Objective
Development of personalized sleep–wake management tools is critical to improving sleep and functional outcomes for shift workers. The objective of the current study was to test the ...performance, engagement and usability of a mobile app (SleepSync) for personalized sleep–wake management in shift workers that aid behavioural change and provide practical advice by providing personalized sleep scheduling recommendations and education.
Methods
Shift workers (n = 27; 20 healthcare and 7 from other industries) trialled the mobile app for two weeks to determine performance, engagement and usability. Primary outcomes were self-reported total sleep time, ability to fall asleep, sleep quality and perception of overall recovery on days off. Secondary performance outcomes included sleep disturbances (insomnia and sleep hygiene symptoms, and sleep-related impairments) and mood (anxiety, stress and depression) pre- and post-app use. Satisfaction with schedule management, integration into daily routine and influence on behaviour were used to determine engagement, while the usability was assessed for functionality and ease of use of features.
Results
Total sleep time (P = .04), ability to fall asleep (P < .001), quality of sleep (P = .001), insomnia (P = .02), sleep hygiene (P = .01), sleep-related impairments (P = .001), anxiety (P = .001), and stress (P = .006) were all improved, with non-significant improvements in recovery on days off (P = .19) and depression (P = .07). All measures of engagement and usability were scored positively by the majority of users.
Conclusions
This pilot trial provides preliminary evidence of the positive impact of the SleepSync app in improving sleep and mood outcomes in shift workers, and warrants confirmation in a larger controlled trial.
Development of HIV-1 prevention methods is a global priority. In this randomized, controlled trial in sub-Saharan Africa, a vaginal ring containing the antiretroviral dapivirine was 27% effective in ...protecting against HIV-1 acquisition.
More than half of the 35 million persons currently living with human immunodeficiency virus type 1 (HIV-1) infection are women. A majority of these women reside in sub-Saharan Africa,
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a region that has some of the highest incidences of HIV-1 infection in any population worldwide.
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The use of antiretroviral medications as pre-exposure prophylaxis is a promising approach to the prevention of HIV-1 acquisition.
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Several clinical trials of the antiretroviral tenofovir showed such protection against HIV-1.
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However, in three trials involving African women, adherence to tenofovir-containing pills and vaginal gels was low, and HIV-1 protection was not shown. . . .
Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target ...the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio IRR, 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio OR, 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. Clinical Trials Registration: NCT01687218.
Background. Tenofovir (TFV) gel partially protected against human immunodeficiency virus (HIV) in one but not subsequent trials. The disappointing results were attributed largely to poor adherence. ...However, timing of gel application relative to sex may impact pharmacokinetics and contribute to outcomes. Thus, we conducted a single-dose pharmacokinetic study of TFV gel applied 1 or 24 hours before or 1 hour before and 1 hour after (BAT) sex and compared results with dosing without sex. Methods. Twenty-four couples were enrolled; cervicovaginal lavage (CVL) and tissue were collected 2 hours after sex with matching timed collections at no sex visits and assayed for drug concentrations and CVL anti-HIV activity. Results. Compared with dosing without sex, median TFV concentrations after sex decreased 72% and 78% (P <.001) in CVL, 75% and 71% (P <.001) in vaginal tissue, and 75% (P = .06) and 55% (P <.001) in cervical tissue with −1 hour and −24 hour dosing, respectively. Median concentration of TFV–diphosphate also decreased significantly in cervical tissue with −1 hour, dosing. BAT dosing resulted in drug levels at least as great as those in the absence of sex. Percent inhibition of HIV infection by post-coital CVL increased significantly from median (interquartile range) of 55% (54%) in the absence of gel to 99% (7%), 77% (57%), and 100% (0.4%) with −1 hour, −24 hour, or BAT dosing, respectively, and correlated significantly with drug concentration. Conclusions. Timing of TFV gel application relative to sex significantly impacts drug levels. BAT dosing or sustained delivery may be optimal for preexposure prophylaxis.
BACKGROUND:Evidence is lacking regarding whether vaginal pre-exposure prophylaxis with topical tenofovir (TFV) reduces the risk of rectal HIV acquisition.
SETTING:Bronx, NY.
METHODS:MTN-014 was a ...phase 1, cross-over, randomized sequence trial comparing the cross-compartment pharmacokinetics and pharmacodynamics of daily TFV reduced-glycerin 1% gel after 14 days each of rectal and vaginal application, with directly observed dosing and a 6-week washout period between phases.
RESULTS:Fourteen HIV-uninfected women enrolled; 91% of doses were observed and 13 women completed all study procedures. TFV and TFV diphosphate (TFV-DP) were detected in most samples collected from the dosing compartment. After vaginal dosing, TFV was detected in 10/14 samples of rectal fluid (RF) (median 4.4 ng/sponge) and 1/13 rectal tissue samples (0.2 ng/mg); TFV-DP was detected in 2/13 rectal tissue samples at 59.8 and 76.5 fmol/mg. After rectal dosing, TFV was detected in 9/14 samples of vaginal fluid (median 1.1 ng/swab) and in 6/14 vaginal tissue samples (median below limit of quantification); TFV-DP was detected in 3/14 vaginal tissue samples at 17.3, 87.6, and 77.1 fmol/mg. Neither cervicovaginal lavage fluid nor RF collected 24 hours after rectal or vaginal dosing resulted in a statistically significant suppression of viral replication.
CONCLUSIONS:In this study of 14 days each of vaginal and rectal application of TFV reduced-glycerin 1% gel, we found only a small degree of cross-compartment distribution of TFV in RF and vaginal fluids and no pharmacodynamic activity in ex vivo testing. Although high TFV concentrations in the dosing compartment may be protective, low cross-compartment tissue concentrations are not likely to be protective.
(Abstracted from N Engl J Med 2016; DOI10.1056/NEJMoa1506110)The objective of this study was to examine the efficacy of dapivirine vaginal rings in providing protection against human immunodeficiency ...virus type 1 (HIV-1). HIV-1 infection incidence is one of the highest in sub-Saharan Africa.
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