Doxycycline as Postsexual Exposure Prophylaxis: Use, Acceptability, and Associated Sexual Health Behaviors Among a Multi-Site Sample of Clinical Trial Participants.

Doxycycline postexposure prophylaxis (doxy-PEP) reduces sexually transmitted infections (STIs) in men who have sex with men (MSM) and transgender women (TGW). In a clinical trial of doxy-PEP, we sought to assess acceptability, impact, and meaning of doxy-PEP use among MSM/TGW. We conducted semistructured, in-depth 1:1 interviews with MSM and TGW enrolled in the intervention arm of the Doxy-PEP study. We queried motivations for and meaning of use, attitudes, beliefs, adherence, effect on sexual behaviors, and partner, community, and structural factors related to use. We coded interview transcripts into content areas, followed by thematic analysis. We interviewed 44 participants (median age 38), 2% were TGW, 17% Black, 61% White, 30% Hispanic, and 45% persons with HIV. We identified three overarching themes. First, participants found doxy-PEP acceptable, and believed it was effective based on their history of STIs, easy to adhere to, and acceptable to sex partners. Second, doxy-PEP benefited their quality of life and mental health, offering "peace of mind" by reducing their anxiety about acquisition or unwitting transmission of STIs. Participants reported feeling more "in control" of preventing STIs, and positive about supporting their personal, partner, and community health. Third, impact on sexual behavior was variable, with most reporting no change or a brief initial change. Participants in a multi-site clinical trial of doxycycline for STI prevention perceived it to be efficacious, and that it provided quality-of-life benefits, including reduced anxiety and sense of control over sexual health. Doxy-PEP had limited impact on sexual behavior. Clinicaltrials.gov: NCT03980223.

Acceptability of Long-Acting Injectable Antiretroviral Therapy Among People with HIV Receiving Care at Three Ryan White Funded Clinics in the United States.

Understanding the acceptability of long-acting injectable antiretroviral therapy (LAI-ART) among people with HIV (PWH), especially priority populations, is essential for effective implementation. We conducted semi-structured interviews with patients in three Ryan White-funded HIV clinics in San Francisco, Chicago, and Atlanta. We employed maximal variation sampling across age, gender, race, ethnicity, and time living with HIV and oversampled for individuals with suboptimal clinical engagement. An 8-step hybrid deductive and inductive thematic analysis approach guided data analysis. Between August 2020 and July 2021, we conducted 72 interviews. Median age was 46 years; 28% were ciswomen, 7% transwomen, 44% Black/African-American and 35% Latinx, 43% endorsed a psychiatric diagnosis, 35% were experiencing homelessness/unstable housing, and 10% had recent substance use. Approximately 24% were sub-optimally engaged in care. We observed a spectrum of LAI-ART acceptability, ranging from enthusiasm to hesitancy to rejection. We also characterized four emergent orientations towards LAI-ART: innovator, pragmatist, deliberator, and skeptic. Overall, the majority of participants expressed favorable initial reactions towards LAI-ART. Most approached LAI-ART pragmatically, but acceptability was not static, often increasing over the course of the interview. Participants considered their HIV providers as essential for affirming personal relevance. HIV stigma, privacy concerns, and medical mistrust had varied impacts, sometimes facilitating and other times hindering personal relevance. These findings held across priority populations, specifically young adults, cis/trans women, racial/ethnic minorities, and individuals with suboptimal clinical engagement. Further research is needed to explore the transition from hypothetical acceptance to uptake and to confirm the actual benefits and drawbacks of this treatment.

RESUMEN: La aceptabilidad de la terapia antirretroviral inyectable de acción prolongada (LAI-ART, por su sigla en inglés) entre personas con VIH es esencial para una implementación efectiva. Durante el periodo de agosto de 2020 a julio de 2021, realizamos 72 entrevistas semiestructuradas con personas con VIH en clínicas públicas ubicadas en San Francisco, Chicago y Atlanta. Un análisis temático, tanto deductivo como inductivo, guio nuestra investigación. Observamos un espectro de aceptabilidad de LAI-ART que va desde el entusiasmo hasta la indecisión y el rechazo. También caracterizamos cuatro orientaciones actitudinales emergentes hacia LAI-ART: innovadora, pragmática, deliberativa y escéptica. Los participantes también señalaron la importancia de sus proveedores de VIH para validar su relevancia personal. El estigma asociado al VIH, preocupaciones sobre la privacidad y desconfianza en el sistema médico tuvieron diversos impactos, a veces facilitando y otras veces obstaculizando la relevancia personal. Entre las poblaciones prioritarias del estudio, los resultados fueron consistentes.

