Methodological Strategies for Prospective Harmonization of Studies: Application to 10 Distinct Outcomes Studies of Preventive Interventions Targeting Opioid Misuse.

The Helping to End Addiction Long-Term (HEAL) Prevention Cooperative (HPC) is rapidly developing 10 distinct evidence-based interventions for implementation in a variety of settings to prevent opioid misuse and opioid use disorder. One HPC objective is to compare intervention impacts on opioid misuse initiation, escalation, severity, and disorder and identify whether any HPC interventions are more effective than others for types of individuals. It provides a rare opportunity to prospectively harmonize measures across distinct outcomes studies. This paper describes the needs, opportunities, strategies, and processes that were used to harmonize HPC data. They are illustrated with a strategy to measure opioid use that spans the spectrum of opioid use experiences (termed involvement) and is composed of common "anchor items" ranging from initiation to symptoms of opioid use disorder. The limitations and opportunities anticipated from this approach to data harmonization are reviewed. Lastly, implications for future research cooperatives and the broader HEAL data ecosystem are discussed.

A National Institutes of Health Approach for Advancing Research to Improve Youth Mental Health and Reduce Disparities.

Even before the COVID-19 pandemic, mental health challenges were the leading cause of disability and poor health outcomes in youth. Challenges are even greater for youth from racially and ethnically minoritized groups in the United States. Racially and ethnically minoritized youth are more vulnerable to mental health problems than White adolescents, yet are less likely to use mental health services. In late 2021, the National Institutes of Health (NIH) sponsored a virtual conference to examine the state of the science around youth mental health disparities (YMHD), focusing on youth from racially and ethnically minoritized populations and the intersection of race and ethnicity with other drivers of mental health disparities. Key findings and feedback gleaned from the conference have informed strategic planning processes related to YMHD, which has included the development of a strategic framework and funding opportunities, designed to reduce YMHD. This commentary briefly describes the collaborative approach used to develop this framework and other strategies implemented across the NIH to address YMHD and serves as an urgent call to action.

Youth living with HIV and partner-specific risk for the secondary transmission of HIV.

BACKGROUND: Secondary transmission remains a significant concern among HIV-infected youth. Little is known, however, about how partner-specific sexual risk behaviors for the secondary transmission of HIV may differ between the 2 largest subgroups of HIV-positive youth, women-who-have-sex-with-men (WSM) and men-who-have-sex-with-men (MSM), METHODS: During 2003-2004, a convenience sample of HIV-infected youth, 13 to 24 years of age, were recruited from 15 Adolescent Medicine Trials Network clinical sites. Approximately 10 to 15 youth were recruited at each site. Participants completed an ACASI survey including questions about sex partners in the past year. Cross-sectional data analyses, including bivariate and multivariable regressions, using generalized estimating equations, were conducted during 2008 to compare recent partner-specific sexual risk behaviors between WSM and MSM. RESULTS: Of 409 participants, 91% (371) were included in this analysis, including 176 WSM and 195 MSM. Ninety-two percent (163 WSM, 177 MSM) provided information on characteristics of their sexual partners. There were significant differences between the 2 groups in recent partner-specific sexual risk behaviors including: lower rates of condom use at last sex among WSM (61% WSM vs. 78% MSM; P = 0.0011); a larger proportion of the sex partners of MSM reported as concurrent (56% MSM vs. 36% WSM; P = 0.0001); and greater use of hard drugs at last sex by MSM and/or their partner (18% MSM vs. 4% WSM; P = 0.0008). When measuring risk as a composite measure of sexual risk behaviors known to be associated with HIV transmission, both groups had high rates of risky behaviors, 74.7% among young MSM compared to 68.1% of WSM. CONCLUSIONS: These data suggest that recent partner-specific sexual risk behaviors for HIV transmission are high among young infected MSM and WSM. These findings suggest the need to offer interventions to reduce the secondary transmission of HIV to all HIV-positive youth in care. However, differences in risk behaviors between young MSM and WSM supports population-specific interventions.

Tax Policy-An Understudied Approach to Reducing Cannabis Use.

This Viewpoint discusses the potential of state taxation of cannabis products to curb use and raise revenue for public services.

The conception of the ABCD study: From substance use to a broad NIH collaboration.

