Human Immunodeficiency Virus (HIV) Care Continuum Outcomes After Transition to Adult Care Among a Prospective Cohort of Youth With HIV in Atlanta, Georgia.

BACKGROUND: Healthcare transition from pediatric to adult-oriented clinical settings is often viewed as a high-risk time for care disengagement. However, there is a paucity of prospective, longitudinal research documenting human immunodeficiency virus (HIV) care outcomes after healthcare transition. METHODS: We conducted a prospective, observational cohort study of healthcare transition among youth enrolled at an HIV care center in Atlanta, Georgia. Pediatric clinic patients (average age, 24 years) were enrolled up to 3 months before the expected transition and were followed up to determine linkage, retention, and viral suppression in adult care through electronic medical record abstractions at the baseline and at 6, 12, 18, and 24 months. RESULTS: The majority of our cohort (n = 70) was male (88.6%) and black (92.9%) and acquired HIV horizontally (80%). Most of our cohort was linked to adult care by 12 months (84%) after enrollment. Of those who linked to adult care by 12 months, retention rates were 86% (95% confidence interval, 78%-94%) at 6 months, 76% (66%-86%) at 12 months, and 66% (55%-78%) at 18 and 24 months. Once in adult care, the proportion with viral suppression was stable (73% at baseline and 74%, 77%, 67%, and 78% at 6, 12, 18, and 24 months, respectively). CONCLUSIONS: Although most youth successfully linked to adult care, retention rates decreased over the 24-month follow-up period. Rates of viral suppression were stable for those who remained in care. Strategies to support retention in adult care will be critical to optimizing this transition for youth with HIV.

HIV in youth prevention in the emergency department initiative: A survey of pediatric emergency medicine providers.

BACKGROUND: The incidence of HIV among adolescents remains high, and adolescents are known to participate in sexual behaviors that increase their risk for HIV, such as unprotected sex and sex with multiple partners. HIV pre-exposure prophylaxis (PrEP) has been shown to be effective at preventing HIV when taken daily and is approved by the FDA for use in adolescents. Efforts to screen patients in adult emergency departments and connect them with PrEP services have been validated. We surveyed pediatric emergency medicine (PEM) providers to determine their knowledge of PrEP, prescribing practices, willingness to prescribe, and barriers to a screening protocol in the pediatric emergency department (PED). METHODS: We administered a survey to a multidisciplinary group of PEM providers to measure knowledge, use, willingness, and implementation barriers to PrEP as well as elements needed for a successful referral system. RESULTS: A total of 87 responses were included for analysis. While 79.1% of all providers had heard of PrEP, only 14.8% of prescribing providers had ever discussed PrEP with a patient, and none had ever prescribed PrEP. Overall, 76.3% of all providers were knowledgeable about PrEP based on answers to true/false questions, with prescribing providers significantly more likely to be knowledgeable compared to nurses (p = 0.005). Knowledgeable providers had higher willingness scores to refer for PrEP compared to providers who were not knowledgeable. Ninety-two percent of providers felt a PrEP referral process from the PED would be feasible. Creation of an eligibility algorithm and educational materials were the most common efforts providers preferred to make them more likely to refer for PrEP. The most notable barriers perceived by providers included patient noncompliance with therapy (20.9%), acceptance of PrEP discussion among patients and parents (19.8%), and cost of therapy (15.1%). CONCLUSION: PEM providers are knowledgeable about PrEP but have little experience with discussing or prescribing PrEP. Their willingness to refer for PrEP and anticipated feasibility of a PrEP referral system is encouraging. These results support the need for future educational efforts among PEM providers and creation of referral systems for PrEP services from the PED.

Factors Associated With Anal High-Grade Intraepithelial Lesions and Carcinoma Among Young Men Who Have Sex With Men and Transgender Women With HIV in Atlanta.

