Leveraging A Digital Pill System to Understand Prevention-Effective Adherence to Oral Hiv Pre-Exposure Prophylaxis Among Men Who Have Sex with Men with Substance Use.

Daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, though efficacy depends on adherence. Digital pill systems (DPS) can enable direct, real-time adherence measurement. HIV-negative men who have sex with men (MSM) with substance use (excluding alcohol) utilized a DPS over 90 days and completed weekly surveys reporting sexual activity, condom use, and substance use. Responses indicating (1) any sexual activity and substance use or (2) condomless anal intercourse (CAI) in the prior week were categorized as high risk for HIV acquisition. PrEP adherence data for the 7-day period preceding each response was dichotomized as ≤ 3 and ≥ 4 doses/week, indicating prevention-effective adherence, and compared by HIV risk level. Thirteen MSM were analyzed (median age: 32). Of 113 surveys, 48.7% indicated high HIV risk, with 12.4% reporting CAI alone, 16.8% any sexual activity and substance use, and 19.5% both CAI and substance use. Weekly mean PrEP adherence was 90.3% (6.3 of 7 doses/week), with ≥ 4 doses/week recorded during 92.0% of weeks. The proportion of participants with ≥ 4 recorded doses/week was 88.9% during weeks with CAI alone, 89.5% during weeks with any sexual activity and substance use, 92.0% during weeks with both CAI and substance use, and 92.8% during lower risk weeks. Participants ingested ≥ 4 doses/week during 89.1% of all high-risk weeks and 94.8% of low-risk weeks. Overall, participants maintained high levels of PrEP adherence while engaging in HIV risk behaviors. DPS can be deployed concurrently with data collection tools to assess ingestion patterns during periods of elevated risk.

The salience of structural barriers and behavioral health problems to ART adherence in people receiving HIV primary care in South Africa.

Multilevel factors (individual and structural) influence adherence to antiretroviral therapy, particularly in high HIV prevalence areas such as South Africa. The present study examined the relative importance of structural barriers to HIV care and behavioral health factors, depression and alcohol use, in Khayelitsha, Cape Town, South Africa. People receiving HIV care in six primary care clinics in Khayelitsha (N = 194) completed the Center for Epidemiologic Studies Depression Scale, the Alcohol Use Disorders Identification Test, the Structural Barriers to Medication Taking questionnaire, and a qualitative rating of past-two-week adherence. Correlations were employed to examine associations among these variables, and hierarchical regression analysis was used to examine the unique effects of structural barriers over and above depression and alcohol use as predictors of adherence. Participants were primarily Black South African (99%) women (83%), and 41 years old on average. All four variables were significantly correlated. The hierarchical regression analysis showed that among behavioral health predictors, alcohol use alone significantly predicted ART adherence (b = -.032, p = .002). When structural barriers was added to the model, it was the only significant unique predictor of ART adherence (b = -1.58, p < .001). Findings highlight the need to consider structural vulnerabilities in HIV care in South Africa when developing behavioral health interventions.

A network analysis of positive psychosocial factors and indication of suboptimal HIV care outcomes among Black women living with HIV.

Black women living with HIV (BWLWH) face barriers that impact health outcomes. However, positive psychosocial indicators may influence HIV care outcomes. Among this cross-sectional study of 119 BWLWH, a network analysis was utilized to examine relationships between positive psychosocial factors and HIV-related health outcomes. A preliminary polychoric analysis was conducted to examine correlations between the variables, and the network analyzed connections between resilience, self-efficacy, self-esteem, perceived social support, religious coping, post-traumatic growth, and an indicator variable for suboptimal HIV care outcomes (low medication adherence, detectable viral load, and missed HIV-related health visits) and determined the centrality measures within the network. Seven significant associations were found among the factors: self-efficacy and self-esteem, post-traumatic growth and resilience, post-traumatic growth and self-efficacy, post-traumatic growth and religious coping, perceived social support and resilience, self-esteem and resilience, self-esteem and perceived social support (bootstrapped 95% CI did not contain zero). Self-efficacy was the strongest indicator associated with the other factors. Although not statistically significant, the indicator for suboptimal HIV care outcomes was negatively associated with perceived social support and religious coping. Future interventions incorporating self-efficacy may be beneficial to the overall well-being of Black women.

