Substance Use and Adherence to HIV Preexposure Prophylaxis for Men Who Have Sex with Men1.
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ABSTRACT:
SUBMITTER: Hoenigl M
PROVIDER: S-EPMC6256399 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
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Substance Use and Adherence to HIV Preexposure Prophylaxis for Men Who Have Sex with Men<sup>1</sup>.
Hoenigl Martin M Jain Sonia S Moore David D Collins Deborah D Sun Xiaoying X Anderson Peter L PL Corado Katya K Blumenthal Jill S JS Daar Eric S ES Milam Joel J Dubé Michael P MP Morris Sheldon S
Emerging infectious diseases 20181201 12
The effectiveness of oral HIV preexposure prophylaxis (PrEP) strongly depends on maintaining adherence. We investigated the association between substance use and PrEP adherence, as well as incident sexually transmitted infections (STIs) in a high-risk cohort of 394 participants (391 men who have sex with men and 3 transgender women) who were enrolled in a PrEP demonstration project. We assessed baseline and ongoing substance use over a 48-week period for stimulants and nonstimulant substances an ...[more]
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Project description:BackgroundAdherence is necessary for efficacy of preexposure prophylaxis (PrEP), and text-messaging methods are promising tools for both adherence assessment and support. Although PrEP adherence is variable, little research has examined patterns of variability or factors associated with longitudinal use.MethodsIn the context of a randomized controlled trial of text-messaging versus standard of care for PrEP adherence, 181 men who have sex with men received once-daily tenofovir disoproxil fumarate/emtricitabine and daily adherence texts for 48 weeks. Growth mixture modeling (GMM) was used to identify subgroups of individuals with similar trajectories of text-reported adherence. Between-group differences in pharmacologic measures of adherence (ie, tenofovir diphosphate and emtricitabine triphosphate levels), as well as predictors and study-end attitudes associated with group membership, were examined.ResultsGMM identified 4 trajectories of text-reported adherence. Classes with higher text-reported adherence had higher drug concentrations. Younger age and minority race were associated with lower adherence, and individuals in classes with lower adherence had greater baseline levels of depression, substance use concerns, and sexual risk. Differences in study satisfaction were also associated with adherence.ConclusionsThis study supports the use of text-reported PrEP adherence. Identifying factors associated with less-than-optimal adherence may aid clinicians in anticipating at-risk patients requiring augmented intervention.Clinical trials registrationNCT01761643.
| S-EPMC6455933 | biostudies-literature
Project description:ImportanceEvidence on HIV preexposure prophylaxis (PrEP) among Chinese men who have sex with men (MSM) is critical to guide its large-scale implementation in low- and middle-income countries.ObjectiveTo evaluate incident HIV infection, adherence, safety, and changes in sexual behaviors among MSM using daily PrEP (D-PrEP) and event-driven PrEP (ED-PrEP) in 4 cities in China.Design, setting, and participantsThis nonrandomized controlled trial was conducted among HIV-seronegative MSM from December 11, 2018, to November 30, 2020, in Beijing, Shenyang, Chongqing, and Shenzhen. Participants self-chose D-PrEP or ED-PrEP regimens at baseline and could switch regimens during the 12-month study period. HIV-negative MSM who declined to initiate PrEP (nonusers) in the same cities joined a separate parallel prospective cohort and served as control individuals.InterventionsPrEP consisted of coformulated tenofovir disoproxil fumarate, 300 mg, and emtricitabine, 200 mg.Main outcomes and measuresThe main outcome was incident HIV infection. Poisson regression was used to obtain the HIV incidence rate ratio (IRR).ResultsA total of 1530 MSM were included in the analysis (median age, 30 [IQR, 25-37] years). At baseline, 520 MSM chose D-PrEP (median age, 29 [IQR, 25-35] years) and 503 chose ED-PrEP (median age, 29 [IQR, 25-36] years). The median HIV Risk Index score was 18 (IQR, 12-22) among D-PrEP users and 18 (IQR, 11-22) among ED-PrEP users. Among 507 PrEP nonusers, the median age was 33 (IQR, 27-43) years, and the median HIV Risk Index score was 12 (IQR, 7-18). Although PrEP users had more baseline behaviors associated with HIV risk, the HIV incidence was lower among all PrEP users (adjusted IRR, 0.09 [95% CI, 0.04-0.21]), ED-PrEP users (adjusted IRR, 0.05 [95% CI, 0.01-0.22]), and D-PrEP users (adjusted IRR, 0.12 [95% CI, 0.04-0.33]) compared with PrEP nonusers. There was no difference in HIV incidence between D-PrEP users and ED-PrEP users (IRR, 0.33 [95% CI, 0.06-2.04]). Event-driven PrEP users consumed 40% fewer tablets than D-PrEP users during the study period. Adherence, defined as the proportion of self-reported days with sexual intercourse in which PrEP was taken according to prescription of at least 90%, increased over time among ED-PrEP users (from 57.4% to 77.8%; P < .001 for trend) and decreased over time among D-PrEP users (from 75.1% to 72.1%; P = .02 for trend). Daily PrEP users reported fewer adverse events than ED-PrEP users (193 of 520 [37.1%] vs 241 of 503 [47.9%]).Conclusions and relevanceThe findings of this study suggest that D-PrEP and ED-PrEP regimens are associated with lower incidence of HIV and a good safety profile among high-risk MSM in China.Trial registrationChinese Clinical Trial Registry number: ChiCTR-IIN-17013762.
