Importance Several randomized clinical trials have demonstrated the efficacy of preexposure prophylaxis (PrEP) in preventing human immunodeficiency virus (HIV) acquisition. Little is known about adherence to the regimen, sexual practices, and overall effectiveness when PrEP is implemented in clinics that treat sexually transmitted infections (STIs) and community-based clinics serving men who have sex with men (MSM). Objective To assess PrEP adherence, sexual behaviors, and the incidence of STIs and HIV infection in a cohort of MSM and transgender women initiating PrEP in the United States. Design, Setting, and Participants Demonstration project conducted from October 1, 2012, through February 10, 2015 (last date of follow-up), among 557 MSM and transgender women in 2 STI clinics in San Francisco, California, and Miami, Florida, and a community health center in Washington, DC. Data were analyzed from December 18, 2014, through August 8, 2015. Interventions A combination of daily, oral tenofovir disoproxil fumarate and emtricitabine was provided free of charge for 48 weeks. All participants received HIV testing, brief client-centered counseling, and clinical monitoring. Main Outcomes and Measures Concentrations of tenofovir diphosphate in dried blood spot samples, self-reported numbers of anal sex partners and episodes of condomless receptive anal sex, and incidence of STI and HIV acquisition. Results Overall, 557 participants initiated PrEP, and 437 of these (78.5%) were retained through 48 weeks. Based on the findings from the 294 participants who underwent measurement of tenofovir diphosphate levels, 80.0% to 85.6% had protective levels (consistent with ≥4 doses/wk) at follow-up visits. African American participants (56.8% of visits; P  = .003) and those from the Miami site (65.1% of visits; P P  = .02) and those reporting at least 2 condomless anal sex partners in the past 3 months (88.6%; P  = .01) were more likely to have protective levels. The mean number of anal sex partners declined during follow-up from 10.9 to 9.3, whereas the proportion engaging in condomless receptive anal sex remained stable at 65.5% to 65.6%. Overall STI incidence was high (90 per 100 person-years) but did not increase over time. Two individuals became HIV infected during follow-up (HIV incidence, 0.43 [95% CI, 0.05-1.54] infections per 100 person-years); both had tenofovir diphosphate levels consistent with fewer than 2 doses/wk at seroconversion. Conclusions and Relevance The incidence of HIV acquisition was extremely low despite a high incidence of STIs in a large US PrEP demonstration project. Adherence was higher among those participants who reported more risk behaviors. Interventions that address racial and geographic disparities and housing instability may increase the impact of PrEP.

https://jamanetwork.com/journals/jamainternalmedicine/articlepdf/2470593/ioi150079.pdf

Preexposure Prophylaxis for HIV Infection Integrated With Municipal- and Community-Based Sexual Health Services

This study examined potential facilitators and barriers to pre-exposure prophylaxis (PrEP) use and their association with PrEP acceptability and motivations for adherence among 184 MSM and transgender women living in New York City. Participants were presented with educational information about PrEP and completed a computerized survey. Overall, 55.4% of participants reported willingness to take PrEP. The most highly endorsed barriers to PrEP use were health concerns, including both long-term impacts and short-term side effects, questions about PrEP's impact on future drug resistance, and concerns that PrEP does not provide complete protection against HIV. The most highly endorsed facilitator was free access to PrEP, followed by access to support services such as regular HIV testing, sexual health care/monitoring, and access to one-on-one counseling. Participants of color rated both barriers and facilitators as more important than their White counterparts. In multivariate models, barrier and facilitator scores significantly predicted not only PrEP acceptability, but also motivation for PrEP adherence among those who were likely to use PrEP. PrEP implementation programs should consider addressing these barriers and facilitators in protocol and policy development. Findings underscore the importance of support services, such as sexual health counseling, to the success of PrEP as a prevention strategy.

From Efficacy to Effectiveness: Facilitators and Barriers to PrEP Acceptability and Motivations for Adherence Among MSM and Transgender Women in New York City

Although the Food and Drug Administration (FDA) approved oral Truvada for pre-exposure prophylaxis (PrEP) for women at risk of HIV infection in the US in July 2012, and the Centers for Disease Control and Prevention (CDC) issued guidance for clinicians to provide PrEP to women “at substantial risk of HIV acquisition” in May 2014, there remain no clinical trial data on efficacy among US women, and there is a dearth of research on knowledge, attitudes, and likelihood of use of PrEP among them. We conducted a qualitative focus group (FG) study with 144 at-risk women in six US cities between July and September 2013, including locations in the Southern US, where HIV infections among women are most prevalent. FG questions elicited awareness of PrEP, attitudes about administration and uptake, and barriers to and facilitators of use. Women expressed anger at the fact that they had not heard of PrEP prior to the study, but once informed most found it attractive. PrEP was seen as additional, not substitute...

