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Despite the prominence of self-efficacy as a predictor of antiretroviral therapy (ART) adherence, relatively little work has examined domain-specific associations with steps in the care continuum or the possibility that substance use may have domain-specific associations with self-efficacy. This study analyzed data from a sample of 174 people living with HIV recruited through three clinics in the New York City metro area. Consistent with hypotheses, path analysis showed that appointments kept and viral load were each predicted only by their respective domain-specific self-efficacy components (i.e., self-efficacy for keeping appointments, B  = 0.01, p  = .04; and self-efficacy for taking ART medications, B  = -0.02, p  < .01). Path models also indicated domain-specific associations with substance use. Self-efficacy for keeping appointments was negatively associated with severity of drug use ( B  = -1.81, p  < .01); meanwhile, self-efficacy for taking ART medications was negatively associated with severity of alcohol use ( B  = -0.52, p  < .01). Accordingly, studies assessing barriers to retention in the HIV care continuum should conduct multi-domain assessments of self-efficacy for differential associations with specific behaviors. Furthermore, HIV care providers might consider screening for domain-specific self-efficacy to identify patients at risk of drop-out and tailoring interventions to various care continuum domains.

This study evaluated the effectiveness of Project PLUS, a 6-session Motivational Interviewing and Cognitive Behavioral intervention to reduce substance use and improve antiretroviral therapy (ART) adherence among PLWH. In a quasi-experimental design, 84 participants from a network of three comprehensive care clinics in New York City received the intervention immediately post-baseline (the Immediate condition) and 90 were assigned to a Waitlist control. Viral load and CD4 data were extracted from electronic medical records (EMR) for a No-Intervention comparison cohort (n = 120). Latent growth curve analyses did not show a consistent pattern of significant between-group differences post-intervention or across time in ART adherence or substance use severity between Immediate and Waitlist participants. Additionally, Immediate intervention participants did not differ significantly from the Waitlist or No-Treatment groups on viral load or CD4 post-intervention or across time. The potential to detect intervention effects may have been limited by the use of a quasi-experimental design, the high quality of standard care at these clinics, or inadequate intervention dose.Trial Registration: ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: NCT02390908; https://clinicaltrials.gov/ct2/show/NCT02390908., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Mobile health (mHealth) interventions that are integrated in HIV clinical settings to facilitate ongoing patient-provider communication between primary care visits are garnering evidence for their potential in improving HIV outcomes. Rango is an mHealth intervention to support engagement in HIV care and treatment adherence. This study used a single-arm prospective design with baseline and 6-month assessments for pre-post comparisons, as well as a matched patient sample for between-group comparisons to test Rango's preliminary efficacy in increasing viral suppression. The Rango sample (n = 406) was predominantly 50 years of age or older (63%; M = 50.67; SD = 10.97, 23-82), Black/African-American (44%) or Hispanic/Latinx (38%), and male (59%). At baseline, 18% reported missing at least one dose of ART in the prior three days and chart reviews of recent VL showed that nearly 82% of participants were virally suppressed. Overall 95% of the patients enrolled in Rango returned for a medical follow-up visit. Of the 65 unsuppressed patients at baseline who returned for a medical visit, 38 (59%) achieved viral suppression and only 5% of the suppressed group at baseline had an increase in viral load at 6 months despite being at risk for ART non-adherence. While viral suppression was similar between Rango participants and patients receiving treatment as usual over the same time period, it is unknown whether those patients were similarly at risk for non-adherence. Our findings support efforts to formally test this innovative approach in addressing ART non-adherence and viral suppression particularly to reach HIV treatment goals.

Given the popularity of geosocial networking applications ("apps") among gay, bisexual, and other men who have sex with men (GBMSM), this study sought to examine GBMSM's willingness to use sexual health and behavior tracking features if integrated within apps they are already using to meet sexual partners. Most GBMSM (91%) recruited on a popular app reported interest in one or more sexual health app features, including features to find LGBT-friendly providers (83%), receive lab results (68%), schedule appointment reminders (67%), chat with a healthcare provider (59%), and receive medication reminder alerts (42%). Fewer GBMSM were interested in tracking and receiving feedback on their sexual behavior (35%) and substance use (24%). Our data suggest that integrating sexual health and behavior tracking features for GBMSM who use apps could be promising in engaging them in HIV prevention interventions. Further research is needed on GBMSM's perspectives about potential barriers in using such features.