| S-EPMC8851305 | biostudies-literature
Project description:Optimal adherence to pre-exposure prophylaxis (PrEP) is critical, but challenging. Men who have sex with men and transgender women have high rates of HIV incidence and substance use. Substance use is associated with reduced adherence to other medications, but associations between substance use and adherence to PrEP are less clear. Thus, the current review 1) systematically evaluates the measurement of substance use and PrEP adherence in studies examining both and 2) summarizes reported findings. Peer-reviewed articles published between 2010 - April 2021 examining associations between substance use and PrEP adherence were reviewed. Fifty studies met inclusion criteria. Assessment of substance use (i.e., mostly via self-reports at baseline) and PrEP adherence (i.e., often via tenofovir diphosphate [TFV-DP] concentration levels at follow-up) varied considerably across studies. Many studies used categorical variables (e.g., substance use: yes/no). Studies using TFV-DP levels defined adherence consistently (i.e., TFV-DP ≥ 700 fmol/punch), with slight variations. Qualitative studies (n = 10) indicated that substance use (mainly alcohol) is related to poorer PrEP adherence. While quantitative findings to date are equivocal for alcohol, there is a pattern of findings linking stimulant use with poorer PrEP adherence. This review reveals four methodological gaps, which can be addressed in future research by: 1) use of uniform benchmarks for substance use measures, 2) prospective assessment for substance use, 3) use of continuous outcome variables wherever possible, and 4) more extensive consideration of potential confounders. Addressing these methodological gaps may help us reach more definitive conclusions regarding associations between substance use and PrEP adherence.
| S-EPMC10869193 | biostudies-literature
Project description:BACKGROUND:Many state and local health departments now promote and support the use of HIV preexposure prophylaxis (PrEP), yet monitoring use of the intervention at the population level remains challenging. METHODS:We report the results of an online survey designed to measure PrEP use among men who have sex with men (MSM) in Washington State. Data on the proportion of men with indications for PrEP based on state guidelines and levels of awareness, interest, and use of PrEP are presented for 1080 cisgender male respondents who completed the survey between January 1 and February 28, 2017. We conducted bivariate and multivariable logistic regression to identify factors associated with current PrEP use. To examine patterns of discontinuation, we conducted Cox proportional hazards regression and fit a Kaplan-Meier curve to reported data on time on PrEP. RESULTS:Eighty percent of respondents had heard of PrEP, 19% reported current use, and 36% of men who had never used PrEP wanted to start taking it. Among MSM for whom state guidelines recommend PrEP, 31% were taking it. In multivariable analysis, current PrEP use was associated with older age, higher education, and meeting indications for PrEP use. Our data suggest that 20% of PrEP users discontinue within 12 months, and men with lower educational attainment were more likely to discontinue. CONCLUSIONS:Despite high levels of use, there is significant unmet need for PrEP in Washington. Our experience indicates that Internet surveys are feasible and informative for monitoring PrEP use in MSM.
| S-EPMC7687921 | biostudies-literature
Project description:BackgroundWhile noninferiority of tenofovir alafenamide and emtricitabine (TAF/FTC) as preexposure prophylaxis (PrEP) for the prevention of human immunodeficiency virus (HIV) has been shown, interest remains in its efficacy relative to placebo. We estimate the efficacy of TAF/FTC PrEP versus placebo for the prevention of HIV infection.MethodsWe used data from the DISCOVER and iPrEx trials to compare TAF/FTC to placebo. DISCOVER was a noninferiority trial conducted from 2016 to 2017. iPrEx was a placebo-controlled trial conducted from 2007 to 2009. Inverse probability weights were used to standardize the iPrEx participants to the distribution of demographics and risk factors in the DISCOVER trial. To check the comparison, we evaluated whether risk of HIV infection in the shared tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) arms was similar.ResultsNotable differences in demographics and risk factors occurred between trials. After standardization, the difference in risk of HIV infection between the TDF/FTC arms was near zero. The risk of HIV with TAF/FTC was 5.8 percentage points lower (95% confidence interval [CI], -2.0% to -9.6%) or 12.5-fold lower (95% CI, .02 to .31) than placebo standardized to the DISCOVER population.ConclusionsThere was a reduction in HIV infection with TAF/FTC versus placebo across 96 weeks of follow-up.Clinical trials registrationNCT02842086 and NCT00458393.
