COVID-19 vaccine effectiveness among people living with and without HIV in South Carolina, USA: protocol of a population-based cohort study

Introduction
Despite the effectiveness of COVID-19 vaccines in preventing severe COVID-19 outcomes, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, which is referred to as ‘breakthrough COVID-19’. People living with HIV (PLWH) appear to have an elevated risk of severe COVID-19 outcomes, yet the effectiveness of the COVID-19 vaccine in this population remains unclear due to the limited research efforts in this population in the real world. This study aims to characterise and compare the breakthrough COVID-19 (eg, prevalence and disease severity) between PLWH and non-PLWH and then examine whether HIV markers play a role in COVID-19 vaccine effectiveness within the PLWH population.

Methods and analysis
This cohort study will merge electronic health records data from multiple data sources in South Carolina (SC), including the ‘HIV Cohort’ (n=12 203) identified from the statewide Enhanced HIV/AIDS Reporting System, ‘Vaccine Cohort’ from the Statewide Immunisation Online Network which provides patient-level immunisation records (n=~1.71 million), and ‘COVID-19 Cohort’ which includes healthcare encounters and COVID-19 diagnosis information for all individuals who were tested for COVID-19 (n=~3.41 million). The PLWH will be matched with a comparison group of non-PLWH by the propensity score matching method. To distinguish the role of immunity level in affecting the vaccine effectiveness, we will conduct subgroup analyses to compare the outcome of virally controlled and immunosuppressed PLWH with non-PLWH. Conditional logistic regression and generalised linear models will be employed to analyse the relationship between HIV status and protection durability by adjusting for potential confounders.

Ethics and dissemination
The study was approved by the Institutional Review Board at the University of South Carolina (Pro00117583) as a Non-Human Subject study. The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences and through social media.

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Agosto 2022

More than just oral PrEP: exploring interest in rectal douche, dissolvable implant, removable implant and injection HIV prevention approaches among racially diverse men who have sex with men in the Northeast Corridor

Objectives
HIV scholars and practitioners have worked to expand strategies for prevention among marginalised populations who are disproportionately impacted by the epidemic, such as racial minority men who have sex with men (MSM). Given this urgency, the objective of this study was to assess interest in biomedical prevention strategies.

Methods
This exploratory and cross-sectional study investigated interest in four biomedical prevention tools—rectal douche, dissolvable implant, removable implant and injection—among a racially diverse sample of MSM from the Northeast Corridor region between Philadelphia and Trenton. Data were collected as part of screening for Connecting Latinos en Pareja, a couples-based HIV prevention intervention for Latino MSM and their partners.

Results
A total of 381 individuals participated in the screener and provided information about their interest in bio tools. Approximately 26% of participants identified as black, 28% as white and 42% as ‘other’ or multiracial; 49% identified as Latino. Majority (54%) reported some form of child sexual abuse. Of the participants who reported being in a primary relationship (n=217), two-thirds reported unprotected anal sex within that relationship over the past 90 days (n=138, 64%) and approximately half (n=117, 54%) reported unprotected anal sex outside of the relationship in this period. Majority of participants reported interest in all bio tools assessed, including dissolvable implants (60%), removable implants (64%), rectal douching (79%) and injection (79%). Although interest in bio tools was broadly unassociated with demographics and sexual risk behaviours, analyses revealed significant associations between reports of child sexual abuse and interest in implant and injection methods.

Conclusions
The authors recommend investing in these prevention methods, particularly rectal douching and injection, as a means of preventing HIV among racial minority MSM. Given the interest in biomedical prevention tools, future studies should explore potential strategies for adherence.

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Agosto 2022

Cost-effectiveness of implementing HIV and HIV/syphilis dual testing among key populations in Viet Nam: a modelling analysis

Objectives
Key populations, including sex workers, men who have sex with men, and people who inject drugs, have a high risk of HIV and sexually transmitted infections. We assessed the health and economic impacts of different HIV and syphilis testing strategies among three key populations in Viet Nam using a dual HIV/syphilis rapid diagnostic test (RDT).

Setting
We used the spectrum AIDS impact model to simulate the HIV epidemic in Viet Nam and evaluated five testing scenarios among key populations. We used a 15-year time horizon and a provider perspective for costs.

Participants
We simulate the entire population of Viet Nam in the model.

Interventions
We modelled five testing scenarios among key populations: (1) annual testing with an HIV RDT, (2) annual testing with a dual RDT, (3) biannual testing using dual RDT and HIV RDT, (4) biannual testing using HIV RDT and (5) biannual testing using dual RDT.

