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.

A Relational Framework for Engaging Latino Sexual Minority Men in Sexual and Behavioral Health Research.

Latino sexual minority men (LSMM) experience sexual and behavioral health disparities. Yet, LSMM are underrepresented in sexual and behavioral health research, creating scientific inequity. There is, therefore, a need to identify the barriers and facilitators to LSMM's participation in sexual and behavioral health research, which is the gap that the current study sought to fill. We interviewed LSMM (n = 28; age 18-40, 57% US born) and key informants (n = 10) regarding LSMM's barriers and facilitators to participating in sexual and behavioral health research and suggestions for increasing participation. The research team coded the data via thematic analysis. We found that relational factors are central to understanding LSMM's participation in sexual and behavioral health research. Some relational experiences (e.g., interpersonal stigma) interfered with participation, whereas others (e.g., altruistic desires to contribute to community well-being) facilitated participation. The findings are consolidated within a new relational framework for understanding LSMM's participation in sexual and behavioral health research. Study findings highlight the centrality of relational factors in influencing LSMM's participation in sexual and behavioral health research. Relational factors can be used to inform the development of culturally relevant recruitment strategies to improve representation of LSMM in sexual and behavioral health research. Implementing these recommendations may address scientific inequity, whereby LSMM are disproportionately impacted by sexual and behavioral health concerns yet underrepresented in related research.

The cost-effectiveness of a resilience-based psychosocial intervention for HIV prevention among MSM in India.

OBJECTIVE: MSM in India are at a high risk for HIV infection given psychosocial challenges, sexual orientation stress, and stigma. We examined the cost-effectiveness of a novel resilience-based psychosocial intervention for MSM in India. DESIGN: We parameterized a validated microsimulation model (CEPAC) with India-specific data and results from a randomized trial and examined two strategies for MSM: status quo HIV care ( SQ ), and a trial-based psychosocial intervention ( INT ) focused on building resilience to stress, improving mental health, and reducing condomless anal sex (CAS). METHODS: We projected lifetime clinical and economic outcomes for MSM without HIV initially. Intervention effectiveness, defined as reduction in self-reported CAS, was estimated at 38%; cost was $49.37/participant. We used a willingness-to-pay threshold of US$2100 (2019 Indian per capita GDP) per year of life saved (YLS) to define cost-effectiveness. We also assessed the 5-year budget impact of offering this intervention to 20% of Indian MSM. RESULTS: Model projections showed the intervention would avert 2940 HIV infections among MSM over 10 years. Over a lifetime horizon, the intervention was cost-effective (ICER = $900/YLS). Results were most sensitive to intervention effectiveness and cost; the intervention remained cost-effective under plausible ranges of these parameters. Offering this intervention in the public sector would require an additional US$28 M over 5 years compared with SQ . CONCLUSION: A resilience-based psychosocial intervention integrated with HIV risk reduction counseling among MSM in India would reduce HIV infections and be cost-effective. Programs using this approach should be expanded as a part of comprehensive HIV prevention in India.

Latinx Sexual Minority Men's Behavioral, Psychosocial, and Medical Experiences during COVID-19: Differences across Immigration Statuses.

Latinx sexual minority men (LSMM) are at the intersection of two communities disproportionately impacted by COVID-19. To develop and deploy appropriate resources to support LSMM, it is important to understand the behavioral, psychosocial, and medical experiences of this population during COVID-19, as well as for LSMM of different immigration statuses. The current study uses the Pandemic Stress Index (PSI) to describe LSMM's self-reported behavioral, psychosocial, and medical experiences during COVID-19. Logistic and linear regressions compared experiences during COVID-19 among LSMM across different immigration statuses (recent, established, and US-born as the reference group). LSMM's responses to the PSI indicated they experienced anxiety (64.4%), depression (59.0%), alcohol/substance use (27.6%), as well as loneliness (50.1%) and sleep problems (60.4%). Overall, over half reported personal financial loss, the odds of which were 2.75 times greater among LSMM who were recent immigrants compared to US-born LSMM (OR = 2.75, 95% CI: 1.30, 5.82). Nearly 8% reported being diagnosed with COVID-19, with the odds four and a half times greater among established immigrants compared to US-born LSMM (OR = 4.52, 95% CI: 1.60, 12.81). The findings have implications for tailored support resources and public health interventions to reach LSMM in general and LSMM with immigration histories.

