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BackgroundPeople who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH.MethodsThe multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of

BackgroundMore than half of persons living with HIV (PLWH) in the United States are insufficiently engaged in HIV primary care and not taking antiretroviral therapy (ART), mainly African Americans/Blacks and Hispanics. In the proposed project, a potent and innovative research methodology, the multiphase optimization strategy (MOST), will be employed to develop a highly efficacious, efficient, scalable, and cost-effective intervention to increase engagement along the HIV care continuum. Whereas randomized controlled trials are valuable for evaluating the efficacy of multi-component interventions as a package, they are not designed to evaluate which specific components contribute to efficacy. MOST, a pioneering, engineering-inspired framework, addresses this problem through highly efficient randomized experimentation to assess the performance of individual intervention components and their interactions. We propose to use MOST to engineer an intervention to increase engagement along the HIV care continuum for African American/Black and Hispanic PLWH not well engaged in care and not taking ART. Further, the intervention will be optimized for cost-effectiveness. A similar set of multi-level factors impede both HIV care and ART initiation for African American/Black and Hispanic PLWH, primary among them individual- (e.g., substance use, distrust, fear), social- (e.g., stigma), and structural-level barriers (e.g., difficulties accessing ancillary services). Guided by a multi-level social cognitive theory, and using the motivational interviewing approach, the study will evaluate five distinct culturally based intervention components (i.e., counseling sessions, pre-adherence preparation, support groups, peer mentorship, and patient navigation), each designed to address a specific barrier to HIV care and ART initiation. These components are well-grounded in the empirical literature and were found acceptable, feasible, and promising with respect to efficacy in a preliminary study.Methods/designStudy aims are: 1) using a highly efficient fractional factorial experimental design, identify which of five intervention components contribute meaningfully to improvement in HIV viral suppression, and secondary outcomes of ART adherence and engagement in HIV primary care; 2) identify mediators and moderators of intervention component efficacy; and 3) using a mathematical modeling approach, build the most cost-effective and efficient intervention package from the efficacious components. A heterogeneous sample of African American/Black and Hispanic PLWH (with respect to age, substance use, and sexual minority status) will be recruited with a proven hybrid sampling method using targeted sampling in community settings and peer recruitment (N = 512).DiscussionThis is the first study to apply the MOST framework in the field of HIV prevention and treatment. This innovative study will produce a culturally based HIV care continuum intervention for the nation's most vulnerable PLWH, optimized for cost-effectiveness, and with exceptional levels of efficacy, efficiency, and scalability.Trial registrationClinicalTrials.gov, NCT02801747 , Registered June 8, 2016.

BackgroundOver 50,000 individuals become infected with HIV annually in the U.S., and over a quarter of HIV infected individuals are heterosexuals. Undiagnosed HIV infection, as well as a lack of retention in care among those diagnosed, are both primary factors contributing to ongoing HIV incidence. Further, there are racial/ethnic disparities in undiagnosed HIV and engagement in care, with African Americans/Blacks and Latinos remaining undiagnosed longer and less engaged in care than Whites, signaling the need for culturally targeted intervention approaches to seek and test those with undiagnosed HIV infection, and link them to care with high retention.Methods/designThe study has two components: one to seek out and test heterosexuals at high risk for HIV infection, and another to link those found infected to HIV care with high retention. We will recruit sexually active African American/Black and Latino adults who have opposite sex partners, negative or unknown HIV status, and reside in locations with high poverty and HIV prevalence. The "Seek and Test" component will compare the efficacy and cost effectiveness of two strategies to uncover undiagnosed HIV infection: venue-based sampling and respondent-driven sampling (RDS). Among those recruited by RDS and found to have HIV infection, a "Treat and Retain" component will assess the efficacy of a peer-driven intervention compared to a control arm with respect to time to an HIV care appointment and health indicators using a cluster randomized controlled trial design to minimize contamination. RDS initial seeds will be randomly assigned to the intervention or control arm at a 1:1 ratio and all recruits will be assigned to the same arm as the recruiter. Participants will be followed for 12 months with outcomes assessed using medical records and biomarkers, such as HIV viral load.DiscussionHeterosexuals do not test for HIV as frequently as and are diagnosed later than other risk groups. The study has the potential to contribute an efficient, innovative, and sustainable multi-level recruitment approach and intervention to the HIV prevention portfolio. Because the majority of heterosexuals at high risk are African American/Black or Latino, the study has great potential to reduce racial/ethnic disparities in HIV/AIDS.Trial registrationClinicalTrials.gov, NCT01607541, Registered May 23, 2012.

