How Many Sexual Partners of an Individual Need to Be Evaluated to Capture HIV/STI Risk Behavior in a Study?

Investigators conducting HIV studies ask participants multiple questions about sexual risk behaviors with their partners to ensure that they can describe the level of HIV risky sexual behavior. The assessment should be as short as possible because of the expense of collecting the data, the burden to the research subject, and ethical concerns. This study used data from the NIMH Collaborative HIV/STD Prevention Trial to answer the question about how many non-spousal/non live-in partners a research participant needs to be asked about to capture sufficient sexual risk behavior (not using a condom with a non-spousal/non live-in partner in the last 3 months). The data provided evidence that 95 % of the sexual risk behavior was captured by asking about two partners while 98 % was captured by three partners. As research funds become increasingly limited, it is important to design as parsimonious and robust a study as possible.

The utility of a composite biological endpoint in HIV/STI prevention trials.

A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention.

Employment as HIV Prevention: An Employment Support Intervention for Adolescent Men Who Have Sex With Men and Adolescent Transgender Women of Color.

BACKGROUND: The purpose of this study was to adapt and pilot-test an employment support, primary HIV intervention tailored to the needs of adolescent men who have sex with men and adolescent transgender women of color. SETTING: The intervention was implemented in 2 settings: controlled environment (Phase 1) and real-world community-based (Phase 2) setting in Chicago, IL. METHODS: Eighty-seven adolescent men who have sex with men and adolescent transgender women of color ages 16-24 participated in Work2Prevent , a 4-session employment and HIV prevention intervention, designed to increase job-readiness and reduce HIV risk. Intervention sessions consisted of group activities: educational games, roleplaying/modeling behavior, and self-regulation exercises. Participants were assessed at baseline, postintervention, and 8-month (Phase 1) or 3-month follow-up (Phase 2). RESULTS: Participants evaluated Work2Prevent as feasible and acceptable, rating intervention quality, usefulness, and satisfaction highly. Overall, 59.6% (Phase 1) and 85.0% (Phase 2) participants attended 2 or more sessions. At 8 months, Phase 1 participants reported a mean increase of 11.4 hours worked per week. Phase 2 participants reported a mean increase of 5.2 hours worked per week and an increase in job-seeking self-efficacy. Phase 2 participants also reported a decrease in transactional sex work. CONCLUSION: Work2Prevent is one of the first structural primary HIV interventions to specifically focus on adolescent employment readiness. Findings suggest Work2Prevent is feasible and acceptable, improved adolescent employment outcomes, and reduced HIV risk associated with transactional sex work. Our study underscores the need for alternative pathways, such as addressing socioeconomic determinants, to prevent adolescent HIV infection.

The PhenX Toolkit: get the most from your measures.

The potential for genome-wide association studies to relate phenotypes to specific genetic variation is greatly increased when data can be combined or compared across multiple studies. To facilitate replication and validation across studies, RTI International (Research Triangle Park, North Carolina) and the National Human Genome Research Institute (Bethesda, Maryland) are collaborating on the consensus measures for Phenotypes and eXposures (PhenX) project. The goal of PhenX is to identify 15 high-priority, well-established, and broadly applicable measures for each of 21 research domains. PhenX measures are selected by working groups of domain experts using a consensus process that includes input from the scientific community. The selected measures are then made freely available to the scientific community via the PhenX Toolkit. Thus, the PhenX Toolkit provides the research community with a core set of high-quality, well-established, low-burden measures intended for use in large-scale genomic studies. PhenX measures will have the most impact when included at the experimental design stage. The PhenX Toolkit also includes links to standards and resources in an effort to facilitate data harmonization to legacy data. Broad acceptance and use of PhenX measures will promote cross-study comparisons to increase statistical power for identifying and replicating variants associated with complex diseases and with gene-gene and gene-environment interactions.

Data compatibility in the addiction sciences: an examination of measure commonality.

The need for comprehensive analysis to compare and combine data across multiple studies in order to validate and extend results is widely recognized. This paper aims to assess the extent of data compatibility in the substance abuse and addiction (SAA) sciences through an examination of measure commonality, defined as the use of similar measures, across grants funded by the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Data were extracted from applications of funded, active grants involving human-subjects research in four scientific areas (epidemiology, prevention, services, and treatment) and six frequently assessed scientific domains. A total of 548 distinct measures were cited across 141 randomly sampled applications. Commonality, as assessed by density (range of 0-1) of shared measurement, was examined. Results showed that commonality was low and varied by domain/area. Commonality was most prominent for (1) diagnostic interviews (structured and semi-structured) for substance use disorders and psychopathology (density of 0.88), followed by (2) scales to assess dimensions of substance use problems and disorders (0.70), (3) scales to assess dimensions of affect and psychopathology (0.69), (4) measures of substance use quantity and frequency (0.62), (5) measures of personality traits (0.40), and (6) assessments of cognitive/neurologic ability (0.22). The areas of prevention (density of 0.41) and treatment (0.42) had greater commonality than epidemiology (0.36) and services (0.32). To address the lack of measure commonality, NIDA and its scientific partners recommend and provide common measures for SAA researchers within the PhenX Toolkit.

Physical activity and physical fitness: standardizing assessment with the PhenX Toolkit.

The focus of the PhenX (Phenotypes and eXposures) Toolkit is to provide researchers whose expertise lies outside a particular area with key measures identified by experts for uniform use in large-scale genetic studies and other extensive epidemiologic efforts going forward. The current paper specifically addresses the PhenX Toolkit research domain of physical activity and physical fitness (PA/PF), which are often associated with health outcomes. A Working Group (WG) of content experts completed a 6-month consensus process in which they identified a set of 14 high-priority, low-burden, and scientifically supported measures. During this process, the WG considered self-reported and objective measures that included the latest technology (e.g., accelerometers, pedometers, and heart-rate monitors). They also sought the input of measurement experts and other members of the research community during their deliberations. A majority of the measures include protocols for children (or adolescents), adults, and older adults or are applicable to all ages. Measures from the PA/PF domain and 20 other domains are publicly available and found at the PhenX Toolkit website, www.phenxtoolkit.org. The use of common measures and protocols across large studies enhances the capacity to combine or compare data across studies, benefiting both PA/PF experts and non-experts. Use of these common measures by the research community should increase statistical power and enhance the ability to answer scientific questions that previously might have gone unanswered.