OBJECTIVE: This study aimed to evaluate factors associated with anal high-grade intraepithelial lesions (HSIL) and anal carcinoma among young men who have sex with men (MSM) and transgender women (TW) with HIV in Atlanta, GA, to better inform screening guidelines and preventative measures. MATERIALS AND METHODS: Cross-sectional retrospective chart review was completed for cisgender MSM and TW with HIV aged 13-25 years at the Grady Ponce and Family Youth Clinic in Atlanta, GA, from 2009 to 2020. High-grade anal disease was defined as anal intraepithelial neoplasia (AIN) 2, 3, or anal carcinoma (AIN 2+). Associations between clinical and demographic factors with AIN 2+ were estimated using logistic regression. Adjusted odds ratios (aORs) and associated 90% CIs are reported. RESULTS: One hundred nine MSM and TW with HIV who underwent anoscopy were included. One hundred three participants received anal biopsies, and 62% had AIN 2+. Being incompletely or unvaccinated against human papillomavirus (HPV, 0-2 doses) relative to being fully vaccinated (3 doses; aOR = 5.85; 90% CI = 1.28-26.83; p = .06) and having ever received surgical treatment for anogenital HPV (aOR = 2.89; 90% CI = 1.10-7.65; p = .07) were associated with AIN 2+, controlling for age and CD4 T-cell count at time of biopsy. CONCLUSIONS: Our study found a high prevalence of anal HSIL among young MSM and TW with HIV. Those who had ever received surgical treatment for anogenital HPV and those who were incompletely or unvaccinated against HPV were more likely to have HSIL. Our data emphasize the urgent need to improve HPV vaccination efforts and to pursue larger surveillance studies of anal HSIL and carcinoma among young MSM and TW with HIV.

Feasibility and acceptability of B6: a social capital program for young Black gay, bisexual and other men who have sex with men living with HIV.

Young Black gay, bisexual and other men who have sex with men (YB-GBMSM) are disproportionately burdened by HIV and often exhibit suboptimal engagement in HIV care. With the goal of increasing engagement in HIV care, we designed a culturally specific, theory-based group-level program, Brothers Building Brothers by Breaking Barriers (B6), which aimed to strengthen resilience and social capital among YB-GBMSM living with HIV. We conducted a pilot trial to evaluate the program's acceptability and feasibility. Through clinic-based recruitment and community outreach events, we recruited and enrolled 71 YB-GBMSM into the study. Participants were randomized to either the B6 program or a control comparison program. Post-session evaluation surveys and in-depth qualitative interviews showed B6 to have high levels of acceptability and satisfaction. Specifically, participants described benefits to interacting in a group with other YB-GBMSM, and several described increased comfort with their own gay identities after participation. No adverse events or safety concerns were reported. However, there were challenges to feasibility, as reflected in recruitment and retention rates. The B6 program was highly acceptable among YB-GBMSM living with HIV; however, innovative program delivery methods and implementation strategies will be needed to improve recruitment and retention in future implementation of B6.

Understanding social capital among young black gay and bisexual men living with HIV: a qualitative exploration.

Social capital, defined as the sum of an individual's resource-containing, reciprocal and trustworthy social network connections, has been associated with improved engagement in care among people living with HIV globally. We conducted a qualitative interview study of social capital among 28 young Black gay, bisexual and other men who have sex with men ages 18-29 living with HIV in Atlanta, Georgia. We asked participants about bonding capital (relationships between individuals with similar demographic characteristics), bridging capital (relationships with individuals of different backgrounds), collective efficacy (involvement with community organisations) and satisfaction with their social networks. We found that participants described bonding capital from friends and family in depth, while more gaps were noted in bridging capital and collective efficacy. Bonding capital derived from families was especially critical to participants' satisfaction with their social capital. Findings suggest that interventions targeting young Black gay, bisexual and other men who have sex with men should build upon strong bonds with family and friends, and/or fill gaps in bridging capital and collective efficacy by connecting young men to mentors and organisations.

Comparison of Targeted and Routine Adolescent HIV Screening in a Pediatric Emergency Department.

