Public Health Implications of Adapting HIV Pre-exposure Prophylaxis Programs for Virtual Service Delivery in the Context of the COVID-19 Pandemic: Systematic Review.

BACKGROUND: The novel coronavirus disease COVID-19 caused by SARS-CoV-2 threatens to disrupt global progress toward HIV epidemic control. Opportunities exist to leverage ongoing public health responses to mitigate the impacts of COVID-19 on HIV services, and novel approaches to care provision might help address both epidemics. OBJECTIVE: As the COVID-19 pandemic continues, novel approaches to maintain comprehensive HIV prevention service delivery are needed. The aim of this study was to summarize the related literature to highlight adaptations that could address potential COVID-19-related service interruptions. METHODS: We performed a systematic review and searched six databases, OVID/Medline, Scopus, Cochrane Library, CINAHL, PsycINFO, and Embase, for studies published between January 1, 2010, and October 26, 2021, related to recent technology-based interventions for virtual service delivery. Search terms included "telemedicine," "telehealth," "mobile health," "eHealth," "mHealth," "telecommunication," "social media," "mobile device," and "internet," among others. Of the 6685 abstracts identified, 1259 focused on HIV virtual service delivery, 120 of which were relevant for HIV prevention efforts; 48 pertained to pre-exposure prophylaxis (PrEP) and 19 of these focused on evaluations of interventions for the virtual service delivery of PrEP. Of the 16 systematic reviews identified, three were specific to PrEP. All 35 papers were reviewed for outcomes of efficacy, feasibility, and/or acceptability. Limitations included heterogeneity of the studies' methodological approaches and outcomes; thus, a meta-analysis was not performed. We considered the evidence-based interventions found in our review and developed a virtual service delivery model for HIV prevention interventions. We also considered how this platform could be leveraged for COVID-19 prevention and care. RESULTS: We summarize 19 studies of virtual service delivery of PrEP and 16 relevant reviews. Examples of technology-based interventions that were effective, feasible, and/or acceptable for PrEP service delivery include: use of SMS, internet, and smartphone apps such as iText (50% [95% CI 16%-71%] reduction in discontinuation of PrEP) and PrEPmate (OR 2.62, 95% CI 1.24-5.5.4); telehealth and eHealth platforms for virtual visits such as PrEPTECH and IowaTelePrEP; and platforms for training of health care workers such as Extension for Community Healthcare Outcomes (ECHO). We suggest a virtual service delivery model for PrEP that can be leveraged for COVID-19 using the internet and social media for demand creation, community-based self-testing, telehealth platforms for risk assessment and follow-up, applications for support groups and adherence/appointment reminders, and applications for monitoring. CONCLUSIONS: Innovations in the virtual service provision of PrEP occurred before COVID-19 but have new relevance during the COVID-19 pandemic. The innovations we describe might strengthen HIV prevention service delivery during the COVID-19 pandemic and in the long run by engaging traditionally hard-to-reach populations, reducing stigma, and creating a more accessible health care platform. These virtual service delivery platforms can mitigate the impacts of the COVID-19 pandemic on HIV services, which can be leveraged to facilitate COVID-19 pandemic control now and for future responses.

Pre-exposure prophylaxis (PrEP) uptake and service delivery adaptations during the first wave of the COVID-19 pandemic in 21 PEPFAR-funded countries.

BACKGROUND: Mitigation measures for the first wave of the COVID-19 pandemic and burden on health systems created challenges for pre-exposure prophylaxis (PrEP) service delivery. We examined PrEP uptake in PEPFAR programs before and after the start of the COVID-19 pandemic. METHODS: We studied two PEPFAR program monitoring indicators, using routine Monitoring, Evaluation, Reporting (MER) indicators capturing uptake of PrEP (PrEP_NEW) and overall use of PrEP (PrEP_CURR). We also analyzed descriptive program narratives to understand successes and challenges field teams encountered after the start of the COVID-19 pandemic. To assess changes in coverage of PrEP across 21 countries, we calculated the "PrEP to need ratio" (PnR) using a published methodology. We defined the pre-COVID time period as April 1, 2019 -March 31, 2020 and the COVID time period as April 1, 2020 -March 31, 2021. FINDINGS: The total number of persons who initiated PrEP increased by 157% from 233,250 in the pre-COVID-19 period compared with 599,935 in the COVID-19 period. All countries, except five, noted significant increases in PrEP uptake. PrEP uptake among adolescent girls and young women (AGYW) increased by 159% from 80,452 AGYW in the pre-COVID-19 period to 208,607 AGYW in the COVID-19 period. There were 77,430 key populations (KP) initiated on PrEP in the pre-COVID-19 period and 209,114 KP initiated in the COVID-19 period (a 170% increase). The PnR increased 214% in the COVID-19 period across all PEPFAR-supported countries. Adaptations, such as multi-month dispensing (MMD) of PrEP; virtual demand creation activities; decentralized, community-based and virtual service delivery, were implemented to maintain PrEP services. CONCLUSIONS: PEPFAR programs continued to maintain and initiate new clients on PrEP despite the challenges posed by the COVID-19 pandemic. Adaptations such as MMD of PrEP and use of technology were vital in expanding service delivery and increasing PrEP coverage. FUNDING: This project has been supported by the U.S. President's Emergency Plan for AIDS Relief.

