Dataset Information

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

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.

SUBMITTER: Hillis A

PROVIDER: S-EPMC7502438 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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

Hillis Alyson A Germain Jennifer J Hope Vivian V McVeigh James J Van Hout Marie Claire MC

AIDS and behavior 20201101 11

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 intern ...[more]

PMID: 32274670

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Project description:BACKGROUND:Pre-exposure prophylaxis (PrEP) is a promising and effective tool to prevent HIV. With the approval of Truvada as daily PrEP by the European Commission in August 2016, individual European Member states prepare themselves for PrEP implementation following the examples of France and Norway. However, context-specific data to guide optimal implementation is currently lacking. OBJECTIVE:With this demonstration project we evaluate whether daily and event-driven PrEP, provided within a comprehensive prevention package, is a feasible and acceptable additional prevention tool for men who have sex with men (MSM) at high risk of acquiring HIV in Belgium. The study's primary objective is to document the uptake, acceptability, and adherence to both daily and event-driven PrEP, while several secondary objectives have been formulated including impact of PrEP use on sexual behavior. METHODS:The Be-PrEP-ared study is a phase 3, single-site, open-label prospective cohort study with a large social science component embedded in the trial. A total of 200 participants choose between daily or event-driven PrEP use and may switch, discontinue, or restart their regimen at the 3-monthly visits for a duration of 18 months. Data are collected on several platforms: an electronic case report form, a Web-based tool where participants register their sexual behavior and pill use, a more detailed electronic self-administered questionnaire completed during study visits on a tablet computer, and in-depth interviews among a selected sample of participants. To answer the primary objective, the recruitment rate, (un)safe sex behavior during the last 6 months, percentage of reported intention to use PrEP in the future, retention rates in different regimens, and attitudes towards PrEP use will be analyzed. Adherence will be monitored using self-reported adherence, pill count, tenofovir drug levels in blood samples, and the perceived skills to adhere. RESULTS:All participants are currently enrolled, and the last study visit is planned to take place around Q3 2018. CONCLUSIONS:As PrEP is not yet available in Belgium for use, this study will provide insights into how to optimally implement PrEP within the current health care provision and will shape national and European guidelines with regard to the place of PrEP in HIV prevention strategies. CLINICALTRIAL:EU Clinical Trial 2015-000054-37; https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-000054-37/BE (Archived by WebCite at http://www.webcitation.org/6nacjSdmM).

Project description:BackgroundOptimising HIV pre-exposure prophylaxis (PrEP) provision requires insight into preferences of PrEP regimens and PrEP discontinuation. We assessed regimen switching and discontinuation and their determinants among men who have sex with men (MSM) participating in the Amsterdam PrEP demonstration project.MethodsBetween 3-August-2015 and 31-May-2016, we enrolled MSM (n = 374) and TGP (n = 2) in a prospective, longitudinal study. Participants could choose between daily or event-driven PrEP regimens at enrolment and every 3 months. We assessed transition intensities (TI) and determinants of switching (i) between regimens, and (ii) from either regimen to discontinuing PrEP using a multi-state Markov model. PrEP discontinuation was defined as formally stopping study participation or having no study visit for ≥6 months.FindingsOf 367 analysed participants, 73·3% chose daily and 26·7% event-driven PrEP at enrolment. Median follow-up was 3·1 years (IQR 2·9-3·2). 121 participants switched their PrEP regimen at least once (cumulative probability 34·2%, 95% CI 29·4-39·6), with 90 switches from event-driven to daily PrEP (TI 0·35/PY, 95% CI 0·29-0·44) and 113 switches from daily to event-driven PrEP (TI 0·16/PY, 95% CI 0·13-0·20). Switching from event-driven to daily PrEP was associated with younger age, not reporting sex with HIV-positive partners, chemsex, and sexual compulsivity. Switching from daily to event-driven PrEP were associated with younger age and lower sexual satisfaction. 67 participants discontinued PrEP (cumulative probability 17·7%, 95% CI 14·1-22·2), with no difference between regimens: event-driven (n = 23, TI 0·08/PY, 95% CI 0·05-0·13) and daily PrEP (n = 44, TI 0·06/PY, 95% CI 0·04-0·08). Discontinuing daily PrEP was associated with younger age, fewer casual partners, and higher number of condomless anal sex acts with casual partners.InterpretationSwitching between PrEP regimens was common, while going from event-driven to daily PrEP use was associated with certain sexual-related determinants (i.e. chemsex, sexual compulsivity, no known HIV-positive partners). PrEP discontinuation rates were low and independent of regimens. PrEP care should consider the reasons for choice and switch of regimen and involve education on safely switching or discontinuing PrEP, especially among younger MSM.FundingZonMw, H-TEAM, RIVM, GGD research funds, Aidsfonds, Amsterdam Diner Foundation, Gilead Sciences, Gilead Sciences Europe Ltd, Janssen Pharmaceuticals, MAC AIDS Fund, ViiV Healthcare.