OBJECTIVES: The aims of the study were (1) to compare targeted and routine HIV screening in a pediatric emergency department (PED) and (2) to compare provider documented HIV risk assessment with adolescent perception of HIV risk assessment conducted during the PED visit. METHODS: This prospective study ran concurrent to a PED routine HIV screening pilot. Adolescents could be tested for HIV by the PED provider per usual care (targeted testing); if not tested, they were approached for the routine screening pilot. A subset of adolescents completed a questionnaire on HIV risk. χ 2 analysis compared adolescents with targeted testing and routine screening. HIV-tested patients were asked if HIV risk was assessed; κ analysis compared this with documentation in the provider note. RESULTS: Over 4 months, 107 adolescents received targeted testing and 344 received routine screening. One 14-year-old patient tested positive by routine screening; this adolescent had 2 PED visits without targeted testing within 60 days. Compared with routine screening, adolescents with targeted testing were more likely female (82% vs 57%, P < 0.001), 16 years or older (71% vs 44%, P < 0.001), or had genitourinary/gynecologic concerns (48% vs 6%, P < 0.001). Adolescents with HIV risk factors were missed by targeted testing but received routine screening. Adolescents with documented HIV risk assessment were more likely to receive targeted testing. There was moderate agreement (κ = 0.61) between provider documentation and adolescent perception of HIV risk assessment. CONCLUSIONS: There are gaps in PED HIV risk assessment and testing, which may miss opportunities to diagnose adolescent HIV. Routine HIV screening addresses these gaps and expands adolescent HIV testing in the PED.

Homonegativity Experienced over the Life Course by Young Black Gay, Bisexual and Other Men Who Have Sex with Men (YB-GBMSM) Living with HIV in Atlanta, Georgia.

Minority stress theory posits that homonegativity-whether experienced, anticipated, or internalized-adversely impacts health. We conducted qualitative interviews with 28 YB-GBMSM living with HIV to explore manifestations of homonegativity over the life course. Thematic analysis identified patterns in the ways that homonegativity was discussed at different points in participants' lives. Stifling, and sometimes traumatic, familial and religious environments led to experienced homonegativity early in life. These experiences led to anticipated and internalized homonegativity, which in turn shaped sexual identity formation processes in adolescence and into young adulthood. Ultimately, many participants distanced themselves from home environments, seeking and often finding extrafamilial support. Most participants eventually reached self-acceptance of both their sexuality and HIV status. In conclusion, experienced, anticipated and internalized homonegativity were pervasive as YB-GBMSM navigated family and religious environments over the life course. Future interventions should work with youth, families, and churches to prevent these harmful experiences.

Beyond "purposeful and planned": varied trajectories of healthcare transition from pediatric to adult-oriented care among youth living with HIV.

Healthcare transition (HCT) from pediatric to adult-oriented healthcare is ideally conceptualized as a planned, continuous process characterized by communication between multiple stakeholders. However, empirical data is lacking regarding processes through which youth living with HIV (YLHIV) are actually transitioned to adult care. We conducted a qualitative study to gain a more comprehensive understanding of both pediatric and adult provider perspectives on the HCT process for YLHIV. Our study included focus groups discussions with 24 (11 pediatric and 13 adult) providers at a comprehensive HIV care center in the Southeastern United States. Providers described YLHIV and their HCT trajectories as diverse and complex. They described three distinct HCT trajectories: the Ideal Transition, the Abrupt Transition, and the De Facto Transition. Providers agreed that the most important determinant of successful engagement in adult-oriented care (post-HCT) appeared to be consistent prior engagement while in pediatric care (pre-HCT). In summary, risk for disengagement is not uniform among YLHIV transitioning to adult care, and HCT does not always occur in a seamless or linear fashion. Our data suggest that interventions aiming to improve HCT should be more tailored, focusing intensified efforts on those YLHIV with difficulty maintaining consistent engagement in pediatric care.

HIV Care Continuum among Postpartum Women Living with HIV in Atlanta.

