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In the United States, young adults have the highest rates of new HIV infections, and are less likely to be aware of their infection, be engaged in care, or achieve HIV viral suppression. As biomedical HIV research increasingly focuses on achieving long-term suppression without antiretroviral therapy (ART) and finding an HIV cure, little is known about perceptions of young adults living with HIV (YLWH) regarding HIV cure research. We recruited a diverse sample of 20 YLWH (18-29 years old) to participate in individual semistructured qualitative interviews to explore knowledge and perceptions of HIV cure research, and motivations and barriers to participation. Most participants had little knowledge of HIV cure research. Motivators of HIV cure research participation included altruism, stigma reduction, and the elimination of the clinical burdens of HIV. Barriers included potential physical side effects, psychological distress, the possibility of disclosure as a result of participating, and the amount of time required to participate. Most participants had concerns about analytic treatment interruptions (i.e., ART interruption to assess HIV remission), and indicated that they would want more frequent laboratory testing and protection for their sex partners during this time. Finally, participants suggested that, if other YLWH are considering participation in cure research, they should first learn as much as possible about the research, and then consider the potential personal benefits and the contribution that they could make to science and their communities. As HIV cure research advances, the participation of YLWH will be critical. Our study provides knowledge about how YLWH view HIV cure research. More sociobehavioral research is needed to ensure that those who are most likely to be the decision-makers and beneficiaries of an HIV cure are included at all levels of research.

The AIDS Clinical Trials Group A5345 study (NCT03001128) included an intensively monitored antiretroviral pause (IMAP), during which participants living with HIV temporarily stopped antiretroviral treatment (ART) in an effort to identify biomarkers that could predict HIV rebound. We evaluated the potential impact of the IMAP on A5345 study participants in the United States by questioning them immediately after the IMAP and at the end of the study. We administered longitudinal sociobehavioral questionnaires to participants following the IMAP when they resumed ART and at the end of the study. We summarized descriptive data from the post-IMAP and end-of-study questionnaires. Open-ended responses were analyzed using conventional content analysis. Reactions to pausing ART involved a mixture of curiosity and satisfaction from contributing to science. All participants indicated adherence with the ART interruption. About half (9/17) of post-IMAP questionnaire respondents reported having sexual partner(s) during the IMAP, and of those, nearly all (8/9) did not find it difficult to use measures to prevent HIV transmission to partners. The majority believed that they benefited from the study, yet some had elevated anxiety following the IMAP and at the end of the study. Most (24/29) respondents who completed the end-of-study questionnaire would recommend the study to other people living with HIV. Our findings underscore the relevance of the psychosocial aspects of participating in studies that involve interruptions of ART. Understanding how participants experience this research is invaluable for informing the design of future research aimed at sustained ART-free virologic suppression.

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.

Youth and young adults living with HIV (YLWH) have a high HIV infection rate and suboptimal oral medication adherence. Biomedical researchers hope that long-acting antiretroviral therapy (LAART) modalities can help those who struggle with daily oral adherence. While adults living with HIV have expressed interest in LAART, little research has explored perspectives of YLWH. This study explores ART experiences and perspectives on LAART through qualitative interviews with twenty diverse YLWH (18-29) in the United States. Data were analyzed using framework analysis. Most participants were satisfied with their current ART yet had experienced side effects or had struggled with daily adherence. Preferences for improving daily oral ART included making pills smaller and reformulating ART into flavored chewable gummies. Most expressed enthusiasm for LAART, although needle aversion and previous injection drug use were potential barriers for some. Approximately half were interested in an ART patch, though its visibility and fear of stigmatization was concerning. Few expressed interest in implantable ART, calling it unappealing. Although younger people are most likely to benefit from these advancements in HIV treatment, additional research is needed to identify gaps in uptake and to further explore perspectives of YLWH to improve the success of new treatment modalities.

