The data-collection on adverse effects of anti-HIV drugs (D:A:D) model for predicting cardiovascular events: External validation in a diverse cohort of people living with HIV.

OBJECTIVES: Little is known about the external validity of the Data-collection on Adverse Effects of Anti-HIV Drugs (D:A:D) model for predicting cardiovascular disease (CVD) risk among people living with HIV (PLWH). We aimed to evaluate the performance of the updated D:A:D model for 5-year CVD risk in a diverse group of PLWH engaged in HIV care. METHODS: We used data from an institutional HIV registry, which includes PLWH engaged in care at a safety-net HIV clinic. Eligible individuals had a baseline clinical encounter between 1 January 2013 and 31 December 2014, with follow-up through to 31 December 2019. We estimated 5-year predicted risks of CVD as a function of the prognostic index and baseline survival of the D:A:D model, which were used to assess model discrimination (C-index), calibration and net benefit. RESULTS: Our evaluable population comprised 1029 PLWH, of whom 30% were female, 50% were non-Hispanic black, and median age was 45 years. The C-index was 0.70 [95% confidence limits (CL): 0.64-0.75]. The predicted 5-year CVD risk was 3.0% and the observed 5-year risk was 8.9% (expected/observed ratio = 0.33, 95% CL: 0.26-0.54). The model had a greater net benefit than treating all or treating none at a risk threshold of 10%. CONCLUSIONS: The D:A:D model was miscalibrated for CVD risk among PLWH engaged in HIV care at an urban safety-net HIV clinic, which may be related to differences in case-mix and baseline CVD risk. Nevertheless, the HIV D:A:D model may be useful for decisions about CVD intervention for high-risk patients.

Patient and clinic staff perspectives on the implementation of a long-acting injectable antiretroviral therapy program in an urban safety-net health system.

BACKGROUND: Long-acting injectable cabotegravir plus rilpivirine (LAI CAB/RPV) has several potential benefits over daily oral formulations for HIV treatment, including the potential to facilitate long-term adherence and reduce pill fatigue. We aimed to assess facilitators of and barriers to LAI CAB/RPV implementation and delivery through the perspectives of physicians and clinical staff, and the experiences of LAI CAB/RPV use among people living with HIV (PLWH) at a Ryan-White supported safety-net clinic in North Texas. METHODS: We conducted semi-structured interviews with recruited clinic staff (physicians, nurses, and support staff) involved with LAI CAB/RPV implementation and PLWH who switched to LAI CAB/RPV and consented to participate in individual interviews. Data were collected from July to October 2023. Our interview guide was informed by the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM), and Proctor Implementation Outcomes frameworks. Qualitative data were analyzed using a rapid qualitative analysis approach to summarize key themes. RESULTS: We recruited and interviewed 15 PLWH who transitioned to LAI CAB/RPV and 11 clinic staff serving these patients. PLWH conveyed that emotional and informational support from family or a trusted clinician influenced their decision to switch to LAI CAB/RPV. PLWH also reported that injectable treatment was more effective, convenient, and acceptable than oral antiretroviral therapy. Clinic staff and physicians reported that staff training, pharmacist-led medication switches, flexible appointments, refrigeration space and designated room for injection delivery facilitated implementation. Clinic staff cited medication costs, understaffing, insurance prior authorization requirements, and lack of medication access through state drug assistance programs as critical barriers. CONCLUSIONS: Our study offers insights into real-world experiences with LAI usage from the patient perspective and identifies potential strategies to promote LAI CAB/RPV uptake. The barriers to and facilitators of LAI CAB/RPV program implementation reported by clinic staff in our study may be useful for informing strategies to optimize LAI CAB/RPV programs.

Effect of 2018 American College of Cardiology/American Heart Association Guideline Change on Statin Prescription for People Living with HIV.

The American College of Cardiology (ACC)/American Heart Association (AHA) guidelines were updated in 2018 to explicitly recommend statin use for primary cardiovascular disease prevention among people living with HIV (PLWH), but little is known about the effect of this guideline change. We aimed to assess the effect of the 2018 ACC/AHA guideline change on statin prescription among PLWH. We used data from an institutional HIV registry to identify PLWH aged 40-75 years, engaged in HIV care between June 2016 and May 2021, had a LDL cholesterol between 70 and 189 mg/dl, 10-year atherosclerotic cardiovascular disease (ASCVD) risk score ≥7.5%, no prior statin prescription, and no history of diabetes or ASCVD. Our outcome of interest was a new statin prescription within 12 months of eligibility. We estimated standardized risk difference (RD) with 95% confidence limits (CL) by comparing prescription probabilities before and after guideline change. Our study population comprised 251 PLWH (171 before, 80 after the guideline change), of whom 57% were aged <55 years, 82% were male, and 45% were non-Hispanic black. The standardized 12-month statin prescription risk was 43% (95% CL: 31%, 60%) after the guideline change and 19% (95% CL: 13%, 26%) before the guideline change (RD = 25%, 95% CL: 9.1%, 40%). Our results suggest that the 2018 ACC/AHA guideline change increased statin prescription among PLWH, but a sizable proportion of eligible PLWH were not prescribed statin. Future studies are needed to identify strategies to enhance implementation of statin prescription guidelines among PLWH.

Brief Report: HIV Pre-exposure Prophylaxis Prescribing in an Urban Safety-Net Health System.

