scholarly journals The Time is Now for Disruptive Innovation in Pre-Exposure Prophylaxis Adherence Monitoring

2020 ◽  
Vol 7 (1) ◽  
pp. 5-9
Author(s):  
Giffin Daughtridge ◽  
◽  
Elijah Kahn-Woods ◽  
Casper Enghuus ◽  
Shane Hebel ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Disruptive Innovation ◽  
Self Report ◽  
Monitoring Methods ◽  
Adherence Support ◽  
Immunodeficiency Virus ◽  
The Us ◽  
Hiv Acquisition ◽  
Adherence Monitoring ◽  
Exposure Prophylaxis

Monitoring adherence to pre-exposure prophylaxis is a critical component of reaching ending the human immunodeficiency virus infection (HIV) epidemic goals in the US. Currently, providers still depend on “self-report” pre-exposure prophylaxis (PrEP) adherence, whereby providers ask their patients about their recent pill taking habits. There appears to be growing consensus across the HIV prevention community that “self-report” is an inadequate method of identifying that is in-need of additional adherence support services. In a recent survey, 97% of providers report utilizing self-reported adherence because it is convenient, but only 10% of these providers believe it is accurate. While “self-report” is convenient, evidence and testimonials from diverse stakeholders across the HIV prevention landscape indicate that there is a desire for more accurate, effective adherence monitoring methods. In this mini-review, we will briefly synthesize the emerging evidence and propose a solution to ensure all patients receive the support needed to protect them from HIV acquisition.

scholarly journals Video chat technology to remotely quantify dietary, supplement and medication adherence in clinical trials

2016 ◽  
Vol 116 (9) ◽  
pp. 1646-1655 ◽  
Author(s):  
Courtney M. Peterson ◽  
John W. Apolzan ◽  
Courtney Wright ◽  
Corby K. Martin
Keyword(s):  
Medication Adherence ◽  
Online Survey ◽  
Self Report ◽  
Rater Agreement ◽  
Monitoring Methods ◽  
Video Chat ◽  
Pill Counts ◽  
Survey Results ◽  
Adherence Monitoring ◽  
Study Participants

AbstractWe conducted two studies to test the validity, reliability, feasibility and acceptability of using video chat technology to quantify dietary and pill-taking (i.e. supplement and medication) adherence. In study 1, we investigated whether video chat technology can accurately quantify adherence to dietary and pill-taking interventions. Mock study participants ate food items and swallowed pills, while performing randomised scripted ‘cheating’ behaviours to mimic non-adherence. Monitoring was conducted in a cross-over design, with two monitors watching in-person and two watching remotely by Skype on a smartphone. For study 2, a twenty-two-item online survey was sent to a listserv with more than 20 000 unique email addresses of past and present study participants to assess the feasibility and acceptability of the technology. For the dietary adherence tests, monitors detected 86 % of non-adherent events (sensitivity) in-person v. 78 % of events via video chat monitoring (P=0·12), with comparable inter-rater agreement (0·88 v. 0·85; P=0·62). However, for pill-taking, non-adherence trended towards being more easily detected in-person than by video chat (77 v. 60 %; P=0·08), with non-significantly higher inter-rater agreement (0·85 v. 0·69; P=0·21). Survey results from study 2 (n 1076 respondents; ≥5 % response rate) indicated that 86·4 % of study participants had video chatting hardware, 73·3 % were comfortable using the technology and 79·8 % were willing to use it for clinical research. Given the capability of video chat technology to reduce participant burden and outperform other adherence monitoring methods such as dietary self-report and pill counts, video chatting is a novel and promising platform to quantify dietary and pill-taking adherence.

scholarly journals United States Ending the Human Immunodeficiency Virus (HIV) Epidemic plan: evaluation of the role of industry funding in published pre-exposure prophylaxis (PrEP) literature