Identifying Implementation Determinants and Strategies for Long-Acting Injectable Cabotegravir-Rilpivirine in People with HIV Who Are Virally Unsuppressed.

BACKGROUND: Early evidence suggests long-acting injectable cabotegravir and rilpivirine (LA-CAB/RPV) may be beneficial for people with HIV (PWH) who are unable to attain viral suppression (VS) on oral therapy. Limited guidance exists on implementation strategies for this population. SETTING: Ward 86, a clinic serving publicly insured PWH in San Francisco. METHODS: We describe multi-level determinants of and strategies for LA-CAB/RPV implementation for PWH without VS, using the Consolidated Framework for Implementation Research. To assess patient and provider-level determinants, we drew on pre-implementation qualitative data. To assess inner and outer context determinants, we undertook a structured mapping process. RESULTS: Key patient-level determinants included perceived ability to adhere to injections despite oral adherence difficulties and care engagement challenges posed by unmet subsistence needs; strategies to address these determinants included a direct-to-inject approach, small financial incentives, and designated drop-in days. Provider-level determinants included lack of time to obtain LA-CAB/RPV, assess injection response, and follow-up late injections; strategies included centralizing eligibility review with the clinic pharmacist, a pharmacy technician to handle procurement and monitoring, regular multidisciplinary review of patients, and development of a clinic protocol. Ward 86 did not experience many outer context barriers due to rapid and unconstrained inclusion of LA-CAB/RPV on local formularies and ability of its affiliated hospital pharmacy to stock the medication. CONCLUSION: Multi-level strategies to support LA-CAB/RPV implementation for PWH without VS are required, which may necessitate additional resources in some settings to implement safely and effectively. Advocacy to eliminate outer-context barriers, including prior authorizations and specialty pharmacy restrictions, is needed.

Differences in internalized HIV stigma across subpopulations of people living with HIV in care across the US.

BACKGROUND: Few studies have examined which subgroups of people with HIV (PWH) carry the greatest burden of internalized HIV stigma (IHS), which may be important to care provision and interventions. METHODS: PWH in the CFAR Network of Integrated Clinical Systems (CNICS) longitudinal, US-based, multisite, clinical care cohort completed tablet-based assessments during clinic visits including a 4-item, Likert scale (low 1-5 high), IHS instrument. Associations between sociodemographic characteristics and IHS scores were assessed in adjusted linear regression models. RESULTS: 12,656 PWH completed the IHS assessment at least once from February 2016 to November 2022, providing 28,559 IHS assessments. At baseline IHS assessment, the mean age was 49 years, 41% reported White, 38% Black/African American, and 16% Latine race/ethnicity, and 80% were cisgender men. The mean IHS score was 2.04, with all subgroups represented among those endorsing IHS. In regression analyses, younger PWH and those in care fewer years had higher IHS scores. In addition, cisgender women vs. cisgender men, PWH residing in the West vs. the Southeast, and those with sexual identities other than gay/lesbian had higher IHS scores. Compared with White-identifying PWH, those who identified with Black/African American or Latine race/ethnicity had lower IHS scores. Age stratification revealed patterns related to age category, including specific age-related differences by gender, geographic region and race/ethnicity. DISCUSSION: IHS is prevalent among PWH, with differential burden by subgroups of PWH. These findings highlight the benefits of routine screening for IHS and suggest the need for targeting/tailoring interventions to reduce IHS among PWH.

The Association of HIV Control and Immunosuppression With Risk of Non-AIDS-Defining Cancer Risk Among Patients on Antiretroviral Therapy.

