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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.

IntroductionCOVID-19 parallels HIV in many ways. Socio-behavioural science has been critical in elucidating the context and factors surrounding individual levels of engagement with known effective prevention and treatment tools for HIV, thus offering important lessons for ongoing efforts to combat the COVID-19 pandemic.DiscussionNon-adherence to effective disease mitigation strategies (e.g. condoms for HIV and masks for COVID-19) can be attributed in part to prioritizing comfort, convenience and individual autonomy over public health. Importantly, misinformation can fuel denialism and conspiracies that discredit scientific knowledge and motivate nonadherence. These preferences and the extent to which individuals can act on their preferences may be constrained by the structures and culture in which they live. Both HIV and COVID-19 have been politicized and influenced by evolving recommendations from scientists, clinicians, policymakers and politically motivated organizations. While vaccines are vital for ending both pandemics, their impact will depend on availability and uptake. Four decades of experience with the HIV epidemic have shown that information alone is insufficient to overcome these challenges; interventions must address the underlying, often complex factors that influence human behaviour. This article builds from socio-behavioural science theory and describes practical and successful approaches to enable and support adherence to prevention and treatment strategies, including vaccine adoption. Key methods include reframing tools to enhance motivation, promoting centralized sources of trusted information, strategic development and messaging with and within key populations (e.g. through social media) and appealing to self-empowerment, altruism and informed decision making. Orchestrated evidence-based activism is needed to overcome manipulative politicization, while consistent transparent messaging around scientific discoveries and clinical recommendations are critical for public acceptance and support. Ultimately, the effectiveness of COVID-19 vaccines will depend on our ability to engender trust in the communities most affected.ConclusionsMany lessons learned from socio-behavioural science in the HIV pandemic are applicable to the COVID-19 pandemic. Individual behaviour must be understood within its interpersonal and societal context to address the current barriers to adherence to disease-mitigating strategies and promote an effective response to the COVID-19 pandemic, which is likely to be endured for the foreseeable future.

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.

China is experiencing an emerging HIV epidemic among men who have sex with men (MSM). Minority stress theory posits that marginalized populations experience additional stress, which influences experiences of psychological distress and health outcomes. This study aimed to understand psychological distress of MSM relative to men who have sex with women (MSW) in an urban Chinese setting. Cross-sectional survey data were collected from 162 HIV-positive Chinese men receiving HIV treatment at Beijing's Ditan Hospital. Multiple linear regression with imputation was used to identify correlates of psychological distress. Relative to MSW, MSM were younger, more educated, and less likely to be in a relationship or have children. While both groups reported clinically elevated levels of depression and anxiety, sexual behavior was not associated with either outcome. Higher endorsement of depression symptomology was associated with worse reported physical health (β = -1.37, p

BackgroundSubstance use is common among people living with human immunodeficiency virus (PLWH) and a barrier to achieving viral suppression. Among PLWH who report illicit drug use, we evaluated associations between HIV viral load (VL) and reduced use of illicit opioids, methamphetamine/crystal, cocaine/crack, and marijuana, regardless of whether or not abstinence was achieved.MethodsThis was a longitudinal cohort study of PLWH from 7 HIV clinics or 4 clinical studies. We used joint longitudinal and survival models to examine the impact of decreasing drug use and of abstinence for each drug on viral suppression. We repeated analyses using linear mixed models to examine associations between change in frequency of drug use and VL.ResultsThe number of PLWH who were using each drug at baseline ranged from n = 568 (illicit opioids) to n = 4272 (marijuana). Abstinence was associated with higher odds of viral suppression (odds ratio [OR], 1.4-2.2) and lower relative VL (ranging from 21% to 42% by drug) for all 4 drug categories. Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with VL suppression (OR, 2.2, 1.6, respectively). Reducing frequency of illicit opioid or methamphetamine/crystal use without abstinence was associated with lower relative VL (47%, 38%, respectively).ConclusionsAbstinence was associated with viral suppression. In addition, reducing use of illicit opioids or methamphetamine/crystal, even without abstinence, was also associated with viral suppression. Our findings highlight the impact of reducing substance use, even when abstinence is not achieved, and the potential benefits of medications, behavioral interventions, and harm-reduction interventions.