Background: Substance use among HIV-positive persons exacerbates health problems. This study sought to estimate the prevalence of alcohol and drug-use diagnoses and examined hypothesized predictors associated with alcohol and drug-use diagnoses among HIV-positive patients in New York City (NYC)., Methods: This cohort study reviewed electronic medical records (EMRs) of 4965 HIV-positive patients based on diagnostic codes. These patients attended a comprehensive care clinic in NYC in 2012. Multinomial logistic regression was used to predict the odds of classification into substance use diagnosis grouping., Results: Of the full sample, only 12.7% of patients had an alcohol use diagnosis documented in their EMR compared with more than one-quarter (26.4%) of patients having a recorded drug use diagnosis (p<0.001). Compared with the No Alcohol or Drugs group, the regression model showed that older age and having a recent inpatient hospital stay independently predicted being in the Alcohol Only group; years living with HIV, having an unsuppressed viral load, and having a recent inpatient hospital stay were associated with higher odds of being in the Drugs Only and Alcohol and Drugs groups; and being women and men who have sex with men (MSM) were associated with decreased odds of being in the Drugs Only and Alcohol and Drugs groups., Conclusions: Substance use diagnosis was associated with viremia and low CD4 counts and hospital stays. This implies that providers should screen for substance use in HIV-positive patients with poor health. Further examination of the extent of such comorbidity is instrumental for intervention efforts., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Daily diary and other intensive longitudinal methods are increasingly being used to investigate fluctuations in psychological and behavioral processes. To inform the development of this methodology, we sought to explore predictors of and patterns in diary compliance and behavioral reports. We used multilevel modeling to analyze data from an online daily diary study of 371 gay and bisexual men focused on sexual behavior and substance use. We found that greater education and older age as well as lower frequency of substance use were associated with higher compliance. Using polynomial and trigonometric functions, we found evidence for circaseptan patterns in compliance, sexual behavior, and substance use, as well as linear declines in compliance and behavior over time. The results suggest potential sources of non-random patterns of missing data and suggest that trigonometric terms provide a similar but more parsimonious investigation of circaseptan rhythms than do third-order polynomial terms.

Emerging research supports the notion that sexual compulsivity (SC) and hypersexual disorder (HD) among gay and bisexual men (GBM) might be conceptualized as comprising three groups-Neither SC nor HD; SC only, and Both SC and HD-that capture distinct levels of severity across the SC/HD continuum. We examined data from 370 highly sexually active GBM to assess how the three groups compare across a range of risk factors for HIV infection. Comparisons focused on psychosexual measures-temptation for condomless anal sex (CAS), self-efficacy for avoiding CAS, sexual excitation and inhibition-as well as reports of actual sexual behavior. Nearly half (48.9 %) of this highly sexually active sample was classified as Neither SC nor HD, 30 % as SC Only, and 21.1 % as Both SC and HD. While we found no significant differences between the three groups on reported number of male partners, anal sex acts, or anal sex acts with serodiscordant partners, the Both SC and HD group reported higher numbers of CAS acts and CAS acts with serodiscordant partners and also had a higher proportion of their anal sex acts without condoms compared to the SC Only group. Our findings support the validity of a three-group classification system of SC/HD severity in differentiating psychosexual and HIV-related sexual risk behavior outcomes in a sample of GBM who report similarly high levels of sexual activity. Notwithstanding the need for sex positive HIV prevention programs, interventions that attempt to help Both SC and HD men deal with distress and address their psychosexual needs specifically may derive HIV prevention benefits.

Once-daily Truvada (Emtricitabine/Tenofovir) as a method of pre-exposure prophylaxis (PrEP) is one of the most promising biomedical interventions to eliminate new HIV infections; however, uptake among gay, bisexual, and other men who have sex with men has been slow amidst growing concern in popular/social media that PrEP use will result in reduced condom use (i.e., risk compensation). We investigated demographic, behavioral, and psychosocial differences in willingness to use PrEP as well as the perceived impact of PrEP on participants' condom use in a sample of 206 highly sexually active HIV-negative gay and bisexual men. Nearly half (46.1 %) said they would be willing to take PrEP if it were provided at no cost. Although men willing to take PrEP (vs. others) reported similar numbers of recent casual male partners (<6 weeks), they had higher odds of recent receptive condomless anal sex (CAS)-i.e., those already at high risk of contracting HIV were more willing to take PrEP. Neither age, race/ethnicity, nor income were associated with willingness to take PrEP, suggesting equal acceptability among subpopulations that are experiencing disparities in HIV incidence. There was limited evidence to suggest men would risk compensate. Only 10 % of men who had not engaged in recent CAS felt that PrEP would result in them starting to have CAS. Men who had not tested for HIV recently were also significantly more likely than others to indicate willingness to take PrEP. Offering PrEP to men who test infrequently may serve to engage them more in routine HIV/STI testing and create a continued dialogue around sexual health between patient and provider in order to prevent HIV infection.