Introduction: While increased healthcare engagement and antiretroviral therapy (ART) adherence occurs during pregnancy, women living with HIV (WLWH) are often lost to follow-up after delivery. We sought to evaluate postpartum retention in care and viral suppression and to identify associated factors among WLWH in a large public hospital in Atlanta, Georgia. Methods: Data from the time of entry into prenatal care until 24 months postpartum were collected by chart review from WLWH who delivered with ≥20 weeks gestational age from 2011 to 2016. Primary outcomes were retention in HIV care (two HIV care visits or viral load measurements >90 days apart) and viral suppression (<200 copies/mL) at 12 and 24 months postpartum. Obstetric and contraception data were also collected. Results: Among 207 women, 80% attended an HIV primary care visit in a mean 124 days after delivery. At 12 and 24 months, respectively, 47% and 34% of women were retained in care and 41% and 30% of women were virally suppressed. Attending an HIV care visit within 90 days postpartum was associated with retention in care at 12 months (aOR 3.66, 95%CI 1.72-7.77) and 24 months (aOR 4.71, 95%CI 2.00-11.10) postpartum. Receiving ART at pregnancy diagnosis (aOR 2.29, 95%CI 1.11-4.74), viral suppression at delivery (aOR 3.44, 95%CI 1.39-8.50), and attending an HIV care visit within 90 days postpartum (aOR 2.40, 95%CI 1.12-5.16) were associated with 12-month viral suppression, and older age (aOR 1.09, 95% CI 1.01-1.18) was associated with 24-month viral suppression. Conclusions: Long-term retention in HIV care and viral suppression are low in this population of postpartum WLWH. Prompt transition to HIV care in the postpartum period was the strongest predictor of optimal HIV outcomes. Efforts supporting women during the postpartum transition from obstetric to HIV primary care may improve long-term HIV outcomes in women.

Regular Marijuana Use is Associated with Poor Viral Suppression in HIV-Infected Adolescents and Young Adults.

There is a paucity of data regarding the impact of drug use on HIV suppression and care retention among adolescents and young adults (AYAs). We recruited a clinic-based sample of HIV infected AYAs to assess the prevalence of self-reported drug use. Clinical data, including retention and viral suppression, were abstracted from the electronic medical record. Logistic regression was used to evaluate marijuana and illicit drug use associations and to identify other risk factors. Of 200 participants (mean age 21, 2.4 years, 69% horizontally infected), 46% reported current drug use, with marijuana as the most commonly used drug. Any illicit drug use (aOR 1.99, 95% CI 1.06-3.73, p = 0.032) and lower education (aOR 2.11, 95% CI 1.09-4.08, p = 0.046) were associated with poor viral suppression in multivariable analyses. Considering marijuana use only, an association with poor viral suppression was more pronounced (aOR 2.10, 95% CI 1.12-3.94, p = 0.021). Drug use did not have a significant association with retention in care, but AYAs who were retained in HIV care were less likely to have poorly suppressed HIV (aOR 0.22, 95% CI 0.10-0.49, p < 0.001). High prevalence of marijuana use among HIV infected AYAs, and its association with poorly suppressed HIV, demonstrates the need for intervention strategies to decrease its consumption.

Social Capital, Depressive Symptoms, and HIV Viral Suppression Among Young Black, Gay, Bisexual and Other Men Who Have Sex with Men Living with HIV.

Social capital, the sum of an individual's resource-containing social network connections, has been proposed as a facilitator of successful HIV care engagement. We explored relationships between social capital, psychological covariates (depression, stigma and internalized homonegativity), and viral suppression in a sample of young Black gay, bisexual and other men who have sex with men (YB-GBMSM). We recruited 81 HIV-positive YB-GBMSM 18-24 years of age from a clinic setting. Participants completed a cross-sectional survey, and HIV-1 viral load (VL) measurements were extracted from the medical record. Sixty-five percent (65%) were virally suppressed (HIV-1 VL ≤ 40 copies/ml). Forty-seven percent (47%) had a positive depression screen. Depressive symptoms affected viral suppression differently in YB-GBMSM with lower vs. higher social capital (p = 0.046, test for statistical interaction between depression and social capital). The odds of viral suppression among YB-GBMSM with lower social capital was 93% lower among those with depressive symptoms (OR 0.07, p = 0.002); however, there was no association between depressive symptoms and viral suppression among those with higher social capital. Our results suggest that social capital may buffer the strong negative effects of depressive symptoms on clinical outcomes in YB-GBMSM living with HIV. In addition to treating depression, there is a role for interventions to augment social capital among YB-GBMSM living with HIV as a strategy for enhancing care engagement.

