scholarly journals Risk-Taking Behaviors and Adherence to HIV Pre-Exposure Prophylaxis in Users of Geosocial Networking Apps: Real-Word, Multicenter Study (Preprint)

2020 ◽  
Author(s):  
Hongyi Wang ◽  
Jing Zhang ◽  
Zhenxing Chu ◽  
Qinghai Hu ◽  
Willa Dong ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Hiv Prevention ◽  
Real World ◽  
Computer Assisted ◽  
Sex Partners ◽  
Condomless Anal Intercourse ◽  
Adherence Assessment ◽  
Event Driven ◽  
Geosocial Networking ◽  
Exposure Prophylaxis

BACKGROUND Over half of men who have sex with men (MSM) use geosocial networking (GSN) apps to encounter sex partners. GSN apps’ users have become a unique large subpopulation among MSM for interventions concerning HIV prevention and control. Pre-exposure prophylaxis (PrEP) is a promising measure for HIV prevention, especially for MSM, but its effectiveness largely depends on medication adherence. However, little is known about PrEP adherence among GSN apps’ users, which is critical to addressing the overall optimization of PrEP compliance outside of clinical trials in the context of large-scale implementation. OBJECTIVE The objective of this study is to understand the correlation between GSN apps’ use and medication adherence among MSM receiving PrEP, with the aim to increase their awareness about PrEP use in order to increase adherence. METHODS This study based on the China Real-world Oral intake of PrEP (CROPrEP) project, a multicenter, real-world study of Chinese MSM on daily and event-driven PrEP. Eligible participants completed a detailed computer-assisted self-interview on sociodemographic, GSN apps’ use, and sexual behavior. Then participants were followed up for 12 months and assessed for various characteristics (eg, PrEP delivery, adherence assessment, PrEP coverage of sexual activities, and regimens switch). A generalized estimation equation was used to analyze the predictors of medication adherence and regimen conversion among GSN apps’ users and nonusers. RESULTS At baseline, 756 of the 1023 eligible participants (73.90%) reported primarily using GSN apps to seek sexual partners, and GSN apps’ users are more likely to have high-risk behaviors such as multiple sex partners and condomless anal intercourse than other nonusers (all <i>P</i>&lt;.05). During follow-up, GSN apps’ users had a significantly low level of pill-counting adherence than nonusers (adjusted odds ratio [aOR] 0.8, 95% CI 0.6-1.0, <i>P</i>=.038). In the event-driven group, GSN apps’ users had marginally lower levels of self-reported adherence (aOR 0.7, 95% CI 0.4-1.0, <i>P</i>=.060) and lower PrEP coverage of sexual practices (aOR 0.6, 95% CI 0.4-1.0, <i>P</i>=.038). Additionally, GSN apps’ users seemed more likely to switch from event-driven to daily regimen (aOR 1.8, 95% CI 0.9-3.3, <i>P</i>=.084). CONCLUSIONS GSN apps’ users are highly prevalent among MSM, despite their higher sexual risk and lower adherence levels, suggesting that eHealth needs to be introduced to the GSN platform to promote PrEP adherence. CLINICALTRIAL Chinese Clinical Trial Registry ChiCTR-IIN-17013762; https://tinyurl.com/yy2mhrv4. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s12879-019-4355-y

scholarly journals Risk-Taking Behaviors and Adherence to HIV Pre-Exposure Prophylaxis in Users of Geosocial Networking Apps: Real-World, Multicenter Study

10.2196/22388 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e22388
Author(s):  
Hongyi Wang ◽  
Jing Zhang ◽  
Zhenxing Chu ◽  
Qinghai Hu ◽  
Willa Dong ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Hiv Prevention ◽  
Real World ◽  
Computer Assisted ◽  
Sex Partners ◽  
Condomless Anal Intercourse ◽  
Adherence Assessment ◽  
Event Driven ◽  
Geosocial Networking ◽  
Exposure Prophylaxis

