Effects of Adjuvant Endocrine Therapy-Specific Perceptions on Response to a Behavioral Intervention for Adjuvant Endocrine Therapy Adherence in Patients With Breast Cancer.

PURPOSE: Adjuvant endocrine therapy (AET) is a life-saving medication for patients with hormone-sensitive breast cancer, yet many struggle with adherence, warranting behavioral intervention. In our recent trial, participation in a group cognitive behavioral intervention (STRIDE) for symptom management and adherence was associated with improvements in symptom distress, coping, quality of life, and mood. We now explore whether baseline patient- and medication-specific factors-which may be modifiable by clinician-led discussions-moderated the effect of STRIDE on adherence rates. METHODS: From October 2019 to June 2021, 100 patients with early-stage breast cancer reporting AET-related distress were enrolled and randomly assigned to STRIDE or a medication monitoring (MM) control group. All patients stored their AET in electronic pill bottles to track objective adherence. Patients also self-reported their adherence on the Medication Adherence Report Scale-5 and their perceptions of AET on the Cancer Therapy Satisfaction Questionnaire at baseline. We conducted hierarchical linear modeling to test moderators of intervention effects on objective adherence rates. We report the time × group × moderator effects. RESULTS: Among patients reporting greater perceived difficulties with AET adherence at baseline, STRIDE participants had higher adherence rates over time compared with MM (b = -13.80; SE = 4.56; P < .01). Patients with greater expectations of therapeutic benefit from AET also had improved adherence rates if they were assigned to STRIDE, versus MM (b = 0.25; SE = 0.10; P = .01). Patients who perceived taking AET as convenient and had been taking their AET for less time had higher adherence rates in STRIDE, versus MM. CONCLUSION: The current study identified patient- and medication-specific factors that may augment AET adherence interventions and may be modifiable through clinician-led discussions, such as perceptions of adherence problems, therapeutic efficacy, and convenience of AET.

A Pilot Randomized Control Trial of the Striving Towards EmPowerment and Medication Adherence (STEP-AD) Intervention for Black Women Living with HIV.

Black women living with HIV (BWLWH) face adversities associated with lower HIV medication adherence, viral non-suppression, and mental health symptoms (e.g., post-traumatic stress disorder) such as trauma/violence, racism, HIV-related discrimination/stigma, and gender-related stressors. We developed the first intervention based in cognitive behavioral therapy and culturally congruent coping for BWLWH to increase medication adherence and decrease PTSD symptoms by enhancing resilience, self-care, engagement in care, and coping for trauma, racism, HIV-related discrimination/stigma, and gender-related stressors. A pilot randomized control trial was conducted with BWLWH and histories of trauma who were at risk for their HIV viral load remaining or becoming detectable (i.e., below 80% medication adherence, detectable viral load in the past year, and/or missed HIV-related appointments). 119 BWLWH were assessed at baseline and 70 met inclusion criteria, completed one session of Life-Steps adherence counseling, and were randomized to either nine sessions of STEP-AD (Striving Towards EmPowerment and Medication Adherence) or ETAU (enhanced treatment as usual consisting of biweekly check-ins). Women completed a post intervention follow up assessment (3 months post baseline) and 3-month post intervention follow-up (6 months post baseline). Via STATA the difference-in-difference methodology with mixed models compared STEP-AD to ETAU on changes in outcomes over time. BWLWH in STEP-AD compared to E-TAU had significantly higher ART adherence (estimate = 9.36 p = 0.045) and lower likelihood of being clinically diagnosed with PTSD (OR = .07, estimate = - 2.66, p = 0.03) as well as borderline significance on higher CD4 count (estimate = 161.26, p = 0.05). Our findings suggest preliminary efficacy of STEP-AD in improving ART adherence, mental health, and immune function.

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.

The impact of syndemic burden, age, and sexual minority status on internalized HIV stigma among people living with HIV in South Florida.

Internalized HIV stigma has been associated with several poor mental and physical health outcomes among people living with HIV (PLWH); yet, little research has explored how internalized HIV stigma may be affected by syndemic burden. This study sought to examine the relationship between syndemic conditions and HIV stigma over and above the potential effects of two social determinants of health, age and sexual minority status, using a linear regression approach (N = 1343). Syndemic burden was significantly positively associated with internalized HIV stigma above and beyond the effects of age and sexual minority status (b = 0.23). Additionally, age (b = -0.02) and being a sexually minority (b = -0.31) were significantly negatively associated with internalized HIV stigma. Findings should inform future treatment targets for this population by specifically working to reduce internalized HIV stigma for people with a greater syndemic burden and, potentially, among young adults and heterosexual PLWH.