2021 ◽  
Author(s):  
Somya Gupta ◽  
Reuben Granich
Keyword(s):  
Industry Funding ◽  
Potential Conflict ◽  
Immunodeficiency Virus ◽  
The Us ◽  
Frequent Testing ◽  
Potential Impact ◽  
Corporate Support ◽  
Exposure Prophylaxis ◽  
The Impact

Pre-exposure prophylaxis (PrEP) is integral to the US End of AIDS strategy. However, low adherence, high costs, frequent testing and monitoring side effects make delivery of PrEP complicated. Gilead has sponsored PrEP-related research efforts and access as part of its marketing efforts. We review potential conflict of interests (COI) in the scientific literature for the US PrEP related articles to understand the impact of Gilead’s corporate sponsorship.We identified 93 US PrEP articles published in the top 10 medical journals and top 10 HIV/AIDS journals in 2018. There were 289 first three and senior authors in these articles, of which, 34 (11%) declared a Gilead COI and 28 (10%) had undeclared Gilead COI. Only 10 authors accounted for 50% of the articles, with 70% of them having potential COI including receiving grants, fees and study drugs. The 93 articles were associated with 51 leading institutions (institution of three or more authors or participating institutions in a trial). Authors from 12 (24%) institutions declared an institutional Gilead COI and 22 (45%) institutions had undeclared Gilead support. Overall, of the 93 included articles, 30 (32%) had declared Gilead COI. Combining declared and undeclared COIs for authors and institutions provided an overall 83 (89%) articles with a potential Gilead COI. Of the 93 articles, 60 (71%) had favorable conclusions in 60 (71%). Declared Gilead support was significantly associated with favorable article conclusions (p<.05) but combined declared/undeclared author and/or institutional Gilead support was not associated with favorable conclusion. Nearly 90% of US PrEP articles had Gilead support and authors failed to report individual or institutional COI in 70% of articles. Direct corporate support is important for scientific research. However, Gilead’s marketing push for PrEP, undeclared COI, and potential influence of Gilead supported authors are of concern given the potential impact on the scientific discourse and the US HIV control strategy.

scholarly journals Knowledge on HIV Prevention Measures Among Male Learners in Secondary Schools in Oshana Region, Namibia

2019 ◽  
Vol 11 (5) ◽  
pp. 10
Author(s):  
Peneyambeko Ipawa Shikulo ◽  
Louise Pretorius ◽  
Ndapeua Shifiona ◽  
Daniel Opotamutale Ashipala
Keyword(s):  
Hiv Prevention ◽  
Secondary Schools ◽  
Control Measures ◽  
Self Report ◽  
Ministry Of Education ◽  
Prevention Measures ◽  
Cross Sectional ◽  
Immunodeficiency Virus ◽  
Cross Sectional Design ◽  
And Control

Human Immunodeficiency virus (HIV) has continued to pose significant social, economic and developmental challenges worldwide.The purpose of the study was to assess the knowledge on HIV prevention among male learners in secondary schools in Oshana Region. The objectives of the study were to: assess and describe the knowledge of male learners in Secondary Schools in Oshana Region about HIV preventive measures. A quantitative, cross sectional design, based on the self-report of the participants, was utilized to achieve the aim of the study. Findings of this study showed that 95.4% had knowledge that HIV can be prevented by consistent and correct use of a condom during sexual intercourse. It has become evident that much still need to be done to make HIV prevention among youth more effective.It is hereby recommended that the Ministry of Education takes the lead to educate the learners on HIV preventive and control measures.

scholarly journals A Web-Based Study of HIV Prevention in the Era of Pre-Exposure Prophylaxis Among Vulnerable HIV-Negative Gay and Bisexual Men, Transmen, and Transwomen Who Have Sex With Men: Protocol for an Observational Cohort Study (Preprint)

2019 ◽  
Author(s):  
Denis Nash ◽  
Matthew Stief ◽  
Caitlin MacCrate ◽  
Chloe Mirzayi ◽  
Viraj V Patel ◽  
...  
Keyword(s):  
High Risk ◽  
Hiv Prevention ◽  
Hiv Testing ◽  
The United States ◽  
Racially Diverse ◽  
Web Based ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
Hiv Negative

