Study protocol for a hybrid type 1 effectiveness-implementation trial testing virtual tobacco treatment in oncology practices [Smokefree Support Study 2.0].

BACKGROUND: Persistent smoking among patients diagnosed with cancer is associated with adverse clinical outcomes, yet an evidence-based tobacco use intervention has not been well-integrated into cancer care in community oncology settings. This paper describes the protocol of a nation-wide clinical trial conducted by the ECOG-ACRIN National Cancer Institute (NCI) Community Oncology Research Program (NCORP) Research Base to assess the effectiveness of a virtual tobacco treatment intervention and the process of implementing tobacco treatment in NCORP community oncology settings. METHODS/DESIGN: This two-arm, multisite (n: 49 NCORP sites) hybrid type 1 effectiveness-implementation randomized controlled trial compares the effectiveness of a Virtual Intervention Treatment (VIT) versus an Enhanced Usual Control (EUC) among English and Spanish speaking patients recently diagnosed with cancer, reporting current smoking and receiving care at a participating NCORP Community or Minority/Underserved Site. The VIT includes up to 11 virtual counseling sessions with a tobacco treatment specialist and up to 12 weeks of nicotine replacement therapy (NRT). The EUC arm receives a referral to the NCI Quitline. The primary study outcome is biochemically confirmed 7-day point prevalence smoking abstinence. Moderators of treatment effect will be assessed. The study evaluates implementation processes from participating NCORP site staff via survey, administrative, and focus group data, including reach, acceptability, appropriateness, fidelity, feasibility, adoption, cost and sustainability outcomes. DISCUSSION: This trial will generate findings about the effectiveness of an evidence-based virtual tobacco treatment intervention targeting patients diagnosed with cancer and illuminate barriers and facilitators that influence implementing tobacco treatment into community oncology settings nationally. In the era of COVID-19, virtual care solutions are vital for maximizing access and utilization of tobacco treatment delivery. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03808818) on January 18th, 2019; Last update posted: May 21st, 2020.

Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial.

To address childhood sexual abuse (CSA) related distress and HIV risk in men who have sex with men (MSM) using cognitive-behavioral therapy for trauma and self-care (CBT-TSC), which is a novel intervention integrating HIV risk reduction with modified cognitive and behavioral therapy strategies for post-traumatic stress. We compared CBT-TSC to HIV voluntary counseling and testing (VCT)-only in an initial 2-arm RCT in 43 HIV-negative MSM at with a history of CSA and HIV risk. Serodiscordant condomless anal/vaginal sex (CAS; CAS with HIV-postive or HIV unknown status partners) and posttraumatic stress disorder (PTSD) symptoms (Davidson Trauma Scale: total score and avoidance, intrusions, hyperarousal subscales) were outcomes immediately post-treatment, and at 6- and 9-month follow-up. At post-treatment, CBT-TSC had decreased odds (approximately 60%) of any CAS and greater reductions in CAS compared to VCT-only. Additionally, the CBT-TSC condition experienced greater reductions in total PTSD and avoidance symptoms. At the follow-up visits, CBT-TSC condition had significant reductions in the odds of any CAS and reductions in CAS. However, for PTSD symptoms, only the avoidance subscale remained significantly different compared to VCT-only. CBT-TSC is a potentially efficacious approach to address HIV risk in MSM with a CSA history, with replication and extension in a larger trial needed. This proof-of-concept trial is the first to integrate the treatment of a commonly occurring mental-health syndemic problem in MSM with a health psychology approach to self-care in MSM.Trial Registration Clinicaltrials.gov NCT01266122.

A Randomized Clinical Trial of a Brief Internet-based Group Intervention to Reduce Sexual Transmission Risk Behavior Among HIV-Positive Gay and Bisexual Men.

Background: HIV disproportionately affects sexual minority men, and developing strategies to reduce transmission risk is a public health priority. Purpose: The goal was to empirically test a newly developed, Information, Motivation, Behavioral skills (IMB) theoretically derived, online HIV sexual risk reduction intervention (called HINTS) among a sample of sexual minority men living with HIV. Methods: Participants were 167 men randomized to either the four-session online HINTS intervention or to a time-matched, online control condition. Participants were assessed at baseline and at 6-month follow-up for demographic, medical and psychosocial factors, and sexual risk behavior. Analyses examined group differences in incidence rates of condomless anal sex (CAS) at follow-up with all male sex partners and by partner serostatus, either seroconcordant or serodiscordant for HIV infection. Results: Men assigned to the HINTS intervention reported decreased CAS with serodiscordant partners, a behavior that confers high risk of HIV transmission, compared to the control group. Men assigned to the HINTS intervention also reported increased CAS with seroconcordant partners, a behavior indicative of serosorting. Although the IMB model did not appear to mediate these intervention effects, some IMB components were associated with behavioral outcomes at 6-month follow-up. Conclusions: A new group-based sexual risk reduction intervention conducted exclusively online was successful in reducing HIV transmission risk behavior in a sample of gay and bisexual men living with HIV. Future work should consider utilizing this intervention with other groups living with HIV, perhaps in combination with biomedical HIV prevention strategies.