BACKGROUND: People living with HIV (PWH) are experiencing an increased prevalence of non-AIDS-defining cancers (NADCs). Our study investigated the association of immunosuppression and HIV control with NADCs among PWH on antiretroviral therapy (ART) in the United States. METHODS: Among patients across 8 clinical cohorts on ART between 1996 and 2016, we assessed immune function and HIV control using 3 parameterizations of CD4 count and HIV-RNA viral load (VL): (1) CD4 or VL at ART initiation; (2) change in CD4 or VL after ART initiation; and (3) proportion of follow-up time at CD4 >500 cells/µL or VL <50 copies/mL. Cox models were used to ascertain the association of these measures with risk of a viral NADC or nonviral NADC. RESULTS: Among 29,568 patients on ART, there were 410 nonviral NADCs and 213 viral NADCs. PWH with a CD4 <200 cells/µL at ART initiation had an 80% elevated risk for developing a viral NADC. Each increase of 100 cells/µL in CD4 after ART initiation decreased risk by 14%. For viral and nonviral NADCs, 10% more follow-up time spent with a CD4 >500 cells/µL was associated with decreased risk [viral, adjusted hazard ratio (aHR): 0.82; 95% confidence intervals (CI): 0.78 to 0.86; nonviral, aHR: 0.88; 95% CI: 0.86 to 91], even after accounting for CD4 at ART initiation. When examining HIV control only, 10% more time with VL <50 copies/mL was significantly associated with decreased viral (aHR: 0.85; 95% CI: 0.82 to 0.89) and nonviral NADC risk (aHR: 0.88; 95% CI: 0.85 to 0.90). CONCLUSIONS: This study demonstrates that even for PWH on ART therapy, maintaining HIV control is associated with lower risk of both viral and nonviral NADCs.

Viral Suppression Trajectories Destabilized After Coronavirus Disease 2019 Among US People With Human Immunodeficiency Virus: An Interrupted Time Series Analysis.

We examined changes in the proportion of people with human immunodeficiency virus (PWH) with virologic suppression (VS) in a multisite US cohort before and since the coronavirus disease 2019 (COVID-19) pandemic. Overall, prior gains in VS slowed during COVID-19, with disproportionate impacts on Black PWH and PWH who inject drugs.

Assessing readiness to implement long-acting injectable HIV antiretroviral therapy: provider and staff perspectives.

BACKGROUND: Long-acting injectable antiretroviral therapy (LAI-ART) represents the next innovation in HIV therapy. Pre-implementation research is needed to develop effective strategies to ensure equitable access to LAI-ART to individuals living with HIV. METHODS: We conducted focus group discussions (FGDs) with providers and staff affiliated with HIV clinics in San Francisco, Chicago, and Atlanta to understand barriers to and facilitators of LAI-ART implementation. Participants also completed a short survey about implementation intentions. FGDs were held via video conference, recorded, transcribed, and thematically analyzed using domains associated with the Consolidated Framework for Implementation Research (CFIR). RESULTS: Between September 2020 and April 2021, we led 10 FDGs with 49 participants, of whom ~60% were prescribing providers. Organizational readiness for implementing change was high, with 85% agreeing to being committed to figuring out how to implement LAI-ART. While responses were influenced by the unique inner and outer resources available in each setting, several common themes, including implementation mechanisms, dominated: (1) optimism and enthusiasm about LAI-ART was contingent on ensuring equitable access to LAI-ART; (2) LAI-ART shifts the primary responsibility of ART adherence from the patient to the clinic; and (3) existing clinic systems require strengthening to meet the needs of patients with adherence challenges. Current systems in all sites could support the use of LAI-ART in a limited number of stable patients. Scale-up and equitable use would be challenging or impossible without additional personnel. Participants outlined programmatic elements necessary to realize equitable access including centralized tracking of patients, capacity for in-depth, hands-on outreach, and mobile delivery of LAI-ART. Sites further specified unknown logistical impacts on implementation related to billing/payer source as well as shipping and drug storage. CONCLUSIONS: Among these HIV care sites, clinic readiness to offer LAI-ART to a subset of patients is high. The main challenges to implementation include concerns about unequal access and a recognition that strengthening the clinic system is critical.

African American/Black race, apolipoprotein L1 , and serum creatinine among persons with HIV.