Intersecting Relationships of Psychosocial and Structural Syndemic Problems Among People with HIV in South Africa: Using Network Analysis to Identify Influential Problems.

In South Africa, little is known about interrelationships between syndemic problems among people with HIV (PWH). A better understanding of syndemic problems may yield important information regarding factors amenable to mitigation. We surveyed 194 PWH in Khayelitsha, outside of Cape Town, South Africa. We used network analysis to examine the frequency of 10 syndemic problems and their interrelationships. Syndemic problems among PWH in South Africa were common; 159 (82.8%) participants reported at least 2 co-occurring syndemic problems and 90 (46.9%) endorsed 4 or more. Network analysis revealed seven statistically significant associations. The most central problems were depression, substance use, and food insecurity. Three clusters of syndemics were identified: mood and violence; structural factors; and behavioral factors. Depression, substance use, and food insecurity commonly co-occur among PWH in sub-Saharan Africa and interfere with HIV outcomes. Network analysis can identify intervention targets to potentially improve HIV treatment outcomes.

RESUMEN: En Sudáfrica, poco se sabe sobre interrelaciones entre problemas sindémicos entre personas con VIH (PCV). Un major entendimiento de los problemas sindémicos puede arrojar información importante sobre los factores susceptibles de mitigación. Utilizamos el análisis de redes para examinar la frecuencia de 10 problemas sindémicos y sus interrelaciones. Problemas sindémicos entre PCV en Sudáfrica eran communes; 159 (82.8%) participantes presentaron al menos 2 problemas sindémicos concurrentes y 90 (46.9%) presentaron 4 o más. El análisis de red reveló siete asociaciones estadísticamente significativas. Los problemas más centrales fueron la depresión, el uso de sustancias y la inseguridad alimentaria. Se indetificaron tres grupos de sindemias: estado de ánimo y violencia; factores estructurales; y factores de comportamiento. La depresión, el uso de sustancias y la inseguridad alimentaria comúnmente ocurren simultáneamente entre las PCV en el África subsahariana e interfieren con los resultados del VIH. El análisis de redes puede identificar objetivos de intervención para potencialmente mejorar los resultados del tratamiento del VIH.

Cognitive Performance, as well as Depression, Alcohol Use, and Gender, predict Anti-Retroviral Therapy Adherence in a South African Cohort of People with HIV and Comorbid Major Depressive Disorder.

Depression and cognitive impairment, which commonly coexist in people with HIV (PWH), have been identified as potential barriers to optimal antiretroviral therapy (ART) adherence. We investigated associations between cognitive performance, depression (as well as other sociodemographic, psychosocial and psychiatric variables) and ART adherence in a South African cohort of PWH with comorbid major depressive disorder (MDD). Cognitive performance and ART adherence were assessed at two time points 8 months apart (Nbaseline = 105, Nfollow-up = 81). Adherence was indicated by self-report, objective measures (Wisepill usage and plasma tenofovir-diphosphate levels), and HIV viral suppression. Mixed-effects regression models examined associations across both time points. Univariate models detected no significant associations between cognitive performance (globally and within-domain) and ART adherence. Multivariate modelling showed increased depression severity (ß = - 0.54, p < 0.001) and problematic alcohol use (ß = 0.73, p = 0.015) were associated with worse adherence as measured subjectively. Being female (OR 0.27, p = 0.048) and having better global cognitive performance (OR 1.83, p = 0.043) were associated with better adherence as indicated by viral suppression. This study identifies poor global cognitive performance, as well as depression and problematic alcohol use, as potential barriers to optimal ART adherence in PWH and comorbid MDD. Hence, clinicians could consider assessing for cognitive deficits, depression, and problematic alcohol use, and should endeavour to provide the appropriate support so as to improve adherence.