http://www.aidsunited.org/data/files/Site_18/Auerbach%20et%20al%20US%20Women%20and%20PrEP%20APC%202014.pdf

Knowledge, Attitudes, and Likelihood of Pre-Exposure Prophylaxis (PrEP) Use Among US Women at Risk of Acquiring HIV

Albert Liu and colleagues report early experiences with uptake and delivery of pre-exposure prophylaxis(PrEP)for HIV prevention in three different settings in San Francisco. PrEP can be an important component of a comprehensive HIV prevention program and can complement efforts to increase HIV testing, linkage to care, and early initiation of antiretroviral therapy. Please see later in the article for the Editors' Summary

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Early Experiences Implementing Pre-exposure Prophylaxis (PrEP) for HIV Prevention in San Francisco

This paper used qualitative methods to explore experiences of men who have sex with men and female sex workers in Nairobi and Mtwapa, Kenya, who used oral pre-exposure prophylaxis (PrEP) for HIV prevention as part of a four-month trial of safety, acceptability and adherence. Fifty-one of 72 volunteers who took part in a randomized, placebo-controlled, blinded trial that compared daily and intermittent dosage of PrEP underwent qualitative assessments after completing the trial. Analyses identified three themes: (i) acceptability of PrEP was high, i.e. side effects were experienced early in the study but diminished over time, however characteristics of pills could improve comfort and use; (ii) social impacts such as stigma, rumors, and relationship difficulties due to being perceived as HIV positive were prevalent; (iii) adherence was challenged by complexities of daily life, in particular post-coital dosing adherence suffered from alcohol use around time of sex, mobile populations, and transactional sex work. These themes resonated across dosing regimens and gender, and while most participants favored the intermittent dosing schedule, those in the intermittent group noted particular challenges in adhering to the post-coital dose. Culturally appropriate and consistent counseling addressing these issues may be critical for PrEP effectiveness.

High Acceptability of HIV Pre-exposure Prophylaxis but Challenges in Adherence and Use: Qualitative Insights from a Phase I Trial of Intermittent and Daily PrEP in At-Risk Populations in Kenya

Objectives: Preexposure prophylaxis (PREP) is an emerging HIV prevention strategy; however, many fear it may lead to neglect of traditional risk reduction practices through behavioral disinhibition or risk compensation. Methods: Participants were 180 HIV-negative high-risk men who have sex with men recruited in New York City, who completed an Audio Computer Assisted Self Interview-administered survey between September 2007 and July 2009. Bivariate and multivariate logistic regression models were used to predict intention to use PREP and perceptions that PREP would decrease condom use. Results: Almost 70% (n = 124) of participants reported that they would be likely to use PREP if it were at least 80% effective in preventing HIV Of those who would use PREP, over 35% reported that they would be likely to decrease condom use while on PREP. In multivariate analyses, arousal/pleasure barriers to condom use significantly predicted likelihood of PREP use (odds ratio = 1.71, P < 0.05) and risk perception motivations for condom use significantly predicted decreased condom use on PREP (odds ratio = 2.48, P < 0.05). Discussion: These data provide support for both behavioral disinhibition and risk compensation models and underscore the importance of developing behavioral interventions to accompany any wide-scale provision of PREP to high-risk populations.

/pdf/preexposure-prophylaxis-and-predicted-condom-use-among-high-1kxbcp0jk7.pdf

Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men.

Intimate relationships have received increasing attention as a context for HIV transmission. We examined the relationships among perceptions that condoms interfere with intimacy, gay-related stigma, and unprotected/protected anal intercourse. Participants included 245 single-identified men who have sex with men. Intimacy Interference was positively associated with number of unprotected anal intercourse acts, and this effect was stronger among participants who reported high levels of gay-related stigma. In contrast, Intimacy Interference was negatively associated with number of protected anal intercourse acts, and gay-related stigma was positively associated with this outcome with no evidence of interaction effects. The findings are explained in the context of rejection sensitivity theory, and implications for public health and clinical intervention are discussed.

Corina L Weinberger

Papers

Preexposure prophylaxis and predicted condom use among high-risk men who have sex with men.

Contextualizing Condom Use: Intimacy Interference Stigma and Unprotected Sex.