Brothers Building Brothers by Breaking Barriers: development of a resilience-building social capital intervention for young black gay and bisexual men living with HIV.

Young Black gay/bisexual and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV/AIDS. Novel intervention strategies are needed to optimize engagement in HIV care for this population. We sought to develop a group-level intervention to enhance resilience by augmenting social capital (defined as the sum of resources in an individual's social network) among YB-GBMSM living with HIV, with the ultimate goal of improving engagement in HIV care. Our multiphase, community-based participatory research (CBPR) intervention development process included: (1) Development and maintenance of a youth advisory board (YAB) comprised of YB-GBMSM living with HIV; (2) Qualitative in-depth interviews with YB-GBMSM living with HIV; (3) Qualitative in-depth interviews with care and service providers at clinics and community-based organizations; and (4) Collaborative development of intervention modules and activities with our YAB, informed by social capital theory and our formative research results. The result of this process is Brothers Building Brothers By Breaking Barriers, a two-day, 10-module group-level intervention. The intervention does not focus exclusively on HIV, but rather takes a holistic approach to supporting youth and enhancing resilience. Intervention modules aim to develop resilience at the individual level (exploration of black gay identity, development of critical self-reflection and coping skills), social network level (exploring strategies for navigating family and intimate relationships) and community level (developing strategies for navigating clinical spaces and plans for community participation). Most intervention activities are interactive, in order to facilitate new social network connections - and accompanying social capital - within intervention groups. In summary, our intensive CBPR approach resulted in a novel, culturally-specific intervention designed to enhance HIV care engagement by augmenting resilience and social capital among YB-GBMSM living with HIV.

Prevalence of Anal Squamous Intraepithelial Lesions in HIV-1-Infected Young Men Who Have Sex With Men and Transwomen.

OBJECTIVE: Anal cancer rates are increasing among HIV-infected persons. Although an efficacious human papillomavirus (HPV) vaccine is available, HPV vaccination rates remain low. Therefore, providers perform anal cancer screening, but there is no consensus on the optimal methods or timing of screening. This study was performed to determine the prevalence of and factors associated with anal squamous intraepithelial lesions in sexually active HIV-infected young men who have sex with men and transgender women. MATERIALS AND METHODS: We performed a single-center, retrospective study of sexually active HIV-infected young men who have sex with men and transgender women aged 13 to 24 years at an HIV clinic in Atlanta GA from 2009 to 2016. We used analysis of variance and χ tests of independence to evaluate bivariate associations and identify demographic, behavioral, and clinical risk factors. RESULTS: Of 314 subjects with a mean (SD) age of 20.4 (2.1) years at initial anal cytology testing, 5% had completed the HPV vaccine series at or before the time that cytology was obtained. Ninety-five percent of the anal cytology tests obtained were abnormal, and 72 (29%) of those subjects returned for diagnostic testing either by intraoperative biopsy or high-resolution anoscopy. Fifty-seven percent of those who underwent biopsy had histologic high-grade squamous intraepithelial lesions including 2 cases of carcinoma in situ. A history of greater than 20 lifetime sexual partners was associated with abnormal histology (probability < 0.001, p = .017). CONCLUSIONS: Our study highlights the value of early, standardized screening to avoid missing anal dysplasia or cancer, particularly in unvaccinated persons with high numbers of sexual partners.

Incidence of Sexually Transmitted Infections in Youth with HIV During Pre-COVID and COVID Era.

