A collaborative approach to research study recruitment in PLWH during the SARS CoV-2 pandemic

Background: Since COVID there are fewer site investigator meetings for non-CTIMP studies to discuss recruitment barriers. Additionally, literature highlights various research trials that have successfully recruited do not report their strategies, consequently impacting ability to learn from success. The pandemic has had considerable impact on enrolment to clinical research, thus services have needed to revaluate their approach. Following the pandemic, patients report more likely to engage in research if offered remote or combined visits. Method(s): We reviewed recruitment strategies at our clinic for two observational studies with large targets (SCAPE-HIV, Positive Voices). SCAPE-HIV, a prospective study exploring immune responses of PLWH to SARS CoV2 infection and vaccination. Positive Voices, a crosssectional questionnaire study. Minimum recruitment targets, 600 and 262 respectively. SCAPE involves open-offer enrolment, Positive Voices from a defined pre-selected cohort. Initial approaches identified people opportunistically at clinic visits, with research staff offering information. However, reaching our targets through COVID became challenging and a move to virtual appointments condensed our opportunities to approach. To increase recruitment, engagement and training of NHS nursing and clinical staff was undertaken alongside remote patient contact. Result(s): After implementing collaborative methods, Positive Voices recruitment increased to 170 in July/ August 2022 (73 in May/June). SCAPE recruitment also improved. Hybrid nurse practitioners dedicating time to approach people during clinic visits and clinic staff involvement attributed to this rise, representing over half of consents (Table A). The clinic team's substantial knowledge of our cohort, combined with their openness to research, leads to greater understanding of how likely individuals are to accept studies. Conclusion(s): Positive Voices and SCAPE-HIV studies have been successful with recruitment due to a collaborative approach, resulting in our site being the highest current recruiting site involved in Positive Voices. This approach has helped motivate the NHS team to become more involved and has become an exemplar for clinical trial delivery within our Trust. (Table Presented).

HIV care during the SARS-COV-2 pandemic for Black people with HIV in the UK

Background: The COVID-19 pandemic disproportionally affected black communities but the impact on HIV care in this group remains poorly understood. We evaluated measures of HIV care during the COVID-19 pandemic in the GEN-AFRICA cohort of black people with HIV living in the U.K. Method(s): We evaluated interruptions to HIV care during the COVID-19 pandemic (01/2020-09/2022) in the GENAFRICA cohort at nine UK clinics who provided HIV outcomes for >80% of their participants. We ascertained death, transfers of care, loss to follow up for >12 months, the highest HIV viral load and interruptions to antiretroviral therapy (ART). We evaluated factors associated with the composite outcome of HIV viraemia (viral load >200 c/mL) and/or an ART interruption using logistic regression analysis;factors associated (P<0.1) in univariable analysis were included in the multivariable model. We also summarized reasons for ART interruptions where recorded. Result(s): 2321 participants (mean age 51.3 years;55.8% women;pre-pandemic current/nadir CD4 of 500/204 cells/mm3 and HIV RNA <200 c/mL in 92.3%) were in care on 01/01/2020. Thirty (1.3%) subsequently died, 24 (1.0%) transferred care and 48 (2.1%) became lost to follow up. 523 (22.7%) reported an episode of COVID-19 and 1771 (87.1%) having been vaccinated against SARSCoV- 2. The composite outcome could be evaluated in 2130 (91.8%);259 (11.2%) had a documented HIV VL >200 c/mL, 228 (9.8%) an ART interruption and 325 (14%) had HIV viraemia/ART interruption. In multivariable analysis, older age, a pre-pandemic HIV RNA <200 c/mL and being vaccinated against SARS-CoV-2 were associated with reduced odds of HIV viraemia/ART interruption (Table) while sex, CD4 (current/nadir), comorbid status and having had COVID-19 were not associated. Reasons for ART interruption were available for 52 participants;38% cited domestic logistic reasons, 27% issues related to foreign travel, 19% psychological reasons, 12% lockdown or changes to the daily routine and 4% personal choice. Conclusion(s): During the COVID-19 pandemic, one in seven black people with HIV experienced an ART interruption and/or HIV viraemia. Pre-pandemic measures of suboptimal engagement in care, pandemic restrictions, and wider health beliefs as reflected by COVID-vaccination, contributed to these undesirable HIV outcomes. (Table Presented).

