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Substance Checking Outreach and PrEP Engagement (SCOPE) Study: protocol for a non-randomised clinical trial in Baltimore, Maryland USA

Por: Schneider · K. E. · Nestadt · D. F. · Martin · E. M. · Morris · M. · Rouhani · S. · Weir · B. W. · Sherman · S. G.
Introduction

As the opioid crisis continues, people who use drugs (PWUD) experience a disproportionate burden of both HIV and overdose, driven by increased injection-related HIV outbreaks and an opaque and rapidly evolving drug market, respectively. Pre-exposure prophylaxis (PrEP) for HIV and point-of-care drug checking services are underused yet potentially impactful interventions to address the harms of the opioid crisis. Implementing such interventions using known strategies to enhance client engagement and reduce access barriers, such as street outreach, mobile services and peer navigation, can optimise intervention and maximise their impact.

Methods and analysis

The Substance Checking Outreach and PrEP Engagement (SCOPE) Study is a non-randomised clinical trial evaluating the impact of the Check It intervention, a mobile community PrEP and drug checking intervention in Baltimore, Maryland, USA. SCOPE will recruit a cohort of 500 PWUD at risk for HIV through street-based recruitment methods. Cohort members will be followed semi-annually for 18 months. The primary study outcomes are engagement with the PrEP continuum of care and the number of non-fatal overdoses. We will use both random effects models and marginal structural models to estimate the effects of Check It on participant engagement on the PrEP continuum and the number of non-fatal overdoses over time.

Ethics and dissemination

Study procedures have been approved by the Johns Hopkins Bloomberg School of Public Health Institutional Review Board. Risks to participants are low, with the most serious risk being potential data confidentiality breaches. This risk was minimised through the use of secure data storage platforms with limited user access. Study findings will be disseminated through peer-reviewed manuscripts, academic presentations, and reports and fact sheets designed for lay audiences.

Trial registration number

This study was registered with clinicaltrials.gov (study ID: NCT05977881; Protocol ID: 00017498).

Understanding Predictors of Lifelong Initiation and Follow-up Treatment for adolescents and youth living with HIV (UPLIFT): an integrated prospective cohort in Eastern Cape, South Africa

Por: Toska · E. · Edun · O. · Zhou · S. · Leon · Z. · Langwenya · N. · Jochim · J. · Tolmay · J. · Sherman · G. · Cluver · L. D.
Purpose

Adolescents living with HIV (ALHIV) are a priority population for achieving global HIV prevention and treatment targets but experience poorer outcomes than adults. Long-term follow-up is essential to understand their transition into adulthood. By linking self-reported survey data with routine laboratory records, we established a social science clinical cohort of ALHIV South Africa’s Eastern Cape to explore factors shaping their long-term health and well-being.

Participants

Eligible participants were adolescents who were part of a three-wave quantitative cohort of ALHIV and not living with HIV (2014–2018) and had consented (adolescent and caregiver) to having their self-reported interviews linked with routine health records (n=1563). Adolescents were recruited into the existing three-wave cohort through clinic and community-based methods (97% enrolment, >90% retention over three waves). Between 2019 and 2022, we abstracted laboratory test records from the National Health Laboratory Services database for all eligible participants, with matching based on demographic variables. Individuals with at least one HIV-related record form our ‘lifelong social science cohort’, a total of 956 ALHIV (852 of 1107 ALHIV and 104 of 456 HIV-uninfected).

Findings to date

A total of 32 886 laboratory test records from 2004 to 2023 were matched through three rounds of data extraction, using iteratively refined record-linking searches. Most records were viral load (8864) and CD4 count (6801) results, with a median of 10 (IQR: 7–14) and 8 (IQR: 5–11) tests per matched adolescent, respectively. Overall, 956 of 1563 adolescents (61%) were successfully linked to laboratory data, including 852 of 1107 (77%) ALHIV. Analysis of the matched cohort survey-laboratory data provided several insights. Self-reported antiretroviral therapy adherence was strongly associated with viral suppression, even after adjusting for covariates. The strongest predictors of suppression were not reporting missed doses in the past 3 days, past week and not missing clinic appointments in the past year. Among adolescent girls and young women living with HIV, access to safe and affordable facilities, and kind and respectful staff were associated with a higher likelihood of multiple improved HIV-related outcomes, including viral suppression. Exposure to sexual and intimate partner violence predicted worse viral load outcomes among adolescents.