BACKGROUND Gay, bisexual, and other men who have sex with men continue to bear a large burden of the HIV epidemic in the United States and are among the only populations with increasing incidence in recent years. OBJECTIVE The Together 5000 (T5K) Study aimed to enroll a US-based, racially diverse sample of HIV-negative men, transmen, and transwomen who are not on pre-exposure prophylaxis (PrEP) into an observational cohort to inform the design, implementation, scale-up, and evaluation of HIV prevention programs. METHODS We used internet-based strategies to enroll a large, racially diverse national sample of HIV-negative men, transmen, and transwomen aged 16 to 49 years at high risk of HIV acquisition via sexual networking apps. Study participants are contacted every 6 months (in between annual surveys) for a brief survey on HIV testing, HIV diagnosis, and PrEP use (ie, attempts to access, PrEP initiation, and PrEP discontinuation). Participants complete annual self-administered at-home HIV testing and Web-based surveys. Using baseline serologic data and self-reported HIV testing history, we reconstructed a cohort of persons who were HIV negative at 12 months before baseline to estimate HIV incidence leading up to cohort enrollment. RESULTS The study sample included 8777 participants from all 50 US states, Puerto Rico, and Guam; 50.91% (4468/8777) were persons of color and 25.30% (2221/8777) were young individuals aged 16 to 24 years. Per eligibility criteria, all T5K participants reported having sex with >2 male partners in the 90 days before enrollment, self-reported not having been diagnosed with HIV, and were not actively taking PrEP. In addition, 79.39% (6968/8777) reported >2 insertive condomless anal sex (CAS) acts, 61.02% (5356/8777) reported >1 receptive CAS acts in the past 90 days. Furthermore, most (7525/8777, 85.74%) reported never having taken PrEP. In total, 70.25% (6166/8777) were sent a self-administered at-home HIV test kit and 82.29% (5074/6166) of those sent a kit returned a sample for testing. The HIV incidence rate during the 12-month period leading up to enrollment was estimated to be 2.41 (95% CI 2.02-2.90) per 100 person-years. CONCLUSIONS A large, national, and racially diverse fully Web-based cohort of HIV-negative men, transmen, and transwomen at high risk for HIV seroconversion has successfully been recruited into longitudinal follow-up. This cohort is at high risk for HIV acquisition and can provide important insights related to the real-world uptake, impact, and equity of HIV prevention interventions in the United States. Participants can be invited to participate in trials aimed at testing strategies to improve the uptake of and engagement in these interventions. INTERNATIONAL REGISTERED REPORT RR1-10.2196/13715

Evaluation of the impact of human immunodeficiency virus pre-exposure prophylaxis on new human immunodeficiency virus diagnoses during the COVID-19 pandemic

2021 ◽  
pp. 095646242110545
Author(s):  
A Keane ◽  
SO Regan ◽  
L Quinn ◽  
D Murphy ◽  
BO Kelly ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Sexual Practices ◽  
First Year ◽  
Hiv Diagnosis ◽  
Eligibility Criteria ◽  
Global Pandemic ◽  
Immunodeficiency Virus ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis ◽  
The Impact

Aims The national PrEP programme launched in Ireland in November 2019 with tenofovir/emtricitabine free to those meeting eligibility criteria. We assessed the impact of the first year of the PrEP programme on new HIV diagnoses in the largest sexual health and HIV service in Ireland. Methods A free PrEP service was established in November 2019. We reviewed the number of new diagnoses of HIV between November 2018–2019, before the introduction of the national PrEP programme and compared this with the number of new HIV diagnosis between November 2019–2020. Results There were 95 new HIV diagnoses (63.3% MSM) between November 2018 and 2019 and 73 new HIV diagnoses (65.7% MSM) between November 2019 and 2020. There was a statistically significant decline in new HIV diagnoses between the 2 years ( P = 0.0003). 546 patients were prescribed PrEP as of December 2020.106 patients (19.4%) changed their PrEP dosing regimen due to lockdown. 178 individuals (32.6%) had a rectal infection diagnosed. Conclusion There has been a reduction in new HIV diagnoses in our cohort (although this has occurred during a global pandemic). It is too early to say if PrEP reduces late presentations of HIV based on our findings. A significant number of rectal infections were identified in the PrEP clinic suggesting ongoing risk despite pandemic restrictions. Further research into sexual practices during COVID-19 is needed to assess if this had an impact on the lower rates of HIV acquisition.