Nearly half of new HIV cases in the United States are among youth. Little is known about the willingness of young adults living with HIV (YLWH) to participate in HIV cure-related research. In 2021, we recruited 271 YLWH aged 18-29 for an online survey. We asked questions about willingness to participate in HIV cure research, perceived risks and benefits, acceptable trade-offs, and perceptions on analytical treatment interruptions. We conducted descriptive analyses to summarize data and bivariate analyses to explore correlations by demographics. Most respondents (mean age = 26) identified as men (86%) and Black Americans (69%). YLWH expressed high willingness to consider participating in cell- and gene-based approaches (75%) and immune-based approaches (71%). Approximately 45% would be willing to let their viral load become detectable for a period of time during an HIV cure study, 27% would not be willing, and 28% did not know. The social risk most likely to deter participation was the possibility of transmitting HIV to sex partners while off HIV medications (65% of respondents would be deterred a great deal or a lot). Compared to the 25-29 age group (

We aimed to characterize the variability in the illness experience and recovery process from COVID-19. We conducted in-depth individual interviews with participants enrolled in the Long-term Immunological Impact of Novel Coronavirus (LIINC) cohort study in San Francisco, California from June through October of 2020. Participants were adults who had a previously confirmed positive SARV-CoV-2 nucleic acid amplification test result, had recovered or were recovering from acute infection, and underwent serial evaluations at our clinical research center. We purposefully sampled 24 English- and Spanish-speaking adults with asymptomatic, mild and severe symptomatic infection, including those who were hospitalized, and those with HIV co-infection. Half of our sample (50.0%) identified as Latinx/Hispanic and most of the participants were men (62.5%). We used thematic analysis to characterize the illness experience, recovery process, and mental health impact of experiencing COVID-19 and present clinical data for each participant. Emergent themes were: (1) across symptom profiles and severity, experiencing COVID-19 was associated with psychological distress, (2) among participants with symptomatic infection, the illness experience was characterized by uncertainty in terms of managing symptoms and recovery, and (3) despite wide-ranging illness experiences, participants shared many common characteristics, including health information-seeking behavior facilitated by access to medical care, and uncertainty regarding the course of their illness and recovery. COVID-19 was associated with elevated levels of psychological distress, regardless of symptoms.

Most HIV cure studies remain in the early stage of investigation and may carry clinical risks to the participants and, in some cases, their partners. Surprisingly little sociobehavioral research has investigated the perceptions of couples-including HIV serodifferent couples-around HIV cure research, including factors that would influence recruitment and retention in trials. We conducted a qualitative study to explore perceptions of diverse HIV serodifferent partners in the United States. We recruited 10 diverse HIV serodifferent couples (20 participants). We found participants had learned to cope with the reality of HIV, including protections during sex, and ascribed both positive and negative meanings to an HIV cure. Partners expressed concern about each other's health and potentially caring for a sick partner and emphasized the importance of safety when participating in an HIV cure trial. They identified the need for partner protection measures during analytical treatment interruptions (ATIs) as an ethical imperative. Participants recounted experiences of HIV stigma due to being in HIV serodifferent relationships and viewed ATIs as leading to a detectable viral load, which could limit sexual expression, complicate disclosure decision making, and worsen HIV-related stigma. Our study's main contribution is to inform efforts to meaningfully engage diverse HIV serodifferent partners in HIV cure research in the United States. Our data suggest people with HIV make decisions to participate in research based on close ones in their life and underscore the critical importance of acknowledging relationship dynamics in decisions to participate in research.

There is evidence for a relationship between housing instability and transactional sex among transgender women. However, less is known about this relationship among monolingual Spanish-speaking transgender women. We compared Spanish- and English-speaking transgender women for differences in ever reporting transactional sex, and if perceived housing stability moderated these differences. Using a cross-sectional design, we surveyed 186 Spanish- and English-speaking transgender women in Philadelphia, Pennsylvania, and the San Francisco Bay Area, California. All variables in this study were from a brief demographic questionnaire in a larger parent study. Using a multivariate regression model for moderation, we tested whether the odds for reporting transactional sex were different between English and Spanish speakers, and whether housing stability moderated these odds. Overall, Spanish and English speakers reporting similar percentages of transactional sex (52.3–53.8%) and similar scores on the housing stability measure. In the moderation regression model, Spanish speakers had 7.9 times the adjusted odds of transaction sex, versus English speakers, but housing stability moderated the probability of transactional sex in the form of a crossover interaction. That is, lesser housing stability was associated with a higher probability of reporting transactional sex among Spanish speakers, yet greater housing stability was also associated with lower probability of reporting transactional sex. Housing stability evidenced both a risk and protective role for Spanish-speaking transgender women, which highlight the importance of this basic health need.