OBJECTIVE: Accurate estimation of kidney function is critical among persons with HIV (PWH) to avoid under-dosing of antiretroviral therapies and ensure timely referral for kidney transplantation. Existing estimation equations for kidney function include race, the appropriateness of which has been debated. Given advancements in understanding of race and the necessity of accuracy in kidney function estimation, this study aimed to examine whether race, or genetic factors, improved prediction of serum creatinine among PWH. DESIGN: This cross-sectional study utilized data from the Center for AIDS Research Network of Integrated Clinical Systems cohort (2008-2018). The outcome was baseline serum creatinine. METHODS: Ordinary least squares regression was used to examine whether inclusion of race or genetic factors [ apolipoprotein-L1 ( APOL1 ) variants and genetic African ancestry] improved serum creatinine prediction. A reduction in root mean squared error (RMSE) greater than 2% was a clinically relevant improvement in predictive ability. RESULTS: There were 4183 PWH included. Among PWH whose serum creatinine was less than 1.7 mg/dl, race was significantly associated with serum creatinine ( ß â€Š= 0.06, SE = 0.01, P  < 0.001) but did not improve predictive ability. African ancestry and APOL1 variants similarly failed to improve predictive ability. Whereas, when serum creatinine was at least 1.7 mg/dl, inclusion of race reduced the RMSE by 2.1%, indicating improvement in predictive ability. APOL1 variants further improved predictive ability by reducing the RMSE by 2.9%. CONCLUSION: These data suggest that, among PWH, inclusion of race or genetic factors may only be warranted at higher serum creatinine levels. Work eliminating existing healthcare disparities while preserving the utility of estimating equations is needed.

Demonstration Project of Long-Acting Antiretroviral Therapy in a Diverse Population of People With HIV.

BACKGROUND: Intramuscular cabotegravir (CAB) and rilpivirine (RPV) is the only long-acting antiretroviral therapy (LA-ART) regimen approved for people with HIV (PWH). Long-acting ART holds promise for improving outcomes among populations with barriers to adherence but is only approved for PWH who have virologic suppression with use of oral ART before initiating injectables. OBJECTIVE: To examine LA-ART in a population of PWH that includes those with viremia. DESIGN: Observational cohort study. SETTING: Urban academic safety-net HIV clinic. PATIENTS: Publicly insured adults living with HIV with and without viral suppression, high rates of unstable housing, mental illness, and substance use. INTERVENTION: Demonstration project of long-acting injectable CAB-RPV. MEASUREMENTS: Descriptive statistics summarizing cohort outcomes to date, based on pharmacy team logs and electronic medical record data. RESULTS: Between June 2021 and November 2022, 133 PWH at the Ward 86 HIV Clinic were started on LA-ART, 76 of whom had virologic suppression while using oral ART and 57 of whom had viremia. The median age was 46 years (IQR, 25 to 68 years); 117 (88%) were cisgender men, 83 (62%) had non-White race, 56 (42%) were experiencing unstable housing or homelessness, and 45 (34%) had substance use. Among those with virologic suppression, 100% (95% CI, 94% to 100%) maintained suppression. Among PWH with viremia, at a median of 33 days, 54 of 57 had viral suppression, 1 showed the expected 2-log10 reduction in HIV RNA level, and 2 experienced early virologic failure. Overall, 97.5% (CI, 89.1% to 99.8%) were projected to achieve virologic suppression by a median of 33 weeks. The current virologic failure rate of 1.5% in the cohort is similar to that across registrational clinical trials at 48 weeks. LIMITATION: Single-site study. CONCLUSION: This project demonstrates the ability of LA-ART to achieve virologic suppression among PWH, including those with viremia and challenges to adherence. Further data on the ability of LA-ART to achieve viral suppression in people with barriers to adherence are needed. PRIMARY FUNDING SOURCE: National Institutes of Health, City and County of San Francisco, and Health Resources and Services Administration.

Patterns of person-centred communications in public HIV clinics: a latent class analysis using the Roter interaction analysis system.