Cognitive performance in a South African cohort of people with HIV and comorbid major depressive disorder.

Cognitive performance in people with HIV (PWH) may be affected by brain injury attributable to the infection itself, by other medical and psychiatric comorbidities (including major depressive disorder; MDD), and by psychosocial factors (e.g., education, food insecurity). We investigated effects of these variables on cognitive performance in a South African cohort of PWH with comorbid MDD and incomplete adherence to antiretroviral therapy (ART). We also examined (a) associations of depression severity with cognitive performance, and (b) whether improvement in depression led to improved cognitive performance. Participants (N = 105) completed baseline neuropsychological, psychiatric, and sociodemographic assessments. Subsequently, 33 were assigned to a cognitive-behavioural therapy for ART adherence and depression (CBT-AD) and 72 to standard-of-care treatment. Eight months post-baseline, 81 (nCBT-AD = 29) repeated the assessments. We investigated (a) baseline associations between sociodemographic, medical, and psychiatric variables and cognitive performance, (b) whether, from baseline to follow-up, depression and cognitive performance improved significantly more in CBT-AD participants, and (c) associations between post-intervention improvements in depression and cognitive performance. At baseline, less education (ß = 0.62) and greater food insecurity (ß = -0.20) predicted poorer overall cognitive performance; more severe depression predicted impairment in the attention/working memory domain only (ß = -0.25). From baseline to follow-up, depression decreased significantly more in CBT-AD participants (p = .017). Improvement over time in depression and cognitive performance was not significantly associated except in the attention/working memory domain (p = .026). Overall, factors associated with cognitive performance were unrelated to brain injury. We conclude that clinicians examining PWH presenting with cognitive difficulties must assess depression, and that researchers investigating cognitive impairment in PWH must collect information on psychosocial factors.

The Relationship Between Harmful Alcohol Use and Antiretroviral Non-adherence in People Accessing HIV Treatment in Cape Town, South Africa: An Event-Level Analysis.

Harmful alcohol consumption can significantly compromise adherence to antiretroviral therapy (ART). Prior research has identified aggregate relationships between alcohol use and ART non-adherence, largely relying on concurrent assessment of these domains. There is relatively limited evidence on more nuanced day-level associations between alcohol use and ART non-adherence, despite potentially important clinical implications. We recruited adults with HIV treatment adherence challenges and harmful alcohol use (n = 53) from HIV care in South Africa. We examined relationships between alcohol use and same and next day ART adherence, accounting for the role of weekends/holidays and participant demographics, including gender. Results demonstrated that ART adherence was significantly worse on weekend/holiday days. Next day adherence was significantly worse in the context of weekend alcohol use and among men. These results suggest the importance of tailoring intervention strategies to support ART adherence during weekend drinking and for men engaged in heavy episodic drinking.

Formative acceptance of ingestible biosensors to measure adherence to TB medications.

