Allison L Agwu

• MD, ScM
• Professor (Associate) at Johns Hopkins University

Long-acting injectables (LAIs) for HIV prevention and treatment could dramatically improve health outcomes and health equity for people with HIV and those who could benefit from pre-exposure prophylaxis. Despite widespread acceptability and demand by providers and potential users of LAIs, implementation has been extremely limited since the introduc...

Background: Twice-yearly subcutaneous lenacapavir has been shown to be efficacious for prevention of HIV infection in cisgender women. The efficacy of lenacapavir for preexposure prophylaxis (PrEP) in cisgender men, transgender women, transgender men, and gender-nonbinary persons is unclear. Methods: In this phase 3, double-blind, randomized, ac...

Five long‐acting (LA) antiretrovirals (ARVs) are currently available in a limited number of countries worldwide for HIV‐1 prevention or treatment—cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine. Implementing use of LA ARVs into routine clinical practice requires significant changes to the current framework of HIV‐1 prevention, tr...

Five long‐acting (LA) antiretrovirals (ARVs) are currently available in a limited number of countries worldwide for HIV‐1 prevention or treatment – cabotegravir, rilpivirine, lenacapavir, ibalizumab, and dapivirine. Implementing use of LA ARVs in routine clinical practice requires significant changes to the current framework of HIV‐1 prevention, tr...

Background In 2023, Tennessee replaced $6.2 M in US Centers for Disease Control and Prevention (CDC) human immunodeficiency virus (HIV) prevention funding with state funds to redirect support away from men who have sex with men (MSM), transgender women (TGW), and heterosexual Black women (HSBW) and to prioritize instead first responders (FR), pregn...

While multi-level theories and frameworks have become a cornerstone in broader efforts to address HIV inequities, little is known regarding their application in adolescent and young adult (AYA) HIV research. To address this gap, we conducted a scoping review to assess the use and application of multi-level theories and frameworks in AYA HIV prevent...

Background Annually ∼5,000 women living with HIV give birth in the US. US Public Health Guidelines recommend that perinatally-exposed infants receive antiretrovirals (ARV) to reduce transmission risk. Low risk infants receive 1 ARV (zidovudine, AZT) for 4 weeks, while highest risk infants receive 3 full dose ARVs for 6 weeks. For newborns in the mo...

Background In 2023, the State of Tennessee rejected $6.2M in US Centers for Disease Control and Prevention (CDC) HIV prevention funding, redirecting support away from men who have sex with men (MSM), transgender women (TGW), people who inject drugs (PWID), and heterosexual Black women (HSBW), and towards first responders (FR), pregnant people (PP),...

Background During the COVID-19 pandemic, many US youth with HIV (YHIV) used telehealth services; others experienced disruptions in clinic and antiretroviral therapy (ART) access. Methods Using the Cost-effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent HIV microsimulation model, we evaluated 3 scenarios: 1) Clinic: in-person care; 2...

Shared decision making for infant feeding in the context of HIV in high-resourced settings is necessary to acknowledge patient autonomy, meet increasing patient requests and address the changing reality of perinatal HIV care. In low-to middle-income countries (LMIC), where the majority of individuals living with HIV reside, persons with HIV are rec...

HIV-1 infection in memory CD4+ T cells forms a latent reservoir that is a barrier to cure. Identification of immune biomarkers that correlate with HIV-1 reservoir size may aid with evaluating efficacy of HIV-1 eradication strategies, towards ART-free remission and cure. In adults living with non-perinatal HIV-1, the immune exhaustion marker PD-1 on...

Background: Adherence to antiretroviral treatment (ART) remains the cornerstone of optimal HIV outcomes, including viral suppression (VS), immune recovery, and decreased transmission risk. For many people with HIV (PWH), particularly those with early-acquired HIV, structural, behavioral, and cognitive barriers to adherence and competing priorities...

We assessed breastfeeding outcomes for a cohort of infants born to women living with HIV (WLHIV) at an urban health care center in the United States. Ten infants were exclusively breastfed for a mean duration of 4.4 (1.0-8.6) months. All had negative HIV RNA PCRs at a median age of 16 months.

Background Women with HIV have higher risk of depressive symptoms in the perinatal period. Evidence on how perinatal depressive symptoms affect viral suppression (VS) and adherence to antiretroviral therapy (ART) remains limited. Methods Perinatal depressive symptoms were assessed using 6 items from the AIDS Clinical Trials Group (ACTG) Quality of...