We tested if Latinx and Black individuals are more likely to somaticize depression compared with their White counterparts. We analyzed 14,745 depression ratings from 4,101 people living with HIV from 2007 to 2014. We calculated the percentage of each depression score accounted for by somatic symptom items (e.g., feeling tired). We analyzed depression scores using generalized estimation equations, which accounts for repeated measures within each person. Somatic symptoms accounted for 70% of depression scores for White patients, 66% for Latinx patients, and 68% for Black patients. Across the 14,745 assessments, adjusting for age and sex, and within-person correlation, the percentage of the depression scores made up of somatic items was lower for Latinx ( b = −.03, p < .0001) and Black patients ( b = −.02, p < .001), compared with White patients. The idea that Latinx and Black individuals are likely to somaticize depression may lead to underdiagnoses and perpetuate stereotypes and inequities that are not supported by empirical data.

Use of long-acting injectable antiretroviral therapy depends on patient awareness, provider discussion, and patient willingness to use. We conducted a postvisit survey with patients at 3 HIV clinics in San Francisco, Chicago, and Atlanta in May 2021 to assess for inequities in these early implementation phases.

BACKGROUND: Analytical treatment interruptions (ATIs) in HIV cure-related research can result in trial participants becoming viremic with HIV, placing HIV-negative sexual partners at elevated risk of acquiring HIV. OBJECTIVE: Our study aimed to generate ethical and practical considerations for designing and implementing appropriate risk mitigation strategies to reduce unintended HIV transmission events during ATIs. METHODS: We conducted 21 in-depth interviews with five types of informants: bioethicists, community members, biomedical HIV cure researchers, socio-behavioral scientists/epidemiologists, and HIV care providers. We used conventional content analysis to analyze the data and generate considerations. RESULTS: Key findings include: 1) Ethical permissibility of ATI trials depends on due diligence and informed consent to mitigate risks to participants and their sexual partners; 2) Participants should receive adequate support and/or counseling if they choose to disclose ATI participation to their partners; 3) Measures to protect sexual partners of trial participants from HIV transmission during ATIs should include referral to and/or provision of pre-exposure prophylaxis, as well as other available means of preventing HIV transmission; 4) There is uncertainty regarding the appropriate management of emerging sexually transmitted infections during ATI trials and possible protection measures for multiple and/or anonymous partners of ATI trial participants. CONCLUSION: While there is no way to completely eliminate the risk of HIV transmission to sexual partners during ATIs, HIV cure trialists and sponsors should consider the ethical concerns related to the sexual partners of ATI participants. Doing so is essential to ensuring the welfare of participants, their partners and the trustworthiness of research.

End-of-life (EOL) HIV cure-related research provides a novel approach to studying HIV reservoirs. The Last Gift is a rapid autopsy research study at the University of California San Diego that enrolls terminally ill people living with HIV (PLWHIV) with a desire to contribute to HIV cure-related research. We conducted in-depth baseline and follow-up interviews with Last Gift study participants. We analyzed interview data applying conventional content analysis. Since summer 2017, 13 participants have been enrolled (n = 11 males and 2 females; aged 45-89 years) and 8 participants interviewed. Terminal illnesses included cancers, heart diseases, and neurodegenerative illnesses. Our analysis revealed five key themes: (1) The Last Gift study has tremendous meaning for participants at the end of their life. (2) HIV-specific altruism was a primary motivator to join the Last Gift study, nested within the context of community, scientific advancement, and moral obligation. (3) Participants did not expect physical benefits yet they perceived emotional/psychological, financial, and societal/scientific benefits. (4) There were minimal participant-perceived risks and concerns. (5) Last Gift participants expressed immense gratitude toward study staff. The Last Gift study provides a framework for ethical HIV cure-related research at EOL and highlighted participants' perspectives, motivations, and experiences. Knowing how PLWHIV understand and experience such studies will remain critical to designing ethical, fully informed HIV cure research protocols that are acceptable to PLWHIV.