Adolescents and young adults (AYAs) living with HIV have high rates of co-sexually transmitted infections (STIs). During the coronavirus disease (COVID) pandemic, STI prevention strategies, including access to testing/treatment facilities, availability of health care workers, and condom availability, may have decreased. This study aimed to determine if differences in STI incidence for first infection and reinfection existed between the pre-COVID and COVID eras in a cohort of AYAs living with HIV in Atlanta, GA. Retrospective chart review was conducted for all patients between ages 13 and 24 at the Grady Ponce Clinic. Two eras were identified: a pre-COVID era (January 1, 2009-December31, 2019) and a COVID era (January 1, 2020-June 30, 2021). STIs recorded included gonorrhea, chlamydia, human papillomavirus, syphilis, trichomonas, herpes simplex virus, lymphogranuloma venereum, hepatitis C, bacterial vaginosis, and chancroid. First and recurrent incidence rates for any STIs were reported. Our sample included 766 sexually active AYAs with HIV. A total of 721 patients were included in the pre-COVID era and 583 (80.9%) had at least one STI. A total of 337 patients were included in the COVID era, and 158 had at least one STI (46.9%). The overall first STI incidence rate increased from 42.47 to 58.67 per 100 person-years (PY) and the recurrent STI incidence rate increased from 121.50 to 169.85 per 100 PY from the pre-COVID to the COVID era (p < 0.001). Our study demonstrated significantly higher incidence rates of first and recurrent STIs in AYAs living with HIV in the COVID era. We urge continuation of existing STI prevention programs to avoid secondary clinical and economic adverse effects of increased infections.

Incidence of SARS-CoV-2 seropositivity in pediatric healthcare workers prior to widespread vaccination: A 5-month longitudinal cohort study.

OBJECTIVES: Determine SARS-CoV-2 IgG antibody incidence over time in unvaccinated pediatric healthcare workers (pHCWs). DESIGN: A prospective longitudinal cohort of unvaccinated pHCWs measuring the incidence of new infection after initial prevalence was established at 4.1% with seropositive predominance in emergency department (ED)-based pHCWs. Serum samples were collected at follow-up visits to detect new SARS-CoV-2 seropositivity. Univariate analysis was performed to estimate different incidence rates between participant demographics, job, employment location, and community risk factors. Anxiety levels about COVID-19 were collected. SARS-CoV-2 antibody decay postinfection and neutralization antibodies were evaluated. Log-linear Poisson regression models were used to estimate incidence. RESULTS: Of 642 initially enrolled, 390 pHCWs presented for at least one follow-up serology test after baseline analysis. The incidence of SARS-CoV-2 seropositivity was 8.2%. The seropositive cohort, like the negative one, consisted mainly of females in non-ED settings and nonphysician roles. There were no statistically significant differences in incidence across variables. Seropositive participants dropped antibody titers by 50% at 3 months. Neutralization antibodies correlated to SARS-CoV-2 binding antibodies (r = 0.43, P < 0.0001). CONCLUSION: The incidence of seropositivity was 8.2%. Although seropositivity was higher among ED staff during the early stages of the pandemic, this difference declined over time, likely due to the universal adoption of personal protective equipment.

Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study.

BACKGROUND: Long-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study. METHODS: In this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m2 and had been on stable ART for at least 90 consecutive days with an HIV-1 viral load of less than 50 copies per mL at a participating IMPAACT study site. Participants had to be willing to continue their pre-study ART during cohort 1. The primary objectives of the study were to confirm doses for oral and injectable cabotegravir and for injectable rilpivirine in adolescents living with HIV. This analysis of participant-reported outcomes included a face scale assessment of pain at each injection and a Pediatric Quality of Life Inventory (PedsQL) at baseline and week 16 for participants in the USA, South Africa, Botswana, and Thailand. A subset of 11 adolescents and 11 parents or caregivers in the USA underwent in-depth interviews after receipt of one or two injections. This trial is registered at ClinicalTrials.gov, NCT03497676. FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections. INTERPRETATION: High acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV. FUNDING: National Institutes of Health and ViiV Healthcare.

Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study.