"It Truly Does Get Better:" Young Sexual Minority Men's Resilient Responses to Sexual Minority Stress.

Due to minority stress, sexual minority men experience mental health disparities. Sexual minority men who engaged in cognitive-behavioral therapy to address the minority stress underlying their distress completed an exercise eliciting their own resilience. This exercise involved writing an advice letter to a hypothetical peer about coping with minority stress. Qualitative analysis of these letters yielded 18 codes grouped into three categories reflecting resilience to minority stress. Categories included (1) cultivating internal affirmation strategies, (2) building supportive relationships and community, and (3) using cognitive and behavioral skills to cope with minority stress. Findings highlight this population's resilience and suggest building resilience through treatment.

High financial hardship and mental health burden among gay, bisexual and other men who have sex with men.

Prior research has documented the ways in which financial hardships negatively impact health, particularly mental health. However, this association between financial hardships and mental health outcomes has rarely been examined in sexual minorities. The purpose of this study was to examine associations between financial hardships and mental health burdens among a sample of gay, bisexual and other men who have sex with men (MSM) in Paris, France. Participants (n = 580) completed a cross-sectional survey advertised on a geosocial networking application. Participants responded to measures of mental health, financial hardship, and socio-demographics. Modified Poisson models were used to estimate risk ratios (RRs) and 95% confidence intervals (CI) for the associations between financial hardship and the following outcomes: 1) depressive symptoms, 2) anxiety symptoms, and 3) psychological distress. After adjusting for socio-demographics, high financial hardships were associated with depressive symptoms (aRR: 1.48, 95% CI: 1.04, 2.11) and psychological distress (aRR: 1.56, 95% CI: 1.09, 2.23). Analyses also demonstrated that stress acts as a mediating variable. These preliminary results suggest that future interventions to reduce financial hardships may have positive effects on the mental health of such a population.

Potential Impact of Targeted HIV Pre-Exposure Prophylaxis Uptake Among Male Sex Workers.

Little is known about the potential population-level impact of HIV pre-exposure prophylaxis (PrEP) use among cisgender male sex workers (MSWs), a high-risk subset of cisgender men who have sex with men (MSM). Using an agent-based model, we simulated HIV transmission among cisgender MSM in Rhode Island to determine the impacts of PrEP implementation where cisgender MSWs were equally ("standard expansion") or five times as likely ("focused expansion") to initiate PrEP compared to other cisgender MSM. Without PrEP, the model predicted 920 new HIV infections over a decade, or an average incidence of 0.39 per 100 person-years. In a focused expansion scenario where 15% of at-risk cisgender MSM used PrEP, the total number of new HIV infections was reduced by 58.1% at a cost of $57,180 per quality-adjusted life-year (QALY) gained. Focused expansion of PrEP use among cisgender MSWs may be an efficient and cost-effective strategy for reducing HIV incidence in the broader population of cisgender MSM.

Project ESTEEM protocol: a randomized controlled trial of an LGBTQ-affirmative treatment for young adult sexual minority men's mental and sexual health.

BACKGROUND: Young gay and bisexual men disproportionately experience depression, anxiety, and substance use problems and are among the highest risk group for HIV infection in the U.S. Diverse methods locate the source of these health disparities in young gay and bisexual men's exposure to minority stress. In fact, minority stress, psychiatric morbidity, substance use, and HIV risk fuel each other, forming a synergistic threat to young gay and bisexual men's health. Yet no known intervention addresses minority stress to improve mental health, substance use problems, or their joint impact on HIV risk in this population. This paper describes the design of a study to test the efficacy of such an intervention, called ESTEEM (Effective Skills to Empower Effective Men), a 10-session skills-building intervention designed to reduce young gay and bisexual men's co-occurring health risks by addressing the underlying cognitive, affective, and behavioral pathways through which minority stress impairs health. METHODS: This study, funded by the National Institute of Mental Health, is a three-arm randomized controlled trial to examine (1) the efficacy of ESTEEM compared to community mental health treatment and HIV counseling and testing and (2) whether ESTEEM works through its hypothesized cognitive, affective, and behavioral minority stress processes. Our primary outcome, measured 8 months after baseline, is condomless anal sex in the absence of PrEP or known undetectable viral load of HIV+ primary partners. Secondary outcomes include depression, anxiety, substance use, sexual compulsivity, and PrEP uptake, also measured 8 months after baseline. DISCUSSION: Delivering specific stand-alone treatments for specific mental, behavioral, and sexual health problems represents the current state of evidence-based practice. However, dissemination and implementation of this one treatment-one problem approach has not been ideal. A single intervention that reduces young gay and bisexual men's depression, anxiety, substance use, and HIV risk by reducing the common minority stress pathways across these problems would represent an efficient, cost-effective alternative to currently isolated approaches, and holds great promise for reducing sexual orientation health disparities among young men. TRIAL REGISTRATION: Registered October 10, 2016 to ClinicalTrials.gov Identifier: NCT02929069 .