Factors associated with severe SARSCOV- 2 infection in people of Black ethnicities living with HIV in the UK

Background: The COVID-19 pandemic has disproportionally affected people of black ethnicities, who have been at greater risk of SARS-CoV-2 acquisition, morbidity and mortality than those of white ethnicity. We describe factors associated with severe COVID-19 infection in the GEN-AFRICA cohort of people of black ethnicities living with HIV in the U.K. Method(s): First reported episodes of COVID-19 up to October 2022 were ascertained by direct questioning and/or medical records review. Pre-pandemic immune-virological and comorbidity status was based on measurements obtained prior to 01/2020 and used to identify risk factors for severe (requiring hospitalisation or resulting in death) COVID-19, using logistic regression Results: COVID-19 status was available for 1806 (72%) of 2503 GEN-AFRICA participants (mean age 49.2 [SD 10.2] years;56% female;80% sub-Saharan African and 14% Caribbean ancestry, median CD4 count 555 [IQR 400-733] cells/mm3;93% undetectable HIV RNA [<200 copies/ mL]);573 (32%) reported a clinical illness consistent with COVID-19;63 (3.5%) experienced severe COVID-19 (hospitalisation 59;death 4). Those who experienced severe COVID-19 were older, more often male, had lower CD4 counts and fewer had undetectable HIV RNA;they more often had prior AIDS, hypertension, diabetes mellitus and chronic kidney disease. Region of ancestry, nadir CD4 count, and obesity were not associated with severe COVID-19. In multivariable analysis, CD4 count <350 cells/mm3, diabetes mellitus and chronic kidney disease were associated with increased odds of severe COVID-19 (Table). Sex and a pre-pandemic HIV RNA were associated with severe disease although this did not reach statistical significance. By October 2022, 1534 (88%) of this sample had received >=1 dose of SARS-CoV-2 vaccine;those who experienced severe COVID-19 were less likely to report vaccination (77% vs. 89%, p=0.01). Conclusion(s): By the end of October 2022, nearly onethird of people of Black ethnicities with HIV in this sample had experienced COVID-19;3.5% had developed severe COVID-19 disease. Pre-pandemic immunovirological and comorbidity status were associated with severe COVID-19. Black populations with less favourable HIV control than observed for GEN-AFRICA participants may have suffered greater COVID-19 morbidity and mortality. (Table Presented).

HIV CARE DURING THE SARS-CoV-2 PANDEMIC IN BLACK PEOPLE WITH HIV IN THE UK

Background: The COVID-19 pandemic disproportionally affected black communities but the impact on HIV care in this group remains poorly understood. We evaluated measures of HIV care during the COVID-19 pandemic in the GEN-AFRICA cohort of black people with HIV living in the United Kingdom. Method(s): We evaluated interruptions to HIV care during the COVID-19 pandemic (01/2020-09/2022) in the GEN-AFRICA cohort at nine UK clinics who provided HIV outcomes for >80% of their participants. We ascertained death, transfers of care, loss to follow up for >12 months, the highest HIV virus load, and interruptions to antiretroviral therapy (ART). We evaluated factors associated with the composite outcome of HIV viraemia (virus load >200 c/mL) and/or an ART interruption using logistic regression analysis;factors associated (P< 0.1) in univariable analysis were included in the multivariable model. We also summarized reasons for ART interruptions where recorded. Result(s): On 01/01/2020, 2321 GEN-AFRICA study participants (mean age 51.3 years;55.8% women;pre-pandemic current/nadir CD4 of 500/204 cells/mm3 and HIV RNA < 200 c/mL in 92.3%) were under active HIV follow up. Thirty (1.3%) subsequently died, 24 (1.0%) transferred care, and 48 (2.1%) became lost to follow up;523 (22.7%) reported an episode of COVID-19 and 1771 (87.1%) having been vaccinated against SARS-CoV-2. The composite outcome could be evaluated in 2130 (91.8%);259 (11.2%) had a documented HIV VL >200 c/mL, 228 (9.8%) an ART interruption, and 325 (14%) had HIV viraemia/ ART interruption. In multivariable analysis, older age, a pre-pandemic HIV RNA < 200 c/mL and being vaccinated against SARS-CoV-2 were associated with reduced odds of HIV viraemia/ART interruption (Table) while sex, CD4 (current/nadir), comorbid status and having had COVID-19 were not or no longer associated. Reasons for ART interruption were available for 52 participants;38% cited domestic logistic reasons, 27% issues related to foreign travel, 19% psychological reasons, 12% lockdown or changes to the daily routine, and 4% personal choice. Conclusion(s): During the COVID-19 pandemic, one in seven black individuals with HIV experienced an ART interruption and/or HIV viraemia. Pre-pandemic measures of suboptimal engagement in care, pandemic restrictions, and wider health beliefs as reflected by SARS-CoV-2 vaccination status, contributed to these undesirable HIV outcomes.

