High levels of adherence to a rectal microbicide gel and to oral Pre-Exposure Prophylaxis (PrEP) achieved in MTN-017 among men who have sex with men (MSM) and transgender women

Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)—if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18–64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ≥80% adherence to daily tablet, 41% having perfect adherence; 83% had ≥80% adherence to daily gel, 29% having perfect adherence; and 93% had ≥80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ≥80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP

Deconstructing Borders: The Federation for American Immigrations Reform and the Anti-Immigration Sentiment in the U.S.

Through examination of the dynamics of the U.S.-Mexico border in the anti-immigration discourse as compared with those found in ethnographies on immigrants' experiences in the United States, the author found that an understanding of the symbol of the border and its implications is key to comprehending the conflicting relationships between the ideologies of anti-immigration movements and those of immigrants. Throughout the history of the United States, anti-immigration movements have constructed internal borders which define outsiders and insiders, or those who belong and are accepted in the• country and those who are not. Nevertheless, as the composition of the immigrant population has changed throughout the years, so have the internal borders. They are constantly adjusted to include some groups and to keep out others. However, anti-immigration groups set up constructions of the border as absolute, unchanging, and fixed. This vision of the physical border as absolute contributes to the strict internal borders that are constructed by the anti-immigration movement. An analysis of this movement's discourse is essential to understanding how the border is made to appear natural and fixed

Behavioral economics-based incentives supported by mobile technology on HIV knowledge and testing frequency among Latino/a men who have sex with men and transgender women: Protocol for a randomized pilot study to test intervention feasibility and acceptability

Abstract Background Mobile Technology and Incentives (MOTIVES) is a randomized pilot study of a mobile technology-based and behavioral economics-supported HIV prevention intervention. Behavioral economics (BE) uses financial incentives in a way that departs from the traditional focus on large monetary payments. Instead, BE suggests that relatively small “nudges” can effectively initiate and sustain behavior change. This pilot study examines the feasibility and acceptability of an HIV prevention intervention that uses text messages in combination with BE incentives to improve retention of HIV prevention information and increase frequency of HIV testing among Latino/a men who have sex with men (MSM) and transgender women (TGW). The pilot will also estimate mission-critical design parameters with point and confidence interval estimates of the intervention to inform a future, fully powered effectiveness study. Methods The project will be conducted in collaboration with Bienestar Human Services, Inc. (Bienestar), a non-profit community-based service organization. The intervention is being tested in a small, randomized controlled trial to pilot the intervention’s feasibility and acceptability among 200 Latino/a MSM and TGW from Bienestar’s HIV testing sites. Information on feasibility will include recruitment, refusal, and retention rates as well as message sending success rates; acceptability will include perceived appropriateness based on responses to the intervention. Participants will be randomized into either the “information only” control group (e.g. receiving text messages with HIV prevention information) or the “information plus” intervention group (e.g. additionally receiving quiz questions that provide the possibility of winning prizes). Participants will be followed for 12 months from enrollment. In addition to using data abstracted from Bienestar’s routine data collection mechanisms, we will also collect survey data (blinded outcome assessment) from participants at 0, 6, and 12 months to provide an initial assessment of whether incentives affect their level of HIV knowledge and testing frequency. Discussion If shown to be acceptable, feasible, and resource-efficient, MOTIVES will provide an innovative way to communicate the latest HIV prevention information and support trimestral HIV screening among Latino/a MSM and TGW. Trial registration ClinicalTrials.gov, NCT03144336. Registered on 5 May 2017

Perceived Risks and Protective Strategies Employed by Young Men Who Have Sex with Men (YMSM) When Seeking Online Sexual Partners

This study examined the perceptions of risk by young men who have sex with men (YMSM) regarding meeting sexual partners through the Internet. Fifty-four YMSM ages 18-29 who reported engaging in bareback sex (intentional unprotected anal intercourse in high-risk contexts) completed a structured assessment and a face-to-face interview. Participants reported using the Internet to meet sexual partners at least once per week, having had multiple sexual partners in the past 2 months (M = 10.50, SD = 9.25), and engaging in occasions of unprotected receptive (M = 5.35, SD = 6.76) and insertive (M = 5.06, SD = 10.11) anal intercourse. A third of the sample reported having had unprotected sex with a partner who was serodiscordant or of unknown serostatus. Despite the obvious HIV risks, the most commonly perceived risks included threats to physical safety and difficulties trusting a stranger. Risk reduction strategies included leaving information about partner and whereabouts with a friend, meeting in a public place, and screening partner through online chatting. Those YMSM who meet partners online may be at risk for physical violence in addition to HIV or sexually transmitted infections (STIs). Public health campaigns should increase awareness of safety concerns when meeting sexual partners online and support YMSM's self-protective actions.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/85184/1/Bauermeister2010_HealthComm.pd