Body image and condomless anal sex among Young Latino sexual minority men.

OBJECTIVE: To investigate body image and condomless anal sex (CAS) among young Latino sexual minority men (SMM)-a population with health disparities in HIV and body image concerns. METHODS: Participants were 151 young Latino SMM from the San Diego area who were HIV-negative or unknown. Participants completed a questionnaire online in either English or Spanish, which included body image and sexual behavior items. A binary CAS variable was created based on the number of CAS partners reported (0 vs 1 + over past 3 months). A logistic regression was conducted with body dissatisfaction, appearance investment, and their interaction term entered as predictor variables and CAS as the outcome. RESULTS: Of 151 participants, 54 (35.8%) reported no CAS in the past 3 months. Appearance investment, but not body dissatisfaction, was associated with higher odds of CAS. However, a significant interaction indicated that body dissatisfaction was associated with higher odds of CAS when appearance investment was high. CONCLUSIONS: Young Latino SMM who are highly invested in, and dissatisfied with, their appearance may be at significantly increased risk for acquiring HIV through elevated odds of CAS. Reducing appearance concerns in this population may lead to reductions in HIV risk behaviors.

Posttraumatic Stress Symptoms and Emerging Adult Sexual Minority Men: Implications for Assessment and Treatment of Childhood Sexual Abuse.

Emerging adulthood (EA) is a developmental period marked by unique challenges that affect health including burgeoning occupational, relational, and financial stability; and increased risk taking in terms of sexual behavior(s) and substance use. Data were collected from 296 HIV-uninfected sexual minority men with childhood sexual abuse (CSA) histories. We analyzed baseline assessment data from a multisite randomized controlled trial that tested the efficaciousness of an experimental psychosocial treatment and examined vulnerabilities known to be linked with CSA. Our analyses compared EA sexual minority men, aged 18-29, with older sexual minority men (OSMM) on posttraumatic stress disorder (PTSD) and other mental health and substance use outcomes. We found higher odds of PTSD, odds ratio (OR) = 0.57, 95% CI [0.33, 0.96]; panic disorder or panic disorder with agoraphobia, OR = 0.36, 95% CI [0.16, 0.85]; and cocaine use, OR = 0.50, 95% CI [0.25, 0.97], among OSMM and higher odds of alcohol intoxication, OR = 5.60, 95% CI [3.20, 9.82]; cannabis use, OR = 3.09, 95% CI [1.83, 5.21]; and non-HIV sexually transmitted infections, OR = 3.03, 95% CI [1.29, 7.13], among the EA men. These results present a complex picture of health risks among sexual minority men in general and EA sexual minority men in particular. HIV seroconversion linked health risk behaviors, among sexual minority men, may be better addressed via increased attention to treating trauma and comorbid mental health and substance use problems using evidence-based psychosocial assessments and integrated treatment platforms that are tailored to this population.

Co-occurring psychosocial problems predict HIV status and increased health care costs and utilization among sexual minority men.

Sexual orientation related health disparities are well documented. Sexual minority men appear to be at risk for mental health problems due to the stress they experience in establishing and maintaining a minority sexual identity. These mental health issues may combine synergistically and lead to higher medical costs to society. We examine whether sexual minority specific syndemic indicators were associated with higher health care costs, health care utilization, or the risk of being HIV-infected. Health care consumers at a community health center (N = 1211) completed a brief screening questionnaire collected over 12 months. Self-reported data were linked with participants' clinical billing records. Adjusted logistic regression models identified that four syndemic indicators (suicidality, substance use, childhood sexual abuse, and intimate partner violence) were each significantly related to each other. Multiple syndemics significantly predicted higher medical care utilization and cost, and were associated with 2.5 times the risk of being HIV-infected (OR 2.49, 95% CI 1.45-4.25). Syndemic indicators did not significantly predict the number of mental health visits or costs per patient. These results confirm and extend earlier findings by relating syndemics to health services use and costs for sexual minority men.