Nationally up to 60 % of persons living with HIV are neither taking antiretroviral therapy (ART) nor well engaged in HIV care, mainly racial/ethnic minorities. This study examined a new culturally targeted multi-component intervention to address emotional, attitudinal, and social/structural barriers to ART initiation and HIV care. Participants (N = 95) were African American/Black and Latino adults with CD4

A substantial proportion of persons living with HIV/AIDS (PLHA) delay, decline, or discontinue antiretroviral therapy (ART) when it is medically indicated (40-45%), largely African-Americans and Latinos/Hispanics. This study explores the feasibility of locating PLHA, who are not on ART (PLHA-NOA) through clinics and peer-referral; compares the two cohorts on multi-level barriers to ART; and examines readiness to initiate/reinitiate ART, a predictor of treatment outcomes. We recruited adult HIV-infected African-American and Latino/Hispanic PLHA-NOA through HIV hospital clinics and peer-referral in 2012-2013. Participants were engaged in structured 1-h assessments with reliable/valid measures on barriers to ART. We found that recruitment through peers (63.2%, 60/95) was more feasible than in clinics (36.8%, 35/90). Participants were 48.0 years old and had lived with HIV for 14.7 years on average, and 56.8% had taken ART previously. Most (61.1%) were male and African-American (76.8%), and 23.2% were Latino/Hispanic. Peer-recruited participants were older, had lived with HIV longer, were less engaged in HIV care, and were more likely to have taken ART previously. The cohorts differed in reasons for discontinuing ART. Levels of ART knowledge were comparable between cohorts (68.5% correct), and there were no differences in attitudes toward ART (e.g., mistrust), which were in the neutral range. In bivariate linear regression, readiness for ART was negatively associated with physician mistrust (B = -10.4) and positively associated with self-efficacy (B = 5.5), positive outcome expectancies (B = 6.3), beliefs about personal necessity of ART (B = 17.5), and positive internal norms (B = 7.9). This study demonstrates the feasibility of engaging this vulnerable population through peer-referral. Peer-recruited PLHA evidence particularly high rates of risk factors compared to those in hospital clinics. Interventions to support ART initiation and continuation are sorely needed for both subgroups.

Objective: Optimizing multicomponent behavioral and biobehavioral interventions presents a complex decision problem. To arrive at an intervention that is both effective and readily implementable, it may be necessary to weigh effectiveness against implementability when deciding which components to select for inclusion. Different components may have differential effectiveness on an array of outcome variables. Moreover, different decision-makers will approach this problem with different objectives and preferences. Recent advances in decision-making methodology in the multiphase optimization strategy (MOST) have opened new possibilities for intervention scientists to optimize interventions based on a wide variety of decision-maker preferences, including those that involve multiple outcome variables. In this study, we introduce decision analysis for intervention value efficiency (DAIVE), a decision-making framework for use in MOST that incorporates these new decision-making methods. We apply DAIVE to select optimized interventions based on empirical data from a factorial optimization trial. Method: We define various sets of hypothetical decision-maker preferences, and we apply DAIVE to identify optimized interventions appropriate to each case. Results: We demonstrate how DAIVE can be used to make decisions about the composition of optimized interventions and how the choice of optimized intervention can differ according to decision-maker preferences and objectives. Conclusions: We offer recommendations for intervention scientists who want to apply DAIVE to select optimized interventions based on data from their own factorial optimization trials. [ABSTRACT FROM AUTHOR]