Evaluating a novel intervention to reduce trauma symptoms and sexual risk taking: qualitative exit interviews with sexual minority men with childhood sexual abuse.

Childhood sexual abuse (CSA) continues to affect sexual minority men (SMM) at disproportionate levels and contributes to multiple negative health outcomes, including sexual-risk taking and HIV acquisition. This paper presents qualitative evaluative feedback from SMM (N = 9) who participated in a 10-session Cognitive Behavioral Therapy-Trauma and Sexual Health (CBT-TSH) intervention to reduce CSA-related posttraumatic stress reaction and distress. The treatment was designed to increase accurate sexual risk appraisals and to improve self-care health behaviors related to HIV/STI acquisition. The researchers identified four emerging themes: (1) motivation to participate, (2) response to cognitive therapy, (3) process of change, and (4) considerations for intervention improvement. These qualitative findings provide useful feedback on the acceptability of an innovative program that integrates CBT for trauma related to CSA with sexual risk-reduction counseling.

Online Partner Seeking and Sexual Risk Among HIV+ Gay and Bisexual Men: A Dialectical Perspective.

For almost two decades, researchers have explored the relationship between online partner seeking (OPS) and HIV/STI transmission risk behavior among men who have sex with men (MSM), including gay- and bisexual-identified men. A dichotomy has emerged with some findings that OPS is associated with greater sexual risk behavior, and a sparser but emerging literature that men may use OPS for sexual risk reduction. This study examined the association between proportion of partners met online and sexual risk behavior in a sample of 170 HIV-positive gay- and bisexual-identified men. Participants completed assessments including psychosocial factors and a comprehensive assessment of sexual behavior, including total number of male partners, and condomless insertive and receptive anal sex with HIV-negative/unknown serostatus partners or HIV-positive male partners. Our findings support taking a dialectical stance and indicate that OPS may impact risk differently given different individual and contextual circumstances.

Factors associated with amplified HIV transmission behavior among American men who have sex with men engaged in care: implications for clinical providers.

BACKGROUND: The HIV epidemic continues unabated in the USA, with men who have sex with men (MSM) being most frequently infected. PURPOSE: The purpose of this study is to understand the biological and behavioral risk factors associated with increased HIV transmission efficiency, which is HIV transmission risk behavior in the context of uncontrolled HIV replication or intercurrent sexually transmitted infections. METHODS: Participants were 201 HIV-infected MSM who received their primary care at an HIV ambulatory care center in Boston. Logistic regression models were conducted to determine factors associated with engaging in behavior associated with potentially amplified transmission. RESULTS: In the final model, heavy alcohol use (AOR, 3.27; 95 % CI 1.37-7.79), as well as stimulant drug use (crystal meth, crack, or other cocaine; AOR, 3.00; CI 1.32-6.84), having at least a college degree (OR, 2.74; CI, 1.15-6.54), and decreased duration of HIV infection (OR, 0.91; CI, 0.85-0.97) were each uniquely associated with enhanced HIV transmission behavior. CONCLUSIONS: HIV primary care providers should routinely assess patients for potential HIV transmission behaviors, particularly those who are younger and more recently diagnosed with HIV, who drink alcohol heavily, and who use any nonprescription drugs, particularly stimulants, in order to decrease the spread of HIV.

Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder: A Randomized Pilot Trial.

BACKGROUND /OBJECTIVES: Neurotypical siblings (NT siblings) of children with autism spectrum disorder (ASD) are at elevated risk for emotional distress and adjustment problems. Resiliency is the ability to cope and adapt with ongoing stressors. We conducted a randomized waitlist-controlled pilot trial to examine the feasibility, acceptability, and preliminary efficacy of an adapted virtual mind-body resiliency group intervention for teen NT siblings of children with ASD. METHODS: We modified the Stress Management and Resiliency Training-Relaxation Response Resiliency Program for NT siblings of children with ASD (SibChat). We randomly assigned teens (aged 14-17) to immediate intervention (IG) versus waitlist control (WLC). The intervention included eight 60-minute weekly video conference group sessions. We assessed feasibility (enrollment, attendance, and retention) and acceptability (post treatment survey and weekly relaxation response practice). We explored group differences in pre-post change scores for 1) stress coping (Measure of Current Status-A) and 2) resiliency (Current Experiences Scale) using independent samples t tests and effect size calculations. RESULTS: We enrolled 83% of screened eligible teens. A total of 90% IG and 75% WLC participants attended at least 6/8 sessions. Among IG participants who completed the post treatment survey, 79% reported practicing relaxation response exercises at least "a few times a week". Comparing change in baseline to time 1, the IG showed better relative changes than the WLC group in stress coping (d = 0.60) and resiliency (d = 0.24). CONCLUSIONS: Our pilot trial showed promising feasibility, acceptability, and preliminary efficacy of SibChat on at least one of the 2 primary outcomes supporting further testing of the SibChat intervention. CLINICAL TRIAL REGISTRATION: US National Library of Medicine. REGISTRATION NUMBER: NCT04369417. https://clinicaltrials.gov/ct2/show/NCT04369417.