Adolescence is a time of dramatic changes in brain structure and function, and the adolescent brain is highly susceptible to being altered by experiences like substance use. However, there is much we have yet to learn about how these experiences influence brain development, how they promote or interfere with later health outcomes, or even what healthy brain development looks like. A large longitudinal study beginning in early adolescence could help us understand the normal variability in adolescent brain and cognitive development and tease apart the many factors that influence it. Recent advances in neuroimaging, informatics, and genetics technologies have made it feasible to conduct a study of sufficient size and scope to answer many outstanding questions. At the same time, several Institutes across the NIH recognized the value of collaborating in such a project because of its ability to address the role of biological, environmental, and behavioral factors like gender, pubertal hormones, sports participation, and social/economic disparities on brain development as well as their association with the emergence and progression of substance use and mental illness including suicide risk. Thus, the Adolescent Brain Cognitive Development study was created to answer the most pressing public health questions of our day.

Barriers and facilitators to adolescent HIV testing.

This study examined the barriers and facilitators of HIV counseling, testing, and referral service (HIV CTR) acceptance among 278 youth aged 12-24 years old. Participants completed a questionnaire before health education sessions with trained counselors. Information was collected on individual characteristics, HIV testing acceptance, risk behaviors, reasons for having never been tested, and what would make it easier to get tested for HIV. Ninety percent of the respondents were minority and 52% were female with an average age of 15 years. High-risk minority youth who had never received HIV CTR listed low perception of risk and never having been offered a test as reasons for not having been tested. Increased availability of oral and rapid testing methods as well as free testing services were listed as facilitating their acceptance of HIV testing. Older youth aged 18-24 years reported that HIV tests in which results can be received rapidly and confidentially would encourage them to obtain HIV testing services. Early identification approaches should be tailored to increase the access to and acceptance of HIV-testing services among the adolescent and young adult populations.

An HIV prevention protocol reviewed at 15 national sites: how do ethics committees protect communities?

To learn whether ethics committees reviewing community-based participatory research concentrate on the protection of communities, in addition to individual participants, data from 15 sites were analyzed. Eighty-two ethics committee concerns related to consent (35%), protocol procedures (49%), data collection (17%), and HIPAA (6%) were identified. Concerns generally involved individual level subject issues; only 17% were related to community issues. To improve community-level protections in research, the authors recommend that both ethics committee members and research staff receive education concerning protection and respect for communities, that a community member group be established to advise researchers throughout the planning and implementation of community-level studies and that local ethics committee boards include members with community-level experience.

The role of community resource assessments in the development of 15 adolescent health community-researcher partnerships.

BACKGROUND: Connect to Protect (C2P): Partnerships for Youth Prevention Interventions is an initiative that alters the community's structural elements to reduce youth HIV rates. OBJECTIVES: This study details a community resource assessment and describes how resources were evaluated in the context of local needs. METHODS: Fifteen sites developed a community resource list, conducted a brief survey, created a youth service directory, and mapped where disease prevalence and community resources intersected. Sites also completed a survey to review and verify local site findings. RESULTS: On average, sites identified 267 potential community resources. Sites narrowed their resource list to conduct a brief survey with 1,162 agencies; the site average was 78. Final products of this process included maps comparing resources with risk data. CONCLUSIONS: The evaluation of local resources is an important initial step in partnership development and is essential for the success of health promotion and disease prevention interventions that target adolescents.

Partnership selection and formation: a case study of developing adolescent health community-researcher partnerships in fifteen U.S. communities.

PURPOSE: This study describes the partner selection process in 15 U.S. communities developing community-researcher partnerships for the Connect to Protect (C2P): Partnerships for Youth Prevention Interventions, an initiative of the Adolescent Trials Network for human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS) Interventions. METHODS: Each site generated an epidemiological profile of urban youth in their community, selected a focus population and geographic area of youth at risk for HIV, conducted a series of successive structured interviews, and engaged in a process of relationship-building efforts culminating in a collaborative network of community agencies. RESULTS: Sites chose as their primary target population young women who have sex with men (n = 8 sites), young men who have sex with men (n = 6), and intravenous drug users (n = 1). Of 1162 agencies initially interviewed, 281 of 335 approached (84%) agreed to join the partnership (average 19/site). A diverse array of community agencies were represented in the final collaborative network; specific characteristics included: 93% served the sites' target population, 54% were predominantly youth oriented, 59% were located in the geographical area of focus, and 39% reported provision of HIV/STI (sexually transmitted infection) prevention services. Relationship-building activities, development of collaborative relationships, and lessons learned, including barriers and facilitators to partnership, are also described. CONCLUSIONS: Study findings address a major gap in the community partner research literature. Health researchers and policymakers need an effective partner selection framework whereby community-researcher partnerships can develop a solid foundation to address public health concerns.