The heightened level of risk for HIV infection among Black and Latino young men who have sex with men (YMSM) is driven by multilevel influences. Using cross-sectional data, we examined HIV testing patterns among urban YMSM of color in a high-HIV seroprevalence area (ages 16 to 21 years). Self-reported frequency of testing was high, with 42% of youth reporting testing at a greater frequency than recommended guidelines. There were no differences between less frequent and more frequent testers on sexual risk behaviors. Most (80%) youth cited reassurance of HIV-negative status as a reason for testing. Further, over half of the sample reported numerous other reasons for HIV testing, which spanned individual, partner, social, and structural levels of influence. Approximately half of respondents indicated that peers, family members, and counselors influenced their motivation to get tested. Of concern, their first HIV test occurred approximately 2 years after their first sexual experience with another male. These results indicate the need to consider developmental issues as well as comprehensive, multilevel efforts to ensure that YMSM of color test at the Centers for Disease Control and Prevention-recommended frequency but not less than this or too frequently.

Homeless youth (HY) who lack employment in the formal economy typically turn to the street economy (e.g., prostitution, drug selling) for survival. Guided by the theory of social control, the present paper explores factors influencing HY's initiation into the street economy. Eighty HY (ages 15-23) were recruited from four community-based organizations. All participated in structured interviews and 25% participated in qualitative interviews. Almost all HY had participated in the street (81%) and formal economies (69%). Five main factors simultaneously influenced initiation into the street economy: social control/bonds, barriers to the formal economy (e.g., homelessness, educational deficits, mental health problems, incarceration, stigma), tangible and social/emotional benefits of the street economy, severe economic need, and the active recruitment of HY into the street economy by others. Qualitative and quantitative data sources were congruent. Intervention efforts are needed at multiple levels of influence to promote HY's success in the formal economy. (Contains 2 figures and 3 tables.)

We examined the risk and protective factors and mental health problems of 105 low SES, urban adolescents whose mothers were coping with alcohol abuse and other drug problems. Approximately half of the mothers were also HIV-infected. As hypothesized, there were few differences between adolescents of HIV-infected and HIV-uninfected mothers in background characteristics, mental health issues and current substance use risk behaviors. In addition to maternal substance abuse, youth in both groups experienced similar risk factors including early foster care placement and high levels of maltreatment. Current patterns of emerging risk behaviors were evident among youth in both groups as well as signs of resiliency including high levels of school attendance. These results underscore the importance of interventions for youth of substance abusing mothers, particularly those living in urban poverty.

Objectives: Although a wealth of literature suggests that childhood physical, emotional, and sexual abuse are related to later-life HIV-related risk behaviors, few studies have explored disinhibition (e.g., impulsivity, risk-taking propensity, and sensation-seeking) as a risk factor in this relationship. Method: This cross-sectional study examined impulsivity, risk-taking propensity, and sensation seeking as mediators in the relationship between abuse history and engagement in HIV-related risk behaviors among a sample of 96 inner-city African American adolescents. Results: Findings indicated that abuse history was positively related to self-reported engagement in HIV-related risk behaviors (B=0.027, SE 0.008, [beta]=0.32, sr[superscript 2]=0.105, p=0.001), as well as risk-taking propensity (B=0.35, SE 0.11, [beta]=.030, sr[superscript 2]=0.090, p=0.003) and sensation seeking (B=0.17, SE 0.05, [beta]=0.35, sr[superscript 2]=0.124, p=0.0004). Abuse history was not related to impulsivity. Further, while sensation-seeking and risk-taking propensity (to a lesser extent) mediated this relationship, impulsivity did not. Conclusions: These findings provide an initial step in the examination of the mechanisms underlying the relationship between childhood abuse and engagement in HIV-related risk behaviors.