Objectives: To quantify the rate of change in epigenetic age compared to chronological age over time in youth with perinatally-acquired HIV (YPHIV) and youth who are perinatally HIV-exposed uninfected (YPHEU). Design: Longitudinal study of 32 YPHIV and 8 YPHEU with blood samples collected at two time points ≥3 years apart. Methods: DNA methyla...

Background Despite advances in HIV diagnosis and treatment, adolescents and young adults 12-25 years old have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which antiretroviral therapy (ART) adhe...

The ongoing COVID-19 pandemic has devastated many countries with ripple effects felt in various sectors of the global economy. In November 2019, the Global Health Security (GHS) Index was released as the first detailed assessment and benchmarking of 195 countries to prevent, detect, and respond to infectious disease threats. This paper presents the...

Introduction: Worldwide, children who acquired human immunodeficiency virus (HIV) at an early age, either perinatally or through blood transfusion, are reaching adolescence and adulthood due to successful antiretroviral treatment (ART). While many are thriving, a significant proportion face unprecedented multilevel challenges that can affect their...

BACKGROUND Despite advances in human immunodeficiency virus (HIV) diagnosis and treatment, adolescents and young adults (AYA) 12-25 years have high HIV incidence, poor engagement and retention in treatment, and low rates of adherence and virologic suppression when compared to their older counterparts. HIV has emerged as a chronic disease for which...

The ongoing COVID-19 pandemic has devastated many countries with ripple effects felt in various sectors of the global economy. In November 2019, the Global Health Security (GHS) Index was released as the first detailed assessment and benchmarking of 195 countries to prevent, detect, and respond to infectious disease threats. This paper presents the...

Adolescents and young adults, aged 13–24 years, are disproportionately affected by HIV in the United States. Youth with HIV (YHIV) face many psychosocial and structural challenges resulting in poor clinical outcomes including lower rates of medication adherence and higher rates of uncontrolled HIV. The Johns Hopkins Intensive Primary Care clinic, a...

Children with perinatally acquired human immunodeficiency virus (PHIV) face a lifetime of combination antiretroviral treatment that often includes dolutegravir (DTG). DTG, an integrase strand inhibitor that has been linked to weight gain in adults, is increasingly being used in children. Understanding its potential short- and long-term sequelae in...

Importance Many adolescents and young adults in the US are disproportionately affected by HIV. Several others who are uninfected are at risk and in need of effective preventive strategies. The uptake rate of preexposure prophylaxis (PrEP) for HIV prevention has remained low among US adolescents. This review assesses the current status of PrEP uptak...

The HIV latent reservoir in resting memory CD4+ T cells prevents cure. Therapeutics to reactivate and eliminate this reservoir are in clinical trials in adults, but not in pediatric populations. We determined, ex vivo, the inducibility and size of the latent reservoir in perinatal compared with adult infections using the Tat/rev Induced Limiting Di...

Background: Adolescents and young adults (AYA) with HIV experience poorer health outcomes compared to adults. To improve care for AYA with HIV, information about patterns of costly healthcare resource utilization is needed. Methods: Among 13-30-year-olds in the US HIV Research Network, we stratified outpatient visits, ED visits and inpatient day...

Background Adolescents and young adults (AYA) with HIV experience worse health outcomes than adults with HIV in the United States. Little is known about AYA patterns of utilization of costly healthcare resources. Methods We estimated utilization of outpatient, emergency department (ED), and inpatient care among 13–30 year-olds from 2006–2015. We s...

We report the case of a young adolescent male who presented with persistent fever and rhabdomyolysis and was ultimately diagnosed with acute HIV. Rhabdomyolysis is an unusual manifestation of acute HIV that has been rarely reported. However, in the absence of another etiology, we propose that HIV should be considered in the differential for rhabdom...

Background: Accurately estimating HIV disease progression and retention on antiretroviral therapy (ART) can help inform interventions to control HIV microepidemics and mathematical models used to inform health-resource allocation decisions. Our objective was to estimate the monthly probabilities of on-ART CD4 T-cell count progression, mortality, A...

Objectives Current guidelines recommend screening sexually active persons with HIV (PWH) for Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) at least annually. Yet, screening rates in many HIV clinics remain low. In this study, we estimated the number needed to screen (NNS) to detect a NG and/or CT infection at each anatomic site among di...

Background: The retention of youth living with HIV (YLHIV) in adult care after transfer from pediatric care in the United States is a challenge. A targeted comprehensive retention strategy (CRS) may improve retention among YLHIV. Methods: A retrospective cohort study of YLHIV after transfer from pediatric to adult care for patients with at least...

Objectives Several single‐tablet regimens (STRs) are now available and are recommended for first‐line antiretroviral therapy (ART); however, STR use for youth with HIV (YHIV) has not been systematically studied. We examined the characteristics associated with initiation of STRs versus multi‐tablet regimens (MTRs) and the virological outcomes for yo...