"Debrief reports" (DRs) use structured forms to capture key concepts from in-depth interviews and focus group discussions. They are completed by interviewers and rapidly disseminated to key team members to facilitate identification of potential problems with study procedures, recruitment, or participant engagement and to inform critical adjustments, which can be especially pertinent in intervention studies. Their reliability and validity have yet to be formally evaluated. To assess the accuracy of DRs in capturing key content, raters analyzed a random sub-sample of 20 pairs of de-identified transcripts and their linked DRs from the VOICE-D trial. Analyses generally supported the accuracy of DRs; however, pertinent information from transcripts was occasionally missed or recorded with discrepancies or lack of detail. Longer transcripts and DR sections describing complex topic areas were more likely to involve discrepancies. Recommendations are offered for further research and optimizing the use of DRs.

: Introduction: Recent advances in long‐acting antiretroviral therapy (LA‐ART) could provide new options for HIV treatment and reduce adherence barriers, if regimens are acceptable to patients. We elicited preferences for key attributes of potential LA‐ART regimens among people with HIV (PWH) in the United States, focusing on four treatment modes (oral tablets, subcutaneous injections, intramuscular injections, and implants), product characteristics and location of administration. Methods: A discrete choice experiment was conducted among PWH aged ≥18 years recruited from HIV clinics in Washington State and Atlanta, Georgia from March 2021 to June 2022. Participants responded to 17 choice scenarios, each with three options: two systematically generated hypothetical LA‐ART regimens and a constant opt‐out (their current daily oral treatment). LA‐ART regimen descriptions included treatment mode, pain, dosing frequency, location, pre‐treatment time with undetectable viral load, pre‐treatment negative reaction testing and “late‐dose leeway” (i.e. flexibility or forgiveness in timing the next dose). We used conditional logistic regression, with an interaction between treatment mode and pain, to estimate preference weights for all attribute levels. Results: Seven hundred participants (350 at each site) enrolled, with median age 51 years (range 18–73); 70% identified as cisgender male, 24% as cisgender female and 6% as non‐binary or transgender. LA oral tablets were the only mode preferred over current daily oral treatment, with annual implants and injections the next most preferred LA‐ART option. Longer time between doses was preferred, and administration at home was preferred to clinics, which were preferred to pharmacies. Attributes with less impact on preferences included oral lead‐in treatment to achieve viral suppression or test for negative reactions and late‐dose leeway around the prescribed dosing interval. Participants in Atlanta were more likely to prefer their current daily oral ART than participants from Seattle. Conclusions: PWH in the United States may soon have several options for LA‐ART. Our results suggest that LA oral tablets will be preferred by many patients over their current daily oral treatment, while implants and injections with longer duration may be acceptable to some. Future research should investigate sources of preference heterogeneity and actual uptake of and adherence to LA‐ART products, when available., INTRODUCTION In 2020, the Centers for Disease Control and Prevention estimated that for every 100 people who were diagnosed with HIV, only 74 had received HIV care and 65 were [...]

