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Systematic review of HIV treatment adherence research among people who inject drugs in the United States and Canada: evidence to inform pre-exposure prophylaxis (PrEP) adherence interventions.

ABSTRACT: BACKGROUND:People who inject drugs (PWID) are at increased risk for HIV acquisition and could benefit from antiretroviral pre-exposure prophylaxis (PrEP). However, PrEP has been underutilized in this population, and PrEP adherence intervention needs are understudied. METHODS:To inform PrEP intervention development, we reviewed evidence on antiretroviral therapy (ART) adherence among HIV-infected PWID. Guided by a behavioral model of healthcare utilization and using the PICOS framework, we conducted a systematic review in four electronic databases to identify original research studies of ART adherence in HIV-infected PWID in the United States and Canada between Jan 1, 2006-Dec 31, 2016. We synthesized and interpreted findings related to developing recommendations for PrEP adherence interventions for PWID. RESULTS:After excluding 618 duplicates and screening 1049 unique records, we retained 20 studies of PWID (mean n?=?465) with adherence-related outcomes (via pharmacy records: n?=?9; self-report: n?=?8; biological markers: n?=?5; electronic monitoring: n?=?2). Predisposing factors (patient-level barriers to adherence) included younger age, female sex, and structural vulnerability (e.g., incarceration, homelessness). Enabling resources (i.e., facilitators) that could be leveraged or promoted by interventions included self-efficacy, substance use treatment, and high-quality patient-provider relationships. Competing needs that require specific intervention strategies or adaptations included markers of poor physical health, mental health comorbidities (e.g., depression), and engagement in transactional sex. CONCLUSIONS:HIV treatment adherence research carries important lessons for efforts to optimize PrEP adherence among PWID. Despite limitations, this systematic review suggests that strategies are needed to engage highly vulnerable and marginalized sub-groups of this underserved population (e.g., younger PWID, women who inject drugs) in PrEP adherence-related research and programming.

SUBMITTER: Bazzi AR

PROVIDER: S-EPMC6323713 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Project description:There are 34 million people living with human immunodeficiency virus (HIV) worldwide and each year this number increases. Until a vaccine is discovered, the prevention of new HIV infections remains an urgent priority. Several trials studying the use of oral and topical agents for the prevention of HIV infection have already been completed. Adherence has proved to be a major challenge in achieving product efficacy.To provide the clinical pharmacist with an understanding of the oral pre-exposure prophylaxis (PrEP) and topical microbicide product pipeline whilst emphasizing the critical importance of adherence to these drugs to avert HIV infection.PubMed/Medline and the web-based clinical trials registry (ClinTrials.gov) were searched using appropriate key words. For the time period 1992-2013--all phase II and phase III safety and effectiveness studies--testing agents for prevention of HIV infection were included in the review. Efficacy estimates, adherence estimates and reported challenges with adherence were extracted.Twenty-four phase II and III clinical trials were found during review. Of these, 20 trials have been completed, and six trials show effectiveness in preventing HIV infection. The majority of the successful trials were to oral PrEP and to date only one microbicide trial of a vaginal antiretroviral microbicide gel has showed effectiveness. Adherence to study product played a major role in trial outcomes and there are several reasons for non-adherence. These include high on-trial pregnancy rates, low trial retention rates, low participant perception of risk, participant characteristics such as age <25 years, single status, migratory partners and trial fatigue. Study product characteristics such as dosage form, dosing interval, as well as associated adverse events may also influence adherence.Moderate to high adherence is critical to demonstrate efficacy of drugs for HIV prevention. For topical agents, intermittent use associated with coitus is more effective than daily use, particularly if sex is infrequent or partners migrant. For oral agents, daily use is effective but the motivation to use the drug and high risk perception is important. In serodiscordant couples, early initiation of highly active antiretroviral therapy in the infected partner affords almost complete protection to the negative partner. Drugs need to be tailored to the population at risk and availability of multiple drug options are important.