Preexposure prophylaxis (PrEP) of HIV infection with tenofovir-containing regimens is effective, but plagued by poor adherence in some studies. Options for safe, effective, and acceptable PrEP products, especially for men and women at risk of HIV via receptive anal intercourse (RAI), are needed. We performed a randomized, partially blinded, first-in-human evaluation of four candidate rectal microbicide vehicles-aqueous gel, aqueous fluid, lipid gel, and lipid fluid-to select a prototype for further clinical development. Eight seronegative participants received three doses of each product with each dose separated by at least 2 weeks: one dose was given alone without simulated RAI in clinic, another dose was followed by simulated RAI in clinic, and another dose was self-administered at home in the context of RAI with a partner. Assessments included safety, acceptability, colon histology, ex vivo HIV infectivity of colon tissue explants, and colonic luminal distribution of vehicle and HIV surrogates. Adverse events were all mild and mainly sigmoidoscopy associated. There were minor differences in colon distribution of products and little effect of RAI. Vehicle distribution covered 95% (±7% standard deviation) of the distribution of an HIV surrogate in the colonic lumen. The lipid fluid vehicle increased HIV colon tissue infectability 5-fold [log10 p24 0.68 (95% confidence interval 0.08, 1.28)] and aqueous gel provided 6-fold protection [log10 p24 0.80 (95% confidence interval 0.20, 1.41)] compared to no product baseline. Colon permeability of lipid vehicles was more than 10-fold greater than aqueous vehicles. All products received similar acceptability ratings, though trends favored the gel products. Intensive simultaneous assessment of safety and toxicity, luminal and tissue distribution, ex vivo HIV infectivity, and product acceptability in relevant sexual contexts provided clear differentiation among candidate gels very early in product development. We selected the aqueous gel for further development as a rectal microbicide vehicle.

Objective: We sought to examine highly sexually active gay and bisexual men's accuracy in predicting their sexual behavior for the purposes of informing future research on intermittent event-driven HIV Pre-Exposure Prophylaxis., Design: For 30 days, 92 HIV-negative men completed a daily survey about their sexual behavior (n = 1688 days of data) and indicated their likelihood of having anal sex with a casual male partner next day., Method: We used multilevel modeling to analyze the association between self-reported likelihood of and subsequent engagement in anal sex., Results: We found a linear association between men's reported likelihood of anal sex with casual partners and the actual probability of engaging in sex, although men overestimated the likelihood of sex. Overall, we found that men were better at predicting when they would not have sex than when they would, particularly if any likelihood value greater than 0% was treated as indicative that sex might occur. We found no evidence that men's accuracy of prediction was affected by whether it was a weekend or whether they were using substances, although both did increase the probability of sex., Discussion: These results suggested that, men taking event-driven intermittent Pre-Exposure Prophylaxis, 14% of doses could have been safely skipped with a minimal rate of false negatives using guidelines of taking a dose unless there was no chance (ie, 0% likelihood) of sex on next day. This would result in savings of over US $1300 per year in medication costs per participant.

Objective: To compare three groups of men who have sex with men (MSM)-men who had attended a sex party in the past year (45.2%); men who had been to a sex party more than a year ago (23.3%); and men who had never been to one (31.5%)-on socio-demographic and behavioural characteristics., Method: In spring 2012, 2063 sexually active MSM in the USA were recruited using banner advertising on a sexual networking website to complete an online survey about their sexual behaviour and attendance at sex parties., Results: A significantly higher proportion of past year attendees were HIV-positive (28.1%), single (31.7%), demonstrated sexual compulsivity symptomology (39.2%), recently used drugs (67.8%), averaged the greatest number of recent male partners (Mdn=15, <90 days), and had greater instances of recent unprotected anal intercourse (UAI) with male partners (median=3, <90 days). Adjusting for covariates, those having been to a sex party in the last year were significantly more likely than others to report UAI. Free lubricant (93.4%) and condoms (81.0%) were the most desirable services/products men wanted at sex parties. More than half of men having been to a sex party expressed interest in free rapid HIV testing at sex parties (52.8%); however, few considered it acceptable to see 'medical providers' (11.7%) and 'peer outreach workers' (9.5%) at sex parties., Conclusions: MSM who have attended a sex party in the last year are appropriate candidates for targeted HIV and sexually transmitted infection (STI) prevention. Collaborating with event promoters presents valuable opportunities to provide condoms, lubricant and HIV/STI testing.