A growing body of research is beginning to elucidate reasons people living with HIV (PLWHIV) might prefer oral daily antiretroviral treatment (ART) compared with emerging long-acting ART (LA-ART) or HIV remission strategies under investigation. Our objective is to provide qualitative insights into the reasons why PLWHIV might prefer one of these HIV control therapies over others. From May to August 2018, we implemented a semistructured cross-sectional survey of PLWHIV in the United States to better understand patient preferences around various HIV treatment and remission options. Using free text, respondents were asked to explain why they preferred one HIV control option over the other two. We analyzed responses to the open-ended survey questions on reasons for preferring oral daily ART versus LA-ART versus HIV remission strategies using conventional content analysis. The results showed that PLWHIV preferred oral daily ART because of its familiarity and known safety and efficacy profile, whereas those who preferred LA-ART would value the convenience it offers. Finally, HIV remission strategies would be preferred to avoid taking ART altogether. The qualitative results provide insights into reasons why PLWHIV in the United States might prefer oral daily ART versus novel therapies. More importantly, they provide information to better align HIV virological control strategies with end-user perspectives. To make informed choices around evolving HIV therapeutics, PLWHIV and HIV care providers would benefit from decision tools to better assess options and trade-offs. More research is needed on how best to effectively support PLWHIV and HIV care providers in shared decision-making.

A growing number of people living with HIV/AIDS are participating in HIV cure-related research at the end of life (EOL). Due to the novelty of EOL HIV cure-related research, there is a need to understand how their next-of-kin (NOK) perceive such research. We conducted in-depth interviews with NOK of the Last Gift study participants at the University of California, San Diego. The Last Gift study occurs in the context of the EOL and involves a full body donation. NOK completed two interviews: (1) shortly after the participants' enrollment in the study and (2) following death. We applied thematic analysis to analyze qualitative data. NOK included seven individuals (five males and two females), including two spouses, one ex-partner, one sister, a grandmother/grandfather, and a close friend. Thematic analysis revealed five key themes: (1) NOK viewed the Last Gift program in a positive light and had an accurate overall understanding of the study; (2) NOK identified factors that motivated participants to donate their body to science; (3) NOK identified benefits of the Last Gift program for both the donors and themselves; (4) NOK did not perceive any physical risks or decisional regrets of study but wanted to minimize psychosocial impacts and ensure the dignity of participants at all times; and (5) NOK noted elements that remained essential to the successful implementation of EOL HIV cure-related research, such as early involvement and clear communication. Our study uniquely contributes to increased understanding and knowledge of what is important from the point of view of supportive NOK to ensure successful implementation of EOL HIV cure-related research. More research will be needed to understand perspectives of less supportive NOK.

Internet-based surveys are increasingly used for health research because they offer several advantages including greater geographic reach, increased participant anonymity, and reduced financial/time burden. However, there is also a need to address inherent challenges, such as the likelihood of fraudulent responses and greater difficulty in determining eligibility.We conducted an online nationwide survey of 18-29 year olds living with HIV in the United States, to assess willingness to participate in HIV cure research. To ensure that respondents met age and HIV serostatus inclusion criteria, we instituted screening procedures to identify ineligible respondents using tools that were built into the survey platform (eg, reCAPTCHA, geolocation) and required documentation of age and serostatus before providing access to the incentivized study survey.Of 1308 eligibility surveys, 569 were incomplete or ineligible because of reported age or serostatus. Of the remaining 739 potentially eligible respondents, we determined that 413 were from fraudulent, bot, or ineligible respondents. We sent individual study survey links to 326 participants (25% of all eligibility survey respondents) whose eligibility was reviewed and confirmed by our study team.Our multicomponent strategy was effective for identifying ineligible and fraudulent responses to our eligibility survey, allowing us to send the study survey link only to those whose eligibility we were able to confirm. Our findings suggest that proactive fraud prevention can be built into the screening phase of the study to prevent wasted resources related to data cleaning and unretrievable study incentives and ultimately improve the quality of data.

Disclosing a seropositive HIV status still is a complex process of assessing the risks, benefits, and potential personal and interpersonal outcomes associated with disclosure, such as stigma, rejection, or emotional support. We examined HIV disclosure practices to family and intersectional stigma related to HIV and sexual orientation among Latino sexual minority men (LSMM) of Mexican and Puerto Rican origin with HIV in the continental USA. Guided by Framework Analysis, we present data from 54 interviews with 33 LSMM participants in HIV care engagement interventions, and 21 project staff implementing the interventions. LSMM disclosed their HIV status to family seeking support. They applied stigma management techniques to manage the information communicated to family about their HIV status, including selective disclosure to some family members, conveying strategic information about the significance of having HIV, non-disclosure, or partial disclosure, silence and deceptions. LSMM HIV disclosure practices to family encompassed appraisals of intersectional stigma related to their sexual orientation and HIV, assessing the potential outcomes of disclosure, and the preservation of family ties.