Objectives: This study's primary objective was to characterize attitudes to long-acting antiretrovirals (LAARV), among youth aged 13 to 24 years living with perinatally- and non-perinatally-acquired HIV (PHIV and NPHIV, respectively). Secondary objectives included: assessing whether those with detectable HIV RNA PCR viral load had higher enthusias...

BACKGROUND The United States (US) Centers for Disease Control and Prevention (CDC) estimates that approximately 60,000 US youth are living with Human Immunodeficiency Virus (HIV). US youth living with HIV (YLWH) have poorer outcomes compared to adults [1]. With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials...

Background The United States Centers for Disease Control and Prevention estimates that approximately 60,000 US youth are living with HIV. US youth living with HIV (YLWH) have poorer outcomes compared with adults, including lower rates of diagnosis, engagement, retention, and virologic suppression. With Adolescent Medicine Trials Network for HIV/AID...

Background: High-level expression of the Fcγ receptor, CD32hi, on CD4+ T cells was associated with enhanced HIV infection of the latent reservoir in one study of adults on antiretroviral therapy. We tested the hypothesis that CD32 was the preferential marker of the latent HIV reservoir in virally suppressed, perinatally, HIV-infected adolescents....

The majority of new human immunodeficiency virus (HIV) infections in children are acquired perinatally, thus emphasizing the importance of effective management of this vulnerable group of infants born to mothers with HIV. Dramatic declines in new childhood HIV infections since 1995 are largely attributable to global efforts to prevent mother-to-chi...

IntroductionGaps in Medicaid enrollment may affect HIV outcomes. We evaluated factors associated with Medicaid enrollment gaps and their effect on viral suppression (VS) within the HIV Research Network (HIVRN).Methods We used a combined dataset with Medicaid enrollment files from 2006-10 and HIVRN demographic and clinical data. A gap was defined as...

Background: Prescription opioid use is greater among people living with HIV (PLWH), yet little is known about the prevalence of specific types of high-risk use among these individuals. Setting: We analyzed clinical and demographic data from the HIV Research Network (HIVRN) and prescribing data from Medicaid for non-cancer patients seeking HIV tr...

Objective: To evaluate the impact of an HIV pre-exposure prophylaxis (PrEP) education intervention on PrEP awareness and use among men who have sex with men (MSM) attending a sexually transmitted diseases (STD) clinic. Data sources/study setting: Men who have sex with men STD clinic patients. Study design: We estimated a difference-in-differen...

Introduction Management of persistently non-adherent youth living with HIV (YLHIV) with virologic failure (VF) on combination antiretroviral therapy (cART) remains challenging. One strategy has been using 3TC/ FTC monotherapy (3TC/FTC), which in the presence of the M184V resistance mutation, does not suppress viral replication nor select for additi...

Baseline immune activation of 3TC/FTC monotherapy arm by immunologic deterioration. (DOCX)

Protocol. (DOC)

CONSORT checklist. (DOC)

Baseline immune characteristics on 3TC/FTC monotherapy arm by immunologic deterioration. (DOCX)

The disparate proportion of new human immunodeficiency virus (HIV) infections occurring annually among young sexual minority men of color in the United States constitutes a public health emergency. Young men of color who have sex with men between the ages of 13 and 24 years make up a group with high HIV incidence, representing approximately 20% of...

Importance: As perinatally human immunodeficiency virus-infected youth (PHIVY) in the United States grow older and more treatment experienced, clinicians need updated information about the association of age, CD4 cell count, viral load (VL), and antiretroviral (ARV) drug use with risk of opportunistic infections, key clinical events, and mortality...

With the increasing proportion of youth living with human immunodeficiency virus (YLHIV) and the aging of the perinatally infected population, there is a need for clinical services that are “youth friendly” to address the multiple challenges YLHIV face in terms of engagement in care and maintenance of combination antiretroviral therapy (cART). Litt...

Background Youth have residual thymic tissue and potentially greater capacity for immune reconstitution than adults after initiation of combination antiretroviral therapy (cART). However, youth face behavioral and psychosocial challenges that may make them more likely than adults to delay ART initiation and less likely to attain similar CD4 outcome...