BACKGROUND: Combined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents. METHODS: In this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m2) with HIV-1 on daily oral ART were enrolled at 15 centres in four countries (Botswana, South Africa, Thailand, and the USA). After 4-6 weeks of oral cabotegravir (cohort 1C) or rilpivirine (cohort 1R), participants received intramuscular long-acting cabotegravir or long-acting rilpivirine every 4 weeks or 8 weeks per the adult dosing regimens, while continuing pre-study ART. The primary outcomes were assessments of safety measures, including all adverse events, until week 4 for oral cabotegravir and until week 16 for long-acting cabotegravir and long-acting rilpivirine, and pharmacokinetic measures, including the area under the plasma concentration versus time curve during the dosing interval (AUC0-tau) and drug concentrations, at week 2 for oral dosing of cabotegravir and at week 16 for intramuscular dosing of cabotegravir and rilpivirine. Enrolment into cohort 1C or cohort 1R was based on the participant's pre-study ART, meaning that masking was not done. For pharmacokinetic analyses, blood samples were drawn at weeks 2-4 after oral dosing and weeks 4-16 after intramuscular dosing. Safety outcome measures were summarised using frequencies, percentages, and exact 95% CIs; pharmacokinetic parameters were summarised using descriptive statistics. This trial is registered at ClinicalTrials.gov, NCT03497676, and is closed to enrolment. FINDINGS: Between March 19, 2019, and Nov 25, 2021, 55 participants were enrolled: 30 in cohort 1C and 25 in cohort 1R. At week 16, 28 (97%, 95% CI 82-100) of the 29 dose-evaluable participants in cohort 1C and 21 (91%; 72-99) of the 23 dose-evaluable participants in cohort 1R had reported at least one adverse event, with the most common being injection-site pain (nine [31%] in cohort 1C; nine [39%] in cohort 1R; none were severe). One (4%, 95% CI 0-22) participant in cohort 1R had an adverse event of grade 3 or higher, leading to treatment discontinuation, which was defined as acute rilpivirine-related allergic reaction (self-limiting generalised urticaria) after the first oral dose. No deaths or life-threatening events occurred. In cohort 1C, the week 2 median cabotegravir AUC0-tau was 148·5 (range 37·2-433·1) µg·h/mL. The week 16 median concentrations for the every-4-weeks and every-8-weeks dosing was 3·11 µg/mL (range 1·22-6·19) and 1·15 µg/mL (<0·025-5·29) for cabotegravir and 52·9 ng/mL (31·9-148·0) and 39·1 ng/mL (27·2-81·3) for rilpivirine, respectively. These concentrations were similar to those in adults. INTERPRETATION: Study data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 weeks or 8 weeks, per the adult dosing regimens, in virologically suppressed adolescents aged 12 years and older and weighing at least 35 kg. FUNDING: The National Institutes of Health and ViiV Healthcare.

A qualitative analysis examining intersectional stigma among young adults living with HIV in Atlanta, Georgia.

HIV-related stigma is a barrier to engagement in care for young adults living with HIV. Other intersecting forms of stigma (e.g., racism, sexism, homophobia), may worsen HIV-related stigma and impact engagement in care. From November 2020 to February 2021, we conducted 20 in-depth qualitative interviews among young adults living with HIV attending a large, comprehensive HIV care center in Atlanta, Georgia. Semi-structured interview guides based on Earnshaw and Chaudoir's HIV Stigma Framework and the theory of intersectionality facilitated discussion around experiences with various forms of stigma and its possible influence on healthcare engagement. Using the social-ecological model, we used thematic analysis to contextualize how young adults living with HIV experienced intersectional stigma and enacted, anticipated, and internalized HIV stigma in both healthcare and non-healthcare settings. Most participants identified as male, Black/African American, and gay. Participants described stigma at intrapersonal, interpersonal, clinic, and community levels. Intrapersonal stigma was associated with delayed care seeking, isolation, and fear of disclosure. Interpersonal stigma included discrimination from family and friends and avoidance of close relationships to elude disclosure. At the clinic level, stigma included negative experiences with staff in HIV and non-HIV healthcare settings, which contributed to decreased engagement in care. Stigma in the community included differential treatment from employers, community leaders, and religious community and was associated with feelings of helplessness related to current societal inequalities. Coping/motivating mechanisms for stigma included prioritizing health, eliciting support from the medical care team and peers. Our findings show different intersecting stigmas are barriers to healthcare at multiple levels for young adults living with HIV, potentially exacerbating existing health and social disparities. To improve engagement in care among young adults living with HIV, future interventions should address the different mechanisms of stigma at community, clinic, interpersonal and intrapersonal levels by enhancing social support and improving healthcare structural competency.