scholarly journals Protocol Development for HMU! (HIV Prevention for Methamphetamine Users), a Study of Peer Navigation and Text Messaging to Promote Pre-Exposure Prophylaxis Adherence and Persistence Among People Who Use Methamphetamine: Qualitative Focus Group and Interview Study (Preprint)

2020 ◽  
Author(s):  
Vanessa M McMahan ◽  
Noah Frank ◽  
Smitty Buckler ◽  
Lauren R Violette ◽  
Jared M Baeten ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Focus Groups ◽  
Text Messaging ◽  
Text Messages ◽  
Transgender People ◽  
Protocol Development ◽  
Sex With Men ◽  
Peer Navigation ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis

BACKGROUND Cisgender men who have sex with men (MSM) and transgender people (TGP) who use methamphetamine are disproportionately impacted by HIV acquisition. Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV, and interventions that support PrEP persistence and adherence should be evaluated among MSM and TGP who use methamphetamine. OBJECTIVE We conducted formative work to inform the development of text messaging and peer navigation interventions to support PrEP persistence and adherence among MSM and TGP who use methamphetamine. In this paper, we describe how the findings from these focus groups and interviews were used to refine the study interventions and protocol for the Hit Me Up! study (HMU!; HIV Prevention in Methamphetamine Users). METHODS Between October 2017 and March 2018, we conducted two focus groups and three in-depth interviews with MSM and TGP who use methamphetamine or who have worked with people who use methamphetamine. During these formative activities, we asked participants about their opinions on the proposed interventions, education and recruitment materials, and study design. We focused on how we could develop peer navigation and text messaging interventions that would be culturally appropriate and acceptable to MSM and TGP who use methamphetamine. Transcripts were reviewed by two authors who performed a retrospective content analysis to describe which specific opinions and recommendations influenced protocol development and the refinement of the interventions. RESULTS Overall, participants thought that MSM and TGP would be interested in participating in the study, although they expected recruitment and retention to be challenging. Participants thought that the peer navigator should be someone who is nonjudgmental, has experience with people who use methamphetamine, and is patient and flexible. There was consensus that three text messages per day were appropriate, adherence reminders should be straightforward, all messages should be nonjudgmental, and participants should be able to tailor the timing and content of the text messages. These suggestions were incorporated into the study interventions via the hiring and training process and into the development of the text library, platform selection, and customizability of messages. CONCLUSIONS It is important to include the opinions and insights of populations most impacted by HIV to develop PrEP interventions with the greatest chance of success. Our formative work generated several recommendations that were incorporated into the interventions and protocol development for our ongoing study. CLINICALTRIAL ClinicalTrials.gov NCT03584282; https://clinicaltrials.gov/ct2/show/NCT03584282

scholarly journals Pre-exposure Prophylaxis (PrEP) for HIV Prevention Among Men Who Have Sex with Men (MSM): A Scoping Review on PrEP Service Delivery and Programming

2020 ◽  
Vol 24 (11) ◽  
pp. 3056-3070
Author(s):  
Alyson Hillis ◽  
Jennifer Germain ◽  
Vivian Hope ◽  
James McVeigh ◽  
Marie Claire Van Hout
Keyword(s):  
Hiv Prevention ◽  
Service Delivery ◽  
Therapeutic Alliance ◽  
Scoping Review ◽  
Scale Up ◽  
Antiretroviral Drugs ◽  
Eligibility Criteria ◽  
Sex With Men ◽  
Hiv Acquisition ◽  
Exposure Prophylaxis