Predicted mean CD4 levels by age group and baseline CD4 at Time of cART initiation and 24 Weeks after cART Initiation. (DOCX)

Predicted (Adjusted) Mean CD4 Levels, by Baseline CD4 and 24-Week Periods from Baseline (Model 2). Note: Entries are mean CD4 levels predicted by regression model 2, averaging over other covariates. (DOCX)

Unadjusted Median CD4 Levels, by Age Group and Weeks from cART Initiation. Cell entries are median CD4, number of observations, and number of unique patients. Number of observations exceeds number of patients in each time interval because one person can contribute multiple observations. Observations in different time periods are not independent; th...

Random Effects Parameters from Second Regression Model. Note: SD- standard deviation; corr- correlation. (DOCX)

Predicted (Adjusted) Mean CD4 Levels, by Age Group and 24-Week Periods from Baseline (Model 2). Note: Entries are mean CD4 levels predicted by regression model 2, averaging over other covariates. (DOCX)

Patients with HIV have increased risk of cardiovascular disease. Though evidence of subclinical atherosclerosis in perinatally acquired HIV (PHIV) is available, myocardial infarction has not been described in this population. We report a case of myocardial infarction in a patient with PHIV with a brief literature review.

Purpose of Review An unprecedented number of youth living with HIV (YLHIV) are aging into adolescence and young adulthood, increasing concerns about the possibility of these youth being lost in the transition from supported care (sometimes in pediatric settings) to more independent healthcare settings. This could further the emerging disparities in...

Background: In the current antiretroviral (ART) era, the evolution of HIV guidelines and emergence of new ART agents might be expected to impact the times to ART initiation and HIV virologic suppression. We sought to determine if times to AI and virologic suppression decreased and if disparities exist by age, race/ethnicity, and HIV risk. Methods...

Background: Prior to Affordable Care Act (ACA) implementation in 2014, 100,000 persons living with HIV (PLWH) lacked healthcare coverage and relied on a safety net of Ryan White HIV/AIDS Program support, local charities, or uncompensated care (RWHAP/Uncomp) to cover visits to HIV providers. We compared HIV provider coverage pre (2011-2013) versus...

Background: Perinatally HIV-infected (PHIV) children and youth are often heavily treatment-experienced, with resultant antiretroviral (ARV) resistance and limited treatment options. For those with virologic failure (VF), new agents such as CCR5 (R5) antagonists may be useful; however, reports of R5 antagonist susceptibility in children have mostly...

Limited data exist on how structures of care impact retention among youth living with HIV (YLHIV). We describe the availability of youth-friendly structures of care within HIV Research Network (HIVRN) clinics and examine their association with retention in HIV care. Data from 680 15- to 24-year-old YLHIV receiving care at 7 adult and 5 pediatric cl...

Antiretroviral (ARV) management in pediatrics is a challenging process in which multiple barriers to optimal therapy can lead to poor clinical outcomes. In a pediatric HIV clinic, we implemented a systematic ARV stewardship program to evaluate ARV regimens and make recommendations for optimization when indicated. A comprehensive assessment tool was...

Background: There is limited information on long-term consequences of continuing combination antiretroviral therapy (cART) consisting of <3 active drugs in treatment-experienced youth with perinatal HIV (PHIV). This study describes the clinical outcomes of PHIV youth who maintained virologic suppression (VS) for ≥1 year despite receiving cART with...

Objective: This study compared 12-month CD4 and viral load outcomes in HIV-infected children and adolescents with virological failure, managed with four treatment switch strategies. Design: This observational study included perinatally HIV-infected (PHIV) children in the Pediatric HIV/AIDS Cohort Study (PHACS) and Pediatric AIDS Clinical Trials...

Background: The HIV care continuum (diagnosis, linkage to care, retention in care, receipt of antiretroviral therapy (ART), viral suppression) has been used to identify opportunities for improving the delivery of HIV care. Continuum steps are typically calculated in a conditional manner, with the number of persons completing the prior step serving...

Screening persons living with HIV for gonorrhea and chlamydia has been recommended since 2003. We compared annual gonorrhea/chlamydia testing to syphilis and lipid testing among 19,368 adults (41% men who have sex with men, 30% heterosexual men, 29% women) engaged in HIV care. In 2004, 22%, 62%, and 70% of all patients were tested for gonorrhea/chl...

Measures of immune outcomes in youth who initiate combination antiretroviral therapy (cART) early in HIV infection are limited. Adolescent Trials Network 061 examined changes over 48 weeks of cART in T-cell subsets and markers of T-cell and macrophage activation in subjects with pre-therapy CD4 > 350 cells/mm. All subjects had optimal viral suppres...

In the United States, 21 years is a critical age of legal and social transition, with changes in social programs such as public insurance coverage. Human immunodeficiency virus (HIV)-infected youth have lower adherence to care and medications and may be at risk of loss to follow-up (LTFU) at this benchmark age. We evaluated LTFU after the 22nd birt...

To compare the growth patterns in the first year of life between children born to perinatally HIV-infected (PHIV) vs. nonperinatally HIV-infected (NPHIV) women in the United States. Retrospective cohort study of HIV-infected pregnant women who received care and delivered a live-born at two urban tertiary centers from January 2004 to March 2012. We...

Pneumocystis jiroveci pneumonia (PJP) is associated with high morbidity and mortality after hematopoietic stem cell transplantation (HSCT). Little is known about PJP infections after HSCT because of the rarity of disease given routine prophylaxis. We report the results of a CIBMTR study evaluating the incidence, timing, prophylaxis agents, risk fac...

Retention in care is important for all HIV-infected persons and is strongly associated with initiation of antiretroviral therapy and viral suppression. However, it is unclear how retention in care and age interact to effect viral suppression. We evaluated whether the association between retention and viral suppression differed by age at entry into...

Background The transmission of human immunodeficiency virus (HIV) among youth through high-risk behaviors continues to increase. Retention in Care is associated with positive clinical outcomes and a decrease in HIV transmission risk behaviors. We evaluated the clinical and demographic characteristics of non–perinatally HIV (nPHIV)-infected youth as...

Objectives Guidelines recommend hepatitis C virus (HCV) screening for all people living with HIV (PLWH). Understanding HCV testing practices may improve compliance with guidelines and can help identify areas for future intervention. Methods We evaluated HCV screening and unnecessary repeat HCV testing in 8,590 PLWH initiating care at 12 U.S. HIV c...

We examined trends in health insurance coverage among 36,999 HIV-infected adults in care at 11 U.S. HIV clinics between 2006 and 2012. Aggregate health insurance coverage was stable during this time. The proportions of patient-years with private, Medicaid, Medicare, and no insurance during this period were 15.9%, 35.7%, 20.1%, and 28.4%, respective...

Young people with behaviorally acquired HIV (BHIV) are less likely than adults to initiate antiretroviral therapy (ART) despite meeting treatment criteria. We explored critical factors involved in healthcare providers' decision making regarding ART initiation for young people with BHIV (aged 12-24 years). Semistructured interviews were conducted wi...

This was a retrospective study of nPHIV-infected 12- to 24-year-olds presenting for care at HIV Research Network (HIVRN) sites between 2002 and 2010.¹ The 13 geographically distributed sites that contributed data over the study period all had institutional review board approval for the study (from Alameda County Medical Center, Children's Hospital...

Background The Johns Hopkins Children's Medical and Surgery Center developed a Web-based Antimicrobial Stewardship Program (ASP) in 2005. The present study aimed to assess longitudinal antimicrobial request and approval patterns for this ASP. Methods We analyzed a total of 16,229 antimicrobial requests for 3,542 patients between June 1, 2005, and...

Abstract Non-nucleoside reverse transcriptase inhibitors (NNRTIs) are commonly used in pediatric patients; however, rapid development of resistance, due to non-adherence and cross-resistance, results in their discontinuation and limits their recycling. We evaluated the clinical experience of recycling NNRTIs despite documented NNRTI resistance (NNR...

Chronic viral hepatitis is a potentially important determinant of healthcare utilization among persons living with HIV (PLWH). We describe hospitalization rates and reasons for hospitalization among PLWH stratified by co-infection with hepatitis B virus (HBV) and/or hepatitis C virus (HCV). Laboratory, demographic, and hospitalization data were obt...

Retention in care is important for all HIV-infected patients, but may be more important for people with advanced HIV disease. We evaluated whether the association between retention in care and viral suppression differed by HIV disease severity. A repeated cross-sectional analysis (2006-2011) involving 35,433 adults at 18 U.S. HIV clinics. Multivari...

Background: In the modern antiretroviral (ART) era our understanding of HIV infection and treatments have advanced considerably. As a result, HIV clinical care has evolved. We sought to evaluate the time to ART initiation (AI) and HIV virologic suppression (VS) in a large clinical cohort in the modern ART era. Methods: We reviewed data from all n...

Background Due to successful antiretroviral therapy (ART), perinatally human immunodeficiency virus (PHIV)–infected children are reaching adolescence and young adulthood. Adolescence is characterized by factors (eg, increased risk-taking) that may hamper management. We examined PHIV-infected youth in a multisite US cohort, assessing factors associa...

Three decades into the HIV/AIDS epidemic there is a growing cohort of perinatally HIV-infected adolescents globally. Their survival into adolescence and beyond represent one of the major successes in the battle against the disease that has claimed the lives of millions of children. This population is diverse and there are unique issues related to a...