ABSTRACT
BACKGROUND: Daily and event-driven HIV pre-exposure prophylaxis (PrEP) with oral tenofovir-emtricitabine is highly effective to prevent HIV in men who have sex with men (MSM). PrEP care generally consists of in-clinic monitoring every 3 months that includes PrEP dispensing, counseling, and screening for HIV and sexually transmitted infections (STIs). However, the optimal frequency for monitoring remains undetermined. Attending a clinic every 3 months for monitoring may be a barrier for PrEP. Online-mediated PrEP care and reduced frequency of monitoring may lower this barrier. OBJECTIVE: The primary objective of this study is to establish the noninferiority of online PrEP care (vs in-clinic care) and monitoring every 6 months (vs every 3 months). The secondary objectives are to (1) examine differences between PrEP care modalities regarding incidences of STIs, HIV infection, and hepatitis C virus infection; retention in PrEP care; intracellular tenofovir-diphosphate concentration; and satisfaction, usability, and acceptability of PrEP care modalities; and (2) evaluate associations of these study outcomes with sociodemographic, behavioral, and psychological characteristics. METHODS: This study is a 2×2 factorial, 4-arm, open-label, multi-center, randomized, controlled, noninferiority trial. The 4 arms are (1) in-clinic monitoring every 3 months, (2) in-clinic monitoring every 6 months, (3) online monitoring every 3 months, and (4) online monitoring every 6 months. The primary outcome is a condomless anal sex act with a casual partner not covered or insufficiently covered by PrEP (ie, "unprotected act") as a proxy for HIV infection risk. Eligible individuals are MSM, and transgender and gender diverse people aged ≥18 years who are eligible for PrEP care at 1 of 4 participating sexual health centers in the Netherlands. The required sample size is 442 participants, and the planned observation time is 24 months. All study participants will receive access to a smartphone app, which contains a diary. Participants are requested to complete the diary on a daily basis during the first 18 months of participation. Participants will complete questionnaires at baseline and 6, 12, 18, and 24 months. Dried blood spots will be collected at 6 and 12 months for assessment of intracellular tenofovir-diphosphate concentration. Incidence rates of unprotected acts will be compared between the online and in-clinic arms, and between the 6-month and 3-month arms. Noninferiority will be concluded if the upper limit of the 2-sided 97.5% CI of the incidence rate ratio is <1.8. RESULTS: The results of the main analysis are expected in 2024. CONCLUSIONS: This trial will demonstrate whether online PrEP care and monitoring every 6 months is noninferior to standard PrEP care in terms of PrEP adherence. If noninferiority is established, these modalities may lower barriers for initiating and continuing PrEP use and potentially reduce the systemic burden for PrEP providers. TRIAL REGISTRATION: ClinicalTrials.gov NCT05093036; https://tinyurl.com/28b8ndvj. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/51023.
ABSTRACT
PrEP uptake in the Netherlands is growing but remains at suboptimal levels. Hence, the analysis of hurdles is paramount. Given the initial focus of PrEP provision among men-who-have-sex-with-men (MSM) via a demonstration project that was launched in June 2015, AmPrEP in Amsterdam, and pharmacies in the main urban areas (so called "Randstad", entailing Amsterdam, Utrecht, Leiden, The Hague and Rotterdam), investigating regional differences is necessary. This study seeks to unravel regional differences jointly with the psycho-social determinants of PrEP uptake. This cross-sectional study included 3232 HIV-negative MSM recruited via the Dutch subsample of the European-MSM-Internet-Survey in late 2017 (EMIS-2017), which aimed to inform interventions for MSM who are highly affected by infections with HIV and other sexually transmitted infections. Prevalence and the standardised prevalence ratio (SPR) of PrEP awareness, intention and uptake were measured on a regional level (Randstad vs. the rest of the country). Multi-level logistic modelling was conducted to identify the association of PrEP uptake with PrEP awareness and intention, socio-demographic, psycho-social determinants and random effects from regional differences. MSM from the Randstad used more PrEP (SPR = 1.4 vs. 0.7) compared to the rest of the country, but there were minor differences for awareness and intention. The regional distinction was estimated to explain 4.6% of the PrEP use variance. We observed a greater influence from PrEP intention (aOR = 4.5, 95% CI 2.0-10.1), while there was limited influence from the awareness of PrEP (aOR = 0.4, 95% CI 0.04-4.4). Lower education (aOR = 0.4, 95% CI 0.2-0.9) was negatively associated with PrEP uptake; however, no significant difference was found between middle (aOR = 1.2, 95% CI 0.7-2.0) and high education. We showed that regional differences-MSM in non-urban regions-and other psycho-social determinants account for lower PrEP uptake. Based on these findings, more fine-tuned PrEP access with a focus on non-urban regions can be implemented, and tailored campaigns increasing intention/use can be conducted among target populations.
Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Cross-Sectional Studies , HIV Infections/epidemiology , HIV Infections/prevention & control , Homosexuality, Male , Humans , Intention , Male , Netherlands , Spatial AnalysisABSTRACT
The Lifestyle Monitor (LSM) was launched in 2013 on behalf of the Ministry of Health, Welfare and Sports to reorganize the multiple data collections in the field of lifestyle and health in the Netherlands. The reorganization should enhance the efficiency and coherence of the lifestyle and health data collections and should provide unambiguous figures for policymakers. This article describes the background and content (including the lifestyle-themes) of the LSM and the tasks and roles of the collaborating parties involved. The measurement methods used and requirements for data requests are described as well. Finally, some examples of figures and trends over the period 2014-2020 to underpin the health policy are described.
ABSTRACT
BACKGROUND: Of newly diagnosed HIV positive men who have sex with men (MSM) in the Netherlands, 29% have a non-Western migration background (MSM-NW). Among MSM-NW, HIV positivity rates are high (0.8%-2.0%), as is the proportion of late stage infections (39%). Factors such as HIV and sexual orientation-related stigma may form barriers for timely testing. Innovative approaches for HIV testing are needed to better reach MSM-NW. Social network testing (SNT) for HIV is an evidence-supported approach where peer recruiters identify persons (network associates) who could benefit from testing in their social or sexual networks. Web-supported SNT might be particularly promising for reaching people who may not be reached by regular care. OBJECTIVE: The purpose of this paper is to describe the design of our pilot PREVENT (Peer-Empowered Voluntary Extended Network Testing). In this pilot, we will explore whether SNT using HIV self-tests is feasible and acceptable among MSM-NW in the Netherlands and whether it reaches those who were never or not recently tested for HIV (>1 year ago). METHODS: The project aims to include 50 to 60 MSM and MSM-NW peers who will distribute 4 to 5 oral HIV self-tests each aiming to reach 200 network associates (NAs). Enrollment of peers includes 4 steps: (1) fostering interest in becoming a peer by health care professionals at sexual health clinics, HIV treatment clinics, and community settings; (2) sending peer contact information to the peer coordinator; (3) registering peers and giving program instructions by the peer coordinator and referring to the Web-based training at time2test; and (4) receiving precoded HIV self-tests for distribution in the peers' networks. NAs who receive the self-test will log in with their test package code in the time2test application for step-by-step test instructions. After testing is complete, NAs receive tailored follow-up information depending on their test result. RESULTS: Between January and May 2019, 10 STI clinics and 7 HIV treatment clinics started recruiting peers. Results of the PREVENT pilot are expected in December 2020. CONCLUSIONS: This is the first Web-supported peer-driven SNT pilot using HIV self-tests in the Netherlands and one of the first in Europe. Implementation is considered successful if it reaches MSM-NW who were never or not recently tested for HIV. Additionally, it may encourage conversations within the networks about risk behavior and barriers to HIV testing, potentially contributing to the Joint United Nations Programme on HIV/AIDS goal of zero HIV infections. TRIAL REGISTRATION: Netherlands Trial Registry NL7424; https://www.trialregister.nl/trial/7424. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/14743.