BackgroundBecause HIV viral suppression is essential for optimal outcomes and prevention efforts, understanding trends and predictors is imperative to inform public health policy.ObjectiveTo evaluate viral suppression trends in people living with HIV (PLWH), including the relationship of associated factors, such as demographic characteristics and integrase strand transfer inhibitor (ISTI) use.DesignLongitudinal observational cohort study.Setting8 HIV clinics across the United States.ParticipantsPLWH receiving clinical care.MeasurementsTo understand trends in viral suppression (≤400 copies/mL), annual viral suppression rates from 1997 to 2015 were determined. Analyses were repeated with tests limited to 1 random test per person per year and using inverse probability of censoring weights to address loss to follow-up. Joint longitudinal and survival models and linear mixed models of PLWH receiving antiretroviral therapy (ART) were used to examine associations between viral suppression or continuous viral load (VL) levels and demographic factors, substance use, adherence, and ISTI use.ResultsViral suppression increased from 32% in 1997 to 86% in 2015 on the basis of all tests among 31 930 PLWH. In adjusted analyses, being older (odds ratio [OR], 0.76 per decade [95% CI, 0.74 to 0.78]) and using an ISTI-based regimen (OR, 0.54 [CI, 0.51 to 0.57]) were associated with lower odds of having a detectable VL, and black race was associated with higher odds (OR, 1.68 [CI, 1.57 to 1.80]) (P < 0.001 for each). Similar patterns were seen with continuous VL levels; when analyses were limited to 2010 to 2015; and with adjustment for adherence, substance use, or depression.LimitationResults are limited to PLWH receiving clinical care.ConclusionHIV viral suppression rates have improved dramatically across the United States, which is likely partially attributable to improved ART, including ISTI-based regimens. However, disparities among younger and black PLWH merit attention.Primary funding sourceNational Institutes of Health.

In China, where there are few mental health resources, the majority of HIV-related efforts have focused on medical treatment and transmission prevention rather than psychosocial support. Yet people living with HIV/AIDS (PLWHA) report high levels of psychological distress, especially upon first receiving their HIV diagnosis. We conducted mixed methods research of a qualitative study with (N = 31) individual interviews and 3 focus groups (n = 6 in each group) of HIV-affected participants, and a quantitative survey (N = 200) with individuals living with HIV in Shanghai and Beijing, China. Our qualitative data revealed themes of forms of distress experienced and types of psychosocial support that our participants wished they could have accessed upon diagnosis as well as suggestions for intervention structure that would be most feasible and acceptable. Our quantitative surveys provided further evidence of the high degree of psychosocial distress among recently diagnosed PLWHA. Our findings informed the development of the Psychology Toolbox intervention, a brief CBT skills-based intervention comprising cognitive restructuring, behavioral activation, and paced breathing, designed to be integrated into primary care for recently diagnosed PLWHA. This study describes the intervention development process and contents of each session. Future research should evaluate the intervention for efficacy as well as examine best strategies for eventual implementation and dissemination.

In China, acute stigma accompanying an HIV diagnosis can lead to self-isolation. In a cultural setting where family relationships are highly valued and contribute critically to well-being, such self-isolation can thwart HIV self-management and engagement in medical care, and so heighten risk for health disparities. To understand this phenomenon, we conducted individual in-depth interviews with 34 persons living with HIV/AIDS (PLwHA) in Shanghai and Beijing. Inductive content analysis revealed a range of forms of self-isolation motivation, beliefs, and behaviors influenced by: 1) internalized stigma and desire to avoid discrimination; 2) HIV-related factors such as HIV knowledge and disease progression; and 3) familial factors such as a sense of responsibility and family members' reactions. Based on a proposed framework centering on dialectical family influences (whereby PLwHA are pushed away from, yet pulled toward the family fold), implications for provision of multidisciplinary care in medical settings are considered, including culturally appropriate strategies to decrease health disparities.