Body mass index, depression and sexual transmission risk behaviors among HIV-positive MSM.

Depression has been shown to be a risk factor for serodiscordant unprotected anal intercourse (SDUAI) in some studies, but not others. Body mass index (BMI) has recently been associated with SDUAI; however, to date, no published study has investigated the interactive effect of depression and BMI on SDUAI. The current study assessed the association between depression, BMI, and SDUAI among HIV-positive MSM. Participants were 430 HIV-positive MSM recruited in a Boston community health center where they received primary care. Participants completed audio computer-assisted self interview (ACASI) measures. Objective height and weight and other clinical variables were accessed through participants' electronic medical records. Depression was positively associated with SDUAI. This association was significantly moderated by BMI. Elevated levels of depression were only associated with SDUAI for underweight participants. These findings suggest that underweight, depressed HIV-positive MSM may be particularly likely to engage in SDUAI.

Challenges and Growth: Lived Experience of Adolescents and Young Adults (AYA) with a Sibling with ASD.

Adolescent and young adult (AYA) siblings of individuals with autism experience unique challenges that can promote both growth and emotional maladjustment. This study explored sibling and parent reports of siblings' lived experiences and identified learning, stressors, and concerns from those experiences. 20 neurotypical (NT) AYA siblings (ages 13-24), and 21 parents were interviewed. Themes that emerged from the data analysis included: (1) learning, empathy, and compassion (2) relationship between the degree of functional impairment and the nature of the sibling relationship; (3) reluctance to share information about siblings with peers; (4) hypervigilance associated with unpredictable behavior; (5) worries and concerns about the future. These findings contribute to the existing literature on the impact and nature of neurotypical siblings' lived experience.

Demonstration and evaluation of a peer-delivered, individually-tailored, HIV prevention intervention for HIV-infected MSM in their primary care setting.

Employing HIV-infected peer counselors in secondary prevention interventions for MSM is appealing for scalable interventions. One-hundred-seventy-six HIV-infected MSM at their primary care facility participated in a secondary HIV-prevention study delivered by HIV-infected MSM peers. Of those who entered the intervention and completed the initial intake, 62% completed all four of the intervention sessions, and 93% completed at least one. While there was no overall change in transmission risk behavior (TRB) for the whole sample, among those who reported HIV TRB at baseline (n = 29), there were significant reductions in TRB over the next year. Themes that emerged in qualitative exit interviews conducted with a subset of participants centered on peer counselor quality, intervention implications, and intervention experience. This demonstration project provides initial evidence for the ability to recruit HIV-infected MSM in care into a peer-based intervention study, and shows how a peer-based intervention can be delivered in the context of HIV care.

Body image disturbance and health behaviors among sexual minority men living with HIV.

OBJECTIVE: Body image disturbance is a common experience for sexual minority men living with HIV, and is associated with poor self-care behaviors. However, to date, no known cohesive theoretical model has been advanced to understand the possible antecedents and outcomes of body image disturbance in this population. Thus, the goal of the current study was to test a biopsychosocial model of body image and self-care behaviors among sexual minority men living with HIV. METHOD: Participants were 106 gay and bisexual men living with HIV who completed a battery of self-report measures, including assessment of body image disturbance, depression, lipodystrophy, appearance orientation, condom use self-efficacy, antiretroviral therapy (ART) adherence, and HIV sexual transmission risk behaviors. Bayesian estimation was employed to assess model fit and direct and indirect pathways within the model. RESULTS: The data fit the model well, with all theorized pathways being significant. Lipodystrophy severity and appearance orientation were associated with elevated body image disturbance. In turn, body image disturbance was related to poorer ART adherence and increased HIV sexual transmission risk behaviors, through the mechanisms of elevated depressive symptoms and poor condom use self-efficacy. CONCLUSIONS: Elevated body image disturbance among sexual minority men living with HIV is associated with important biopsychosocial variables, which in turn are related to poorer ART adherence and increased HIV sexual transmission risk behaviors. Integrative psychosocial interventions addressing co-occurring body image disturbance, depression, and HIV self-care behaviors may be a fruitful area for future clinical practice and research.