevention option for them. In a robust Poisson model (n = 128), endorsement of ED PrEP as a good prevention choice was significantly more common in participants who were uninsured, preferred taking PrEP only when needed, and those who had concerns about side-effects. Furthermore, participants reported many sexual behaviors patterns and preparatory practices compatible with use of ED PrEP.

RESUMEN: Si bien la PrEP diaria es innegablemente efectiva, la adopción generalizada sigue siendo baja. Las modalidades de PrEP no diarias, como la PrEP impulsada por eventos (ED PrEP), ofrecen una manera eficiente de brindar protección de PrEP a las poblaciones prioritarias. Realizamos una encuesta a domicilio con pacientes que recibían servicios de salud sexual en una clínica LGBTQ en Nueva York (n = 147). Los participantes respondieron preguntas sobre su conocimiento y sus preferencias de la ED PrEP, su comportamiento sexual, y sus prácticas de preparación sexual. Solo el 50% de nuestra muestra conocía la ED PrEP, alrededor del 30% cumplía con los requisitos para la ED PrEP, y el 35% eligió ED PrEP como una buena opción de prevención del HIV para ellos. En un modelo robusto de Poisson (n = 128), la aprobación de la ED PrEP como una buena opción de prevención fue significativamente más común en los participantes que no tenían seguro, preferían tomar la PrEP solo cuando era necesario, y aquellos que tenían preocupaciones sobre los efectos secundarios. Además, los participantes informaron muchos patrones de comportamiento sexual y prácticas preparatorias compatibles con el uso de ED PrEP.

PrEP Uptake and Discontinuation Among a U.S. National Sample of Transgender Men and Women.

Pre-exposure prophylaxis (PrEP) has revolutionized HIV prevention efforts by effectively preventing the sexual transmission of HIV infection. Few studies have examined PrEP uptake and discontinuation among transgender individuals who are underserved in HIV prevention efforts. An online U.S. nationwide survey screened 294 HIV-negative transgender people for participation in a larger cohort study. We analyzed associations between demographic characteristics and PrEP use and discontinuation. We conducted thematic analyses of open-ended responses to identify reasons for PrEP discontinuation. Fifty-one participants (17.4%) reported ever receiving a PrEP prescription. Transgender men reported higher PrEP use than transgender women (χ2 = 18.06; p < 0.0001). PrEP discontinuation was reported by 49.0% of individuals who reported PrEP use. Reasons for PrEP discontinuation were related to side effects, insurance coverage, relationship status, and access to providers. HIV prevention efforts to increase PrEP should include mechanisms for PrEP uptake and re-initiation among transgender individuals.

RESUMEN: La profilaxis pre-exposición (PrEP) ha revolucionado la prevención del VIH al prevenir efectivamente la transmisión del VIH. Pocos estudios han examinado la adopción y descontinuación de PrEP entre las personas transgénero quienes son desatendidas en los esfuerzos de prevención del VIH. Una encuesta nacional en-línea de EEUU calificó a 294 personas transgénero VIH-negativas para participar en un estudio cohorte más grande. Analizamos las asociaciones entre las características demográficas y el uso y descontinuación de PrEP. Realizamos análisis temáticos de las respuestas a preguntas abiertas para identificar razones para la descontinuación de PrEP. Cincuenta y uno participantes (17.4%) reportaron haber tomado PrEP alguna vez. Los hombres transgénero reportaron mayor uso de PrEP que las mujeres transgénero (χ2 = 18.06; p < 0.0001).  La descontinuación de PrEP fue reportada por 49.0% de los individuos que reportaron haber usado PrEP. Las razones por la descontinuación se relacionaron a los efectos secundarios, la cobertura del seguro medico, el estado civil, y el acceso a proveedores de salud. Los esfuerzos de prevención del VIH para aumentar el uso de PrEP deben incluir mecanismos para la adopción y reinicio entre las personas transgénero.