Project description:Trials to assess microbicide safety require strict adherence to prescribed regimens. If adherence is suboptimal, safety cannot be adequately assessed. MTN-017 was a phase 2, randomized sequence, open-label, expanded safety and acceptability crossover study comparing 1) daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), 2) daily use of reduced-glycerin 1% tenofovir (RG-TFV) gel applied rectally, and 3) RG-TFV gel applied before and after receptive anal intercourse (RAI)-if participants had no RAI in a week, they were asked to use two doses of gel within 24 hours. Product use was assessed by mixed methods including unused product return count, text messaging reports, and qualitative plasma TFV pharmacokinetic (PK) results. Convergence interviews engaged participants in determining the most accurate number of doses used based on product count and text messaging reports. Client-centered adherence counseling was also used. Participants (N = 187) were men who have sex with men and transgender women enrolled in the United States (42%), Thailand (29%), Peru (19%) and South Africa (10%). Mean age was 31.4 years (range 18-64 years). Based on convergence interviews, over an 8-week period, 94% of participants had ?80% adherence to daily tablet, 41% having perfect adherence; 83% had ?80% adherence to daily gel, 29% having perfect adherence; and 93% had ?80% adherence to twice-weekly use during the RAI-associated gel regimen, 75% having perfect adherence and 77% having ?80% adherence to gel use before and after RAI. Only 4.4% of all daily product PK results were undetectable and unexpected (TFV concentrations <0.31 ng/mL) given self-reported product use near sampling date. The mixed methods adherence measurement indicated high adherence to product use in all three regimens. Adherence to RAI-associated rectal gel use was as high as adherence to daily oral PrEP. A rectal microbicide gel, if efficacious, could be an alternative for individuals uninterested in daily oral PrEP.

Project description:BACKGROUND:Strengthening HIV prevention is imperative given the continued high HIV incidence worldwide. The introduction of oral PrEP as a new biomedical HIV prevention tool can be a potential game changer because of its high clinical efficacy and the feasibility of its provision to different key populations. Documenting the existing experience with PrEP service delivery in a variety of real-world settings will inform how its uptake and usage can be maximised. METHODS:We conducted a scoping review using the five-step framework provided by Arksey and O'Malley. We systematically searched the existing peer-reviewed international and grey literature describing the implementation of real-world PrEP service delivery models reporting on four key components: the target population of PrEP services, the setting where PrEP was delivered, PrEP providers' professionalisation and PrEP delivery channels. We restricted our search to English language articles. No geographical or time restrictions were set. RESULTS:This review included 33 articles for charting and analysing of the results. The identified service delivery models showed that PrEP services mainly targeted people at high risk of HIV acquisition, with some models targeting specific key populations, mainly men who have sex with men. PrEP was often delivered centralised and in a clinical or hospital setting. Yet also community-based as well as home-based PrEP delivery models were reported. Providers of PrEP were mainly clinically trained health professionals, but in some rare cases community workers and lay providers also delivered PrEP. In general, in-person visits were used to deliver PrEP. More innovative digital options using mHealth and telemedicine approaches to deliver specific parts of PrEP services are currently being applied in a minority of the service delivery models in mainly high-resource settings. CONCLUSIONS:A range of possible combinations was found between all four components of PrEP service delivery models. This reflects differentiation of care according to different contextual settings. More research is needed on how integration of services in these contexts could be expanded and optimised to respond to key populations with unmet HIV prevention needs in different settings.

Dataset Information

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

Publications

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

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