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Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the PRELUDE demonstration project.

ABSTRACT: BACKGROUND:In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of PRELUDE participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP. METHODS:PRELUDE is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based risk assessment tool which followed the New South Wales (NSW) PrEP guidelines. Selection was validated using an independent online behavioural survey, completed by study participants upon enrolment. Demographic information was analysed using descriptive statistics, and kappa tests were used to determine agreement between reporting of high-risk practices in the risk assessment and behavioural survey. RESULTS:During 2014-15, 471 individuals were targeted for enrolment; 341 were assessed for PrEP eligibility and 313 were enrolled. Of these, 303 (97%) identified as GBM. Overall, 85% of GBM met at least one high-risk criterion; 68% reported receptive intercourse with an HIV-positive or unknown status casual male partner, and 37% reported methamphetamine use in the three months preceding enrolment. The remaining 15% were enrolled based on medium-risk behaviours, or at the clinicians' discretion. We found an 82% total agreement between self-reported high-risk behaviour and clinicians' categorisation of GBM as being at high risk for HIV based on PrEP eligibility criteria. CONCLUSIONS:Behavioural eligibility criteria used by clinicians successfully identified individuals at high risk for HIV infection. This targeted approach ensures that the greatest public health and HIV prevention benefits can be derived in a setting without universal access to PrEP.

SUBMITTER: Vaccher SJ

PROVIDER: S-EPMC5614574 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the PRELUDE demonstration project.

Vaccher Stefanie J SJ Grulich Andrew E AE Haire Bridget G BG Conway Damian P DP Poynten Isobel M IM Ooi Catriona C Foster Rosalind R Templeton David J DJ Zablotska Iryna B IB

PloS one 20170926 9

<h4>Background</h4>In Australia, pre-exposure prophylaxis (PrEP) is targeted to individuals at high risk for HIV infection. We describe the HIV risk profile and characteristics of PRELUDE participants, and evaluate the population validity of the sample in representing high-risk gay and bisexual men (GBM) eligible for PrEP.<h4>Methods</h4>PRELUDE is an on-going, open-label, single-arm observational study. Participants were identified in clinics and screened for eligibility using a paper-based ris ...[more]

PMID: 28950022

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Project description:Introduction:The effectiveness of daily pre-exposure prophylaxis (PrEP) is well established. However, there has been increasing interest in non-daily dosing schedules among gay and bisexual men (GBM). This paper explores preferences for PrEP dosing schedules among GBM at baseline in the PRELUDE demonstration project. Materials and methods:Individuals at high-risk of HIV were enrolled in a free PrEP demonstration project in New South Wales, Australia, between November 2014 and April 2016. At baseline, they completed an online survey containing detailed behavioural, demographic, and attitudinal questions, including their ideal way to take PrEP: daily (one pill taken every day), event-driven (pills taken only around specific risk events), or periodic (daily dosing during periods of increased risk). Results:Overall, 315 GBM (98% of study sample) provided a preferred PrEP dosing schedule at baseline. One-third of GBM expressed a preference for non-daily PrEP dosing: 20% for event-driven PrEP, and 14% for periodic PrEP. Individuals with a trade/vocational qualification were more likely to prefer periodic to daily PrEP [adjusted odds ratio (aOR)?=?4.58, 95% confidence intervals (95% CI): (1.68, 12.49)], compared to individuals whose highest level of education was high school. Having an HIV-positive main regular partner was associated with strong preference for daily, compared to event-driven PrEP [aOR?=?0.20, 95% CI: (0.04, 0.87)]. Participants who rated themselves better at taking medications were more likely to prefer daily over periodic PrEP [aOR?=?0.39, 95% CI: (0.20, 0.76)]. Discussion:Individuals' preferences for PrEP schedules are associated with demographic and behavioural factors that may impact on their ability to access health services and information about PrEP and patterns of HIV risk. At the time of data collection, there were limited data available about the efficacy of non-daily PrEP schedules, and clinicians only recommended daily PrEP to study participants. Further research investigating how behaviours and PrEP preferences change correspondingly over time is needed. Trial registration:ClinicalTrials.gov NCT02206555. Registered 28 July 2014.