Studies of persons living with HIV (PLWH) have compared current non-drinkers to at-risk drinkers without differentiating whether current non-drinkers had a prior alcohol use disorder (AUD). The purpose of this study was to compare current non-drinkers with and without a prior AUD on demographic and clinical characteristics to understand the impact of combining them. We included data from six sites across the US from 1/2013 to 3/2015. Patients completed tablet-based clinical assessments at routine clinic appointments using the most recent assessment. Current non-drinkers were identified by AUDIT-C scores of 0. We identified a prior probable AUD by a prior AUD diagnosis in the electronic medical record (EMR) or a report of attendance at alcohol treatment in the clinical assessment. We used multivariate logistic regression to examine factors associated with prior AUD. Among 2235 PLWH who were current non-drinkers, 36% had a prior AUD with more patients with an AUD identified by the clinical assessment than the EMR. Higher proportions with a prior AUD were male, depressed, and reported current drug use compared to non-drinkers without a prior AUD. Former cocaine/crack (70% vs. 25%), methamphetamine/crystal (49% vs. 16%), and opioid/heroin use (35% vs. 7%) were more commonly reported by those with a prior AUD. In adjusted analyses, male sex, past methamphetamine/crystal use, past marijuana use, past opioid/heroin use, past and current cocaine/crack use, and cigarette use were associated with a prior AUD. In conclusion, this study found that among non-drinking PLWH in routine clinical care, 36% had a prior AUD. We found key differences between those with and without prior AUD in demographic and clinical characteristics, including drug use and depression. These results suggest that non-drinkers are heterogeneous and need further differentiation in studies and that prior alcohol misuse (including alcohol treatment) should be included in behavioural health assessments as part of clinical care.

For HIV-infected parents, deciding whether and how to disclose their illness to their children is a major stressor. In China, due to significant HIV stigma, disclosure distress is acute. Our objective was to understand HIV-infected parents' concerns regarding disclosure of their HIV status to their children. HIV-infected parents (N = 10) were recruited to attend a three-session nursing intervention. In our post hoc analysis, progress notes from each session were analyzed for themes to illuminate parental decision-making processes. By the end of the intervention, all parents had considered the importance of HIV disclosure and stated that they felt somewhat prepared to disclose. Primary themes included (a) severe stigma experienced by fathers who were sexually active with men, (b) need for both parents to agree on plans for disclosure, and (c) parents' fears about the consequences of disclosure. Parents living with HIV can benefit from nurse-delivered interventions during parental HIV disclosure decision-making.

Parents who are HIV-positive confront difficult decisions regarding whether, when, and how to disclose their HIV status to their children. In China, a setting of acute HIV stigma where family harmony is culturally valued, limited research has been conducted on parental disclosure. We aimed to develop a model of parental disclosure that accounts for the cultural context in China based on a mixed-methods study. In our individual, in-depth interviews (N = 24) as well as survey data (N = 84) collected from parents living with HIV in Shanghai and Beijing, we found the primary barriers to disclosure were stigma, fear of exposing the mode by which they acquired HIV, psychologically burdening the child, rejection by the child, and negative social consequences for the family. Parents concurrently cited many motivations for disclosure, such as disease progression, ensuring safety of the child, gaining assistance, and fulfilling their parental responsibility. Most parents had not actively disclosed their HIV status (68 %); many parents reported some form of partial disclosure (e.g., sharing they have a blood disease but not labeling it HIV), unplanned disclosure, or unintentional disclosure to their children by other people. Findings informed the development of a Chinese Parental HIV Disclosure Model, with primary components accounting for distal cultural factors, decision-making (balancing approach and avoid motivations), the disclosure event, and outcomes resulting from the disclosure. This model highlights the cultural context of the Chinese parental disclosure process, and may be useful in guiding future observational research and intervention work.

PurposeThe aim of this study was to assess the psychometric properties of the Chinese (Mandarin) version of the Medical Outcomes Study Social Support Survey (MOS-SSS-CM) among people living with HIV/AIDS (PLWHA) in Mainland China.MethodsA cross-sectional study was conducted with a convenience sample of 200 Chinese PLWHA. They completed the MOS-SSS-CM along with the Chinese version of the Beck Depression Inventory Revised (BDI-II) scale, the Zung Self-Rating Anxiety Scale (SAS), the Perceived Stress Scale (PSS-10), and the World Health Organization Quality of Life Brief (WHOQOL-BREF) scale.ResultsInternal consistency (Cronbach's α) was 0.97 for the overall MOS-SSS-CM and 0.82-0.91 for the five subscales originally proposed. However, 11 of the 19 items demonstrated unsatisfactory item discriminant validity. An exploratory factor analysis yielded a two-factor solution with tangible and social-emotional dimensions, which demonstrated satisfactory reliability and better discrimination between different subscales than did the original five-factor model. The concurrent validity of the two-factor scale was further confirmed by its significant negative correlations with the BDI-II (r=-0.41, p