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.

Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial.

PURPOSE: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. METHODS: At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence. RESULTS: Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = -0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = -1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = -1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators. CONCLUSIONS: A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention. STUDY REGISTRATION: NCT03837496.

If we build it, will they come? A scoping review of objective engagement metrics in asynchronous psychosocial telehealth interventions for breast cancer survivors.

Burgeoning technologies and the COVID-19 pandemic resulted in a boom of telehealth for immunocompromised patients, such as those with cancer. Telehealth modalities overcome barriers and promote accessibility to care. Currently, efficacious psychosocial interventions exist to address negative aftereffects of a cancer diagnosis and treatment. Many of these interventions often incorporate asynchronous telehealth (e.g., web-based, smartphone mobile app) features. However, asynchronous platforms are limited by suboptimal engagement. Subjective indicators of perceived engagement in the forms of acceptability, feasibility, and adherence are often captured, yet prior research has found discrepancies between perceived and actual engagement. The FITT (frequency, intensity, time/duration, type of engagement) model, originally developed for use to quantify engagement within exercise trials, provides a framework to assess objective engagement of psychosocial interventions for breast cancer. Using 14 keywords and searching six databases through 11/2023, 56 studies that used asynchronous telehealth interventions in breast cancer were identified. All FITT domains were reported at least once across studies with intensity metrics most commonly reported. Nine metrics were described across FITT domains. Human-centered design principles to guide telehealth development and privacy considerations are discussed. Findings offer suggestions for how to represent and optimize objective engagement in asynchronous telehealth cancer care.

PrEP and Behavioral Health Treatment Referral Among HIV Test Counselors in Miami-Dade County: A Rapid Qualitative Study Using the Consolidated Framework for Implementation Research.

HIV test counselors are well positioned to refer individuals to pre-exposure prophylaxis (PrEP) and behavioral health treatments. HIV test counselors in Miami-Dade County (N = 20), a priority jurisdiction for Ending the HIV Epidemic, completed interviews to assess determinants of PrEP and behavioral health treatment referrals. To identify determinants, we used a rapid deductive qualitative analysis approach and the Consolidated Framework for Implementation Research (CFIR). Identified determinants sometimes served as facilitators (e.g., relative priority, leadership importance) and sometimes as barriers (e.g., lack of access to knowledge and information, available resources for referrals) to making referrals. We also observed differences in determinants between PrEP and behavioral health referrals. For example, complexity (perceived difficulty of the referral) was a barrier to behavioral health more often than PrEP referral. Our findings suggest that determinants across many CFIR domains affect referral implementation, and the corresponding need for multiple implementation strategies to improve implementation of PrEP and behavioral health referrals in the context of HIV testing.

PrEP to Party: Exploring MSM's PrEP Use and Interest in the Context of Sexually Themed Events.

Sexually themed events present a unique opportunity for scaling up pre-exposure prophylaxis (PrEP) to men who have sex with men (MSM). This study descriptively explored PrEP uptake among MSM who anticipated attending a week-long major South Florida sexually themed event and examined potential facilitators and barriers to PrEP engagement among potential attendees. Of the participating HIV-negative MSM (n = 96), 66.7% were currently taking PrEP. Prior attendance at sexually themed events was significantly associated with current PrEP engagement and almost 75% of HIV-negative MSM not on PrEP reported high interest in taking PrEP if offered for free at future events.

Peer ambassador stories: formative qualitative research to enhance the reach of PrEP, HIV testing, and behavioral health treatments to LMSM in South Florida.

Existing HIV prevention interventions, such as pre-exposure prophylaxis (PrEP), and behavioral health treatments inadequately reach Latino men who have sex with men (LMSM) in the US. This study involved formative research to inform the content, design, and implementation of a scalable, low resource implementation strategy - peer ambassador stories - stories from peers to normalize using PrEP, HIV testing, and behavioral health treatment. We conducted semi-structured interviews with 20 LMSM to elucidate their content, design, and implementation preferences for peer ambassador stories. Men were asked about story prompts, story contributor characteristics, story platform features, design preferences, and recommendations for enhancing the adoption and use of the peer ambassador technology platform among LMSM. Interviews were transcribed and analyzed via rapid qualitative analysis. Qualitative analyses identified 14 themes within 4 pre-specified domains. Collectively, the themes unified around the central concept that technology-delivered peer ambassador stories require a personalized, relational, culturally relevant touch to be acceptable and appropriate for LMSM. This study suggests that disseminating peer ambassador stories using electronic platforms and audio/video formats may enhance the reach of services and if they are personalized, relational, and culturally relevant. Findings have broad implications for informing other peer-based strategies to mitigate HIV disparities among LMSM.