Background Over half of men who have sex with men (MSM) use geosocial networking (GSN) apps to encounter sex partners. GSN apps’ users have become a unique large subpopulation among MSM for interventions concerning HIV prevention and control. Pre-exposure prophylaxis (PrEP) is a promising measure for HIV prevention, especially for MSM, but its effectiveness largely depends on medication adherence. However, little is known about PrEP adherence among GSN apps’ users, which is critical to addressing the overall optimization of PrEP compliance outside of clinical trials in the context of large-scale implementation. Objective The objective of this study is to understand the correlation between GSN apps’ use and medication adherence among MSM receiving PrEP, with the aim to increase their awareness about PrEP use in order to increase adherence. Methods This study based on the China Real-world Oral intake of PrEP (CROPrEP) project, a multicenter, real-world study of Chinese MSM on daily and event-driven PrEP. Eligible participants completed a detailed computer-assisted self-interview on sociodemographic, GSN apps’ use, and sexual behavior. Then participants were followed up for 12 months and assessed for various characteristics (eg, PrEP delivery, adherence assessment, PrEP coverage of sexual activities, and regimens switch). A generalized estimation equation was used to analyze the predictors of medication adherence and regimen conversion among GSN apps’ users and nonusers. Results At baseline, 756 of the 1023 eligible participants (73.90%) reported primarily using GSN apps to seek sexual partners, and GSN apps’ users are more likely to have high-risk behaviors such as multiple sex partners and condomless anal intercourse than other nonusers (all P<.05). During follow-up, GSN apps’ users had a significantly low level of pill-counting adherence than nonusers (adjusted odds ratio [aOR] 0.8, 95% CI 0.6-1.0, P=.038). In the event-driven group, GSN apps’ users had marginally lower levels of self-reported adherence (aOR 0.7, 95% CI 0.4-1.0, P=.060) and lower PrEP coverage of sexual practices (aOR 0.6, 95% CI 0.4-1.0, P=.038). Additionally, GSN apps’ users seemed more likely to switch from event-driven to daily regimen (aOR 1.8, 95% CI 0.9-3.3, P=.084). Conclusions GSN apps’ users are highly prevalent among MSM, despite their higher sexual risk and lower adherence levels, suggesting that eHealth needs to be introduced to the GSN platform to promote PrEP adherence. Trial Registration Chinese Clinical Trial Registry ChiCTR-IIN-17013762; https://tinyurl.com/yy2mhrv4. International Registered Report Identifier (IRRID) RR2-10.1186/s12879-019-4355-y

Crossover and Repeated Randomization in Event Driven Trials for HIV Prevention: Addressing the Impact of Heterogeneity in Risk in the Trial Design

2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Clara P. Domínguez Islas ◽  
Elizabeth R. Brown
Keyword(s):  
Hiv Prevention ◽  
Study Finding ◽  
Population Level ◽  
Ethical Considerations ◽  
On Demand ◽  
Higher Power ◽  
Event Driven ◽  
Exposure Prophylaxis ◽  
Future Work ◽  
The Impact

Abstract The availability of effective Pre-Exposure Prophylaxis (PrEP) for HIV introduces new challenges for testing novel on-demand, user-controlled HIV prevention products, including lower placebo arm incidence and increased between-participant variability in HIV risk. In this paper, we discuss how low HIV incidence may result in longer trials in which the variability in participants' risk may impact the estimate of risk reduction. We introduce a measure of per-exposure efficacy that may be more relevant than the population level reduction in incidence for on demand products and explore alternatives to the parallel arm design that could target better this parameter of interest: the crossover and the re-randomization designs. We propose three different ways in which crossover and re-randomization of intervention assignments could be implemented in event-driven trials. We evaluate the performance of these designs through a simulation study, finding that they allow for better estimation and higher power than the traditional event-driven parallel arm design. We conclude by discussing future work, practical challenges and ethical considerations that need to be addressed to take these designs closer to implementation.

scholarly journals Mapping the use of Group-Based Trajectory Modelling in medication adherence research: A scoping review protocol

2020 ◽  
Vol 3 ◽  
pp. 25
Author(s):  
Caroline A. Walsh ◽  
Sara Mucherino ◽  
Valentina Orlando ◽  
Kathleen E. Bennett ◽  
Enrica Menditto ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Scoping Review ◽  
Real World ◽  
Research Question ◽  
Future Research ◽  
Adherence Behaviour ◽  
Or Groups ◽  
Scoping Reviews ◽  
Adherence Assessment ◽  
Trajectory Modelling