Rates of HIV infection continue to rise for men who have sex with men (MSM), and may be partially due to lack of testing among groups at risk for HIV. Mobile applications have demonstrated promise to identify at-risk MSM, though more research is needed to address testing patterns among this population. We conducted an online survey of 1,351 MSM in the New York City (NYC) area recruited from Grindr and analyzed predictors of lifetime and past-year testing using Pearson's chi-squared statistic, Fisher's exact tests, and logistic regression. A majority (90 %) of men had been tested within their lifetimes, and most (71 %) had been tested within the prior year. Among those who had never been tested (n = 135), one-third had engaged in unprotected anal intercourse (UAI) in the prior 3 months and nearly one-third identified themselves as HIV-negative rather than unknown. Older age, reporting an HIV-negative (versus unknown) status, and recent UAI were independently associated with lifetime testing. Greater proportions of men who had recently engaged in UAI reported testing within the past year compared with those who had not engaged in UAI. Overall, rates of testing among MSM in this sample exceeded those of the general population, including the general population in NYC. A greater proportion of this sample had never tested compared to a population-based sample of NYC MSM, though a higher percentage had also tested in the past year. This study demonstrated that 1 in 10 NYC men using Grindr and 1 in 5 who were 18-24 years of age had never received an HIV test in their lives. Using the existing infrastructure and popularity of mobile technology such as Grindr to identify and link men to information regarding HIV testing may be a useful strategy for prevention.

Main partnerships represent one context in which HIV transmission may occur that has been insufficiently addressed to date for gay and bisexual men, but few studies have focused on the acceptability of couples-based voluntary HIV counseling and testing (CVCT) for male couples in the U.S. Our aim in this study was to explore the acceptability of CVCT among a national U.S. sample of 1,532 gay and bisexual men surveyed online using a sexual networking site. We examined the role of demographic (i.e., geographic region, age, relationship status, sexual orientation, race/ethnicity) and HIV risk (i.e., substance use, number of sexual partners, unprotected anal intercourse, sexual role identity, and sexual compulsivity) factors that may be associated with CVCT among the full sample and among partnered men separately. We found that single men expressed higher interest in CVCT than partnered men and that greater age was more strongly associated with lower interest in CVCT for partnered men than for single men. The intersection of sexual orientation and race/ethnicity was also significantly associated with CVCT interest, with a higher proportion of Black bisexual men being interested than White bisexual men. These findings suggest that the uptake of CVCT may be less impacted by HIV risk factors than by demographic factors and that young gay and bisexual men of color-for whom rates of HIV continue to rise-may be the group with the highest levels of interest in CVCT.

Rectally applied antiretroviral microbicides for preexposure prophylaxis (PrEP) of HIV infection are currently in development. Since enemas (rectal douches) are commonly used by men who have sex with men prior to receptive anal intercourse, a microbicide enema could enhance PrEP adherence by fitting seamlessly within the usual sexual practices. We assessed the distribution, safety, and acceptability of three enema types-hyperosmolar (Fleet), hypoosmolar (distilled water), and isoosmolar (Normosol-R)-in a crossover design. Nine men received each enema type in random order. Enemas were radiolabeled [(99m)Tc-diethylene triamine pentaacetic acid (DTPA)] to assess enema distribution in the colon using single photon emission computed tomography/computed tomography (SPECT/CT) imaging. Plasma (99m)Tc-DTPA indicated mucosal permeability. Sigmoidoscopic colon tissue biopsies were taken to assess injury as well as tissue penetration of the (99m)Tc-DTPA. Acceptability was assessed after each product use and at the end of the study. SPECT/CT imaging showed that the isoosmolar enema had greater proximal colonic distribution (up to the splenic flexure) and greater luminal and colon tissue concentrations of (99m)Tc-DTPA when compared to the other enemas (p<0.01). Colon biopsies also showed that only the hyperosmolar enema caused sloughing of the colonic epithelium (p<0.05). In permeability testing, the hypoosmolar enema had higher plasma (99m)Tc-DTPA 24-h area under the concentration-time curve and peak concentration compared to the hyperosmolar and isoosmolar enemas, respectively. Acceptability was generally good with no clear preferences among the three enema types. The isoosmolar enema was superior or similar to the other enemas in all categories and is a good candidate for further development as a rectal microbicide vehicle.