Sex Differences in the Cognitive Performance of a South African Cohort of People With HIV and Comorbid Major Depressive Disorder.

Women with HIV (WWH) may be more vulnerable to cognitive impairment than men with HIV (MWH), which may be explained by the direct effects of HIV or by sociodemographic and psychiatric characteristics. We recruited 105 people with HIV (PWH; 76 women) with incomplete antiretroviral therapy adherence, comorbid major depressive disorder, and socioeconomically disadvantaged backgrounds. Participants completed neuropsychological testing and measures gathering sociodemographic, medical, and psychiatric information. We compared WWH and MWH cognitive performance using unadjusted and adjusted regressions, and within each respective group, we explored predictors of cognitive performance. Results showed no significant between-sex differences in cognitive performance, both globally and within domains. Fewer years of education (ß = 0.94), illiteracy (ß = 4.55), and greater food insecurity (ß = -0.28) predicted lower cognitive performance in WWH but not MWH. We conclude that sex differences in PWH are likely due to sample characteristics representing broader inequalities, rather than true biological differences.

Efficacy, safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir for HIV pre-exposure prophylaxis in transgender women: a secondary analysis of the HPTN 083 trial.

BACKGROUND: The HIV Prevention Trials Network (HPTN) 083 trial showed that long-acting injectable cabotegravir was more effective than tenofovir disoproxil fumarate plus emtricitabine in preventing HIV in cisgender men and transgender women who have sex with men. We aimed to characterise the cohort of transgender women included in HPTN 083. METHODS: HPTN 083 is an ongoing, phase 2b/3, randomised, multicentre, double-blind, double-dummy clinical trial done at 43 sites in seven countries (Argentina, Brazil, Peru, the USA, South Africa, Thailand, and Viet Nam). HIV-negative participants were randomly assigned (1:1) to receive injectable cabotegravir or tenofovir disoproxil fumarate plus emtricitabine. The study design and primary outcomes of the blinded phase of HPTN 083 have already been reported. An enrolment minimum of 10% transgender women was set for the trial. Here we characterise the cohort of transgender women enrolled from Dec 6, 2016, to May 14, 2020, when the study was unblinded. We report sociodemographic characteristics, use of gender affirming hormone therapy, and behavioural assessments of the transgender women participants. Laboratory testing and safety evaluations are also reported. The trial is registered at ClinicalTrials.gov, NCT02720094. FINDINGS: HPTN 083 enrolled 570 transgender women (304 tenofovir disoproxil fumarate plus emtricitabine; 266 injectable cabotegravir). Transgender women were primarily from Asia (225 [39%]) and Latin America (205 [36%]); 330 (58%) reported using gender affirming hormone therapy. Intimate partner violence was common (270 [47%] reported emotional abuse and 172 [30%] reported physical abuse) and 323 (57%) reported a history of childhood sexual abuse. 159 (28%) transgender women disagreed that they were at risk for HIV, and 142 (25%) screened positive for depressive symptoms. During study follow-up, incidence of syphilis was 16·25% (95% CI 13·28-19·69), rectal gonorrhoea was 11·66% (9·14-14·66), and chlamydia was 20·61% (17·20-24·49). Frequency of adverse events was similar between the treatment groups. Nine seroconversions occurred among transgender women during the blinded phase of the study (seven in the tenofovir disoproxil fumarate plus emtricitabine group and two in the injectable cabotegravir group); overall incidence was 1·19 per 100 person-years (95% CI 0·54-2·25): 1·80 per 100 person-years (0·73-3·72) in the tenofovir disoproxil fumarate plus emtricitabine group and 0·54 per 100 person-years (0·07-1·95) in the injectable cabotegravir group (hazard ratio 0·34 [95% CI 0·08-1·56]). Cabotegravir concentrations did not differ by gender affirming hormone therapy use. INTERPRETATION: HIV prevention strategies for transgender women cannot be addressed separately from social and structural vulnerabilities. Transgender women were well represented in HPTN 083 and should continue to be prioritised in HIV prevention studies. Our results suggest that injectable cabotegravir is a safe and effective pre-exposure prophylaxis option for transgender women. FUNDING: National Institute of Allergy and Infectious Diseases and ViiV Healthcare.