| S-EPMC11011171 | biostudies-literature
Project description:BackgroundThis study estimated the number of daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) doses required to achieve and maintain (after discontinuation) intracellular drug concentrations that protect against human immunodeficiency virus (HIV) infection for men who have sex with men (MSM).MethodsTenofovir diphosphate (TFV-DP) concentrations in peripheral blood mononuclear cells (PBMCs) and rectal mononuclear cells from an intensive pharmacokinetic study ("Cell-PrEP" [preexposure prophylaxis]) of 30 days of daily TDF/FTC followed by 30 days off drug were evaluated. A regression formula for HIV risk reduction derived from PBMCs collected in the preexposure prophylaxis initiative study was used to calculate inferred risk reduction. The time required to reach steady state for TFV-DP in rectal mononuclear cells was also determined.ResultsTwenty-one HIV-uninfected adults participated in Cell-PrEP. The inferred HIV risk reduction, based on PBMC TFV-DP concentration, reached 99% (95% confidence interval [CI], 69%-100%) after 5 daily doses, and remained >90% for 7 days after stopping drug from steady-state conditions. The proportion of participants reaching the 90% effective concentration (EC90) was 77% after 5 doses and 89% after 7 doses. The percentage of steady state for natural log [TFV-DP] in rectal mononuclear cells was 88% (95% CI, 66%-94%) after 5 doses and 94% (95% CI, 78%-98%) after 7 doses.ConclusionsHigh PrEP activity for MSM was achieved by approximately 1 week of daily dosing. Although effective intracellular drug concentrations persist for several days after stopping PrEP, a reasonable recommendation is to continue PrEP dosing for 4 weeks after the last potential HIV exposure, similar to recommendations for postexposure prophylaxis.
| S-EPMC4402345 | biostudies-literature
Project description:Using cross-sectional survey data (Engage, 2017-2018) from 1,137 men who have sex with men, ≥16 years old, in Montreal, we compared observed human immunodeficiency virus (HIV) seroconcordance in previous-6-months' sexual partnerships with what would have been observed by chance if zero individuals serosorted. Of 5 recent partnerships where both individuals were HIV-negative, we compared observed concordance in preexposure prophylaxis (PrEP) use with the counterfactual if zero individuals selected partners based on PrEP use. We estimated the concordance by chance using a balancing-partnerships approach assuming proportionate mixing. HIV-positive respondents had a higher proportion of HIV-positive partners (66.4%, 95% confidence interval (CI): 64.0, 68.6) than by chance (23.9%, 95% CI: 23.1, 24.7). HIV-negative respondents (both on and not on PrEP) had higher proportions of HIV-negative partners (82.9% (95% CI: 81.1, 84.7) and 90.7% (95% CI: 89.6, 91.7), respectively) compared with by chance (76.1%, 95% CI: 75.3, 76.9); however, those on PrEP had a higher proportion of HIV-positive partners than those not on PrEP (17.1% (95% CI: 15.3, 18.9) vs. 9.3% (95% CI: 8.3, 10.4). Those on PrEP also had a higher proportion of partners on PrEP among their HIV-negative partners (50.6%, 95% CI: 42.5, 58.8) than by chance (28.5%, 95% CI: 27.5, 29.4). The relationship between PrEP and sexual-mixing patterns demonstrated by less population-level serosorting among those on PrEP and PrEP-matching warrants consideration during PrEP roll-out.
| S-EPMC7119299 | biostudies-literature
Project description:BackgroundPreexposure prophylaxis (PrEP) is an effective strategy to reduce the risk of HIV infection. However, the efficacy of PrEP is highly dependent on adherence. Meanwhile, adherence changes over time, making it difficult to manage effectively.ObjectiveOur study aimed to explore and predict the patterns of change in PrEP adherence among men who have sex with men (MSM) and evaluate the impact of the WeChat-based reminder intervention on adherence, thus providing more information for PrEP implementation strategies.MethodsFrom November 2019 to June 2023, in a randomized controlled longitudinal study of the PrEP demonstration project in Western China (Chongqing, Sichuan, and Xinjiang) based on a mobile health (mHealth) reminder intervention, participants were randomly divided into reminder and no-reminder groups, with those in the reminder group receiving daily reminders based on the WeChat app. Participants were followed up and self-reported their medication adherence every 12 weeks for a total of 5 follow-up visits. We used the growth mixture model (GMM) to explore potential categories and longitudinal trajectories of adherence among MSM, and patterns of change in PrEP adherence were predicted and evaluated based on the decision tree.ResultsA total of 446 MSM were included in the analysis. The GMM identified 3 trajectories of adherence: intermediate adherence group (n=34, 7.62%), low adherence ascending group (n=126, 28.25%), and high adherence decline group (n=286, 64.13%). We included 8 variables that were significant in the univariate analysis in the decision tree prediction model. We found 4 factors and 8 prediction rules, and the results showed that HIV knowledge score, education attainment, mHealth intervention, and HIV testing were key nodes in the patterns of change in adherence. After 10-fold cross-validation, the final prediction model had an accuracy of 75%, and the classification accuracy of low and intermediate adherence was 78.12%.ConclusionsThe WeChat-based reminder intervention was beneficial for adherence. A short set of questions and prediction rules, which can be applied in future large-scale validation studies, aimed at developing and validating a short adherence assessment tool and implementing it in PrEP practices among MSM.