Resilience takes a village: black women utilize support from their community to foster resilience against multiple adversities.

Black women living with HIV (BWLWH) represent the highest percentage of women with HIV in the U.S. and experience worse health outcomes than other women living with HIV, in part due to experiences of trauma, racism, HIV-stigma, and stressors they face as women. However, their own stories of resilience in the face of multiple adversities and insights of community stakeholders may inform our field on how to best empower this population to strive despite adversities. Thirty BWLWH in the U.S. and fifteen community stakeholders were interviewed about women's experiences and adaptive coping strategies used to cope with trauma, racism, HIV-stigma, and gender-related stressors. Interviews were coded using thematic content analysis. A major theme that spanned across interviews with BWLWH and community stakeholders was that resilience was fostered by members of their "village". In the midst of or following adverse experiences BWLWH used social support from their children, grandchildren, other family members, friends/peers, and caring providers in order to overcome their adversities and focus on their health and well-being. Promoting resilience among BWLWH requires an understanding of the most adaptive strategies utilized to "bounce back" following or in the face of adversities. Our findings highlight that both BWLWH and community stakeholders recognize social support from their "village" as an importance resilience resource. Research and applied efforts need to be geared at strengthening both BWLWH and their "village" in order to promote resilience and reduce health disparities.

Introduction to the special section on sexual and gender minority health.

The field of sexual and gender minority health has advanced exponentially in the past decade. The Journal of Consulting and Clinical Psychology (JCCP) has made important strides in publishing work on sexual and gender minority health. Although the following set of articles was not originally planned as a special section, most of the articles address, in some way, sexual and gender minority specific stressors such as perceived or overt stigma and/or the higher risk for emotional and substance use problems facing this population. Together, the papers in this section are models of some of the best work being conducted on sexual and gender minority health. Not only do they address significant problems, they do so in large, nonoverlapping samples, using novel and strong methodologies. (PsycINFO Database Record

The Role of Relationship Dynamics and Gender Inequalities As Barriers to HIV-Serostatus Disclosure: Qualitative Study among Women and Men Living with HIV in Durban, South Africa.

BACKGROUND: This qualitative study investigated gender power inequalities as they contribute to relationship dynamics and HIV-serostatus disclosure among men and women living with HIV in Durban, South Africa. HIV serodiscordance among men and women within stable partnerships contributes to high HIV incidence in southern Africa, yet disclosure rates remain low. Given the emphasis on prevention for HIV-serodiscordant couples, this research supports the urgent need to explore how best to support couples to recognize that they are part of this priority population and to access appropriate prevention and treatment. METHODS: Thirty-five in-depth individual interviews were conducted with 15 HIV-positive men and 20 HIV-positive women (not couples) receiving care at public-sector clinics near Durban. A structured coding scheme was developed to investigate men's and women's attitudes toward HIV-serostatus disclosure and behaviors of sharing (or not sharing) HIV serostatus with a partner. Narratives were analyzed for barriers and facilitators of disclosure through the lens of sociocultural gender inequality, focusing on reasons for non-disclosure. RESULTS: Among 35 participants: median age was 33 years (men) and 30 years (women); average years since HIV diagnosis was 1 (men) and 1.5 (women). Four themes related to gender inequality and HIV-serostatus disclosure emerged: (1) Men and women fear disclosing to partners due to concerns about stigma and relationship dissolution, (2) suspicions and mistrust between partners underlies decisions for non-disclosure, (3) unequal, gendered power in relationships causes differential likelihood and safety of disclosure among men and women, and (4) incomplete or implicit disclosure are strategies to navigate disclosure challenges. Findings illustrate HIV-serostatus disclosure as a complex process evolving over time, rather than a one-time event. CONCLUSION: Partner communication about HIV serostatus is infrequent and complicated, with gender inequalities contributing to fear, mistrust, and partial or implicit disclosure. Relationship dynamics and gender roles shape the environment within which men and women can engage successfully in the HIV-serostatus disclosure process. Integrated interventions to reduce barriers to trustful and effective communication are needed for HIV-affected men and women in partnerships in which seeking couples-based HIV counseling and testing (CHCT) is challenging or unlikely. These data offer insights to support HIV-serostatus disclosure strategies within relationships over time.

