Dataset Information

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

ABSTRACT:

Introduction

HIV pre-exposure prophylaxis (PrEP) is an effective intervention to reduce acquisition of HIV. PrEP provision has increased in recent years, however, it is not known whether PrEP implementation has been equitably implemented across all risk groups, particularly groups experiencing high levels of health inequity. A PrEP care continuum (PCC) has been proposed to evaluate the success of PrEP implementation programmes, but the extent to which health equity characteristics are currently taken into account in the PCC has not been described. The objectives of this proposed systematic review are to (i) identify and collate outcome measure definitions for the main stages of the PCC (awareness, acceptability, uptake, adherence and retention), (ii) describe how equity characteristics are considered in outcome definitions of the PCC and (iii) describe data sources for capturing equity characteristics.

Methods and analysis

Quantitative studies published between 1 January 2012 and 3 March 2020 will be included. Five databases (MEDLINE, PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, Applied Social Sciences Index and Abstracts) will be searched to identify English language publications that include an outcome measure definition of at least one of the five main stages of the PCC. Risk of bias will be assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies. Data on outcome measure definitions and equity characteristics will be extracted. Results will be presented in a narrative synthesis and all findings will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Ethics and dissemination

Ethical approval is not required. The results will be disseminated via submission for publication to a peer-reviewed journal when complete. The review findings will have relevance to healthcare professionals, policymakers and commissioners in informing how to best evaluate PrEP implementation programmes and inform new implementation strategies for vulnerable and less advantaged populations.

Prospero registration number

CRD42020169779.

SUBMITTER: Cabecinha M

PROVIDER: S-EPMC7868247 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

Cabecinha Melissa M Solomon Danielle D Rait Greta G Saunders John J Saunders John J Mohammed Hamish H McDonagh Lorraine Katherine LK

BMJ open 20210204 2

<h4>Introduction</h4>HIV pre-exposure prophylaxis (PrEP) is an effective intervention to reduce acquisition of HIV. PrEP provision has increased in recent years, however, it is not known whether PrEP implementation has been equitably implemented across all risk groups, particularly groups experiencing high levels of health inequity. A PrEP care continuum (PCC) has been proposed to evaluate the success of PrEP implementation programmes, but the extent to which health equity characteristics are cu ...[more]

PMID: 33542038

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Project description:As pre-exposure prophylaxis (PrEP) effectiveness is strongly linked to adherence, we sought to determine if certain self-report measures could be used to inform objective PrEP adherence. We studied participants from the TAPIR study (a multicenter randomized study of daily text messages to support adherence to PrEP In At-Risk), a 48-week randomized controlled trial of HIV-uninfected men who have sex with men (MSM) randomized to receive text message to support adherence versus standard of care. Self-reported medication adherence was assessed using several validated measures modified for PrEP. Objective PrEP adherence was determined through dried blood spot (DBS) measurement of intracellular tenofovir diphosphate (TFV-DP) and emtricitabine triphosphate (FTC-TP). A summary of adherence was estimated using responses to the seven adherence items at weeks 12 and 48 using confirmatory factor analysis. Correlations between self-report questions and drug concentrations were estimated with Pearson's correlations for continuous outcomes and point-biserial correlations for dichotomous outcomes. Receiver operating characteristic (ROC) analyses were conducted to assess the performance of self-report measures in predicting protective or perfect TFV-DP concentrations. Of the 369 participants who completed week 12 or 48 visits, the mean age was 35 (standard deviation 9 years), with 79% White, 12% Black, and 29% Hispanic. Correlations between self-report measures of adherence (both individual items and the adherence factor) and quantifiable FTC-TP and continuous TFV-DP concentrations showed that all self-report measures were significantly associated with these objective measures. Compared to a summary measure of self-reported adherence, the 4-week percent taken question medication recall was the only self-report item similarly or more strongly associated with recent adherence and long-term protective and perfect adherence at weeks 12 and 48. ROC analysis also showed that 4-week percent taken question had a reasonable AUC (0.798 at week 12 and 0.758 at week 48) in predicting protective TFV-DP concentrations. All single-item self-report questions assessing PrEP adherence were significantly associated with biomarker quantification, with the 4-week percent taken question performing best. Therefore, in the absence of drug concentration measurements, a 4-week self-report percent taken question may be a good single-item measure of PrEP adherence.

Project description:Background:Cost-effectiveness analysis (CEA) is frequently used as an input for guiding priority setting in health. However, CEA seldom incorporates information about trade-offs between total health gains and equity impacts of interventions. This study investigates to what extent equity considerations have been taken into account in CEA in low- and middle-income countries (LMICs), using rotavirus vaccination as a case study. Methods:Specific equity-related indicators for vaccination were first mapped to the Guidance on Priority Setting in Health Care (GPS-Health) checklist criteria. Economic evaluations of rotavirus vaccine in LMICs identified via a systematic review of the literature were assessed to explore the extent to which equity was considered in the research objectives and analysis, and whether it was reflected in the evaluation results. Results:The mapping process resulted in 18 unique indicators. Under the 'disease and intervention' criteria, severity of illness was incorporated in 75% of the articles, age distribution of the disease in 70%, and presence of comorbidities in 5%. For the 'social groups' criteria, relative coverage reflecting wealth-based coverage inequality was taken into account in 30% of the articles, geographic location in 27%, household income level in 8%, and sex at birth in 5%. For the criteria of 'protection against the financial and social effects of ill health', age weighting was incorporated in 43% of the articles, societal perspective in 58%, caregiver's loss of productivity in 45%, and financial risk protection in 5%. Overall, some articles incorporated the indicators in their model inputs (20%) while the majority (80%) presented results (costs, health outcomes, or incremental cost-effectiveness ratios) differentiated according to the indicators. Critically, less than a fifth (17%) of articles incorporating indicators did so due to an explicit study objective related to capturing equity considerations. Most indicators were increasingly incorporated over time, with a notable exception of age-weighting of DALYs. Conclusion:Integrating equity criteria in CEA can help policy-makers better understand the distributional impact of health interventions. This study illustrates how equity considerations are currently being incorporated within CEA of rotavirus vaccination and highlights the components of equity that have been used in studies in LMICs. Areas for further improvement are identified.

Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.

Project description:INTRODUCTION:Oral pre-exposure prophylaxis (PrEP) provision is a priority intervention for high HIV prevalence settings and populations at substantial risk of HIV acquisition. This mathematical modelling analysis estimated the impact, cost and cost-effectiveness of scaling up oral PrEP in 13 countries. METHODS:We projected the impact and cost-effectiveness of oral PrEP between 2018 and 2030 using a combination of the Incidence Patterns Model and the Goals model. We created four PrEP rollout scenarios involving three priority populations-female sex workers (FSWs), serodiscordant couples (SDCs) and adolescent girls and young women (AGYW)-both with and without geographic prioritization. We applied the model to 13 countries (Eswatini, Ethiopia, Haiti, Kenya, Lesotho, Mozambique, Namibia, Nigeria, Tanzania, Uganda, Zambia and Zimbabwe). The base case assumed achievement of the Joint United Nations Programme on HIV/AIDS 90-90-90 antiretroviral therapy targets, 90% male circumcision coverage by 2020 and 90% efficacy and adherence levels for oral PrEP. RESULTS:In the scenarios we examined, oral PrEP averted 3% to 8% of HIV infections across the 13 countries between 2018 and 2030. For all but three countries, more than 50% of the HIV infections averted by oral PrEP in the scenarios we examined could be obtained by rollout to FSWs and SDCs alone. For several countries, expanding oral PrEP to include medium-risk AGYW in all regions greatly increased the impact. The efficiency and impact benefits of geographic prioritization of rollout to AGYW varied across countries. Variations in cost-effectiveness across countries reflected differences in HIV incidence and expected variations in unit cost. For most countries, rolling out oral PrEP to FSWs, SDCs and geographically prioritized AGYW was not projected to have a substantial impact on the supply chain for antiretroviral drugs. CONCLUSIONS:These modelling results can inform prioritization, target-setting and other decisions related to oral PrEP scale-up within combination prevention programmes. We caution against extensive use given limitations in cost data and implementation approaches. This analysis highlights some of the immediate challenges facing countries-for example, trade-offs between overall impact and cost-effectiveness-and emphasizes the need to improve data availability and risk assessment tools to help countries make informed decisions.

Project description:ObjectiveTo estimate the number of women who received human immunodeficiency virus (HIV) and sexually transmitted infection (STI) testing and HIV pre-exposure prophylaxis (PrEP) services by race and ethnicity in seven THRIVE (Targeted Highly Effective Interventions to Reverse the HIV Epidemic)-funded jurisdictions and to estimate associations of age and syphilis and gonorrhea diagnoses with receipt of HIV PrEP services.MethodsWe analyzed data collected from 2015 to 2020 in Birmingham, Alabama; Baltimore City, Maryland; Washington, DC, New Orleans, Louisiana; Brooklyn, New York; Philadelphia, Pennsylvania; and Hampton Roads, Virginia. We compared Black women and women of additional racial and ethnic groups by age, HIV status at enrollment, receipt of STI testing and test positivity, and steps in the PrEP continuum (screened, eligible, referred, linked, and prescribed). We also examined the association of age, syphilis, or gonorrhea with the following steps in the PrEP continuum: screened, referred, linked, and prescribed.ResultsBlack women made up 69.2% (8,758/12,647) of women served in THRIVE. Compared with non-Black women, Black women were more likely to have a positive test result for syphilis (3.3% vs 2.1%), gonorrhea (4.9% vs 3.5%), chlamydia (5.1% vs 1.9%), or more than one STI (1.4% vs 0.3%). Among women with negative HIV test results or unknown HIV status, Black women were more likely to be screened for PrEP eligibility (88.4% vs 64.9%). Among Black women, the proportion screened for PrEP was higher among those diagnosed with syphilis (97.3%) or gonorrhea (100%) than among those without an STI (88.1% and 87.8%, respectively). Among 219 Black women who presented with syphilis, only 10 (4.6%) were prescribed PrEP; among 407 with gonorrhea, only 11 (2.7%) were prescribed PrEP.ConclusionAlthough most Black women seeking services received STI testing, the proportion of Black women who were eligible for PrEP and prescribed PrEP was low. To achieve national HIV-prevention goals, it is imperative that Black women have access to PrEP information and services.

Dataset Information

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

Introduction

Methods and analysis

Ethics and dissemination

Prospero registration number

Publications

Equity considerations in outcome measures of the HIV pre-exposure prophylaxis care continuum in high-income countries: a systematic review protocol.

Similar Datasets

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