Managing metabolic issues: Evaluation of a short-term comparative implementation project introducing a dietitian to an HIV service

Background: Persons living with HIV (PLWH) face a number of nutritional issues including dyslipidaemia, non-alcoholic steatohepatitis, diabetes, and obesity that can be attributed to HIV infection/medications. Poor management of these complications can reduce quality of life and increase health costs. We implemented a dietetic service within our HIV clinic for 6 months and evaluated the outcomes. Method: Twice weekly dietetic clinics were established. Eligible patients were offered group, face-to- face or telephone consultations. Medical records and our database were used to obtain demographics, treatments and co-morbidities. Cholesterol markers were measured along with weight, height, and body mass index (BMI). Results: 84 (total clinic cohort 3308) PLWH were referred. 61/84 attended their appointment;36 selected face-to- face, 25 selected telephone for their first appointment. Patients did not opt for group sessions. DNA rates were similar in both groups (31% and 28% respectively). In attendees median age was 54y, 59% male, 34% Black African origin. Eighty-five per cent of patients were diagnosed before 2010. 95.1% had undetectable viral load and 82% had CD4 count ≥400 cells/mm3 at most recent consultation. 82% of patients were on ≥1 NRTI and 36% were on a PI. Major reason for referral (40/61) was weight management;other reasons included type II diabetes management (7/61), irritable bowel syndrome (IBS) (8/61) and poor appetite (5/61). 15% of patients had an HbA1c of ≥48mmol/L and 11% of patients were pre-diabetic (HbA1c 42-48 mmol/L), 50% had TChol>5.0mmol/L, 11% had TChol:HDL ratio >5 and 38% had a LDL level >3mmol/L. Of the patients with available BMI, 32% (13/41) were classed as overweight and 56% (23/41) were classed as obese. 18% of attendees were ≥55y female and post-menopause could have been a contributing factor for weight gain. 28% of telephone and 31% of face-to- face consultations were scheduled for at least one follow up. Conclusion: PLWH are at risk of complex metabolic conditions, which can be difficult to manage. A dietician was able to provide expert and personalised advice to our patients and helped to empower them to take care of their own health. Patients engaged with both telephone and face-to- face consultations. Due to the short-term funding available in addition to the COVID-19 pandemic, longer term impact could not be evaluated.

Pharmacist-led antiretroviral therapy (ART) switch during a pandemic: Improving patient safety and reducing footfall in a London tertiary centre

Background: The COVID-19 pandemic mandated reduced face-to- face consultations/monitoring for our people living with HIV (PLWH). Eviplera (EVI) has a low genetic barrier to resistance and drug-drug interactions (DDIs) that may lead to virological failure (VF). We have had 23 known DDI related VFs between 2012-2018. Stringent food requirements may also reduce compliance. The commissioning of Delstrigo (DEL) presents an option for stable PLWH receiving EVI to switch to a regimen without food requirements, a higher barrier to resistance (in vitro) and fewer DDIs. A dedicated pharmacist contacted PLWH receiving EVI to counsel them regarding a remote DEL switch. Method: Clinician lists were obtained of PLWH on EVI and screened for switch suitability. A pharmacist undertook a telephone consultation with eligible patients due for a follow- up between September-November 2020. Patient decision was recorded and conveyed to the treating clinician prior to routine appointments. A follow-up survey was sent via SMS to all patients to record satisfaction scores. Post-switch, a follow-up was planned to look at viral outcomes and other safety/tolerability parameters. Results: 135 patients were found to be on EVI at our site. 23 patients from three clinicians were deemed appropriate for pilot consultation. 19/23 (82.6%) agreed to DEL switch. 16 responded to survey;14/16 (87.5%) of patients reported being either satisfied or very satisfied with a pharmacist-led switch. 15/16 (94%) would opt for future consultations with pharmacists. 57% (13/23) of patients were successfully switched at the time of writing. Of the patients who were switched and followed up, 100% continued on DEL. 6/13 (46%) had a complete follow-up. Of the six who have had follow-up, 100% remained virologically suppressed. Conclusion: The pilot improved patient safety, reduced footfall and offered patients choice. Switching to DEL currently represents a cost saving compared to continuing EVI. Lack of food restriction was the most popular switch incentive for patients. Pharmacist-led switches are safe, efficient and can improve patient care alongside saving costs.