The abuse of alcohol and other substances by mothers raising adolescent children has serious adverse effects on family functioning and youth outcomes, and on mothers' own health and adaptation. Mothers who are also HIV-infected face additional challenges. In the present report, we describe a multi-session intervention conducted in individual sessions for mothers with alcohol and other substance use problems who are raising adolescent children. We outline the primary components of the intervention and include case studies and examples of exercises and tools. We found that engagement with the intervention and high rates of attendance were facilitated by tapping into mothers' desires to improve their relationships with their adolescent children, the use of a harm reduction approach toward substance use, and intensive outreach. We also discuss lessons learned in the course of implementing and evaluating the intervention.

In the present report we describe patterns of traumatic events and Post-traumatic Stress Disorder (PTSD), both partial and full, among homeless youth and those at risk for homelessness, with an emphasis on gender differences. Participants were 85 homeless and at-risk youth (49% female) recruited from a drop-in center in New York City in 2000. Youth completed a structured interview lasting 1.5 h. Rates of childhood maltreatment were substantial. Further, almost all youth experienced at least one traumatic event, with most experiencing multiple types of trauma. Gender differences were found in the types, but not prevalence or magnitude, of childhood maltreatment and traumatic events experienced. Partial symptomatology of PTSD was common for females but not males. Symptoms of depression and anxiety were found to co-occur with PTSD for females, which may complicate treatment efforts. Further investigation of the impact of trauma on homeless males is needed.

Staff in drug treatment programs are in an optimal position to support the hepatitis C related needs of their patients. To do so effectively, however, staff need to have accurate information about the hepatitis C virus (HCV). This article examines the HCV knowledge of staff (N = 104) in two drug-free and two methadone maintenance treatment programs (MMTPs) in the New York metropolitan area. Five of 20 items on an HCV Knowledge Assessment were not answered correctly by the majority of the participating staff, and total scores on the Assessment averaged 70%, 71%, and 45% among the medically credentialed staff, non-medically credentialed staff in the MMTPs, and non-medically credentialed staff in the drug-free programs, respectively. The majority of those in the latter group had never participated in a training specifically devoted to HCV. Results suggest the need for effective HCV-related training for all staff in drug treatment programs. (Contains 3 tables.)

The objective of this paper is to profile the role of homelessness in drug and sexual risk in a population of young men who have sex with men (YMSM). Data are from a cross-sectional survey collected between 2000 and 2001 in New York City (N=569). With the goal of examining the import of homelessness in increased risk for the onset of drug and sexual risk, we compare and contrast three subgroups: (1) YMSM with no history of homelessness, (2) YMSM with a past history of homelessness but who were not homeless at the time of the interview, and (3) YMSM who were currently homeless. For each group, we describe the prevalence of a broad range of stressful life events (including foster care and runaway episodes, involvement in the criminal justice system, etc.), as well as selected mental health problems (including past suicide attempts, current depression, and selected help-seeking variables). Additionally, we examine the prevalence of selected drug and sexual risk, including exposure to a broad range of illegal substances, current use of illegal drugs, and prevalence of lifetime exposure to sex work. Finally, we use an event history analysis approach (time-event displays and paired t-test analysis) to examine the timing of negative life experiences and homelessness relative to the onset of drug and sexual risk. High levels of background negative life experiences and manifest mental health distress are seen in all three groups. Both a prior experience of homelessness and currently being homeless are both strongly associated with both higher levels of lifetime exposure to drug and sexual risk as well as higher levels of current drug and sexual risk. Onset of these risks occur earlier in both groups that have had an experience of housing instability (e.g., runaway, foster care, etc.) but are delayed or not present among YMSM with no history of housing instability. Few YMSM had used drug prior to becoming homeless. While causal inferences are subject to the limitations of a cross-sectional design, the findings pose an empirical challenge to the prevailing assumption that prior drug use is a dominant causal factor in YMSM becoming homeless. More broadly, the data illustrate the complexity of factors that must be accounted for, both in advancing our epidemiological understanding of the complexity of homelessness and its relationship to the onset of drug and sexual risk among high risk youth populations.