Introduction: Researchers have investigated group sexual encounters (GSEs) as potential sources for HIV/STI transmission among men who have sex with men (MSM); however, much of this work has focused on organized sex parties., Aim: To compare behavioral and social characteristics of groups of men who engaged in three types of GSEs: threesomes, spontaneous group sex, and organized sex parties., Methods: In 2012, 1,815 U.S.-based MSM completed an online survey., Main Outcome Measure: We compared men based on their most recent type of GSE: threesome (68.2%), spontaneous group sex (19.7%), or organized sex party (12.1%)., Results: Using multinomial logistic regression, with type of GSE as the dependent variable, MSM who were HIV-positive, used stimulants (cocaine, methamphetamine, crack), consumed five or more alcoholic drinks, and reported receptive unprotected anal intercourse (UAI) during the most recent GSE had significantly higher odds of having had spontaneous group sex as compared to a threesome. MSM who were HIV-positive, not in a relationship, and did not report receptive UAI during the most recent GSE had significantly higher odds of having attended an organized sex party as compared to a threesome. MSM who were in a relationship, had consumed five or more alcoholic drinks, had used stimulants, and reported receptive UAI during the most recent GSE had significantly higher odds of having had spontaneous group sex as compared to an organized sex party. Compared to others, those having engaged in a GSE were more likely to report recent UAI (65% vs. 45%)., Conclusions: Men having engaged in a GSE were at greater risk for behaviors that transmit HIV and STIs. Unique social and behavioral characteristics inherent to threesomes, spontaneous group sex, and sex parties highlight the need to identify prevention strategies to help those who participate in GSEs reduce their risk for HIV and STI transmission., (© 2013 International Society for Sexual Medicine.)

We adapted time-space sampling to enroll men who have sex with men (MSM) off Craigslist.org for face-to-face interviews. Men responding to our ads (n = 322) were instructed to either complete an online pre-screening survey (to determine preliminary eligibility) or call our office directly. Of those taking further initiative to enroll, 29 % (n = 41) called directly and 71 % (n = 101) opted to first complete the online survey. Participants scheduled via online pre-screening were more likely to present for their face-to-face assessment than men deemed eligible directly via phone screening (72.3 vs. 47.1 %). Online pre-screening was a useful tool to offer potential participants when recruiting on Craigslist and improved study enrollment.

The emergence of barebacking (intentional unprotected anal intercourse in situations where there is risk of HIV infection) among men who have sex with men (MSM) has been partially attributed to a decrease in HIV-related concerns due to improved anti-retroviral treatment. It is important to understand the level of concern these men have regarding HIV infection because it can affect their interest in risk reduction behaviors as well as their possible engagement in risk reduction interventions. As part of a study on MSM who use the Internet to seek sexual partners, 89 ethnic and racially diverse men who reported never having an HIV-positive test result completed an in-depth qualitative interview and a computer-based quantitative assessment. Of the 82 men who were asked about concerns of HIV infection during the qualitative interviews, 30 expressed "significant concern" about acquiring HIV, 42 expressed "moderate concern," and 10 expressed "minimal concern." Themes that emerged across the different levels of concern were their perceptions of the severity of HIV infection, having friends who were HIV positive, and their own vulnerability to HIV infection. However, these themes differed depending on the level of concern. Among the most frequently mentioned approaches to decrease risk of HIV infection, participants mentioned avoiding HIV-positive sex partners, limiting the number of partners with whom they barebacked, and not allowing partners to ejaculate inside their rectum. Findings suggest that many MSM who bareback would be amenable to HIV prevention efforts that do not depend solely on condom use.