INTRODUCTION: Safety-net health systems are key settings for HIV pre-exposure prophylaxis (PrEP) implementation, but little evidence is available about the frequency of PrEP prescribing in safety-net settings. We assessed PrEP prescribing among people with indications for PrEP at an urban safety-net health system that serves a county designated as an Ending the HIV Epidemic priority jurisdiction. METHODS: We identified adults (aged 18 years or older) who engaged in primary care between January 2015 and December 2019 and had a documented indication for PrEP. PrEP indications included the presence of a behavioral or sexual risk factor of HIV acquisition or a positive bacterial sexually transmitted infection at the index visit. PrEP prescribing was defined as the proportion of patients with indications for PrEP who received a new prescription for PrEP. We estimated the cumulative incidence of PrEP prescription with corresponding 95% confidence limits (CL). RESULTS: Our study population comprised 2957 individuals, of whom 58% was aged younger than 45 years, 56% was women, 67% was racial or ethnic minorities, and 60% was uninsured or provided care as part of a hospital-based managed care plan for individuals without insurance. We identified 41 individuals who were prescribed PrEP. The cumulative incidence of PrEP prescribing within 1 year of the first documented PrEP indication was 1.3% (95% CL: 0.91% to 1.7%). CONCLUSIONS: Our results suggest extremely low frequency of PrEP prescribing among people with indications for PrEP in an urban safety-net health system. Strategies are needed to improve PrEP implementation in high-priority populations and safety-net settings.

Knowledge needs for implementing HIV pre-exposure prophylaxis among primary care providers in a safety-net health system.

Safety-net health systems are a primary source of care for socioeconomically disadvantaged individuals who may be eligible for HIV pre-exposure prophylaxis (PrEP) and are priority groups under the Ending the HIV Epidemic (EHE) initiative. Nevertheless, little evidence is available about barriers to PrEP implementation in safety-net settings. We aimed to assess the association between PrEP knowledge and prescribing practices, and to ascertain unmet knowledge needs to implement PrEP. In 2019, we surveyed primary care providers (PCPs) in a safety-net health system that serves an EHE priority jurisdiction located in North Texas. Our questionnaire ascertained self-reported prescribing practices, knowledge, and training needs related to PrEP. We used penalized logistic regression to estimate odds ratio (OR) and 95% posterior limits (PL) for the association between provider self-rated knowledge of PrEP and PrEP prescribing. Our study population comprised 62 primary care providers, of whom 61% were female, 60% were non-Hispanic White, 76% were physicians (76%), 57% had ≥ 10 years of practice experience, 45% reported low self-rated PrEP knowledge, and 35% prescribed PrEP in the past year. Providers with low PrEP knowledge had 69% lower odds of prescribing PrEP within the past year (OR = 0.31, 95% PL: 0.12, 0.82). Eligibility for PrEP, side effects and adherence concerns were key unmet knowledge needs. Our findings suggest that low provider PrEP knowledge may be a barrier to PrEP prescribing among safety-net PCPs. Our results provide insight about specific educational needs of PCPs in a safety-net health system, which are amenable to educational intervention.

Rates and Correlates of HIV Incidence in Namibia's Zambezi Region From 2014 to 2016: Sentinel, Community-Based Cohort Study.

BACKGROUND: Direct measures of HIV incidence are needed to assess the population-level impact of prevention programs but are scarcely available in the subnational epidemic hotspots of sub-Saharan Africa. We created a sentinel HIV incidence cohort within a community-based program that provided home-based HIV testing to all residents of Namibia's Zambezi region, where approximately 24% of the adult population was estimated to be living with HIV. OBJECTIVE: The aim of this study was to estimate HIV incidence, detect correlates of HIV acquisition, and assess the feasibility of the sentinel, community-based approach to HIV incidence surveillance in a subnational epidemic hotspot. METHODS: Following the program's initial home-based testing (December 2014-July 2015), we purposefully selected 10 clusters of 60 to 70 households each and invited residents who were HIV negative and aged ≥15 years to participate in the cohort. Consenting participants completed behavioral interviews and a second HIV test approximately 1 year later (March-September 2016). We used Poisson models to calculate HIV incidence rates between baseline and follow-up and multivariable Cox proportional hazard models to assess the correlates of seroconversion. RESULTS: Among 1742 HIV-negative participants, 1624 (93.23%) completed follow-up. We observed 26 seroconversions in 1954 person-years (PY) of follow-up, equating to an overall incidence rate of 1.33 per 100 PY (95% CI 0.91-1.95). Among women, the incidence was 1.55 per 100 PY (95% CI 1.12-2.17) and significantly higher among those aged 15 to 24 years and residing in rural areas (adjusted hazard ratio [aHR] 4.26, 95% CI 1.39-13.13; P=.01), residing in the Ngweze suburb of Katima Mulilo city (aHR 2.34, 95% CI 1.25-4.40; P=.01), who had no prior HIV testing in the year before cohort enrollment (aHR 3.38, 95% CI 1.04-10.95; P=.05), and who had engaged in transactional sex (aHR 17.64, 95% CI 2.88-108.14; P=.02). Among men, HIV incidence was 1.05 per 100 PY (95% CI 0.54-2.31) and significantly higher among those aged 40 to 44 years (aHR 13.04, 95% CI 5.98-28.41; P<.001) and had sought HIV testing outside the study between baseline and follow-up (aHR 8.28, 95% CI 1.39-49.38; P=.02). No seroconversions occurred among persons with HIV-positive partners on antiretroviral treatment. CONCLUSIONS: Nearly three decades into Namibia's generalized HIV epidemic, these are the first estimates of HIV incidence for its highest prevalence region. By creating a sentinel incidence cohort from the infrastructure of an existing community-based testing program, we were able to characterize current transmission patterns, corroborate known risk factors for HIV acquisition, and provide insight into the efficacy of prevention interventions in a subnational epidemic hotspot. This study demonstrates an efficient and scalable framework for longitudinal HIV incidence surveillance that can be implemented in diverse sentinel sites and populations.