INTRODUCTION: Poor client-provider communication is a critical barrier to long-term retention in care among people living with HIV. However, standardized assessments of this key metric are limited in Africa. We used the Roter Interaction Analysis System (RIAS) to quantitatively characterize patterns of person-centred communication (PCC) behaviours in Zambia. METHODS: We enrolled pairs of people living with HIV making routine HIV follow-up visit and their providers at 24 Ministry of Health-facilities supported by the Centre for Infectious Disease Research in Zambia in Lusaka province between August 2019 and November 2021. Client-provider encounters were audio-recorded and coded using RIAS by trained research staff. We performed latent class analysis to identify interactions with distinctive patterns of provider PCC behaviours (i.e. rapport building, person-centred counselling, PCC micropractices [e.g. brief empathy statements], assessing barriers to care, shared decision-making and leveraging discretionary power) and compared their distribution across client, provider, interaction and facility characteristics. RESULTS: We enrolled 478 people living with HIV and 139 providers (14% nurses, 73.6% clinical officers, 12.3% were medical officers). We identified four distinct profiles: (1) "Medically Oriented Interaction, Minimal PCC Behaviours" (47.6% of interactions) was characterized by medical discussion, minimal psychosocial/non-medical talk and low use of PCC behaviours; (2) "Balanced Medical/Non-medical Interaction, Low PCC Behaviours" (21.0%) was characterized by medical and non-medical discussion but limited use of other PCC behaviours; (3) "Medically Oriented Interaction, Good PCC Behaviours" (23.9%) was characterized by medically oriented discussion, more information-giving and increased use of PCC behaviours; and (4) "Highly person-centred Interaction" (7.5%) was characterized by both balanced medical/non-medical focus and the highest use of PCC behaviours. Nurse interactions were more likely to be characterized by more PCC behaviours (i.e. Class 3 or 4) (44.8%), followed by medical officers (33.9%) and clinical officers (27.3%) (p = 0.031). Longer interactions were also more likely to integrate more PCC behaviours (p < 0.001). CONCLUSIONS: PCC behaviours are relatively uncommon in HIV care in Zambia, and often limited to brief rapport-building statements and PCC micropractices. Strengthening PCC, such as shared decision-making and leveraging discretionary power to better accommodate client needs and preferences, may be an important strategy for improving the quality in HIV treatment programmes.

Provider perspectives on patient-centredness: participatory formative research and rapid analysis methods to inform the design and implementation of a facility-based HIV care improvement intervention in Zambia.

INTRODUCTION: Implementation of patient-centred care (PCC) practices in HIV treatment depends on healthcare workers' (HCWs) perceptions of the acceptability, appropriateness and feasibility of such practices (e.g. use of intentional, metric-driven activities to improve patient experiences). METHODS: We applied rapid, rigorous formative research methods to refine a PCC intervention for future trial. In 2018, we conducted focus group discussions (FGDs) with 46 HCWs purposefully selected from two pilot sites. We elicited HCW perceptions of HIV service delivery, HCW motivation and perceived value of patient experience measures intended to improve PCC. FGDs utilized participatory methods to understand HCW responses to patient-reported care engagement challenges and Scholl's PCC Framework principles (e.g. seeing a patient as a unique person), enablers (e.g. care coordination) and activities (e.g. patient involvement). Our rapid analysis used analytic memos, thematic analysis, research team debriefs and HCW feedback to inform time-sensitive trial implementation. RESULTS: While HCWs nearly universally identified with and supported principles of PCC in both facilities, they raised practical barriers given the practice environment. HCWs described motivation to help patients, attached value to seeing positive health outcomes and the importance of teamwork. However, HCWs reported challenges with enablers needed to deliver PCC. HCWs cited a work culture characterized by differential power dynamics between cadres and departments restricting HCW autonomy and resource access. Barriers included inflexibility in accommodating individual patient needs due to high patient volumes, limited human resources, laboratory capacity, infrastructure and skills translating patient perspectives into practice. HCW motivation was negatively influenced by encounters with "difficult patients," and feeling "unappreciated" by management, resulting in cognitive dissonance between HCW beliefs and behaviours. However, the enactment of PCC values also occurred. Results suggested that PCC interventions should reduce practice barriers, highlighting the value of mentors who could help HCWs dynamically engage with health system constraints, to facilitate PCC. CONCLUSIONS: While HCWs perceived PCC principles as acceptable, they did not think it universally appropriate or feasible given the practice environment. Participatory and rapid methods provided timely insight that PCC interventions must provide clear and effective systems enabling PCC activities by measuring and mitigating relational and organizational constraints amenable to change such as inter-cadre coordination.

Alcohol use and the longitudinal HIV care continuum for people with HIV who enrolled in care between 2011 and 2019.

PURPOSE: We described the impact of alcohol use on longitudinal engagement in HIV care including loss to follow-up, durability of viral suppression, and death. METHODS: We followed a cohort of 1781 people with HIV from enrolled in care at one of seven US clinics, 2011-2019 through 102 months. We used a multistate, time-varying Markov process and restricted mean time to summarize engagement in HIV care over follow-up according to baseline self-reported alcohol use (none, moderate, or unhealthy). RESULTS: Our sample (86% male, 54% White) had median age of 35 years. Over 102 months, people with no, moderate, and unhealthy alcohol use averaged 62.3, 61.1, and 59.5 months virally suppressed, respectively. People who reported unhealthy or moderate alcohol use spent 5.1 (95% confidence intervals (CI): 0.8, 9.3) and 7.6 (95%CI: 3.1, 11.7) more months lost to care than nondrinkers. Compared to no use, unhealthy alcohol use was associated with 3.4 (95%CI: -5.6, -1.6) fewer months in care, not virally suppressed. There were no statistically significant differences after adjustment for demographic and clinical characteristics. CONCLUSIONS: Moderate or unhealthy drinking at enrollment in HIV care was associated with poor retention in care. Alcohol use was not associated with time spent virally suppressed.