We examined the association between HIV/AIDS risk behaviors and romantic feelings among single, young gay and bisexual men (YGBM). Romantic feelings may have positive (romantic ideation) and negative (romantic obsession) connotations. Consequently, we hypothesized that YGBM would report greater risks if they reported having obsessive thoughts about their relationship desires; conversely, we hypothesized that YGBM who envision a romantic relationship would report fewer unprotected partners. Using cross-sectional data from a study examining YGBM's online dating experiences (N = 376; ages 18-24), we found a positive association between romantic obsession and number of partners for unprotected receptive (URAI) and insertive (UIAI) anal intercourse. Conversely, we found a negative association between romantic ideation and number of partners for URAI and UIAI. Is love risky or protective? Our results indicate support for both perspectives. We discuss the implications of our findings, highlighting the importance of addressing romantic pursuits into existing HIV prevention interventions for YGBM.

Previously, we estimated the HIV risk reduction that men who have sex with men could attain using a rapid HIV home test to screen sexual partners versus using condoms inconsistently. Here, we clarify the assumptions of our published formulas. Using models that more closely resemble our study population, our results show a difference from that presented in the original article in the magnitude of the relative advantage (i.e., lower risk of HIV infection) for HIV home test use versus inconsistent condom use. We present a general formula that can accommodate different types of partnerships in estimating risk of HIV infection.

In a multi-site study of vaginal microbicide acceptability conducted with sexually active young women, quantitative assessments revealed significant differences in acceptability by site. Participants in Puerto Rico rated the gel more favourably than mainland US participants in terms of liking the gel and likelihood of future use. To explain these differences, we examined responses to qualitative behavioural assessments. Young women in mainland USA associated gel leakage with uncomfortable sensations experienced during menstruation, while young women in Puerto Rico had positive associations of gel use with douching. These negative or positive associations affected assessments of the gel's physical qualities. In addition, young women's perceptions of primary partners' support for microbicide use influenced sexual satisfaction with the gel and, ultimately, product acceptability. Finally, geographic HIV-risk context contributed to heightened HIV-risk perception, which influenced likelihood of future microbicide use, even for women in stated monogamous relationships. Future microbicide acceptability studies should take into account potential differences in acceptability by site such as HIV-risk perception based on local HIV prevalence, popularity of vaginal hygiene products in a specific area and male attitudes in different cultures concerning women's use of HIV protection strategies.

An ethnically diverse sample of 120 mostly gay-identified men who engaged in "bareback" intercourse was recruited via the Internet in New York City. By study design three quarters of participants were HIV-uninfected and engaged in condomless receptive anal intercourse. In the course of face-to-face in-depth interviews, participants were asked what led them to have their first bareback experience as well as to continue with the behavior. Qualitative analysis identified the pivotal role that sexual pleasure and intimacy have in this population and how drives for sexual satisfaction, adventure, intimacy, and love overpower health concerns and condom use recommendations. Men interested in bareback sex use a variety of defense mechanisms to account for, justify, and exonerate their behavior. HIV-prevention interventions have paid insufficient attention to libidinal drives, a crucial element of psychological functioning.

Objectives: Successful control of the HIV/AIDS pandemic requires reduction of HIV-1 transmission at sexually-exposed mucosae. No prevention studies of the higher-risk rectal compartment exist. We report the first-in-field Phase 1 trial of a rectally-applied, vaginally-formulated microbicide gel with the RT-inhibitor UC781 measuring clinical and mucosal safety, acceptability and plasma drug levels. A first-in-Phase 1 assessment of preliminary pharmacodynamics was included by measuring changes in ex vivo HIV-1 suppression in rectal biopsy tissue after exposure to product in vivo., Methods: HIV-1 seronegative, sexually-abstinent men and women (N = 36) were randomized in a double-blind, placebo-controlled trial comparing UC781 gel at two concentrations (0.1%, 0.25%) with placebo gel (1∶1∶1). Baseline, single-dose exposure and a separate, 7-day at-home dosing were assessed. Safety and acceptability were primary endpoints. Changes in colorectal mucosal markers and UC781 plasma drug levels were secondary endpoints; ex vivo biopsy infectibility was an ancillary endpoint., Results: All 36 subjects enrolled completed the 7-14 week trial (100% retention) including 3 flexible sigmoidoscopies, each with 28 biopsies (14 at 10 cm; 14 at 30 cm). There were 81 Grade 1 adverse events (AEs) and 8 Grade 2; no Grade 3, 4 or procedure-related AEs were reported. Acceptability was high, including likelihood of future use. No changes in mucosal immunoinflammatory markers were identified. Plasma levels of UC781 were not detected. Ex vivo infection of biopsies using two titers of HIV-1(BaL) showed marked suppression of p24 in tissues exposed in vivo to 0.25% UC781; strong trends of suppression were seen with the lower 0.1% UC781 concentration., Conclusions: Single and 7-day topical rectal exposure to both concentrations of UC781 were safe with no significant AEs, high acceptability, no detected plasma drug levels and no significant mucosal changes. Ex vivo biopsy infections demonstrated marked suppression of HIV infectibility, identifying a potential early biomarker of efficacy. (Registered at ClinicalTrials.gov; #NCT00408538).