A Pilot Randomized Controlled Trial of an Integrated In-person and Mobile Phone Delivered Counseling and Text Messaging Intervention to Reduce HIV Transmission Risk among Male Sex Workers in Chennai, India.

Men who have sex with men (MSM) are at increased risk for HIV infection in India, particularly those who engage in transactional sex with other men (i.e., male sex workers; MSW). Despite the need, HIV prevention efforts for Indian MSW are lacking. As in other settings, MSW in India increasingly rely on the use of mobile phones for sex work solicitation. Integrating mobile phone technology into an HIV prevention intervention for Indian MSW may mitigate some of the challenges associated with face-to face approaches, such as implementation, lack of anonymity, and time consumption, while at the same time proving to be both feasible and useful. This is a pilot randomized controlled trial to examine participant acceptability, feasibility of study procedures, and preliminary efficacy for reducing sexual risk for HIV. MSW (N = 100) were equally randomized to: (1) a behavioral HIV prevention intervention integrating in-person and mobile phone delivered HIV risk reduction counseling, and daily, personalized text or voice messages as motivating "cognitive restructuring" cues for reducing condomless anal sex (CAS); or (2) a standard of care (SOC) comparison condition. Both groups received HIV counseling and testing at baseline and 6-months, and completed ACASI-based, behavioral and psychosocial assessments at baseline, 3, and 6 months. Mixed-effects regression procedures specifying a Poisson distribution and log link with a random intercept and slope for month of follow-up was estimated to assess the intervention effect on the primary outcomes: (1) CAS acts with male clients who paid them for sex, and (2) CAS acts with male non-paying sexual partners-both outcomes assessed over the past month. The intervention was both feasible (98% retention at 6-months) and acceptable (>96% of all intervention sessions attended); all intervention participants rated the intervention as "acceptable" or "very acceptable." A reduction in the reported number of CAS acts with male clients who paid them for sex in the past month was seen in both study conditions. MSW in the intervention condition reported a faster rate of decline in the number of CAS acts with male clients in the past month from the baseline to both the 3-month (B = -1.20; 95% CI -1.68, -0.73; p < 0.0001) and 6-month (B = -2.44; 95% CI -3.35, -1.53; p < 0.00001) assessment visits compared to the SOC condition. Post-hoc contrasts indicated that, at 3 months, participants in the intervention condition reported 1.43 (SD = 0.29) CAS acts with male clients in the past month compared to 4.85 (SD = 0.87) in the control condition (p = 0.0003). Furthermore, at 6 months, the intervention condition participants reported 0.24 (SD = 0.09) CAS acts with male clients in the past month compared to 2.79 (SD = 0.79) in the control condition (p < 0.0001). Findings are encouraging and provide evidence of feasibility and acceptability, and demonstrate initial efficacy (for reducing sexual risk for HIV) of a behavioral HIV prevention intervention for Indian MSW that combines daily, personalized text or voice messages with mobile phone-delivered sexual risk reduction counseling and skills building. Future testing of the intervention in a fully powered randomized controlled efficacy trial is warranted.

Treatment Satisfaction and Adherence to Oral Chemotherapy in Patients With Cancer.

PURPOSE: Although patients with cancer overwhelming prefer oral to intravenous chemotherapy, little is known about adherence to oral agents. We aimed to identify the rates and correlates of adherence in patients with diverse malignancies. MATERIALS AND METHODS: Ninety patients with chronic myeloid leukemia or metastatic renal cell carcinoma, non-small-cell lung cancer, or breast cancer enrolled in this prospective, single-group, observational study of medication-taking behaviors. Adherence was measured via self-report and with an electronic pill cap (Medication Event Monitoring System cap). Patients completed surveys regarding symptom distress, mood, quality of life, cancer-specific distress, and satisfaction with clinician communication and treatment at baseline and 12-week follow-up. RESULTS: As measured by the Medication Event Monitoring System, patients took, on average, 89.3% of their prescribed oral chemotherapy over the 12 weeks. One quarter of the sample was less than 90% adherent, and women were more adherent than men (mean difference, 9.59%; SE difference, 4.50%; 95% CI, -18.65 to -0.52; P = .039). Improvements in patient symptom distress (B = -0.79; 95% CI, -1.41 to -0.18), depressive symptoms (B = -1.57; 95% CI, -2.86 to -0.29), quality of life (B = 0.38; 95% CI ,0.07 to 0.68), satisfaction with clinician communication and treatment (B = 0.73; 95% CI, 0.49 to 0.98), and perceived burden to others (B = -1.28; 95% CI, -2.20 to -0.37) were associated with better adherence. In a multivariate model, improved treatment satisfaction (B = 0.71; 95% CI, 0.48 to 0.94) and reduced perceived burden (B = -0.92; 95% CI, -1.76 to -0.09) were the strongest indicators of better adherence. CONCLUSION: Women and patients who reported increased treatment satisfaction and reduced burden to others were more adherent to oral chemotherapy. Interventions that help patients improve communication with clinicians and reduce burden may optimize oral chemotherapy adherence.