The Rapid interaction: a qualitative study of provider approaches to implementing Rapid ART.

BACKGROUND: Offering antiretroviral therapy (ART) to patients directly following an HIV diagnosis ("Rapid ART") improves clinical outcomes and is feasible and acceptable for patients and providers. Despite this, implementation of Rapid ART is not yet standard practice in the USA. Structural-level implementation guidance is available, but research at the individual provider level that explores the patient-provider interaction itself remains scarce. The Consolidated Framework for Implementation Research (CFIR) provides a nuanced guide to investigating the less visible, more social elements of implementation like the knowledge and feelings of people, and the influences of culture and resources on individual approaches. METHODS: We conducted a multi-site qualitative study, exploring intervention commonalities across three HIV clinic environments: an HIV primary care clinic; an HIV/STI testing, treatment, and prevention clinic; and a large federally qualified health center (FQHC). Qualitative data were gathered from 27 provider informants-Rapid ART program staff and clinicians-using an interview guide developed using the CFIR. An experienced qualitative team conducted a comprehensive thematic analysis and identified cross-cutting themes in how providers approach and engage in the Rapid interaction, as well as longer-form narratives from providers that describe more fully what this interaction looks like for them. RESULTS: Three main themes represent the range and content of individual provider approaches to the Rapid interaction: (1) patient-centeredness; (2) emotional support and partnership; and (3) correcting misperceptions about HIV. Each theme encompassed both conceptual approaches to offering Rapid ART and concrete examples of messaging to the patient that providers used in the Rapid interaction. We describe and show examples of these themes, offer key take-aways for implementation, and provide expanded narratives of providers' personal approaches to the Rapid interaction. CONCLUSIONS: Exploration of provider-level approaches to Rapid ART implementation, as carried out in the patient-provider Rapid interaction, contributes a critical layer of evidence for wider implementation. It is our hope that, together with existing research showing positive outcomes and core components of systems-level implementation, these findings add to an instructive body of findings that facilitates the implementation of Rapid ART as an enhanced model of HIV care.

The temporal relationship of alcohol use and subsequent self-reported health status among people with HIV.

Background: Alcohol use among people with HIV is associated with worse HIV treatment outcomes. Its impact on self-reported health status is unclear. Setting: Longitudinal cohort of people with HIV engaged in care across 7 clinics participating in the Centers for AIDS Research Network of Integrated Care Systems between January 2011 and June 2014. Methods: A total of 5046 participants were studied. A quantile regression model estimated the association of alcohol use levels with subsequent self-reported health status score, accounting for multiple covariates including depressive symptoms. Women, men who have sex with women, and men who have sex with men were analyzed separately. Results: Prevalence of heavy alcohol use was 21%, 31%, and 37% among women, men who have sex with women, and men who have sex with men, respectively. Women with heavy alcohol use had a subsequently decreased median self-reported health status score compared to women with no or moderate alcohol use (odds ratio [OR]: 0.76; 95% confidence interval [CI]: 0.58-0.99); this association was not explained by the presence of depressive symptoms. There was no observed association of alcohol use level on subsequent self-reported health status among men who have sex with women. Men who have sex with men reporting no alcohol use had a subsequently decreased median self-reported health status compared to moderate alcohol use (OR: 0.88; 95% CI: 0.80-0.97). Conclusion: Heavy alcohol use is associated with worsened self-reported health status at subsequent visits among women with HIV and not men with HIV.

A mixed methods study on men's and women's tuberculosis care journeys in Lusaka, Zambia-Implications for gender-tailored tuberculosis health promotion and case finding strategies.