We studied the overall acceptability of UC781 gel formulation when applied rectally. Ten women and twenty-six men, all HIV-uninfected, were enrolled in a Phase 1, randomized, blinded, placebo-controlled safety and acceptability study of the vaginal microbicide gel UC781 applied rectally. Participants were randomized to three groups: 0.1% UC781 gel, 0.25% UC781 gel, or a placebo gel. Acceptability was assessed using structured questionnaires and qualitative in-depth interviews. After using UC781 gel rectally for seven consecutive days, participants' reports suggest that a UC781 gel formulation is highly acceptable and comparable to a placebo gel. The gels received favorable ratings overall and on attributes such as color, smell and consistency. All of the participants reported high intentions to use a gel like the one they used in this study. Acceptability research is essential in early phases of microbicide development to identify potential problems, understand user preferences, and introduce changes if needed.

Rationale: To explore age of onset of rectal douching among men who have sex with men (MSM) and reasons leading to and maintaining douching behavior; and to consider whether rectal douches containing microbicidal agents might be acceptable for men at HIV risk., Methods: In stage 1, we used qualitative methods to explore douching behavior in a sample of 20 MSM. Subsequently, we developed a structured questionnaire that was administered in stage 2 to 105 MSM., Results: More than half of participants who completed stage 1 douched during the trial despite having been advised not to do so. Of the 105 human immunodeficiency virus uninfected participants in stage 2, 51% reported using rectal douches in the prior 6 months; 47% douched before and 25% after anal intercourse. Most participants reported douching frequently or always. On average, men reported douching about 2 hours before or 1 hour following intercourse. Average age of onset was late 20s. Most men who douched wanted to be clean or were encouraged to douche by their partners. Some men thought douching after sex could prevent sexually transmitted infections., Conclusion: Rectal douching appears to be a popular behavior among men who have receptive anal intercourse. It is necessary to identify harmless douches. If human immunodeficiency virus or sexually transmitted infections preventive douches can be developed, rectal douching before or following sexual intercourse could become an important additional prevention tool. To reshape an existing behavior to which some men strongly adhere, like douching, by suggesting use of 1 type of douche over another may be more successful than trying to convince MSM to engage in behaviors they never practiced before or those they resist (e.g., condom use).

We estimated the HIV risk reduction that could be attained by using a rapid HIV home test (HT) to screen sexual partners versus using condoms in different proportions of anal intercourse (AI) occasions among men who have sex with men (MSM). Special attention was paid to the role of the window period during which infected cases go undetected. Our results show that if MSM engage in AI without condoms following a non-reactive HT result, they have lower chances of becoming infected by someone still in the window period than by following heuristics and using condoms inconsistently. For MSM who do not use condoms, use of HT as a screening device may be a useful risk reduction strategy. This advantage increases with higher HIV population prevalence. With higher HIV incidence, this strategy will not provide any advantage if condoms are used in as little as one out of four occasions.

Although condom use is an effective barrier against HIV transmission, some men who have sex with men (MSM) engage in bareback sex (unprotected anal sex in risky contexts) and increase their risk for HIV (re)infection. Understanding MSM's decision to bareback (vis-à-vis condom use) is essential to develop effective HIV/AIDS prevention programs for this population. An ethnically diverse sample of men who bareback (n = 120) was recruited exclusively on the Internet and stratified to include two thirds who reported both unprotected receptive anal intercourse (URAI) and being HIV uninfected. We used exploratory factor analysis to explore the domains within the Decisional Balance to Bareback (DBB) scale, and test the association between DBB and risky sexual behaviors. HIV-positive MSM (n = 31) reported higher costs/losses associated with condom use than HIV-negative men (n = 89). We found two underlying factors in the DBB scale: a Coping with Social Vulnerabilities subscale (eight items; alpha = .89) and a Pleasure and Emotional Connection subscale (five items; alpha = .92). We found a positive association between DBB (i.e. greater gains associated with bareback sex) and URAI occasions, number of partners, and having one or more sero-discordant partners in the past 3 months. We conclude that because MSM may avoid using condoms in order to cope with psychosocial vulnerabilities and create intimacy with other MSM, this population could benefit from alternatives to condoms such as pre/post exposure prophylaxis and rectal microbicides.