Novel Use of Active Leptospermum Honey for Ringed Fixator Pin Site Care in Diabetic Charcot Deformity Patients.

INTRODUCTION: Open reduction with external fixation (OREF) utilizing fine wire ringed fixators for correction of Charcot deformity has gained popularity over the past decade. Pin site infections are a well-documented complication of external fixation as well as a driver of escalating health care costs. We aimed to demonstrate the safety and efficacy of a novel method of pin site care utilizing active Leptospermum honey-impregnated dressings (MediHoney) in diabetic patients undergoing deformity correction with OREF. METHODS: Twenty-one diabetic patients with Charcot deformities of the lower extremity were prospectively enrolled and followed for pin site complications following OREF for deformity correction. Active Leptospermum honey dressings were applied at metal-cutaneous interfaces at the end of the OREF procedure and replaced weekly for a total of 8 weeks. Patients were monitored for pin site infections from the time of surgery until external fixator removal. Sixteen consecutive patients receiving standard OREF for Charcot deformities were evaluated retrospectively to serve as a control group. RESULTS: Of the 21 enrolled patients, 19 underwent OREF and followed up throughout the study period. Treated patients had a mean age of 58.5 years and mean body mass index measuring 33.3 kg/m2 as documented prior to surgery. The 15 patients with hemoglobin A1c labs drawn in the 3 months preceding surgery averaged 7.5. Fixators were removed at an average of 12.1 weeks after adequate bony healing. Of the 244 pin sites in 19 patients, 3 pin sites (1.2% of pins) in 2 patients (10.5% of patients) showed evidence of superficial infection. All infections resolved with oral antibiotics. Infection rates were significantly reduced when compared to the standard care control group. CONCLUSIONS: Pilot data in a prospectively collected case series demonstrate safety and efficacy of active Leptospermum honey-impregnated dressings when used for fine wire ringed fixator pin site care in diabetic Charcot deformity patients. Further investigation in the form of a prospective randomized controlled study is warranted to demonstrate the potential value of this novel intervention. LEVELS OF EVIDENCE: Level IV.

A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer.

UNLABELLED: Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs). MATERIALS AND METHODS: This prospective, open-label, randomized, parallel group trial was implemented at 8 clinical sites in the United States. Eligibility criteria included adults with type 1 or type 2 diabetes mellitus who have 1 or more ulcers with a Wagner classification of grade 1 or superficial 2 measuring between 1 cm2 and 25 cm2 in area, presenting for more than 1 month with no signs of infection/osteomyelitis; ABI > 0.7; HbA1c Less than 12%; and serum creatinine less than 3.0 mg/dL. Eligible subjects were randomized (1:1) to receive either SOC alone (n = 14) or DAMA+SOC (n = 15) until wound closure or 6 weeks, whichever occurred first. The endpoint was the proportion of subjects with complete wound closure (defined as complete reepithelialization without drainage or need for dressings). RESULTS: Thirty-five percent of subjects in the DAMA+SOC cohort achieved complete wound closure at or before week 6, compared with 0% of the SOC alone cohort (intent-to-treat population, P = 0.017). There was a more robust response noted in the per protocol population, with 45.5% of subjects in the DAMA+SOC cohort achieving complete wound closure, while 0% of SOC-alone subjects achieved complete closure (P = 0.0083). No treatment-related adverse events were reported. CONCLUSION: The results suggest DAMA is safe and effective in the management of DFUs, but additional research is needed.