We investigated individual behaviors taken by white, African American, and Latino United States (US) households in response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and likelihood of using digital tools for symptom surveillance/reporting. We analyzed cross-sectional week 1 data (April 2020) of the coronavirus disease 2019 (COVID-19) Impact Survey in a large, nationally representative sample of US adults. In general, all groups engaged in the same prevention behaviors, but whites reported being more likely to use digital tools to report/act on symptoms and seek testing, compared with African Americans and Latinos. Individual behaviors may not explain COVID-19 case disparities, and digital tools for tracking should focus on uptake among race/ethnic minorities., Individual behaviors to protect against exposure to severe acute respiratory syndrome coronavirus were nearly identical across white, African American, and Latino respondents in a probability-based survey representative of US households.

Objective: The objective of the study was to evaluate a novel measure of HIV care engagement in a large sample of non-Latino White, Latino, and African American patients. The Index of Engagement in HIV care (the Index) measures the degree to which a patient feels engaged/disengaged from HIV care. However, its measurement invariance, or the degree to which observed scores can be meaningfully compared across racial/ethnic groups, has not been established. Methods: The 10-item Index is a self-report measure initially validated in the Center for AIDS Research Network of Integrated Systems cohort study. Using Center for AIDS Research Network of Integrated Systems survey data, Index scores were linked to patients' electronic medical records, which included viral load (VL) and appointment attendance data. We conducted measurement invariance analyses to test the Index's performance in the 3 racial/ethnic groups and its cross-sectional association with VL and retention in HIV care (2 primary outcomes). Results: A total of 3,127 patients completed the Index, which showed good reliability across the 3 groups (alphas >.84). Confirmatory factor analysis model fit statistics showed that the Index demonstrated configural, metric, and scalar invariance, supporting the conclusion that the Index is a single factor construct. Lastly, lower Index scores associated with a concurrent detectable VL and poor retention in HIV care for all 3 groups. Conclusion: Having demonstrated invariance, the Index scores can be used to compare engagement levels across non-Latino Whites, Latinos, and African Americans in HIV care settings. Improving HIV care retention requires tools that can accurately identify people struggling to stay engaged in HIV care, especially racial/ethnic minorities. (PsycInfo Database Record (c) 2020 APA, all rights reserved).

Minimizing error in self-reported sexual behavior could reduce investigators' likelihood of rejecting truly successful interventions to decrease HIV and STI transmission risk. Sexual behavior assessments can elicit problematic data. This may manifest in the form of elevated levels of non-response, inaccurate point estimates, or misclassification errors resulting in inappropriately answering or, perhaps more importantly, skipping questions. We programed conversational interviewing elements into 20 sexual behavior questions in an exit survey of gay bathhouse patrons (N = 459) administered using ACASI. Those elements, called alternate pathways, included follow-up questions to responses to confirm that operational definitions were applied in the answer (with return to the initial question if confirmation failed), and assurances of confidentiality and requests for best guesses in reaction to non-response (including "don't know"). These elements were invoked in nearly 10% of participants, and approximately 74% of all invocations resulted in a usable numeric response, or 87% if the data need only estimate prevalence. Almost two-thirds of the problematic data issues occurred in answers to sexual contact questions, with others related to follow-up questions about specific sexual behavior. It is at this level of important filtering questions where the benefits of the approach are likely to be maximized.