HIV Provider Documentation and Actions Following Patient Reports of At-risk Behaviors and Conditions When Identified by a Web-Based Point-of-Care Assessment.

We compared same-day provider medical record documentation and interventions addressing depression and risk behaviors before and after delivering point-of-care patient-reported outcomes (PROs) feedback for patients who self-reported clinically relevant levels of depression or risk behaviors. During the study period (1 January 2006-15 October 2010), 2289 PRO assessments were completed by HIV-infected patients. Comparing the 8 months before versus after feedback implementation, providers were more likely to document depression (74% before vs. 87% after feedback, p = 0.02) in patients with moderate-to-severe depression (n = 317 assessments), at-risk alcohol use (41 vs. 64%, p = 0.04, n = 155) and substance use (60 vs. 80%, p = 0.004, n = 212). Providers were less likely to incorrectly document good adherence among patients with inadequate adherence after feedback (42 vs. 24%, p = 0.02, n = 205). While PRO feedback of depression and adherence were followed by increased provider intervention, other domains were not. Further investigation of factors associated with the gap between awareness and intervention are needed in order to bridge this divide.

Cognitive behavioural therapy for adherence and depression in patients with HIV: a three-arm randomised controlled trial.

BACKGROUND: Depression is highly prevalent in people with HIV and has consistently been associated with poor antiretroviral therapy (ART) adherence. Integrating cognitive behavioural therapy (CBT) for depression with adherence counselling using the Life-Steps approach (CBT-AD) has an emerging evidence base. The aim of this study was to test the efficacy of CBT-AD. METHODS: In this three-arm randomised controlled trial in HIV-positive adults with depression, we compared CBT-AD with information and supportive psychotherapy plus adherence counselling using the Life-Steps approach (ISP-AD), and with enhanced treatment as usual (ETAU) including Life-Steps adherence counselling only. Participants were recruited from three sites in New England, USA (two hospital settings and one community health centre). Patients were randomly assigned (2:2:1) to receive CBT-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), ISP-AD (one Life-Steps session plus 11 weekly integrated sessions lasting up to 1 h each), or ETAU (one Life-Steps session and five assessment visits roughly every 2 weeks), randomisation was done with allocation software, in pairs, and stratified by three variables: study site, whether or not participants had been prescribed antidepressant medication, and whether or not participants had a history of injection drug use. The primary outcome was ART adherence at the end of treatment (4 month assessment) assessed via electronic pill caps (Medication Event Monitoring System [MEMS]) with correction for pocketed doses, analysed by intention to treat. FINDINGS: Patients were recruited from Feb 26, 2009, to June 21, 2012. Patients who were assigned to CBT-AD (94 randomly assigned, 83 completed assessment) had greater improvements in adherence (estimated difference 1·00 percentage point per visit, 95% CI 0·34 to 1·66, p=0·003) and depression (Center for Epidemiological Studies depression [CESD] score estimated difference -0·41, -0·66 to -0·16, p=0·001; Montgomery-Asberg depression rating scale [MADRS] score -4·69, -8·09 to -1·28, p=0·007; clinical global impression [CGI] score -0·66, -1·11 to -0·21, p=0·005) than did patients who had ETAU (49 assigned, 46 completed assessment) after treatment (4 months). No significant differences in adherence were noted between CBT-AD and ISP-AD (97 assigned, 87 completed assessment). No study-related adverse events were reported. INTERPRETATION: Integrating evidenced-based treatment for depression with evidenced-based adherence counselling is helpful for individuals living with HIV/AIDS and depression. Future efforts should examine how to best disseminate effective psychosocial depression treatments such as CBT-AD to people living with HIV/AIDS and examine the cost-effectiveness of such approaches. FUNDING: National Institute of Mental Health, National Institute of Allergy and Infectious Diseases.