BACKGROUND: Tuberculosis (TB) represents a significant public health threat in India. Adherence to antitubercular therapy (ATT) is the key to reducing the burden of this infectious disease. Suboptimal adherence to ATT and lack of demonstrated feasibility of current strategies for monitoring ATT adherence highlights the need for alternative adherence monitoring systems. METHODS: A quantitative survey was conducted to assess the acceptance of and willingness to use a digital pill system (DPS) as a tool for monitoring ATT adherence among stakeholders directly involved in the management of patients with TB in India. Participants reviewed a video explaining the DPS and completed a survey, which covered sociodemographics, degree of involvement with TB patients, initial impressions of the DPS, and perceived challenges for deploying the technology in India. Participants were also asked to interpret mock DPS adherence data. RESULTS: The mean age was 34.3 (SD = 7.3), and participants (N = 50) were predominantly male (70%). The sample comprised internists (52%) and pulmonologists (30%), with a median of 4 years' experience (IQR 3, 6) in the management of TB patients. No participants had previously used a DPS, but some reported prior awareness of the technology (22%). Most reported that they would recommend use of a DPS to patients on ATT (76%), and that they would use a DPS in both the intensive and continuation phases of TB management (64%). The majority viewed the DPS (82%) as a useful alternative to directly observed therapy-short course (DOTS), particularly given the ongoing COVID-19 pandemic. Participants reported that a DPS would be most effective in patients at risk of nonadherence (64%), as well as those with past nonadherence (64%). Perceived barriers to DPS implementation included lack of patient willingness (92%), cost (86%), and infrastructure constraints (66%). The majority of participants were able to accurately interpret patterns of adherence (80%), suboptimal adherence (90%), and frank nonadherence (82%) when provided with mock DPS data. CONCLUSIONS: DPS are viewed as an acceptable, feasible, and useful technology for monitoring ATT adherence by stakeholders directly involved in TB management. Future investigations should explore patient acceptance of DPS and pilot demonstration of the system in the TB context.

Improving Detection of Depression in People Living with HIV: Psychometric Properties of the South African Depression Scale (SADS).

Most measures developed in high income countries to screen for major depressive disorder (MDD) among people living with HIV (PWH) demonstrate suboptimal psychometric properties when utilized in non-western, resource limited settings due to their high false positive rates. For standardized MDD screening to be implementable in local settings, a measure is needed that reduces diagnostic burden by being highly sensitive while limiting false positives. This study sought to evaluate the ability of the locally developed South African Depression Scale (SADS) to screen for MDD in PWH in Cape Town. The SADS was administered along with the SCID-5-RV as gold standard to 236 PWH. It demonstrated good discriminating ability in detecting MDD with an area under the curve of 0.85. A cut-off of 27 yielded 78.2% sensitivity and 54.4% PPV. Given its robust psychometric properties, routine use of the SADS in community clinics to screen at-risk PWH, combined with evidence-based depression treatment, could improve the health outcomes and well-being of PWH in South Africa.ResumenLa mayoría de las medidas desarrolladas en países de ingresos altos para detectar el trastorno depresivo mayor (TDM) entre las personas que viven con el VIH (PVV) demuestran propiedades psicométricas subóptimas cuando se utilizan en entornos no occidentales de recursos limitados debido a sus altas tasas de falsos positivos. Para que la detección de TDM estandarizada sea implementable en entornos locales, se necesita una medida que reduzca la carga diagnóstica al ser altamente sensible mientras limita los falsos positivos. Este estudio trató de evaluar la capacidad de la Escala de Depresión Sudafricana (SADS, por sus siglas en inglés) desarrollada localmente para detectar TDM en PVV en Ciudad del Cabo. El SADS se administró junto con el SCID-5-RV como el test de referencia a 236 PWH. Demostró una buena capacidad discriminatoria en la detección de TDM con un área bajo la curva de 0,85. Un corte de 27 produjo un 78,2% de sensibilidad y un 54,4% de VPP. Dadas sus sólidas propiedades psicométricas, el uso rutinario del SADS en clínicas comunitarias para detectar las PVV en riesgo, combinado con un tratamiento de depresión basado en la evidencia, podría mejorar los resultados de salud y el bienestar de las PVV en Sudáfrica.

Improving the measurement of food insecurity among people with HIV in South Africa: a psychometric examination.