A qualitative exploration of how to support PrEP adherence among young men who have sex with men.

New HIV infections disproportionately affect young men who have sex with men (YMSM). PrEP is effective in preventing HIV acquisition; however, adherence is critical and is often suboptimal among YMSM. Interventions addressing the unique PrEP adherence challenges faced by YMSM are needed. We conducted qualitative interviews with 20 HIV-negative, YMSM (ages 15-24) with a PrEP indication and 11 healthcare professionals to inform adaption of a PrEP adherence intervention (Life-Steps for PrEP) for YMSM. We explored environmental, healthcare, and individual factors influencing uptake, adherence, attitudes, and perspectives (including desired modifications) on the Life-Steps intervention. Interviews were analyzed using content analysis. Of YMSM study participants (mean age 21.6) 55% were White, 15% Hispanic, and 5% Black. Most YMSM were PrEP-experienced (70%). Healthcare professionals (6 prescribers, 1 nurse, 2 health educators, 2 other/unspecified) averaged 6.9 years of experience caring for YMSM. All described stigma as a barrier to PrEP; YMSM expressed concern around being perceived as "risky" and concern about inadvertent PrEP disclosure if family/friends found their medication, or if parental insurance was used. Difficulty with planning for potential adherence challenges were identified by both groups. YMSM highlighted benefits of a nurse-led intervention (i.e., adding "legitimacy"), but stressed need for nonjudgmental, "savvy" interventionists. YMSM expressed a desire for comprehensive YMSM-specific sexual health information. These findings informed modification and expansion of Life-Steps content. Results highlight key potential barriers, many of which center around privacy. Content that addresses PrEP stigma, disclosing PrEP use, navigating insurance, and planning ahead in a nonjudgmental environment by trusted providers emerged as important components of a YMSM-focused delivery of Life-Steps for PrEP.

Pathways Between Intersectional Stigma and HIV Treatment Engagement Among Men Who Have Sex with Men (MSM) in India.

In India and other low-and-middle-income countries, little is known about how intersectional stigma affects MSM engagement in ART. Informed by the Health Stigma and Discrimination Framework, we qualitatively examined how multiple stigmas influence ART engagement among Indian MSM. We conducted 3 focus groups (N = 22) with MSM living with HIV, aged 21-58 years, in Delhi and Hyderabad to identify potential intervention targets and solutions to improve treatment outcomes. Framework analysis and techniques were used to code and analyze translated audio-recordings. Findings revealed enacted stigma, associated with HIV and MSM identity, manifested as familial shame and healthcare discrimination, inhibiting access to support, and decreasing HIV care engagement. Anticipated stigma led to worry about disclosure and societal repercussions. Community-Based-Organizations, ART centers, and family members were primary sources of support, leading to increased ART initiation and retention. Potential solutions included using MSM peer-counselors, increasing social support, and providing HIV education to the general community.

The Relationship Between Intersectional Oppression and Affirmation and Latino Sexual Minority Men's Mental Health.

Purpose: Latino sexual minority men (LSMM) may experience oppression based on their ethnicity, sexual orientation, and migratory status, yet scientific literature is only beginning to explore the intersection of these experiences. This study examined mental health (MH) in relation to LSMM's experiences of intersectional oppression and affirmation. Methods: We conducted a secondary analysis of baseline data from a cohort study examining LSMM's (n = 290) health care engagement in Miami, FL, from February to September 2020. Latent class analysis (LCA) identified classes based on self-reported multiple identity discrimination (e.g., race, ethnicity, and skin color), sexual orientation stigma/affirmation, and migration-related stress. Logistic and linear regressions examined associations between class membership and anxious, depressive, post-traumatic stress, somatic symptoms, and overall MH burden. Results: The LCA revealed a three-class solution: (1) affirmed LSMM (73.8%), (2) LSMM with intersectional oppression (21.7%), and (3) LSMM with immigration stress (4.5%). The three classes varied in terms of multiple identity discrimination, sexual orientation stigma/affirmation, and migration-related stress. Compared with Class 1, Class 2 had greater conditional probabilities of reporting clinically significant depressive (p = 0.033) and post-traumatic stress symptoms (p = 0.031), and at least one MH concern (p = 0.018). Greater depressive symptoms (p = 0.007), post-traumatic stress symptoms (p = 0.049), somatic symptoms (p = 0.024), and clinically significant MH concerns (p = 0.018) were found among Class 2 than among Class 1. Conclusion: Findings identified three groups of LSMM based on their experiences of intersectional oppression and affirmation. Discrimination at the intersection of multiple identities, sexual orientation stigma/affirmation, and migration-related stress were associated with LSMM's MH outcomes, particularly among immigrants.