Calibration and validation of an oral fluid-based sensitive/less-sensitive assay to distinguish recent from established HIV-1 infections.

Sensitive/less-sensitive (S/LS) serum-based serologic methods have been developed to measure human immunodeficiency virus (HIV) incidence by distinguishing recent from established infections. Such methods require venipuncture. The goal of this study was to develop an alternative to serum-based S/LS testing using oral fluid (OF) as the testing medium. Serum/OF pairs were collected from 342 patients attending 15 Adolescent Trials Network (ATN) clinical sites. The sera were tested with the use of the dilutional Vironostika (DV; Biomerieux, Durham, NC) S/LS assay (DV(SOD=1.0)) as the reference against which an OF LS assay was calibrated using 40 of the OF pairs. Receiver operating characteristic (ROC) curve analyses pinpointed the OF LS test parameters that maximized concordance with the serum-based DV. Validation of the calibrated OF LS included testing of the remaining 302 serum/OF pairs. During calibration the maximum concordance with the DV was 95.2% and 89.5% for 21 recent and 19 established samples, respectively, at a 1:50 OF sample dilution and an optical density (OD) cutoff of 0.280. When applied to the validation sample set (N=302), the concordance was 73.6% for the recent samples and 89.6% for the established samples. The OF LS assay showed a good concordance with the serum-based reference S/LS assay. It presents an alternative to invasive specimen collection, and has the potential for increasing test compliance in young subjects. However, because of the uncertainty of the performance characteristics of the serum-based S/LS assay with which it was compared, further validation of the OF LS using seroconversion sample pairs is needed.

Laying the foundation for Connect to Protect: a multi-site community mobilization intervention to reduce HIV/AIDS incidence and prevalence among urban youth.

Despite the considerable resources that have been dedicated to HIV prevention interventions and services over the past decade, HIV incidence among young people in the United States remains alarmingly high. One reason is that the majority of prevention efforts continue to focus solely on modifying individual behavior, even though public health research strongly suggests that changes to a community's structural elements, such as their programs, practices, and laws or policies, may result in more effective and sustainable outcomes. Connect to Protect is a multi-city community mobilization intervention that focuses on altering or creating community structural elements in ways that will ultimately reduce youth HIV incidence and prevalence. The project, which spans 6 years, is sponsored by the Adolescent Medicine Trials Network for HIV/AIDS Interventions at multiple urban clinical research sites. This paper provides an overview of the study's three phases and describes key factors in setting a firm foundation for the initiation and execution of this type of undertaking. Connect to Protect's community mobilization approach to achieving structural change represents a relatively new and broad direction in HIV prevention research. To optimize opportunities for its success, time and resources must be initially placed into laying the groundwork. This includes activities such as building a strong overarching study infrastructure to ensure protocol tasks can be met across sites; tapping into local site and community expertise and knowledge; forming collaborative relationships between sites and community organizations and members; and fostering community input on and support for changes at a structural level. Failing to take steps such as these may lead to insurmountable implementation problems for an intervention of this kind.

Promoting identification of HIV-infected youths: borrowing concepts from the media to reduce the HIV epidemic?

The HIV/AIDS epidemic is dramatically affecting adolescents. Although it is estimated that 50% of new HIV infections in the United States is among people under 25 years of age, adolescents seek HIV counseling and testing services at a much lower rate than adults. Furthermore, many HIV-infected adolescents remain unaware of their status and do not seek health care. As HIV identification remains the most important gap in the efforts to control the spread of the HIV epidemic among youths, there is an increasing need to implement creative strategies to attract youths to HIV screening services. This article describes the implementation of an innovative HIV/AIDS social marketing campaign designed to attract at-risk urban adolescents to youth-friendly HIV counseling and testing services and link them to comprehensive health care. In addition, the article describes the key elements of the social marketing initiative: 1) designing a meaningful message, 2) attaining audience credibility, and 3) mobilizing the community.