OBJECTIVE: Food insecurity is a structural barrier to HIV care in peri-urban areas in South Africa (SA), where approximately 80 % of households are moderately or severely food insecure. For people with HIV (PWH), food insecurity is associated with poor antiretroviral therapy adherence and survival rates. Yet, measurement of food insecurity among PWH remains a challenge. DESIGN: The current study examines the factor structure of the nine-item Household Food Insecurity Access Scale (HFIAS, isiXhosa-translated) among PWH in SA using a restrictive bifactor model. SETTING: Primary care clinics in Khayelitsha, a peri-urban settlement in Cape Town, SA. PARTICIPANTS: Participants (n 440) were PWH who received HIV care in Khayelitsha screening for a clinical trial. Most were categorised as severely (n 250, 56·82 %) or moderately (n 107, 24·32 %) food insecure in the past 30 d. RESULTS: Revised parallel analysis suggested a three-factor structure, which was inadmissible. A two-factor structure was examined but did not adequately fit the data. A two-factor restrictive bifactor model was examined, such that all items loaded on a general factor (food insecurity) and all but two items loaded on one of two specific additional factors, which adequately fit the data (comparative fit index = 0·995, standardised root mean square residual = 0·019). The two specific factors identified were: anxiety/insufficient quality and no food intake. Reliability was adequate (ω = 0·82). CONCLUSIONS: Results supported the use of a total score, and identified two specific factors of the HFIAS, which may be utilised in future research and intervention development. These findings help identify aspects of food insecurity that may drive relationships between the construct and important HIV-related variables.

Tobacco Use and Health-Related Quality of Life Among Individuals with Depression Who Are Receiving Treatment for HIV in Cape Town, South Africa.

BACKGROUND: Tobacco use is the leading cause of preventable death worldwide, and prevalence rates are high among people living with HIV (PLWH), particularly in men. Depression is also common among PLWH, especially among smokers, who may use tobacco to manage mood. Although HIV and depression have been linked to functional impairment and poor health-related quality of life (HRQOL), little research has examined the degree to which smoking impacts these relationships in low- and middle-income countries with high HIV burden. METHOD: Participants (N = 289) were people living with HIV (PLWH) who were being assessed for inclusion in a study targeting depression as a barrier to HIV medication adherence. Linear regression models measured the effect of gender on tobacco use (assessed by the WHO-ASSIST) and on each of the five HRQOL functional impairment domains (assessed by the SF-21). Separate multivariable regression models examined the relationships between habitual tobacco use, defined as daily, almost daily, or weekly use, and the HRQOL domains. RESULTS: The prevalence of habitual tobacco use was 23.9% (48.1% among men, 15.5% among women). Habitual tobacco use was associated with decreased cognitive functioning for the whole sample (B = - 8.99, p < 0.05) and with lower levels of pain-related impairment for men (B = 18.1, p < 0.05). Although men reported more tobacco use (B = 8.50, p < 0.001), they reported less pain-related limitations than women (B = 8.70, p < 0.05). CONCLUSIONS: In our sample, men reported higher rates of habitual tobacco use than women. Smoking was associated with cognitive impairment and with less pain-related impairment among men. Future smoking cessation treatments tailored to PLWH who have symptoms of depression may benefit from strategies that consider pain management as a pathway to habitual smoking and recognize that motivations for use may differ by gender.

Examining a Syndemics Network Among Young Latino Men Who Have Sex with Men.

BACKGROUND: Although studies consistently find that syndemic indicators are additively associated with increased HIV/STI risk behavior (e.g., condomless anal sex; CAS) among men who have sex with men (MSM), information is lacking about how syndemic indicators are associated with each other. Young Latino MSM are one of the most at-risk groups for acquiring HIV in the U.S. Understanding the associations of syndemic indicators with each other and with CAS may improve understanding of how to enhance sexual and behavioral health in this population. METHOD: Network analysis using the graphical LASSO (glasso) algorithm was employed to explore associations between CAS and syndemic indicators among 139 young Latino MSM. Structural and psychosocial syndemic indicators were assessed via self-report. CAS was defined as the number of partners in the past 3 months with whom one engaged in CAS. RESULTS: Results of the network analysis suggested the variables with the highest centrality were unstable housing, prison history, childhood sexual abuse, and CAS. Specific significant associations included links between CAS and alcohol use (b = 0.40), childhood sexual abuse and unstable housing (b = - 0.75), alcohol use and childhood sexual abuse (b = 0.40), and substance use and intimate partner violence (b = 0.43). CONCLUSION: This pattern of interconnectedness demonstrates the potential for network analysis to examine nuanced interrelationships of syndemic indicators. The specific associations in this sample raise the question whether a primary focus of interventions should address the more central syndemic indicators for this population, such as alcohol use and unstable housing, and whether this would, via downstream effects, affect other aspects of behavioral health in this population.