Although some rectal douches result in surface epithelium loss and potential increase of HIV transmission, men who have sex with men (MSM) continue to use them. We describe the prevalence of this practice among MSM engaging in unprotected receptive anal intercourse (URAI) in risky circumstances. A multiethnic sample with overrepresentation of HIV-negative MSM who had URAI in the previous year was recruited exclusively through the Internet. Participants were 105 MSM (78 HIV-negative, 27 HIV-positive). A total of 53% of HIV-negative and 96% of HIV-positive men douched in preparation for sex, most of them frequently or always, mainly for hygienic purposes. 27% of HIV-negative and 44% of HIV-positive douched after sex, partly believing douching protected from infections. Douching practices started around age 25. Regression analyses found the association between HIV status and douching occasions persisted after controlling for demographic characteristics and number of URAI occasions. Rectal douching in preparation for sex is common among men who practice URAI. This population could benefit from alternatives to condoms, such as rectal microbicides. Given the popularity of pre-coital douching and its frequency, a harmless rectal douche that could deliver a rectal microbicide could have great acceptability.

We describe enrollment for the One Thousand Strong panel, present characteristics of the panel relative to other large US national studies of gay and bisexual men (GBM), and examine demographic and behavioral characteristics that were associated with passing enrollment milestones. A US national sample of HIV-negative men was enrolled via an established online panel of over 22,000 GBM. Participants ( n = 1071) passed three milestones to join our panel. Milestone 1 was screening eligible and providing informed consent. Milestone 2 involved completing an hour-long at-home computer-assisted self-interview (CASI) survey. Milestone 3 involved completing at-home self-administered rapid HIV testing and collecting/returning urine and rectal samples for gonorrhea and chlamydia testing. Compared to those who completed milestones: Those not passing milestone 1 were more likely to be non-White and older; those not passing milestone 2 were less likely to have insurance or a primary care physician; and those not passing milestone 3 were less educated, more likely to be bisexual as opposed to gay, more likely to live in the Midwest, had fewer male partners in the past year, and less likely to have tested for HIV in the past year. Effect sizes for significant findings were small. We successfully enrolled a national sample of HIV-negative GBM who completed at-home CASI assessments and at-home self-administered HIV and urine and rectal STI testing. This indicates high feasibility and acceptability of incorporating self-administered biological assays into otherwise fully online studies. Differences in completion of study milestones indicate a need for further investigation into the reasons for lower engagement by certain groups. [ABSTRACT FROM AUTHOR]

Epidemiological, behavioral, and clinical data on sexual compulsivity in Brazil are very limited. This study sought to adapt and validate the Sexual Compulsivity Scale (SCS), the 22-item version of the Compulsive Sexual Behavior Inventory (CSBI-22), and the Hypersexual Disorder Screening Inventory (HDSI) for use in Brazil. A total of 153 participants underwent psychiatric assessment and completed self-reported measures. The adaptation process of the instruments from English to Portuguese followed the guidelines of the International Society for Pharmacoeconomics and Outcomes Research. The reliability and validity of the HDSI criteria were evaluated and the construct validity of all measures was examined. For the SCS and HDSI, factor analysis revealed one factor for each measure. For the CSBI-22, four factors were retained although we only calculated the scores of two factors (control and violence). All scores had good internal consistency (alpha >.75), presented high temporal stability (>.76), discriminated between patients and controls, and presented strong (ρ > .81) correlations with the Sexual Addiction Screening Test (except for the violence domain = .40) and moderate correlations with the Impulsive Sensation Seeking domain of the Zuckerman Kuhlman Personality Questionnaire (ρ between .43 and .55). The sensitivity of the HDSI was 71.93 % and the specificity was 100 %. All measures showed very good psychometric properties. The SCS, the HDSI, and the control domain of the CSBI-22 seemed to measure theoretically similar constructs, as they were highly correlated (ρ > .85). The findings support the conceptualization of hypersexuality as a cluster of problematic symptoms that are highly consistent across a variety of measures. [ABSTRACT FROM AUTHOR]