Background There is mounting evidence for the presence of postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC), but there is limited information on the spectrum, magnitude, duration, and patterns of these sequelae as well as their influence on quality of life. Methods We assembled a cohort of adults with a documented history of SARS-CoV-2 RNA positivity at ≥2 weeks past onset of coronavirus disease 2019 (COVID-19) symptoms or, if asymptomatic, first positive test. At 4-month intervals, we queried physical and mental health symptoms and quality of life. Results Of the first 179 participants enrolled, 10 were asymptomatic during the acute phase of SARS-CoV-2 infection, 125 were symptomatic but not hospitalized, and 44 were symptomatic and hospitalized. During the postacute phase, fatigue, shortness of breath, concentration problems, headaches, trouble sleeping, and anosmia/dysgeusia were most common through 8 months of observation. Symptoms were typically at least somewhat bothersome and sometimes exhibited a waxing-and-waning course. Some participants experienced symptoms of depression, anxiety, and post-traumatic stress, as well as difficulties with performance of usual activities. The median visual analogue scale rating of general health was lower at 4 and 8 months compared with pre-COVID-19. Two clusters of symptom domains were identified. Conclusions Many participants report bothersome symptoms following onset of COVID-19 with variable patterns of persistence and impact on quality of life. The substantial variability suggests the existence of multiple subphenotypes of PASC. A rigorous approach to the prospective measurement of symptoms and functional manifestations sets the stage for the next phase of research focusing on the pathophysiologic causes of the various subgroups of PASC.

BackgroundYoung adults living with HIV (YLWH) have suboptimal adherence to antiretroviral therapy (ART) and HIV care outcomes. Mobile health technologies are increasingly used to deliver interventions to address HIV health outcomes. However, not all YLWH have equal and consistent access to mobile technologies.MethodsUsing our novel Mobile Technology Vulnerability Scale (MTVS) to evaluate how vulnerable an individual feels with regard to their personal access to mobile technology in the past 6 months, we conducted a cross-sectional online survey with 271 YLWH (18-29 years) in the US to evaluate the relationships between MTVS and self-reported ART adherence.ResultsParticipants reported changes in phone numbers (25%), stolen (14%) or lost (22%) phones, and disconnections of phone service due to non-payment (39%) in the past 6 months. On a scale of 0 to 1 (0 having no mobile technology vulnerability and 1 having complete mobile technology vulnerability), participants had a mean MTVS of 0.33 (SD =0.26). Black and financially constrained participants had the highest MTVS, which was significantly higher that other racial/ethnic and financially non-constrained groups, respectively. Higher MTVS was significantly associated with ART non-adherence and non-persistence.ConclusionsFindings suggest the need to measure MTVS to recognize pitfalls when using mobile health interventions and identify populations whose inconsistent mobile technology access may be related to worse health outcomes.

Background An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.

Background We investigated the prospective association between a brief self-report measure of engagement in human immunodeficiency virus (HIV) care (the Index of Engagement in HIV Care; hereafter “Index”) and suboptimal retention and viral suppression outcomes. Methods The Centers for AIDS Research Network of Integrated Clinical Systems cohort study combines medical record data with patient-reported outcomes from 8 HIV clinics in the United States, which from April 2016 to March 2017 included the 10-item Index. Multivariable logistic regression was used to estimate the risk and odds ratios of mean Index scores on 2 outcomes in the subsequent year: (1) not keeping ≥75% of scheduled HIV care appointments; and (2) for those with viral suppression at Index assessment, having viral load >200 copies/mL on ≥1 measurement. We also used generalized linear mixed models (GLMMs) to estimate the risk and odds ratios of appointment nonattendance or unsuppressed viral load at any given observation. We generated receiver operating characteristic curves for the full models overlaid with the Index as a sole predictor. Results The mean Index score was 4.5 (standard deviation, 0.6). Higher Index scores were associated with lower relative risk of suboptimal retention (n = 2576; logistic regression adjusted risk ratio [aRR], 0.88 [95% confidence interval, .87–.88]; GLMM aRR, 0.85 [.83–.87]) and lack of sustained viral suppression (n = 2499; logistic regression aRR, 0.75 [.68–.83]; GLMM aRR, 0.74 [.68–.80]). The areas under the receiver operating characteristic curve for the full models were 0.69 (95% confidence interval, .67–.71) for suboptimal retention and 0.76 (.72–.79) for lack of sustained viral suppression. Conclusions Index scores are significantly associated with suboptimal retention and viral suppression outcomes.