Pathways to Health: an Examination of HIV-Related Stigma, Life Stressors, Depression, and Substance Use.

BACKGROUND: Despite antiretroviral treatment (ART) being an efficacious treatment for HIV, essentially making it a chronic non-terminal illness, two related and frequent concerns for many people living with HIV/AIDS (PLWHA) continue to be HIV-related stigma and life stress. These two variables are frequently associated with depression, substance use, and poorer functional health. Studies to date have not fully examined the degree to which these constructs may be associated within one model, which could reveal a more nuanced understanding of how HIV-related stigma and life stress affect functional health in PLWHA. METHODS: The current study employed hybrid structural equation modeling to examine the interconnectedness and potential indirect relationships of HIV-related stigma and life stress to worse health through substance use and depression, controlling for ART adherence and age. Participants were 240 HIV-infected individuals who completed a biopsychosocial assessment battery upon screening for an RCT on treating depression in those infected with HIV. RESULTS: Both HIV-related stigma and stressful life events were directly related to depression, and depression was directly related to health. There were significant indirect effects from stigma and stress to health via depression. There were no significant effects involving substance use. CONCLUSION: It is important to continue to develop ways to address stigma, stressful life events, and their effects on distress in those living with HIV. Expanding our knowledge of disease progression risk factors beyond ART adherence is important to be able to design adjuvant interventions, particularly because treatment means that people living with HIV have markedly improved life expectancy and that successful treatment means that HIV is not transmittable to others.

Openness to adopting evidence-based practice in public substance use treatment in South Africa using task shifting: Caseload size matters.

BACKGROUND: In response to the lack of coverage for substance use treatment in the Western Cape province of South Africa, the local government expanded funding for evidence-based practices (EBPs) for treating substance use. Yet, little is known about provider and staff attitudes towards adopting EBPs in this setting, which is particularly relevant in this context where task shifting clinical care increases demands on paraprofessional providers. This study aimed to (1) assess attitudes towards adopting EBPs among a range of staff working in substance use treatment in Cape Town using a task shifting model; and (2) evaluate factors associated with openness towards adopting EBPs in this setting. METHODS: Staff (n = 87) were recruited from 11 substance use treatment clinics. Demographics and job-related characteristics were assessed. Staff perceptions of organizational factors were assessed using the TCU Organizational Readiness for Change (ORC) scale. The dependent variable, attitudes towards adopting EBPs, was assessed using the Evidence-Based Practice Attitude Scale (EBPAS). RESULTS: This study is one of the first to administer the EBPAS in South Africa and found good internal consistency (total score: α = .82). In a multivariable model adjusting for site and factors associated with EBPAS total score at the bivariate level, only smaller caseload size was associated with greater openness to adopting EBPs (B = 1.61, SE = .73; t = 2.21; p<.05). CONCLUSIONS: As pressure to scale up implementation of EBPs in South African substance use treatment services intensifies, additional efforts are needed to understand barriers to adopt EBPs in this setting. Supporting staff adoption of EBPs in resource-limited settings may require additional resources to limit staff caseloads in the context of task shifting.

Smartphone and Wearable Device-Based Digital Phenotyping to Understand Substance use and its Syndemics.