Rectal 1% Tenofovir Gel Use Associates with Altered Epidermal Protein Expression

Abstract Rectal use of a 1% tenofovir (TFV) gel is currently being evaluated for HIV prevention. While careful assessment of mucosal safety of candidate microbicides is a primary concern, tools to assess mucosal toxicity are limited. Mass spectrometry-based proteomics is a sensitive and high-throughput technique that can provide in-depth information on inflammation processes in biological systems. In this study, we utilized a proteomics approach to characterize mucosal responses in study participants involved in a phase 1 clinical trial of a rectal TFV-based gel. Project Gel was a phase 1 randomized (1:1), double-blind, multisite, placebo-controlled trial in which 24 participants received rectal TFV or a universal placebo [hydroxyethyl cellulose (HEC)] over a course of 8 daily doses. Rectal mucosal swabs were collected after 0, 1, and 8 doses and were analyzed by label-free tandem mass spectrometry. Differential protein expression was evaluated using a combination of paired (time-effects) and unpaired (across study arm) t-tests, and multivariate [least absolute shrinkage and selection operator (LASSO)] modeling. Within the TFV arm, 7% (17/249, p < .05) and 10% (25/249, p < .05) of total proteins changed after 1 and 8 daily applications of TFV gel, respectively, compared to 3% (7/249, p < .05) and 6% (16/249, p < .05) in the HEC arm. Biofunctional analysis associated TFV use with a decrease in epidermal barrier proteins (adj. p = 1.21 × 10−10). Multivariate modeling identified 13 proteins that confidently separated TFV gel users (100% calibration and 96% cross-validation accuracy), including the epithelial integrity factors (FLMNB, CRNN, CALM), serpins (SPB13, SPB5), and cytoskeletal proteins (VILI, VIME, WRD1). This study suggested that daily rectal applications of a 1% TFV gel may be associated with mucosal proteome changes involving epidermal development. Further assessment of more extended use of TFV-gel is recommended to validate these initial associations

Challenges and solutions implementing an SMS text message-based survey CASI and adherence reminders in an international biomedical HIV PrEP study (MTN 017)

BackgroundWe implemented a text message-based Short Message Service computer-assisted self-interviewing (SMS-CASI) system to aid adherence and monitor behavior in MTN-017, a phase 2 safety and acceptability study of rectally-applied reduced-glycerin 1% tenofovir gel compared to oral emtricitabine/tenofovir disoproxil fumarate tablets. We sought to implement SMS-based daily reminders and product use reporting, in four countries and five languages, and centralize data management/automated-backup.MethodsWe assessed features of five SMS programs against study criteria. After identifying the optimal program, we systematically implemented it in South Africa, Thailand, Peru, and the United States. The system consisted of four windows-based computers, a GSM dongle and sim card to send SMS. The SMS-CASI was, designed for 160 character SMS. Reminders and reporting sessions were initiated by date/time triggered messages. System, questions, responses, and instructions were triggered by predetermined key words.ResultsThere were 142,177 total messages: sent 86,349 (60.73%), received 55,573 (39.09%), failed 255 (0.18%). 6153 (4.33%) of the message were errors generated from either our SMS-CASI system or by participants. Implementation challenges included: high message costs; poor data access; slow data cleaning and analysis; difficulty reporting information to sites; a need for better participant privacy and data security; and mitigating variability in system performance across sites. We mitigated message costs and poor data access by federating the SMS-CASI system, and used secure email protocols to centralize data backup. We developed programming syntaxes to facilitate daily data cleaning and analysis, and a calendar template for reporting SMS behavior. Lastly, we ambiguated text message language to increase privacy, and standardized hardware and software across sites, minimizing operational variability.ConclusionWe identified factors that aid international implementation and operation of SMS-CASI for real-time adherence monitoring. The challenges and solutions we present can aid other researchers to develop and manage an international multilingual SMS-based adherence reminder and CASI system