Rejection Sensitivity and Sexual Minority Men's Social Anxiety Disorder: The Moderating Role of Sexual Identity Strength.

Although gay-related rejection sensitivity (RS) is associated with social anxiety among sexual minority men, little attention has been given to the validity of gay-related RS measures and to individual differences that might moderate the association between gay-related RS and social anxiety. In a population-based sample of sexual minority men, Study 1 (N = 114) investigated the incremental validity of gay-related RS and showed that gay-related RS scores significantly added to the prediction of social anxiety symptoms, even after controlling for personal RS scores. In a clinical sample of sexual minority men, Study 2 (N = 254) examined interrelationships among gay-related RS, sexual identity strength, and current social anxiety symptoms and disorder diagnosis. Results revealed that the expected count of current social anxiety symptoms and the odds of social anxiety disorder diagnosis, as assessed with a structured diagnostic interview, increased as a function of gay-related RS scores. Sexual identity strength moderated these relationships, such that the associations between gay-related RS scores and interviewer-assessed social anxiety symptoms and disorder were only significant for those high, but not low, in sexual identity strength. Together, results from the present studies lend support to the incremental validity of gay-related RS scales in predicting social anxiety symptoms and suggest that sexual minority men who consider their sexual orientation to be self-defining might be particularly vulnerable to the mental health correlates of gay-related RS.

Development and feasibility testing of an integrated PTSD and adherence intervention cognitive processing therapy-life steps (CPT-L) to improve HIV outcomes: Trial protocol.

Despite high rates of Post-Traumatic Stress Disorder (PTSD) in persons living with HIV (PLWH) and poor HIV-related health outcomes associated with PTSD, an effective evidence-based treatment for PTSD symptoms in PLWH does not exist. Negative reinforcement conceptual models posit that avoidant behavior (hallmark symptom of PTSD) demonstrated by PLWH with co-occurring PTSD can contribute to poor antiretroviral therapy (ART) adherence. However, research evaluating the impact of evidence-based treatment for PTSD among HIV infected populations on HIV outcomes is scarce. The Cognitive Processing Therapy (CPT) protocol is an evidence-based PTSD treatment that may address internalized stigma with targeted modifications and improve ART adherence and subsequent viral suppression through reduction of avoidant coping. This study will be the first pilot open-label randomized control trial (RCT) to test feasibility of an integrated evidence-based PTSD treatment (CPT) with an adherence intervention (Lifesteps) delivered in a Ryan White clinic to improve PTSD symptoms, adherence to ART, and retention in HIV care. Primary aims are to (1) conduct theater testing of the CPT and Lifesteps research protocol and evaluate acceptability (n = 12) and (2) deliver a modified CPT protocol (CPT-Lifesteps, or CPT-L) in 60 PLWH/PTSD exploring impact of CPT-L on PTSD symptoms and HIV outcomes compared to a Lifesteps + Standard of Care condition. This innovative research extends PTSD treatment approaches as a paradigm to reduce barriers to ART adherence. Findings of this innovative study are significant because they support the Undetectable = Untransmittable (U[bond, double bond]U) campaign and can help prevent the transmission of HIV infection through increased viral suppression.

Barriers and facilitators to PrEP use and HIV testing for subgroups of Latino sexual minority men.

Pre-exposure prophylaxis (PrEP) and HIV testing inadequately reach Latino sexual minority men (LSMM), fueling HIV disparities. This study identified determinants of LSMM's PrEP use and HIV testing and examined differences across subgroups (i.e., age and immigration history). First, we identified the most to least endorsed barriers and facilitators of PrEP use and HIV testing among LSMM (1) over vs. under 40 years old, and (2) across immigration histories (U.S. born, recent immigrant, established immigrant). Next, we examined differences in barrier/facilitator ratings across these age and immigration status groups. Key overall determinants were cost, knowledge, and perceived benefit/need. However, there was variation in determinants across age groups (i.e., cost, affordability, navigation support, and normalization) and immigration statuses (i.e., language, immigration concerns, and HIV knowledge). There were also differences across service types; mistrust and concerns was a barrier related to PrEP but not HIV testing. We found unique and common multilevel factors across prevention services and subgroups. Language, cost, and clinic/system issues are key barriers in accessing HIV prevention that should be considered when developing implementation strategies to enhance the reach of these services to LSMM.