Digital phenotyping is a process that allows researchers to leverage smartphone and wearable data to explore how technology use relates to behavioral health outcomes. In this Research Concepts article, we provide background on prior research that has employed digital phenotyping; the fundamentals of how digital phenotyping works, using examples from participant data; the application of digital phenotyping in the context of substance use and its syndemics; and the ethical, legal and social implications of digital phenotyping. We discuss applications for digital phenotyping in medical toxicology, as well as potential uses for digital phenotyping in future research. We also highlight the importance of obtaining ground truth annotation in order to identify and establish digital phenotypes of key behaviors of interest. Finally, there are many potential roles for medical toxicologists to leverage digital phenotyping both in research and in the future as a clinical tool to better understand the contextual features associated with drug poisoning and overdose. This article demonstrates how medical toxicologists and researchers can progress through phases of a research trajectory using digital phenotyping to better understand behavior and its association with smartphone usage.

Real-World Implementation Challenges Associated with a Digital Pill System to Measure Adherence to HIV Pre-Exposure Prophylaxis from Two Studies of Men Who Have Sex With Men.

Once-daily oral pre-exposure prophylaxis (PrEP) is highly effective for HIV prevention, but its efficacy is dependent on adherence, which can be challenging for men who have sex with men (MSM) with substance use. Digital pill systems (DPS) represent a novel tool for directly measuring adherence through ingestible radiofrequency sensors that confirm ingestions in real-time. We examined operational challenges across two studies involving DPS to measure PrEP adherence. While most participants successfully operated the system, a number of technological and sociobehavioral challenges requiring intervention were identified across both studies. Technological issues were both system- and participant-related, and were primarily addressed with technical updates and participant re-education, while sociobehavioral issues, including health and housing changes and issues with technology access, warranted innovative solutions. Future research leveraging DPS technology should develop robust supportive infrastructure and mitigation procedures to promptly identify and resolve operational issues to optimize the potential benefits of DPS use.

Acceptance of digital phenotyping linked to a digital pill system to measure PrEP adherence among men who have sex with men with substance use.

Once-daily oral HIV pre-exposure prophylaxis (PrEP) is an effective strategy to prevent HIV, but is highly dependent on adherence. Men who have sex with men (MSM) who use substances face unique challenges maintaining PrEP adherence. Digital pill systems (DPS) allow for real-time adherence measurement through ingestible sensors. Integration of DPS technology with other digital health tools, such as digital phenotyping, may improve understanding of nonadherence triggers and development of personalized adherence interventions based on ingestion behavior. This study explored the willingness of MSM with substance use to share digital phenotypic data and interact with ancillary systems in the context of DPS-measured PrEP adherence. Adult MSM on PrEP with substance use were recruited through a social networking app. Participants were introduced to DPS technology and completed an assessment to measure willingness to participate in DPS-based PrEP adherence research, contribute digital phenotyping data, and interact with ancillary systems in the context of DPS-based research. Medical mistrust, daily worry about PrEP adherence, and substance use were also assessed. Participants who identified as cisgender male and were willing to participate in DPS-based research (N = 131) were included in this subsample analysis. Most were White (76.3%) and non-Hispanic (77.9%). Participants who reported daily PrEP adherence worry had 3.7 times greater odds (95% CI: 1.03, 13.4) of willingness to share biometric data via a wearable device paired to the DPS. Participants with daily PrEP adherence worry were more likely to be willing to share smartphone data (p = 0.006) and receive text messages surrounding their daily activities (p = 0.003), compared to those with less worry. MSM with substance use disorder, who worried about PrEP adherence, were willing to use DPS technology and share data required for digital phenotyping in the context of PrEP adherence measurement. Efforts to address medical mistrust can increase advantages of this technology for HIV prevention.

HPTN 083-02: factors influencing adherence to injectable PrEP and retention in an injectable PrEP study.