Future plans

This integrated prospective cohort provides an opportunity to characterise long-term HIV treatment outcomes among ALHIV in Africa. We will investigate how individual, familial, community and healthcare experiences in childhood, and adolescence shape these outcomes. Since the COVID-19 pandemic happened during the period of matched data, we will also investigate the potential effect of the COVID-19 pandemic on adolescent HIV treatment outcomes, with potential subgroup analyses for individuals with available COVID-19-related results.

Expanding access to maggot containment dressings through redesign and innovation

Abstract

There are two major styles of maggot debridement dressings: (1) confinement dressings that form a cage around the wound, and (2) containment dressings that completely surround the maggots within a sealed porous bag. For producers and clinicians wanting to prepare containment dressings using readily available polyester bags, it is currently difficult to seal these bags without expensive high-temperature plastic welders. This study aimed to identify simple and affordable methods for sealing maggots within polyester net bags. Heat sealing was the most effective and simplest method to seal the polyester net bags, but the high melting point of polyester required industrial grade heat sealers. An inner lining of polyethylene or polypropylene film at the open side of the bag allowed for complete sealing using low-cost hand-actuated impulse heat sealers. This design even facilitated the addition of plastic zipper-locks, allowing secure closure of the bag without electricity or special equipment. Other sealing methods were identified, but most were time-consuming, required practice or not consistently successful. The maggot containment bag designs and closure methods described herein should prove useful to clinicians without access to contained maggots and to maggot producers without the resources to seal polyester containment bags. Clinical trials are expected to follow.

Stigma, social and structural vulnerability, and mental health among transgender women: A partial least square path modeling analysis

Abstract

Introduction

Existing literature suggests that transgender women (TW) may be at high risk for adverse mental health due to stress attributed to combined experiences of stigma and complex social and structural vulnerabilities. Little research has examined how these co-occurring experiences relate to mental health. We aimed to test a theoretically driven conceptual model of relationships between stigma, social and structural vulnerabilities, and mental health to inform future intervention tailoring.

Design/Methods

Partial least square path modeling followed by response-based unit segmentation was used to identify homogenous clusters in a diverse community sample of United States (US)-based TW (N = 1418; 46.2% White non-Hispanic). This approach examined associations between latent constructs of stigma (polyvictimization and discrimination), social and structural vulnerabilities (housing and food insecurity, unemployment, sex work, social support, and substance use), and mental health (post-traumatic stress and psychological distress).

Results

The final conceptual model defined the structural relationship between the variables of interest within stigma, vulnerability, and mental health. Six clusters were identified within this structural framework which suggests that racism, ethnicism, and geography may be related to mental health inequities among TW.

Conclusion

Our findings around the impact of racism, ethnicism, and geography reflect the existing literature, which unfortunately shows us that little change has occurred in the last decade for TW of color in the Southern US; however, the strength of our evidence (related to sampling structure and sample size) and type of analyses (accounting for co-occurring predictors of health, i.e., stigma and complex vulnerabilities, reflecting that of real-world patients) is a novel and necessary addition to the literature. Findings suggest that health interventions designed to offset the negative effects of stigma must include anti-racist approaches with components to reduce or eliminate barriers to resources that contribute to social and structural vulnerabilities among TW. Herein we provide detailed recommendations to guide primary, secondary, and tertiary prevention efforts.

Clinical Relevance

This study demonstrated the importance of considering stigma and complex social and structural vulnerabilities during clinical care and design of mental health interventions for transgender women who are experiencing post-traumatic stress disorder and psychological distress. Specifically, interventions should take an anti-racist approach and would benefit from incorporating social support-building activities.

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