Background Sexual and gender minority (SGM; i.e., non-heterosexual and transgender or gender-expansive, respectively) people experience physical health disparities attributed to greater exposure to minority stress (experiences of discrimination or victimization, anticipation of discrimination or victimization, concealment of SGM status, and internalization of stigma) and structural stigma. Purpose To examine which components of minority stress and structural stigma have the strongest relationships with physical health among SGM people. Methods Participants (5,299 SGM people, 1,902 gender minority individuals) were from The Population Research in Identity and Disparities for Equality (PRIDE) Study. Dominance analyses estimated effect sizes showing how important each component of minority stress and structural stigma was to physical health outcomes. Results Among cisgender sexual minority women, transmasculine individuals, American Indian or Alaskan Native SGM individuals, Asian SGM individuals, and White SGM individuals a safe current environment for SGM people had the strongest relationship with physical health. For gender-expansive individuals and Black, African American, or African SGM individuals, the safety of the environment for SGM people in which they were raised had the strongest relationship with physical health. Among transfeminine individuals, victimization experiences had the strongest relationship with physical health. Among Hispanic, Latino, or Spanish individuals, accepting current environments had the strongest relationship with physical health. Among cisgender sexual minority men prejudice/discrimination experiences had the strongest relationship with physical health. Conclusion Safe community environments had the strongest relationships with physical health among most groups of SGM people. Increasing safety and buffering the effects of unsafe communities are important for SGM health.

Background The pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research. Methods We conducted a scoping review of the growing HIV cure research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing. Discussion Despite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation). Conclusion HIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time.

The AIDS Clinical Trials Group (ACTG) A5345 study included an intensively monitored antiretroviral pause (IMAP), during which a cohort of participants temporarily stopped antiretroviral treatment during chronic HIV infection. We surveyed participant perceptions and understanding of A5345 using a cross-sectional sociobehavioral questionnaire. Participants completed the baseline questionnaire either before or after initiating the study's IMAP. Questionnaire responses were linked to existing demographic data. Quantitative responses were analyzed overall and stratified by IMAP status. Open-ended responses were analyzed using conventional content analysis. Thirty-two participants completed the baseline sociobehavioral questionnaire. Half (n = 16) completed it before (i.e., pre-IMAP initiation group) and half (n = 16) after IMAP initiation (i.e., post-IMAP initiation group). Eight pre-IMAP initiation respondents (50%) and 11 post-IMAP respondents (69%) responded “yes” when asked if they perceived any direct benefits from participating in A5345. Perceived societal-level benefits included furthering HIV cure-related research and helping the HIV community. Perceived personal-level benefits included the opportunity to learn about the body's response to IMAP and financial compensation. The majority of respondents—13 from each group (81% of each)—reported risks from participation, for example, viral load becoming detectable. A5345 participants perceived both societal- and personal-level benefits of study participation. While the majority of survey respondents perceived participatory risks, nearly one in five did not. Key messages pertaining to study-related risks and benefits may need to be clarified or reiterated periodically throughout follow-up in HIV cure-related studies with IMAPs. Clinical Trail Registration Number: NCT03001128.

HIV-related stigma is a known barrier to retention in care. However, no large-scale, multi-site studies have prospectively evaluated the effect of internalized stigma on retention in care. The Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort study integrates medical record and survey data from people living with HIV (PLWH) seen in HIV primary care clinics across the United States, and assesses internalized stigma yearly using a validated 4-item Likert scale. We used multivariable logistic regression models to evaluate associations between mean internalized stigma and two prospective retention in care outcomes: keeping the next primary care appointment and keeping all scheduled primary care appointments in the 12 months following stigma assessment. From February 2016 to November 2017, 5968 PLWH completed the stigma assessment and had adequate follow-up time. Mean stigma was 1.9 (standard deviation 1.08). Increased mean stigma scores were associated with decreased odds of attending the next primary care appointment [adjusted odds ratio (aOR) = 0.93, 95% confidence interval (CI) 0.88–0.99, p = 0.02], and all primary care appointments in the subsequent 12 months (aOR = 0.94, 95% CI 0.89–0.99, p = 0.02). In both models, younger age and Black race were also independently associated with suboptimal appointment attendance. There was no support for interactions between internalized stigma and covariates. Internalized HIV stigma had an independent negative effect on the odds of subsequent appointment attendance. This study highlights the importance of identifying even low levels of internalized stigma. Interventions to address internalized HIV stigma are critical to supporting retention in care and improving clinical outcomes.