Abstract Pre-exposure prophylaxis (PrEP) is an evidence-based new biomedical HIV prevention intervention, which involves the pre-emptive use of daily (or event-based) antiretroviral drugs, to reduce risk of HIV acquisition if exposed. PrEP has recently been positioned as an integral prevention tool to reduce HIV acquisition risk among men who have sex with men (MSM) at country-level and within global prevention strategies. Given this global scale up of PrEP, we conducted a scoping review of extant international literature documenting service related perspectives, models and lessons learnt in PrEP programming for MSM. A systematic search of literature was conducted, and restricted to English language records in the timeframe 2008 to February 2019. Eligibility criteria centered on whether studies broadly described PrEP programming and service delivery for MSM as well as health communication. Following exclusion of ineligible records and removal of duplicates, 84 records were charted and thematically analysed according to scoping review methods. Four themes emerged from the thematic analysis of data; ‘PrEP service aspects, settings and staff’; ‘PrEP prescriber experiences, therapeutic alliance and care planning’; ‘PrEP adherence within formal service structures’; and ‘Multi-disciplinary and innovative PrEP care pathways’. The review highlights the complexities in providing optimal PrEP services for MSM by mapping and illustrating the importance of understanding the informal and formal routes to PrEP use among this HIV risk population; the barriers to uptake; the requirement for the presence of a positive therapeutic alliance between patient and prescriber in supporting patient initiation and adherence to PrEP regimes; and the need for availability in different culturally and ethnically sensitive models of PrEP service delivery according to low to high risk groups within the MSM communities.

scholarly journals Evidence of an Association of Increases in Pre-exposure Prophylaxis Coverage With Decreases in Human Immunodeficiency Virus Diagnosis Rates in the United States, 2012–2016

2020 ◽  
Author(s):  
Dawn K Smith ◽  
Patrick S Sullivan ◽  
Betsy Cadwell ◽  
Lance A Waller ◽  
Azfar Siddiqi ◽  
...  
Keyword(s):  
United States ◽  
Human Immunodeficiency Virus ◽  
Hiv Infections ◽  
The United States ◽  
Virus Diagnosis ◽  
Hiv Surveillance ◽  
Immunodeficiency Virus ◽  
The Us ◽  
Diagnosis Rate ◽  
Exposure Prophylaxis

Abstract Background Annual human immunodeficiency virus (HIV) diagnoses in the United States (US) have plateaued since 2013. We assessed whether there is an association between uptake of pre-exposure prophylaxis (PrEP) and decreases in HIV diagnoses. Methods We used 2012–2016 data from the US National HIV Surveillance System to estimate viral suppression (VS) and annual percentage change in diagnosis rate (EAPC) in 33 jurisdictions, and data from a national pharmacy database to estimate PrEP uptake. We used Poisson regression with random effects for state and year to estimate the association between PrEP coverage and EAPC: within jurisdictional quintiles grouped by changes in PrEP coverage, regressing EAPC on time; and among all jurisdictions, regressing EAPC on both time and jurisdictional changes in PrEP coverage with and without accounting for changes in VS. Results From 2012 to 2016, across the 10 states with the greatest increases in PrEP coverage, the EAPC decreased 4.0% (95% confidence interval [CI], −5.2% to −2.9%). On average, across the states and District of Columbia, EAPC for a given year decreased by 1.1% (95% CI, −1.77% to −.49%) for an increase in PrEP coverage of 1 per 100 persons with indications. When controlling for VS, the state-specific EAPC for a given year decreased by 1.3% (95% CI, −2.12% to −.57%) for an increase in PrEP coverage of 1 per 100 persons with indications. Conclusions We found statistically significant associations between jurisdictional increases in PrEP coverage and decreases in EAPC independent of changes in VS, which supports bringing PrEP use to scale in the US to accelerate reductions in HIV infections.

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