| S-EPMC11657909 | biostudies-literature
Project description:BackgroundThis study examined the feasibility of a combination prevention intervention for young men who have sex with men (YMSM), an anticipated target population for HIV preexposure prophylaxis (PrEP).MethodsProject PrEPare, a pilot study using a randomized 3-arm design, compared an efficacious behavioral HIV prevention intervention (Many Men, Many Voices-3 MV) alone, 3 MV combined with PrEP (tenofovir/emtricitabine), and 3 MV combined with placebo. Eligible participants were 18- to 22-year-old HIV-uninfected men who reported unprotected anal intercourse in the past year. Participants were screened for preliminary eligibility at youth venues and community organizations and were also referred through social networks. Laboratory screening determined final eligibility. Behavioral and biomedical data were collected at baseline and every 4 weeks thereafter for 24 weeks.ResultsSixty-eight youth (mean age = 19.97 years; 53% African American, 40% Latino) were enrolled; 58 were randomized. Self-reported medication adherence averaged 62% (range, 43%-83%), whereas rates of detectable tenofovir in plasma of participants in the emtricitabine/tenofovir disoproxil fumarate arm ranged from 63.2% (week 4) to 20% (week 24). There were 5 ≥ grade 2 adverse events possibly/probably related to the study medication. Sexual risk behavior declined from baseline to week 24 in all study arms.ConclusionsThe feasibility of enrolling at-risk youth, particularly young men who have sex with men of color, into Project PrEPare has been demonstrated. The acceptability of the group intervention along with counseling and testing was high. Self-reported medication adherence and corresponding plasma drug concentrations were low indicating the need for enhanced adherence counseling. Exploration of PrEP use among youth in nonrandomized open label trials is warranted.
| S-EPMC3656981 | biostudies-literature
Project description:BackgroundPreexposure prophylaxis (PrEP) is available as a daily pill for preventing infection with the human immunodeficiency virus (HIV). Innovative methods of administering PrEP systemically or topically are being discussed and developed.ObjectiveThe objective of our study was to assess attitudes toward different experimental modalities of PrEP administration.MethodsFrom April to July 2015, we recruited 1106 HIV-negative men who have sex with men through online social media advertisements and surveyed them about their likelihood of using different PrEP modalities. Participants responded to 5-point Likert-scale items indicating how likely they were to use each of the following PrEP modalities: a daily oral pill, on-demand pills, periodic injection, penile gel (either before or after intercourse), rectal gel (before/after), and rectal suppository (before/after). We used Wilcoxon signed rank tests to determine whether the stated likelihood of using any modality differed from daily oral PrEP. Related items were combined to assess differences in likelihood of use based on tissue or time of administration. Participants also ranked their interest in using each modality, and we used the modified Borda count method to determine consensual rankings.ResultsMost participants indicated they would be somewhat likely or very likely to use PrEP as an on-demand pill (685/1105, 61.99%), daily oral pill (528/1036, 50.97%), injection (575/1091, 52.70%), or penile gel (438/755, 58.01% before intercourse; 408/751, 54.33% after). The stated likelihoods of using on-demand pills (median score 4) and of using a penile gel before intercourse (median 4) were both higher than that of using a daily oral pill (median 4, P<.001 and P=.001, respectively). Compared with a daily oral pill, participants reported a significantly lower likelihood of using any of the 4 rectal modalities (Wilcoxon signed rank test, all P<.001). On 10-point Likert scales created by combining application methods, the reported likelihood of using a penile gel (median 7) was higher than that of using a rectal gel (median 6, P<.001), which was higher than the likelihood of using a rectal suppository (median 6, P<.001). The modified Borda count ranked on-demand pills as the most preferred modality. There was no difference in likelihood of use of PrEP (gel or suppository) before or after intercourse.ConclusionsParticipants typically prefer systemic PrEP and are less likely to use a modality that is administered rectally. Although most of these modalities are seen as favorable or neutral, attitudes may change as information about efficacy and application becomes available. Further data on modality preference across risk groups will better inform PrEP development.
| S-EPMC4909393 | biostudies-literature