Background The relationship of internalized HIV stigma to key care cascade metrics in the United States is not well established using large-scale, geographically diverse data. Setting Center for AIDS Research Network of Integrated Clinical Systems (CNICS) cohort study. Methods Beginning in February 2016, we administered a yearly, validated 4-item internalized HIV stigma scale (response scale 1 = strongly disagree to 5 = strongly agree, Cronbach's alpha 0.91) at 7 CNICS sites and obtained cohort data through November 2017. We compared mean stigma levels by sociodemographic characteristics and used multivariable logistic regression, controlling for the same sociodemographic covariates, to evaluate the association between mean stigma and (1) concurrent viremia; (2) missed visits; and (3) poor visit constancy. We used inverse probability weighting (IPW) to account for differences between patients who did and did not undergo stigma assessment. Results Of 13,183 CNICS patients, 6448 (49%) underwent stigma assessment. Mean stigma was 1.99 (SD 1.07), and 28.6% agreed/strongly agreed with at least 1 stigma question. Patients younger than 50 years, racial/ethnic minorities, cis-women, and heterosexuals had higher mean stigma. Mean stigma score was associated with concurrent viremia [adjusted odds ratio (AOR) 1.13, 95% confidence interval (CI): 1.02 to 1.25, P 0.02], missed visits (AOR 1.10, 95% CI: 1.02 to 1.19, P 0.01), and poor visit constancy, although the effect on visit constancy was attenuated in the IPW model (AOR 1.05, 95% CI: 0.98 to 1.13, P 0.17). Conclusions Higher internalized HIV stigma had a modest but statistically significant association with concurrent viremia and poor retention in care. Further inquiry with prospective analyses is warranted.

BackgroundEngagement in care is critical to achieving and sustaining optimal benefits of efficacious antiretroviral therapies for HIV infection. Current metrics of engagement in care, including problematic patterns of retention in care, adherence to treatment, and viral suppression, are often detected late in the disengagement process. We sought to develop and validate a patient-centered screener of engagement in care that can be used to identify deficits in patient perceptions of engagement before the development of poor outcomes, including loss to follow-up, treatment nonadherence, virologic failure, and the resulting increased likelihood of HIV-associated morbidity and mortality and onward transmission of HIV.Setting and methodsUsing input from patients, providers, and researchers through in-person focus groups and an online Delphi process, we developed a self-report measure of engagement in care that was validated with 3296 patients from 7 clinics across the United States.ResultsResults supported a single dimension of engagement in care measured by 10 items. Lower scores on the HIV Index were related to higher depression and anxiety symptoms, greater use of alcohol and stimulants, and increased likelihood of reporting internalized HIV stigma. Higher Index scores were positively associated with self-report measures of antiretroviral therapy adherence, corroborative clinic records documenting appointment attendance, and increased likelihood of recent viral load suppression.ConclusionsThe HIV Index offers promise as a patient-centered diagnostic and prognostic screener for engagement in care that can be used to trigger interventions to promote better clinical outcomes for persons living with HIV.

Background: HIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify standards, safeguards, and protections to ensure cell and gene therapy HIV cure research remains ethical and acceptable to as many stakeholders as possible as it advances on a global scale.Methods: To elicit ethical and practical considerations to guide cell and gene therapy HIV cure research, we implemented a qualitative, in-depth interview study with three key stakeholder groups in the United States: 1) biomedical HIV cure researchers, 2) bioethicists, and 3) community stakeholders. Interviews were transcribed verbatim. We applied conventional content analysis focused on inductive reasoning to analyze the rich qualitative data and derive key ethical and practical considerations related to cell and gene therapy towards an HIV cure.Results: We interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of cell and gene therapy towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, cell and gene therapy strategies considered unacceptable, additional ethical considerations, considerations for first-in-human cell and gene therapy HIV cure trials. Informants also proposed important safeguards to developing cell and gene therapy approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of cell and gene therapy interventions, and mitigating risks of immune overreactions.Conclusion: Rapidly evolving cell and gene therapy towards an HIV cure is accompanied by a host of ethical and practical challenges. To minimize risks to potential participants and facilitate the translation of scientific advancements from the bench to the clinic, cell and gene therapy HIV cure research must be thoughtfully developed and implemented. To protect the public trust in cell and gene therapy HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve.