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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.

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.

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.

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.

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.

Background HIV cure research involving cell and gene therapy has intensified in recent years. There is a growing need to identify ethical standards and safeguards to ensure cell and gene therapy (CGT) HIV cure research remains valued and acceptable to as many stakeholders as possible as it advances on a global scale. Methods To elicit preliminary ethical and practical considerations to guide CGT 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 permitted evaluation of informants’ perspectives on how CGT HIV cure research should ethically occur, and 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 CGT towards an HIV cure. Results We interviewed 13 biomedical researchers, 5 community members, and 1 bioethicist. Informants generated considerations related to: perceived benefits of CGT towards an HIV cure, perceived risks, considerations necessary to ensure an acceptable benefit/risk balance, CGT strategies considered unacceptable, additional ethical considerations, and considerations for first-in-human CGT HIV cure trials. Informants also proposed important safeguards to developing CGT approaches towards an HIV cure, such as the importance of mitigating off-target effects, mitigating risks associated with long-term duration of CGT interventions, and mitigating risks of immune overreactions. Conclusion Our study identified preliminary considerations for CGT-based HIV cure across three key stakeholder groups. Respondents identified an ideal cure strategy as one which would durably control HIV infection, protect the individual from re-acquisition, and eliminate transmission to others. Known and unknown risks should be anticipated and perceived as learning opportunities to preserve and honor the altruism of participants. Preclinical studies should support these considerations and be transparently reviewed by regulatory experts and peers prior to first-in-human studies. To protect the public trust in CGT HIV cure research, ethical and practical considerations should be periodically revisited and updated as the science continues to evolve. Additional ethics studies are required to expand stakeholder participation to include traditionally marginalized groups and clinical care providers.

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.

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 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.

Long-acting injectable antiretroviral therapy (LAI-ART) is one of the latest advancements in HIV control with the potential to overcome oral ART barriers to adherence. The objective of this article is to anticipate and examine implementation considerations for LAI-ART using components of the PRISM model, a Practical, Robust Implementation and Sustainability Model for integrating research findings into practice. We conducted a scoping review from January to August 2020 of the growing literature on LAI-ART implementation and other fields using LAI therapies. Key considerations regarding LAI-ART were parsed from the searches and entered into the PRISM implementation science framework. The PRISM framework posed multiple questions for consideration in the development of an optimal implementation strategy for LAI-ART in the United States. These questions revealed the necessity for more data, including acceptability of LAI-ART among many different subgroups of people living with HIV (PLWH), cost effectiveness, patient satisfaction, and patient-reported outcomes, as well as more detailed information related to the external environment for optimal LAI-ART implementation. Ethical considerations of LAI-ART will also need to be considered. The anticipation of, and excitement for, LAI-ART represent the hope for a new direction for HIV treatment that reduces adherence barriers and improves prognoses for PLWH. We have a unique window of opportunity to anticipate implementation considerations for LAI-ART, so this new therapy can be used to its fullest potential. Outstanding questions remain, however, that need to be addressed to help achieve HIV suppression goals in diverse populations.

HIV cure research carries serious risks and negligible benefits. We investigated how participants understand these risks and what influences their willingness to participate. Through internet-based and in-person convenience sampling, 86 HIV+ participants completed an experimental survey. Participants were randomized to read a standard consent form describing a hypothetical HIV cure study or one adapted using Fuzzy Trace Theory—a decision-making model to facilitate complex information processing. We measured consent understanding and cognitive (e.g., safe/harmful) and affective (e.g., concerning, satisfying) evaluations of HIV cure research. Participants who read the adapted consent form had improved consent understanding, but only positive affective evaluations were associated with a willingness to participate. Consent processes can use decision-making theories to facilitate comprehension of study information.

Objective We sought to examine the prospective association between internalized HIV stigma and unsuppressed viral load and to investigate whether this relationship was sequentially mediated by depressive symptoms and antiretroviral therapy (ART) adherence. Design Longitudinal study in a multisite observational clinical cohort. Methods The Center for AIDS Research Network of Integrated Clinical Systems patient-reported outcomes survey measures internalized HIV stigma yearly using a four-item assessment (response scale 1 = strongly disagree to 5 = strongly agree). We obtained patient-reported outcome, lab, and appointment data from six center for AIDS research network of integrated clinical systems sites. We used multivariable logistic regression to examine the association between mean stigma and subsequent viremia. We then used Bayesian sequential mediation to fit a longitudinal sequential path model spanning four time points to test if depressive symptoms at T1 and ART adherence at T2 mediated the effect of stigma at T0 on viral load at T3, adjusting for baseline covariates. Results Between February 2016 and November 2018, 6859 patients underwent stigma assessment and were 81% cis-men, 38% Black, 16% Latinx, 32% heterosexual-identified, and 49% at least 50 years of age. Mean stigma level was 2.00 (SD 1.08). Stigma was significantly associated with subsequent viremia (adjusted odds ratio = 1.16, 95% confidence interval: 1.05-1.28, P = 0.004), as were younger age and Black race. The chained indirect effect from stigma to unsuppressed viral load through depressive symptoms and then adherence was significant (standardized β = 0.002; SD = 0.001). Conclusion Internalized HIV stigma positively predicts subsequent viremia through depressive symptoms and ART adherence. Addressing the link between stigma and depressive symptoms could help improve viral suppression.

Efforts to recognize and minimize the risk to study participants will be necessary to safely and ethically resume scientific research in the context of the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. These efforts are uniquely challenging in the context of human immunodeficiency virus (HIV) cure clinical trials, which often involve complex experimental therapy regimens and perhaps analytic treatment interruption, in which participants pause antiretroviral therapy. In this viewpoint, we discuss our approach to reopening an HIV cure trial in this context, with a focus on key considerations regarding study design, informed consent and participant education, and study implementation. These recommendations might be informative to other groups seeking to resume HIV cure research in settings similar to ours.

Two HIV virologic control advances are in various stages of development, including long-acting antiretroviral therapy (ART) formulations and strategies aimed at sustained ART-free HIV control. Perceptions of risks and benefits toward HIV virologic control strategies may be different based on an individual's age due to differing experiences of the impacts of the domestic HIV epidemic, altruistic attitudes toward research participation, and general levels of engagement in health care. We examined preferences of HIV virologic control strategies by age groups. In 2018, we conducted a nationwide, online cross-sectional survey to examine differences in HIV virologic control strategies among a sample of people living with HIV who were

There are two concurrent and novel major research pathways toward strategies for HIV control: (1) long-acting antiretroviral therapy (ART) formulations and (2) research aimed at conferring sustained ART-free HIV remission, considered a step toward an HIV cure. The importance of perspectives from people living with HIV on the development of new modalities is high, but data are lacking. We administered an online survey in which respondents selected their likelihood of participation or nonparticipation in HIV cure/remission research based on potential risks and perceived benefits of these new modalities. We also tested the correlation between perceptions of potential risks and benefits with preferences of virologic control strategies and/or responses to scenario choices, while controlling for respondent characteristics. Of the 282 eligible respondents, 42% would be willing to switch from oral daily ART to long-acting ART injectables or implantables taken at 6-month intervals, and 24% to a hypothetical ART-free remission strategy. We found statistically significant gender differences in perceptions of risk and preferences of HIV control strategies, and possible psychosocial factors that could mediate willingness to switch to novel HIV treatment or remission options. Our study yielded data on possible desirable product characteristics for future HIV treatment and remission options. Findings also revealed differences in motivations and preferences across gender and other sociodemographic characteristics that may be actionable as part of research recruitment efforts. The diversity of participant perspectives reveals the need to provide a variety of therapeutic options to people living with HIV and to acknowledge their diverse experiential expertise when developing novel HIV therapies.

Depression is the leading cause of disability worldwide with health implications for people living with HIV. Primary partnerships like marriage could be protective against depression but may worsen depression depending on the relationship quality. We examined depression and its association with relationship dynamics in a cross-sectional sample of 211 HIV-affected married couples in Malawi. We fit multivariable multilevel linear regression models for depressive symptoms. Men and women reported similar levels of depressive symptoms; 28% had a score indicative of probable depression. Almost half of couples had at least one partner with probable depression. In the adjusted models, equality (B = - 0.22; p

Objective The objective of the study was to investigate whether acculturation to U.S. culture is associated with greater posttraumatic stress disorder (PTSD) symptomatology through diminished family cohesion among Latinos living with HIV on the U.S.-Mexico border. Method Baseline survey data were analyzed from a sample of Latinos seeking HIV care from a publicly funded HIV clinic in El Paso, Texas. We used a regression-based bootstrapping approach to test our mediation hypothesis. Results A total of 248 Latinos living with HIV completed the survey, with 96.4% being of Mexican descent, 19.4% female (gender self-identification), and 63.7% nonheterosexual (sexual orientation self-identification). Family cohesion mediated the relationship between U.S. acculturation and PTSD symptom scores (a1 ⁎ b1 = .03, 95% confidence interval [.01-.06]), an effect independent of acculturation to Latino culture. Conclusions Acculturation to U.S. culture may negatively impact mental health through weakening family bonds in this vulnerable population. (PsycINFO Database Record

Interventions aiming to improve access to and retention in HIV care are optimized when they are tailored to clients' needs. This paper describes an initiative of interventions implemented by ten demonstration sites using a transnational framework to tailor services for Mexicans and Puerto Ricans living with HIV. Transnationalism describes how immigrants (and their children) exist in their "receiving" place (e.g., continental U.S.) while simultaneously maintaining connections to their country or place of origin (e.g., Mexico). We describe interventions in terms of the strategies used, the theory informing design and the tailoring, and the integration of transnationalism. We argue how applying the transnational framework may improve the quality and effectiveness of services in response to the initiative's overall goal, which is to produce innovative, robust, evidence-informed strategies that go beyond traditional tailoring approaches for HIV interventions with Latino/as populations.

The disparity in viral suppression rates between Latino and non-Latino White patients in HIV care appears to be narrowing, but it is unclear if depression and substance use perpetuate this disparity. We analyzed electronic medical records (EMR) from the CFAR Network of Integrated Clinical Systems (CNICS) cohort. First observations/enrollment data collected between 2007–2013 were analyzed, which included survey (race/ethnicity, depression, substance use, adherence) and clinical data (viral suppression). We estimated indirect effects with a regression-based bootstrapping method. In 3,129 observations, Latinos and non-Latino Whites did not differ in depression or alcohol use (ORs=1.11, 0.99, ns), but did in drug use (OR=1.13, p

Research on patient engagement in health care shows that better health outcomes and lower healthcare costs are observed among highly engaged patients. Similar to other illnesses, high levels of patient engagement in HIV care are considered essential to maintaining optimal health, and patients who are on treatment and retained in HIV care are known to have better health outcomes. In this article, we draw on focus group discussion data with patients living with HIV in order to explain tacit expectations associated with engagement in care. The main objective of our research was to elicit an explanatory model of engagement in HIV care from the patients’ perspective. We conducted focus group discussions with a sample of two distinct types of patients: those who regularly attended medical appointments and those who did not. In total, we conducted six focus group discussions (n = 43) across in three cities in the US; these included two focus group discussions with a well-engaged and less-well-engaged group in each location. Both types of patients assigned a moral dimension to engagement in care, in that well-engaged patients were considered to be ‘good’ patients. Aspiring to become a ‘good’ patient provided a meaningful goal for some and deepened vulnerabilities among patients that struggled to achieve this status. More vulnerable patients may feel less secure in health care interactions and these feelings may be amplified if patients have an unreasonable impression of what constitutes a ‘good’ patient; thereby leading to disengagement in care. Our findings can inform the development of patient-centered, tailored messages to better serve patients struggling to stay engaged in HIV care.

The study of collectivism has implications for HIV prevention research, especially in studies that use a social networking or community mobilization approach. However, research on collectivism in race/ethnicity and sexual minority groups is limited. We psychometrically evaluated a brief version of the Individualism-Collectivism Interpersonal Assessment Inventory (ICIAI) in a chain-referral sample of 400 Latino, 393 Asian/Pacific Islander, and 403 African American men who have sex with men (MSM). Data were collected via a one-time survey on demographics, the ICIAI, acculturation, and ethnicity identity. We conducted a multiple groups confirmatory factor analysis to assess for measurement invariance across the three groups of MSM, as well as tested its reliability and validity. The ICIAI evidenced good psychometric properties and was invariant across all groups. We highlight implications for how this measure of collectivism can be applied toward the study of HIV prevention and in lesbian, gay, bisexual and transgender communities.

Relying on the most frequently reported barriers to adherence and convenient definitions of non-adherence may lead to less valid results. We used a dominance analysis (a regression-based approach) to identify the most important barriers to adherence based on effect size using data collected through an online survey. The survey included the Adherence Barrier Questionnaire, self-reported non-adherence defined as a 4-day treatment interruption, and HIV clinical outcomes. The sample (N=1217) was largely male, gay identified, and White. Nearly 1 in 3 participants reported "simply forgot" as a barrier; however, in a dominance analysis, it yielded a small effect size it its association with a 4-day treatment interruption. Further, dominance analyses stratified by race/ethnicity and age suggested that not all barriers impact all groups equally. The most frequently reported barriers to adherence were not the most important, and interventions should focus on barriers more strongly linked to clinical outcomes.

We conducted a preliminary RCT among 40 HIV-positive Latinos of Mexican descent on the U.S.-Mexico border who indicated imperfect adherence and depressive symptomatology. Participants were randomly assigned to culturally adapted cognitive-behavioral therapy for adherence and depression (CBT-AD) with an alarmed pillbox or usual care. Outcomes were depressive symptoms (self-report and blind clinician ratings), adherence (self-report and electronic pillbox), and biological markers. The intervention, delivered in English and Spanish, proved feasible and acceptable. Generalized estimating equations in intent-to-treat analyses showed some effects of “moderate” to “large” size, with maintenance over time. For example, intervention (vs. control) participants demonstrated at post-intervention a greater drop in BDI scores (OR = - 3.64, p = .05) and greater adherence according to the electronic pillbox (OR = 3.78, p = .03). Biological markers indicated some relative improvement for CD4 count but not VL. The promising results suggest a larger trial to determine efficacy is warranted.

Objective To evaluate the psychometric properties of a newly developed Medication Literacy Assessment in Spanish and English (MedLitR x SE). Design Descriptive, nonexperimental, cross-sectional study. Setting El Paso, TX, from December 2006 to June 2009. Participants 181 English- or Spanish speaking adults. Intervention Survey administered in two phases. Main outcome measures Descriptive statistics, internal consistency, confirmatory factor analysis (CFA) and fit indices, and criterion-related validity. Results The 20-item MedLitR x SE tool showed adequate internal consistency and reliability, and CFA revealed overall good model fit. In phase 2, the shorter 14-item MedLitR x SE showed good total test reliability and correlated well with the Short Test of Functional Health Literacy in Adults. Item response theory analyses showed no language bias and a one-dimensional (i.e., one factor) model of medication literacy. Conclusion The initial and latest shorter version of the MedLitR x SE tool demonstrated good psychometric properties. This tool may provide a new option to assess "medication literacy" in English and Spanish.

HIV+White, Latino, and African Americans (N=1131) completed a survey advertised on social media to re-examine the effect of depressive symptoms (via the Patient Health Questionnaire; PHQ-9) and race/ethnicity on antiretroviral therapy nonadherence (defined as past 3-month, 4-day treatment interruption). An adjusted logistic regression showed a 15% increase in odds for a treatment interruption per 1-unit increase on the PHQ-9. The effect of depressive symptoms on nonadherence was greater for Latinos (OR=1.80, p&nbsp

Although neurocognitive impairment is an established risk factor for medication non-adherence, standard neurocognitive tests developed for clinical purposes may not fully capture the complexities of non-adherence behavior or effectively inform theory-driven interventions. Prospective memory, an innovative cognitive construct describing one’s ability to remember to do something at a later time, is an understudied factor in the detection and remediation of medication non-adherence. This review orients researchers to the construct of prospective memory, summarizes empirical evidence for prospective memory as a risk factor for non-adherence, discusses the relative merits of current measurement techniques, and highlights potential prospective memory-focused intervention strategies. A comprehensive literature review was conducted of published empirical studies investigating prospective memory and medication adherence. Overall, reviewed studies suggest that prospective memory is an important component of medication adherence, providing incremental ecological validity over established predictors. Findings indicate that prospective memory-based interventions might be an effective means of improving adherence.