Project description:BackgroundOperational research is required to design delivery of pre-exposure prophylaxis (PrEP) and early antiretroviral treatment (ART). This paper presents the primary analysis of programmatic data, as well as demographic, behavioural, and clinical data, from the TAPS Demonstration Project, which offered both interventions to female sex workers (FSWs) at 2 urban clinic sites in South Africa.Methods and findingsThe TAPS study was conducted between 30 March 2015 and 30 June 2017, with the enrolment period ending on 31 July 2016. TAPS was a prospective observational cohort study with 2 groups receiving interventions delivered in existing service settings: (1) PrEP as part of combination prevention for HIV-negative FSWs and (2) early ART for HIV-positive FSWs. The main outcome was programme retention at 12 months of follow-up. Of the 947 FSWs initially seen in clinic, 692 were HIV tested. HIV prevalence was 49%. Among those returning to clinic after HIV testing and clinical screening, 93% of the women who were HIV-negative were confirmed as clinically eligible for PrEP (n = 224/241), and 41% (n = 110/270) of the women who were HIV-positive had CD4 counts within National Department of Health ART initiation guidelines at assessment. Of the remaining women who were HIV-positive, 93% were eligible for early ART (n = 148/160). From those eligible, 98% (n = 219/224) and 94% (n = 139/148) took up PrEP and early ART, respectively. At baseline, a substantial fraction of women had a steady partner, worked in brothels, and were born in Zimbabwe. Of those enrolled, 22% on PrEP (n = 49/219) and 60% on early ART (n = 83/139) were seen at 12 months; we observed high rates of loss to follow-up: 71% (n = 156/219) and 30% (n = 42/139) in the PrEP and early ART groups, respectively. Little change over time was reported in consistent condom use or the number of sexual partners in the last 7 days, with high levels of consistent condom use with clients and low use with steady partners in both study groups. There were no seroconversions on PrEP and 7 virological failures on early ART among women remaining in the study. Reported adherence to PrEP varied over time between 70% and 85%, whereas over 90% of participants reported taking pills daily while on early ART. Data on provider-side costs were also collected and analysed. The total cost of service delivery was approximately US$126 for PrEP and US$406 for early ART per person-year. The main limitations of this study include the lack of a control group, which was not included due to ethical considerations; clinical study requirements imposed when PrEP was not approved through the regulatory system, which could have affected uptake; and the timing of the implementation of a national sex worker HIV programme, which could have also affected uptake and retention.ConclusionsPrEP and early ART services can be implemented within FSW routine services in high prevalence, urban settings. We observed good uptake for both PrEP and early ART; however, retention rates for PrEP were low. Retention rates for early ART were similar to retention rates for the current standard of care. While the cost of the interventions was higher than previously published, there is potential for cost reduction at scale. The TAPS Demonstration Project results provided the basis for the first government PrEP and early ART guidelines and the rollout of the national sex worker HIV programme in South Africa.

Project description:IntroductionSince many countries in sub-Saharan Africa are willing to implement HIV oral pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM), data are needed to assess its feasibility and relevance in real life. The study objectives were to assess drug uptake, adherence, condom use and number of sexual partners, HIV incidence and trends in the prevalence of gonorrhoea and chlamydia.MethodsIn this oral PrEP demonstration study conducted prospectively in Benin, a combination of tenofovir disoproxil fumarate-TDF 300 mg and emtricitabine-FTC 200 mg (TDF-FTC) was offered daily or on-demand to MSM. Participants were recruited from 24 August to 24 November 2020 and followed over 12 months. At enrolment, month-6 and month-12, participants answered to a face-to-face questionnaire, underwent a physical examination and provided blood samples for HIV, gonorrhoea and chlamydia.ResultsOverall, 204 HIV-negative men initiated PrEP. The majority of them (80%) started with daily PrEP. Retention rates at month-3, 6, 9 and 12 were 96%, 88%, 86% and 85%, respectively. At month-6 and month-12, respectively, 49% and 51% of the men on daily PrEP achieved perfect adherence (self-reported), that is seven pills taken during the last week. For event-driven PrEP, the corresponding proportions for perfect adherence (last seven at-risk sexual episodes covered) were 81% and 80%, respectively. The mean number (standard deviation) of male sexual partners over the last 6 months was 2.1 (1.70) at baseline and 1.5 (1.27) at month-12 (p-value for trend <0.001). Consistent condom use during the last 6 months was 34% (enrolment), 37% (month-6) and 36% (month-12). Three HIV seroconversions (2-daily and 1-event-driven) were recorded. Crude HIV incidence (95% confidence interval) was 1.53 (0.31-4.50)/100 person-years. Neisseria gonorrhoeae and/or Chlamydia trachomatis prevalence at the anal and/or pharyngeal and/or urethral sites was 28% at baseline and 18% at month-12 (p-value = 0.017).ConclusionsIn West Africa, oral PrEP introduction in routine practice as a component of a holistic HIV prevention package is feasible and may not result in a significant increase in condomless sex among MSM. Since HIV incidence was still higher, additional interventions, such as culturally tailored adherence counselling, may be needed to optimize the benefits of PrEP.

Dataset Information

Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the PRELUDE demonstration project.

Publications

Validation of participant eligibility for pre-exposure prophylaxis: Baseline data from the PRELUDE demonstration project.

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