Development of a Mobile App to Increase the Uptake of HIV Pre-exposure Prophylaxis Among Latino Sexual Minority Men: Qualitative Needs Assessment.

BACKGROUND: HIV disproportionally impacts Latino sexual minority men (SMM). Uptake of pre-exposure prophylaxis (PrEP), an effective biomedical intervention to prevent HIV, is low in this group compared with White SMM. Mobile health technology represents an innovative strategy to increase PrEP uptake among Latino SMM. OBJECTIVE: We aimed to describe the qualitative process leading to the development of SaludFindr, a comprehensive HIV prevention mobile app aiming to increase PrEP uptake, HIV testing, and condom use by Latino SMM. METHODS: We conducted 13 in-depth interviews with Latino SMM living in the Atlanta area to explore their main barriers and facilitators to PrEP uptake and to analyze their opinions of potential SaludFindr app functionalities. To explore potential app functions, we used HealthMindr, an existing HIV prevention app, as a template and added new proposed features intended to address the specific community needs. RESULTS: We identified general PrEP uptake barriers that, although common among non-Latino groups, had added complexities such as the influence of religion and family on stigma. Low perceived PrEP eligibility, intersectional stigma, lack of insurance, cost concerns, and misconceptions about PrEP side effects were described as general barriers. We also identified Latino-specific barriers that predominantly hinder access to existing services, including a scarcity of PrEP clinics that are prepared to provide culturally concordant services, limited availability of Spanish language information related to PrEP access, distrust of peers as credible sources of information, perceived ineligibility for low-cost services owing to undocumented status, fear of immigration authorities, and competing work obligations that prevent PrEP clinic attendance. Health care providers represented a trusted source of information, and 3 provider characteristics were identified as PrEP facilitators: familiarity with prescribing PrEP; being Latino; and being part of lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA+) group or ally. The proposed app was very well accepted, with a particularly high interest in features that facilitate PrEP access, including a tailored list of clinics that meet the community needs and a private platform to seek PrEP information. Spanish language availability and free or low-cost PrEP care represented the 2 main clinic criteria that would facilitate PrEP uptake. Latino representation in clinic staff and providers; clinic perception as a safe space for undocumented patients; and LGBTQIA+ representation was listed as additional criteria. Only 8 of 47 clinics listed on the Centers for Diseases Control and Prevention PrEP locator website for the Atlanta area fulfilled at least 2 main criteria. CONCLUSIONS: This study provides further evidence of the substantial PrEP uptake barriers that Latino SMM face; exposes the urgent need to increase the number of accessible PrEP-providing clinics for Latino SMM; and proposes an innovative, community-driven, and mobile technology-based tool as a future intervention to overcome some of these barriers.

Examining HIV Organizational Structures and their Influence on Engagement with Young Black Gay, Bisexual, and other Men who have Sex with Men in Atlanta, Georgia.

Young Black gay, bisexual, and other men who have sex with men (YB-GBMSM) are disproportionately impacted by HIV. Structural influences on these disparities, including characteristics of the various organizations that serve YB-GBMSM living with HIV, remain understudied. We drew on Weick's model of organizing to conduct and analyze qualitative interviews with 28 HIV service providers representing healthcare and community-based organizations in Atlanta, Georgia. Enactment of HIV service provision was described as following simplified and standardized responses-defined as "rules", and/or more dynamic exchanges to formulate responses -otherwise known as "communication behavior cycles" (CBCs). Rules, including patient quotas and limited hours of operation, were viewed as rigid, out-of-touch, and inhibiting engagement with YB-GBMSM. CBCs, such as patient feedback loops and rejection of traditional hierarchies, fostered creative insights to combating the epidemic and increased levels of cultural awareness and community buy-in. Organizations should strive to enact CBCs, to foster culturally congruent approaches to service delivery for YB-GBMSM.