Men and women with undiagnosed tuberculosis (TB) in high burden countries may have differential factors influencing their healthcare seeking behaviors and access to TB services, which can result in delayed diagnoses and increase TB-related morbidity and mortality. A convergent, parallel, mixed-methods study design was used to explore and evaluate TB care engagement among adults (≥18 years) with newly diagnosed, microbiologically-confirmed TB attending three public health facilities in Lusaka, Zambia. Quantitative structured surveys characterized the TB care pathway (time to initial care-seeking, diagnosis, and treatment initiation) and collected information on factors influencing care engagement. Multinomial multivariable logistic regression was used to determine predicted probabilities of TB health-seeking behaviors and determinants of care engagement. Qualitative in-depth interviews (IDIs; n = 20) were conducted and analyzed using a hybrid approach to identify barriers and facilitators to TB care engagement by gender. Overall, 400 TB patients completed a structured survey, of which 275 (68.8%) and 125 (31.3%) were men and women, respectively. Men were more likely to be unmarried (39.3% and 27.2%), have a higher median daily income (50 and 30 Zambian Kwacha [ZMW]), alcohol use disorder (70.9% [AUDIT-C score ≥4] and 31.2% [AUDIT-C score ≥3]), and a history of smoking (63.3% and 8.8%), while women were more likely to be religious (96.8% and 70.8%) and living with HIV (70.4% and 36.0%). After adjusting for potential confounders, the probability of delayed health-seeking ≥4 weeks after symptom onset did not differ significantly by gender (44.0% and 36.2%, p = 0.14). While the top reasons for delayed healthcare-seeking were largely similar by gender, men were more likely to report initially perceiving their symptoms as not being serious (94.8% and 78.7%, p = 0.032), while women were more likely to report not knowing the symptoms of TB before their diagnosis (89.5% and 74.4%; p = 0.007) and having a prior bad healthcare experience (26.4% and 9.9%; p = 0.036). Notably, women had a higher probability of receiving TB diagnosis ≥2 weeks after initial healthcare seeking (56.5% and 41.0%, p = 0.007). While men and women reported similar acceptability of health-information sources, they emphasized different trusted messengers. Also, men had a higher adjusted probability of stating that no one influenced their health-related decision making (37.9% and 28.3%, p = 0.001). In IDIs, men recommended TB testing sites at convenient community locations, while women endorsed an incentivized, peer-based, case-finding approach. Sensitization and TB testing strategies at bars and churches were highlighted as promising approaches to reach men and women, respectively. This mixed-methods study found important differences between men and women with TB in Zambia. These differences suggest the need for gender-tailored TB health promotion, including addressing harmful alcohol use and smoking among men, and sensitizing HCWs to prolonged delays in TB diagnosis among women, and also using gender-specific approaches as part of community-based, active case-finding strategies to improve TB diagnosis in high burden settings.

Risk of HIV Viral Rebound in the Era of Universal Treatment in a Multicenter Sample of Persons With HIV in Primary Care.

Background: Antiretroviral therapy (ART) is recommended for people with HIV (PWH), irrespective of CD4 cell count, to improve their health and reduce the risk of transmission to sexual partners through long-term viral suppression. We identified risk factors for viral rebound among patients with a period of stable viral suppression to inform counseling and monitoring. Methods: We conducted a multisite, retrospective study of PWH with a 2-year period of sustained viral suppression in the United States using the Centers for AIDS Research Network of Integrated Clinical Systems cohort. We used multivariable logistic regression to identify characteristics independently associated with any viral rebound (viral load [VL] ≥200 copies/mL) and sustained viral rebound (VL ≥200 copies/mL followed by a VL that was also ≥200 copies/mL within 6 months), within 2 years of follow-up. Results: Among 3496 eligible patients with a 2-year period of sustained viral suppression, most (90%) continued to have viral suppression over 2 additional years; 10% experienced viral rebound, and 4% experienced sustained viral rebound. In multivariable analyses, Black race, current smoking, integrase strand transfer inhibitor use, and 5- to 9-year duration of ART were positively associated, and being age ≥50 years was negatively associated, with any viral rebound. Only current smoking and 5- to 9-year (vs 2- to 4-year) duration of ART were positively associated, and being age ≥60 years was negatively associated, with sustained viral rebound. Conclusions: Most people retained in clinical care and with HIV viral suppression on ART will have persistent viral suppression. However, some patients may benefit from additional treatment adherence support.

The Brief Human Immunodeficiency Virus (HIV) Index: A Rapid 3-Item Scale to Measure Engagement in HIV Care.

We created a brief version of The Index, a validated patient-reported measure that has potential to quickly identify patients at risk for poor retention. We analyzed Index scores from 2406 patients from 2016 to 2017 in a national cohort of patients in human immunodeficiency virus (HIV) care. Index scores predicted poor retention 12 months after administered.

Implementation strategies to screen, refer and link women involved in the carceral system to PrEP for HIV prevention.

PURPOSE: Women involved in the carceral system (CS) experience several conditions that increase their risk for HIV (e.g. high rates of substance use, psychiatric disorders, histories of victimization). The purpose of this study is to explore perspectives on potential strategies to connect women in the CS to pre-exposure prophylaxis (PrEP) services. DESIGN/METHODOLOGY/APPROACH: This study conducted in-depth interviews with 27 women involved in the CS eligible for PrEP. Using vignettes, interviews explored attitudes, barriers and facilitators toward PrEP screening, referral and linkage facilitated via a CS stakeholder, an mHealth application or providing PrEP service referrals during detention via a navigator. FINDINGS: Most women were, on average, 41.3 years, from racial and ethnic minority groups (56% black/African American; 19% Latinx). Inductive thematic analysis revealed CS involved women expressed mostly positive attitudes toward CS-based PrEP implementation. Younger women were more accepting of and interested in mHealth interventions. Implementation facilitators included leveraging relationships with trusted allies (e.g. "peers") and existing systems collaborations. Recommended implementation strategies included providing HIV and PrEP-specific education and training for system stakeholders and addressing issues related to privacy, system mistrust and stigma. ORIGINALITY/VALUE: Results provide a critical foundation for the implementation of interventions to improve PrEP access for women involved in the CS and have important implications for implementation strategies for all adults involved in the CS. Improving access to PrEP among this population may also support progress toward addressing national disparities in PrEP uptake, where women, black and Latinx populations have substantial unmet need.

Associations between alcohol and cigarette use and type 1 and 2 myocardial infarction among people with HIV.

OBJECTIVES: People with HIV have a higher risk of myocardial infarction (MI) than the general population, with a greater proportion of type 2 MI (T2MI) due to oxygen demand-supply mismatch compared with type 1 (T1MI) resulting from atherothrombotic plaque disruption. People living with HIV report a greater prevalence of cigarette and alcohol use than do the general population. Alcohol use and smoking as risk factors for MI by type are not well studied among people living with HIV. We examined longitudinal associations between smoking and alcohol use patterns and MI by type among people living with HIV. DESIGN AND METHODS: Using longitudinal data from the Centers for AIDS Research Network of Integrated Clinical Systems cohort, we conducted time-updated Cox proportional hazards models to determine the impact of smoking and alcohol consumption on adjudicated T1MI and T2MI. RESULTS: Among 13 506 people living with HIV, with a median 4 years of follow-up, we observed 177 T1MI and 141 T2MI. Current smoking was associated with a 60% increase in risk of both T1MI and T2MI. In addition, every cigarette smoked per day was associated with a 4% increase in risk of T1MI, with a suggestive, but not significant, 2% increase for T2MI. Cigarette use had a greater impact on T1MI for men than for women and on T2MI for women than for men. Increasing alcohol use was associated with a lower risk of T1MI but not T2MI. Frequency of heavy episodic alcohol use was not associated with MI. CONCLUSIONS: Our findings reinforce the prioritization of smoking reduction, even without cessation, and cessation among people living with HIV for MI prevention and highlight the different impacts on MI type by gender.

A factorial experiment grounded in the multiphase optimization strategy to promote viral suppression among people who inject drugs on the Texas-Mexico border: a study protocol.

BACKGROUND: People who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH. METHODS: The multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of < 40 copies per mL at 6-,9-, and 12-month follow-up assessments. Results will yield effect sizes for each component and each additive and interactive combination of components. The research team and partners will make decisions about what constitutes the optimized multi-component intervention by judging the observed effect sizes, interactions, and statistical significance against real-world implementation constraints. The secondary aims are to test mediators and moderators of the component-to-outcome relationship at the 6-month follow-up assessment. DISCUSSION: We are testing well-studied and available intervention components to support PWIDLH to reduce drug use and improve their mental health and engagement in HIV care. The intervention design will allow for a better understanding of how these components work in combination and can be optimized for the setting. TRIAL REGISTRATION: This project was registered at clinicaltrials.gov (NCT05377463) on May 17th, 2022.