Primary and secondary outcome measures
The primary outcome is incremental cost-effectiveness ratios. Secondary outcomes include HIV and syphilis cases.

Results
Annual testing using a dual HIV/syphilis RDT was cost-effective (US$10 per disability-adjusted life year (DALY)) and averted 3206 HIV cases and treated 27 727 syphilis cases compared with baseline over 15 years. Biannual testing using one dual test and one HIV RDT (US$1166 per DALY), or two dual tests (US$5672 per DALY) both averted an additional 875 HIV cases, although only the former scenario was cost-effective. Annual or biannual HIV testing using HIV RDTs and separate syphilis tests were more costly and less effective than using one or two dual RDTs.

Conclusions
Annual HIV and syphilis testing using dual RDT among key populations is cost-effective in Vietnam and similar settings to reach global reduction goals for HIV and syphilis.

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Agosto 2022

DNA Methylation Analysis to predict Regression of high-grade anal Intraepithelial Neoplasia in HIV+ men (MARINE): a cohort study protocol

Introduction
Anal cancer precursors, or high-grade anal intraepithelial neoplasia (HGAIN), are highly prevalent in HIV-seropositive (HIV+) men who have sex with men (MSM). Around 30% of lesions regress within 1 year, but current histopathological assessment is unable to distinguish between HGAIN likely to regress and HGAIN likely to persist or progress to cancer. We aim to assess if host cell DNA methylation markers can predict regression of HGAIN, thus determining the need for immediate treatment or active surveillance. This could reduce overtreatment and the associated anal and psycho-sexual morbidity.

Methods and analysis
This is an active surveillance cohort study in three centres located in Amsterdam, the Netherlands, in 200 HIV+ MSM diagnosed with HGAIN. Participants will not be treated, but closely monitored during 24 months of follow-up with 6 monthly visits including cytology, and high-resolution anoscopy with biopsies. The primary study endpoint is histopathological regression of each baseline HGAIN lesion at the end of the study. Regression is defined as ≤low grade anal intraepithelial neoplasia in the exit biopsy at 24 months. Regression proportions in lesions with low versus high methylation levels (ASCL1, ZNF582), other biomarkers (HPV genotype, HPV-E4, p16INK4A, Ki-67) and immunological markers at baseline will be compared. Main secondary endpoints are the histological and clinical outcome (ie, the number of octants affected by HGAIN) of each baseline HGAIN lesion and overall HGAIN disease (i.e., all lesions combined) after each visit. The health-related quality of life of the study group will be compared with that of a control group of 50 HIV+ MSM receiving regular HGAIN treatment.

Ethics and dissemination
Ethics approval was obtained from the Institutional Review Board of the Academic Medical Center (Amsterdam, The Netherlands; reference no. 2021_099). Participants are required to provide written informed consent. Findings will be disseminated through publication in peer-reviewed scientific journals and presentations at international scientific conferences; dissemination to policy makers and the target patient group will be achieved through our (inter-)national network, professional associations and collaboration with a patient representative organisation.

Trial registration number
NL9664.

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Agosto 2022

Evaluating the impact of a multicountry interprofessional training programme to improve HIV knowledge and clinical confidence among healthcare workers in sub-Saharan Africa: a cohort study

Objective
To assess the impact of an interprofessional case-based training programme to enhance clinical knowledge and confidence among clinicians working in high HIV-burden settings in sub-Saharan Africa (SSA).

Setting
Health professions training institutions and their affiliated clinical training sites in 12 high HIV-burden countries in SSA.

Participants
Cohort comprising preservice and in-service learners, from diverse health professions, engaged in HIV service delivery.

Intervention
A standardised, interprofessional, case-based curriculum designed to enhance HIV clinical competency, implemented between October 2019 and April 2020.

Main outcome measures
The primary outcomes measured were knowledge and clinical confidence related to topics addressed in the curriculum. These outcomes were assessed using a standardised online assessment, completed before and after course completion. A secondary outcome was knowledge retention at least 6 months postintervention, measured using the same standardised assessment, 6 months after training completion. We also sought to determine what lessons could be learnt from this training programme to inform interprofessional training in other contexts.

Results
Data from 3027 learners were collected: together nurses (n=1145, 37.9%) and physicians (n=902, 29.8%) constituted the majority of participants; 58.1% were preservice learners (n=1755) and 24.1% (n=727) had graduated from training within the prior year. Knowledge scores were significantly higher, postparticipation compared with preparticipation, across all content domains, regardless of training level and cadre (all p6 months, knowledge and self-reported confidence scores were greater compared with precourse scores (all p

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Luglio 2022