Project description:IntroductionHIV pre-exposure prophylaxis (PrEP), in which people take HIV medication to prevent HIV acquisition, underpins global HIV transmission elimination strategies. Effective prevention needs people to adhere to PrEP and remain in care during periods of risk, but this is difficult to achieve. We undertook a process evaluation of Scotland's PrEP programme to explore barriers and facilitators to PrEP adherence and retention in care and to systematically develop evidence-based, theoretically-informed recommendations to address them.MethodsWe conducted semi-structured interviews and focus groups (09/2018-07/2019) with patients who identified as gay or bisexual men and were either using PrEP, had declined the offer of PrEP, had stopped PrEP, or had been assessed as ineligible for PrEP (n = 39 of whom n = 5 (13%) identified as trans, median age 31 years and interquartile range 14 years), healthcare professionals involved in PrEP provision (n = 54 including specialist sexual health doctors and nurses of various grades, PrEP prescribing general practitioners, health promotion officers, midwifes, and a PrEP clinical secretary), and clients (n = 9) and staff (n = 15) of non-governmental organisations with an HIV prevention remit across Scotland. We used thematic analysis to map key barriers and facilitators to priority areas that could enhance adherence and retention in care. We used implementation science analytic tools (Theoretical Domains Framework, Intervention Functions, Behaviour Change Technique Taxonomy, APEASE criteria) and expert opinion to systematically generate recommendations.ResultsBarriers included perceived complexity of on-demand dosing, tendency for users to stop PrEP before seeking professional support, troublesome side-effects, limited flexibility in the settings/timings/nature of review appointments, PrEP-related stigma and emerging stigmas around not using PrEP. Facilitators included flexible appointment scheduling, reminders, and processes to follow up non-attenders. Examples of the 25 recommendations include: emphasising benefits of PrEP reviews and providing appointments flexibly within individualised PrEP care; using clinic systems to remind/recall PrEP users; supporting PrEP conversations among sexual partners; clear on-demand dosing guidance; encouraging good PrEP citizenship; detailed discussion on managing side-effects and care/coping planning activities.ConclusionsPrEP adherence and retention in care is challenging, reducing the effectiveness of PrEP at individual and population levels. We identify and provide solutions to where and how collaborative interventions across public health, clinical, and community practice could address these challenges.

Project description:IntroductionHIV prevalence among criminal justice (CJ)-involved adults is five times higher than the general population. Following incarceration, CJ-involved individuals experience multilevel barriers to HIV prevention. Pre-exposure prophylaxis (PrEP) is a widely available, daily medication efficacious in preventing HIV. Little is known about PrEP knowledge, acceptability, initiation and sustained use among CJ-involved persons or about how these outcomes vary by multilevel factors. The Southern Pre-Exposure Prophylaxis Study (SPECS) will investigate barriers and facilitators for PrEP initiation and sustained use among CJ-involved adults, building a foundation for PrEP interventions for this underserved population.Methods and analysisSPECS uses a mixed-methods sequential design, including a multisite, prospective cohort study in three southern states-North Carolina, Florida and Kentucky-and subsequent qualitative interviews. HIV-negative adults clinically indicated for PrEP with CJ-involvement in the past year (n=660; 220 per site)-will be recruited for four quantitative interviews separated by 6 months, with 18 months of follow-up. Interviews will measure CJ involvement, substance use, sexual behaviours, PrEP acceptability and use, healthcare access and utilisation, support systems and psychological and emotional well-being. We will estimate probabilities of PrEP acceptability and use in a CJ-involved population using descriptive and multivariable analyses. After the follow-up, a subsample that never initiated PrEP, initiated but did not sustain PrEP or sustained PrEP will be asked to participate in a qualitative interview to contextualise their experiences and decisions around PrEP. An inductive approach will guide qualitative analyses.Ethics and disseminationPrEP initiation and sustained use rates are unknown among CJ-involved adults. This research will identify individual, social and structural factors that predict PrEP initiation and use. Data generated from the study have the potential to guide research and the development and tailoring of PrEP interventions to CJ-involved populations and provide context to HIV-related outcomes for those with CJ experiences.

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Systematic review of HIV treatment adherence research among people who inject drugs in the United States and Canada: evidence to inform pre-exposure prophylaxis (PrEP) adherence interventions.

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