China faces a growing HIV epidemic; psychosocial needs of HIV-positive individuals remain largely unaddressed. Research is needed to consider the gap between need for mental healthcare and lack of sufficiently trained professionals, in a culturally acceptable manner. This study assessed explicit and implicit forms of social support and mental health symptoms in 120 HIV-positive Chinese. Explicit social support refers to interactions involving active disclosure and discussion of problems and request for assistance, whereas implicit social support refers to the emotional comfort one obtains from social networks without disclosing problems. We hypothesized and found using multiple linear regression, that after controlling for demographics, only implicit, but not explicit social support positively predicted mental health. Future research is warranted on the effects of utilizing implicit social support to bolster mental health, which has the potential to circumvent the issues of both high stigma and low professional resources in this population.

ObjectiveRegular HIV RNA testing for all HIV-positive patients on antiretroviral therapy (ART) is expensive and has low yield since most tests are undetectable. Selective testing of those at higher risk of failure may improve efficiency. We investigated whether a novel analysis of adherence data could correctly classify virological failure and potentially inform a selective testing strategy.DesignMultisite prospective cohort consortium.MethodsWe evaluated longitudinal data on 1478 adult patients treated with ART and monitored using the Medication Event Monitoring System (MEMS) in 16 US cohorts contributing to the MACH14 consortium. Because the relationship between adherence and virological failure is complex and heterogeneous, we applied a machine-learning algorithm (Super Learner) to build a model for classifying failure and evaluated its performance using cross-validation.ResultsApplication of the Super Learner algorithm to MEMS data, combined with data on CD4 T-cell counts and ART regimen, significantly improved classification of virological failure over a single MEMS adherence measure. Area under the receiver operating characteristic curve, evaluated on data not used in model fitting, was 0.78 (95% confidence interval: 0.75 to 0.80) and 0.79 (95% confidence interval: 0.76 to 0.81) for failure defined as single HIV RNA level >1000 copies per milliliter or >400 copies per milliliter, respectively. Our results suggest that 25%-31% of viral load tests could be avoided while maintaining sensitivity for failure detection at or above 95%, for a cost savings of $16-$29 per person-month.ConclusionsOur findings provide initial proof of concept for the potential use of electronic medication adherence data to reduce costs through behavior-driven HIV RNA testing.

PurposeEvaluation and comparison of the factor structure of the Medical Outcomes Study Social Support Survey (MOS-SSS) using both confirmatory factor analysis (CFA) and exploratory factor analysis (EFA) with two samples of people living with HIV/AIDS in China.MethodsSecondary analyses were conducted with data from two comparable samples of 320 people living with HIV/AIDS from the same hospital using the same inclusion criteria. The first sample of 120 was collected in 2006, and the second sample of 200 was collected in 2012. For each sample, CFA was first performed on the original four-factor structure to check model fit, followed by EFA to explore other factor structures and a subsequent CFA for model fit statistics to be compared to the original four-factor CFA.ResultsIn both samples, CFA on the originally hypothesized four-factor structure yielded an acceptable model fit. The EFA yielded a two-factor solution in both samples, with different items included in each factor for the two samples. Comparison of CFA on the a priori four-factor structure and the new two-factor structure in both samples indicated that both factor structures were of acceptable model fit, with the four-factor model performing slightly better than the two-factor model.ConclusionFactor structure of the MOS-SSS is method-dependent, with CFA supporting a four-factor structure, while EFA yielded a two-factor structure in two separate samples. We need to be careful in selecting the analytic method when applying the MOS-SSS to various samples and choose the factor structure that best fits the theoretical model.