INTRODUCTION: HPTN 083 demonstrated the superiority of long-acting cabotegravir (CAB-LA) versus daily oral emtricitabine/tenofovir disoproxil fumarate (TDF/FTC) as pre-exposure prophylaxis (PrEP) among cisgender men and transgender women who have sex with men (MSM/TGW). HPTN 083 provided the first opportunity to understand experiences with injectable PrEP in a clinical trial. METHODS: Participants from two US sites (Chicago, IL and Atlanta, GA) and one international site (Rio de Janeiro, Brazil) were purposively sampled for individual qualitative interviews (N = 40), between November 2019 and March 2020, to explore trial experiences, barriers to adherence and other factors that may have impacted study implementation or outcomes. The blinded phase ended early due to efficacy; this analysis includes interviews conducted prior to unblinding with three groups defined by adherence (i.e. injection visit attendance): adherent (n = 27), non-adherent (n = 12) and early discontinuers (n = 1). Data were organized using NVivo software and analysed using content analysis. RESULTS: Participants (mean age: 27) were primarily cisgender MSM (90%) and Black/African American (60%). Reasons for trial enrolment and PrEP use included a preference for using HIV prevention medication versus treatment in the event of HIV acquisition; the ability to enhance health via study-related education and services; access to a novel, convenient HIV prevention product at no cost; and contributing to MSM/TGW communities through research. Participants contrasted positive experiences with study staff with their routine clinical care, and emphasized increased scheduling flexibility, thorough communication, non-judgemental counselling and open, affirming environments (e.g. compassion, less stigma) as adherence facilitators. Injection experiences were positive overall; some described early injection-related anxiety, which abated with time and when given some measure of control (e.g. pre-injection countdown), and minimal injection site discomfort. Some concerns and misperceptions about injectable PrEP were reported. Barriers to adherence, across all adherence categories, included structural factors (e.g. financial constraints, travel) and competing demands (e.g. work schedules). CONCLUSIONS: Respondents viewed injectable PrEP trial participation as a positive experience and a means of enhancing wellbeing. Study site flexibility and affirming clinic environments, inclusive of non-judgemental counselling, were key facilitators of adherence. To support injection persistence, interventions that address structural barriers and promote flexible means of injection delivery may be most effective.

"Trajectories of treatment response in a cognitive-behavioral therapy intervention for depression and adherence in persons with HIV in South Africa".

BACKGROUND: People with HIV (PHW) are at greater risk of depression than the general population. Insight into the time-to-treatment-response and predictors of response to psychotherapy may improve implementation in primary care. METHODS: We assessed depression treatment response among 80 participants in a trial of cognitive-behavioral therapy for adherence and depression (CBT-AD) for PWH with MDD and suboptimal antiretroviral therapy (ART) adherence. Participants self-reported depressive symptoms (CESD) at each therapy session. Clinicians assessed participants' depression (HAMD), along with potential predictors of response, every four months for one year. Latent class analyses examined classes of responders for the active and the post-treatment phases. Regression analyses identified predictors of class membership for each phase. RESULTS: During the active treatment phase (CESD) we identified an early response (at session 2 and with continued trajectory of improvement) and a non-response group. There were also two classes during post-treatment (HAM-D): early responders (4-month) and late responders (12-month). Distress aversion was associated with lower likelihood of early response to CBT-AD (aOR = 0.74, 95%CI[0.56-0.90], p = .009), and social support was associated with increased likelihood of early response (aOR = 2.24, 95%CI[1.07-5.46], p = .045). LIMITATIONS: Self-reported depression during the treatment phase may have resulted from social desirability bias. CONCLUSIONS: Most participants responded to CBT-AD early during treatment (89 %) and had sustained improvements in depression by 4 months (80 %). Distress aversion was a risk factor for late response, and social support was protective. Future research is needed to assess the optimal dose of CBT-AD in resource limited settings.