The use of group-based trajectory modelling (GBTM) within the medication adherence literature is rapidly growing. Researchers are adopting enhanced methods to analyse and visualise dynamic behaviours, such as medication adherence, within ‘real-world’ populations. Application of GBTM based on longitudinal adherence behaviour allows for the identification of adherence trajectories or groups.  A group is conceptually thought of a collection of individuals who follow a similar pattern of adherence behaviour over a period of time. A common obstacle faced by researchers when implementing GBTM is deciding on the number of trajectory groups that may exist within a population. Decision-making can introduce subjectivity, as there is no ‘gold standard’ for model selection criteria. This study aims to examine the extent and nature of existing evidence on the application of GBTM for medication adherence assessment, providing an overview of the different GBTM techniques used in the literature. The methodological framework will consist of five stages: i) identify the research question(s); ii) identify relevant studies; iii) select studies; iv) chart the data and finally, v) collate, summarise and report the results. Original peer-reviewed articles, published in English, describing observational and interventional studies including both concepts and/or sub-concepts of GBTM and medication adherence or any other similar terms, will be included. The following databases will be queried: PubMed/MEDLINE; Embase (Ovid); SCOPUS; ISI Web of Science and PsychInfo. This scoping review will utilise the PRISMA extension for Scoping Reviews (PRISMA-ScR) tool to report results. This scoping review will collect and schematise different techniques in the application of GBTM for medication adherence assessment available in the literature to date, identifying research and knowledge gaps in this area. This review can represent an important tool for future research, providing methodological support to researchers carrying out a group-based trajectory analysis to assess medication adherence in a real-world context.

scholarly journals Mapping the use of Group-Based Trajectory Modelling in medication adherence research: A scoping review protocol

2020 ◽  
Vol 3 ◽  
pp. 25
Author(s):  
Caroline A. Walsh ◽  
Sara Mucherino ◽  
Valentina Orlando ◽  
Kathleen E. Bennett ◽  
Enrica Menditto ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Scoping Review ◽  
Real World ◽  
Research Question ◽  
Future Research ◽  
Adherence Behaviour ◽  
Or Groups ◽  
Scoping Reviews ◽  
Adherence Assessment ◽  
Review Protocol

The use of group-based trajectory (GBTM) modelling within the medication adherence literature is rapidly growing. Researchers are adopting enhanced methods to analyse and visualise dynamic behaviours, such as medication adherence, within ‘real-world’ populations. Application of GBTM based on longitudinal adherence behaviour allows for the identification of adherence trajectories or groups.  A group is conceptually thought of a collection of individuals who follow a similar pattern of adherence behaviour over a period of time. A common obstacle faced by researchers when implementing GBTM is deciding on the number of trajectory groups that may exist within a population. Decision-making can introduce subjectivity, as there is no ‘gold standard’ for model selection criteria. This study aims to examine the extent and nature of existing evidence on the application of GBTM for medication adherence assessment, providing an overview of the different GBTM techniques used in the literature. The methodological framework will consist of five stages: i) identify the research question(s); ii) identify relevant studies; iii) select studies; iv) chart the data and finally, v) collate, summarise and report the results. Original peer-reviewed articles, published in English, describing observational studies including both concepts and/or sub-concepts of GBTM and medication adherence or any other similar terms, will be included. The following databases will be queried: PubMed/MEDLINE; Embase (Ovid); SCOPUS; ISI Web of Science and PsychInfo. This scoping review will utilise the PRISMA extension for Scoping Reviews (PRISMA-ScR) tool to report results. This scoping review will collect and schematise different techniques in the application of GBTM for medication adherence assessment available in the literature to date, identifying research and knowledge gaps in this area. This review can represent an important tool for future research, providing methodological support to researchers carrying out a group-based trajectory analysis to assess medication adherence in a real-world context.

scholarly journals Study on Pre-Exposure Prophylaxis Regimens among Men Who Have Sex with Men: A Prospective Cohort Study

2019 ◽  
Vol 16 (24) ◽  
pp. 4996
Author(s):  
Dan Wu ◽  
Hao Tao ◽  
Jianghong Dai ◽  
Hao Liang ◽  
Ailong Huang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Clinical Intervention ◽  
Western China ◽  
Adherence Rate ◽  
Systematic Sampling ◽  
Serum Concentrations ◽  
Medication Regimen ◽  
Event Driven ◽  
Sex With Men ◽  
Exposure Prophylaxis