The Clinical Impact and Cost-Effectiveness of Clinic-Based Cognitive Behavioral Therapy for People With HIV, Depression, and Virologic Failure in South Africa.

BACKGROUND: Depression affects 25%-30% of people with HIV (PWH) in the Republic of South Africa (RSA) and is associated with both antiretroviral therapy (ART) nonadherence and increased mortality. We evaluated the cost-effectiveness of task-shifted, cognitive behavioral therapy (CBT) for PWH with diagnosed depression and virologic failure from a randomized trial in RSA. SETTING: RSA. METHODS: Using the Cost-Effectiveness of Preventing AIDS Complications model, we simulated both trial strategies: enhanced treatment as usual (ETAU) and ETAU plus CBT for ART adherence and depression (CBT-AD; 8 sessions plus 2 follow-ups). In the trial, viral suppression at 1 year was 20% with ETAU and 32% with CBT-AD. Model inputs included mean initial age (39 years) and CD4 count (214/µL), ART costs ($7.5-22/mo), and CBT costs ($29/session). We projected 5- and 10-year viral suppression, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs: $/QALY [discounted 3%/yr]; cost-effectiveness threshold: ≤$2545/QALY [0.5× per capita GDP]). In sensitivity analyses, we determined how input parameter variation affected cost-effectiveness. RESULTS: Model-projected 5- and 10-year viral suppression were 18.9% and 8.7% with ETAU and 21.2% and 9.7% with CBT-AD, respectively. Compared with ETAU, CBT-AD would increase discounted life expectancy from 4.12 to 4.68 QALYs and costs from $6210/person to $6670/person (incremental cost-effectiveness ratio: $840/QALY). CBT-AD would remain cost-effective unless CBT-AD cost >$70/session and simultaneously improved 1-year viral suppression by ≤4% compared with ETAU. CONCLUSIONS: CBT for PWH with depression and virologic failure in RSA could improve life expectancy and be cost-effective. Such targeted mental health interventions should be integrated into HIV care.

Factors Associated with Antiretroviral Therapy Adherence Among a Community-Based Sample of Sexual Minority Older Adults with HIV.

Older sexual minorities (e.g., gay, bisexual) living with HIV are at risk for poor HIV outcomes due to their frequent experience with both psychosocial challenges and structural barriers to care. This study utilized a stochastic search variable selection (SVSS) approach to explore potential psychosocial and structural factors associated with HIV-related health outcomes among a community-based sample of older sexual minorities (N = 150) in South Florida, an U.S. HIV-epidemic epicenter. After SVSS, a forward entry regression approach suggested unstable housing, illicit substance use, current nicotine use, and depression were all associated with poorer ART adherence among older sexual minority adults living with HIV. No associations between potential correlates and biological measures of HIV disease severity were observed. Findings highlight a need to focus on multiple levels of intervention that target a combination of psychosocial and structural factors to improve HIV-care outcomes among older sexual minorities and achieve Ending the HIV Epidemic goals.

Minorías sexuales mayores (p.ej., gay, bisexual) que viven con VIH están en riesgo de resultados negativos de VIH debido a sus experiencias con desafíos psicosociales y barreras estructurales. Este estudio uso selección de variables de búsqueda estocástica (SVSS) para explorar factores psicosociales y estructurales asociadas con resultados de salud relacionado a VIH entre una muestra comunitaria de minorías sexuales mayores (N = 150) el la Sur de la Florida, un epicentro de la epidemia de VIH en EE. UU. Después de SVSS, una regresión de entrada directa sugirió que vivienda inestable, uso de sustancias ilícitas, consumo actual de nicotina, y depresión eran asociados con menos adherencia de terapias antirretroviral entre adultos mayores de minorías sexuales que viven con el VIH. No se encontraron asociaciones entre correlatos potenciales y medidas biológicas de VIH. Recomendaciones destacan una necesidad de concentrarse en múltiples niveles de intervención que apuntan una combinación de factores psicosociales y estructurales para mejorar resultados de VIH entre las minorías sexuales mayores y lograr las metas de Finalizando la Epidemia del VIH.