Background: There are limited studies on the medication regimen of pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) in China. This study compared the effectiveness of and adherence to two prophylactic HIV medication regimens, which provided evidence and guidance for the application and promotion of the PrEP strategy in the MSM population in China. Methods: We conducted an open, non-randomized, multicenter, parallel, controlled clinical intervention study in western China. Subjects were recruited by convenience sampling at research centers in Chongqing, Guangxi, Xinjiang and Sichuan, China from April 2013 to March 2015, and they were categorized into the daily PrEP, event-driven and blank control groups. Tenofovir disoproxil fumarate (TDF; 300 mg/dose) was administered to subjects in the daily PrEP and event-driven groups, and all subjects were followed up every 12 weeks for 96 weeks. Demographic, behavioral, psychological characteristics and AIDS-related attitudes were assessed using self-completed questionnaires. TDF serum concentrations in subjects in Chongqing and Sichuan were quantified after systematic sampling. Results: Of the 2422 enrolled MSM, 856 were eligible for statistical analysis (PrEP group: 385 and event-driven group: 471); 30 and 32 subjects in daily PrEP and event-driven groups, respectively, were HIV-positive; the incidence of HIV infection was as follows: daily PrEP group, 6.60 cases/100 person-years and event-driven group, 5.57 cases/100 person-years (relative risk (RR) 95% confidence interval (CI) was 0.844 (0.492–1.449)); HIV incidence did not differ significantly when stratified by medication adherence or sites. When the medication adherence rate was ≥80%, the median TDF serum concentrations were 0.458 mg/L, and 0.429 mg/L in the daily PrEP, and event-driven groups, respectively (not significant; p > 0.05); Subjects who were in the event-driven PrEP group (OR = 2.152, 95% CI: 1.566–2.957), had fewer male sexual partners in the last two weeks (OR = 0.685, 95% CI: 0.563–0.834), were one year older on average (OR = 1.022, 95% CI: 1.002–1.043), considered that medication kept them safe, were less worried about others knowing they took medicine and were more likely to have high adherence. Conclusions: The efficacies of daily TDF and event-driven TDF use were not significantly different in preventing new infections among HIV-negative MSM. Event-driven TDF use is economical and effective and is worth popularizing. Our results provide evidence for the application and promotion of the PrEP strategy in the MSM population in China.

Sex partners as bystanders in HIV prevention trials: Two test cases for research ethics

2019 ◽  
Vol 16 (5) ◽  
pp. 455-457
Author(s):  
Till Bärnighausen
Keyword(s):  
Hiv Prevention ◽  
Research Ethics ◽  
Hiv Treatment ◽  
Treatment As Prevention ◽  
Test Cases ◽  
Sex Partners ◽  
Research Subjects ◽  
Prevention Trials ◽  
Hiv Treatment As Prevention ◽  
Exposure Prophylaxis

Research involving human subjects can impose risk on some ‘bystanders’– people who are not themselves research subjects but whom the study may affect. We examine the consequences of research for a particular category of bystanders – research subjects’ sex partners – in trials testing interventions to reduce (1) HIV transmission (HIV treatment-as-prevention trials) and (2) HIV acquisition (HIV pre-exposure prophylaxis trials). Both types of trials provide useful test cases for assessing whether bystanders to research deserve special consideration in ethics reviews, and potentially some of the benefits and protections that research subjects receive. In HIV treatment-as-prevention trials, there are two groups of people who are alike in many important respects but treated very differently by research ethics: research subjects who contribute data on the primary endpoint of the trial (because some of them have sex with the people receiving the treatment conditions of the trials) – and bystanders who are not enrolled in the trials but who could have contributed primary endpoint data in the same way as the first group. In pre-exposure trials, the sex partners of people participating in pre-exposure prophylaxis trials are bystanders, even though they are necessary for the success of the trial. Research subjects’ autonomy is fiercely protected by trial enrolment processes. Bystanders, by contrast, often have no choice but to be affected by the study, because of their relationship to a research subject. In HIV prevention trials, standing by can come with important risks, including the same ones on which the success of the research hinges. It is thus important to consider the ethical obligations to protect bystanders, and the related procedural responsibilities.

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