Adding to the HIV Prevention Portfolio – the Achievement of Structural Changes by 13 Connect to Protect® Coalitions

Opportunities to control risk factors that contribute to HIV transmission and acquisition extend far beyond individuals and include addressing social and structural determinants of HIV risk, such as inadequate housing, poor access to healthcare and economic insecurity. The infrastructure within communities, including the policies and practices that guide institutions and organizations, should be considered crucial targets for change. This paper examines the extent to which 13 community coalitions across the U.S. and Puerto Rico were able to achieve “structural change” objectives (i.e., new or modified practices or policies) as an intermediate step toward the long-term goal of reducing HIV risk among adolescents and young adults (12-24 years old). The study resulted in the completion of 245 objectives with 70% categorized as structural in nature. Coalitions targeted social services, education and government as primary community sectors to adopt structural changes. A median of 12 key actors and six new key actors contributed to accomplishing structural changes. Structural change objectives required a median of seven months to complete. The structural changes achieved offer new ideas for community health educators and practitioners seeking to bolster their HIV prevention agenda

Connect to Protect® Researcher-Community Partnerships: Assessing Change in Successful Collaboration Factors over Time

Fifteen research sites within the Adolescent Medicine Trials Network for HIV/AIDS Interventions launched Connect to Protect community coalitions in urban areas across the United States and in Puerto Rico. Each coalition has the same overarching goal: Reducing local youth HIV rates by changing community structural elements such as programs, policies, and practices. These types of transformations can take significant amounts of time to achieve; thus, ongoing successful collaboration among coalition members is critical for success. As a first step toward building their coalitions, staff from each research site invited an initial group of community partners to take part in Connect to Protect activities. In this paper, we focus on these researcher-community partnerships and assess change in collaboration factors over the first year. Respondents completed the Wilder Collaboration Factors Inventory at five time points, approximately once every two to three months. Results across all fifteen coalitions show significant and positive shifts in ratings of process/structure (p<.05). This suggests that during the first year they worked together, Connect to Protect researcher-community partners strengthened their group infrastructures and operating procedures. The findings shed light on how collaboration factors evolve during coalition formation and highlight the need for future research to examine change throughout subsequent coalition phases. (Peer Reviewed

Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men.

The aims of this study were to: 1) determine prevalence of anogenital and oral HPV, 2) determine concordance between HPV at anal, perianal, scrotal/penile, and oral sites; and 3) describe factors associated with anogenital HPV types targeted by the 9-valent vaccine. Data were collected from 2012 to 2015 among men who have sex with men 18-26 years of age enrolled in a vaccine trial (N = 145). Penile/scrotal, perianal, anal, and oral samples were tested for 61 HPV types. Logistic regression was used to identify factors associated with types in the 9-valent vaccine. Participants' mean age was 23.0 years, 55.2% were African-American, and 26.2% were Hispanic; 93% had anal, 40% penile, and 6% oral HPV. Among those with anogenital infection, 18% had HPV16. Concordance was low between anogenital and oral sites. Factors independently associated with a 9-valent vaccine-type HPV were: race (African-American vs. White, OR=2.67, 95% CI=1.11-6.42), current smoking (yes vs. no, OR=2.37, 95% CI=1.03-5.48), and number of recent receptive anal sex partners (2+ vs. 0, OR=3.47, 95% CI=1.16-10.4). Most MSM were not infected with HPV16 or HPV18, suggesting that they may still benefit from HPV vaccination, but anogenital HPV was very common, highlighting the importance of vaccinating men before sexual initiation. CLINICAL TRIAL NUMBER: NCT01209325

HPV Vaccination among Sexual and Gender Minority Youth Living with or at High-Risk for HIV

Background: Human papillomavirus (HPV) is epidemic among young people, especially those at highest risk of acquiring HPV-related cancers. Methods: Youth aged 14–24 years old (N = 1628) were recruited from 13 clinics, community agencies, and social media sites in Los Angeles, California, and New Orleans, Louisiana, that specialized in serving sexual and gender minority youths (SGMY), especially males at risk for HIV. A cross-sectional comparison of sociodemographic and risk histories of HPV vaccinated/unvaccinated youths was conducted using both univariate and multivariate regressions. Results: About half (51.9%) of youth were vaccinated, with similar percentages across states and across genders. Sexual and gender minority youths (SGMY, i.e., gay, bisexual, transgender, and non-heterosexual; 68.8%) and their heterosexual peers (15%) were equally likely to be vaccinated (54%), even though their risk for HPV-related cancers is very different. Vaccinations were higher among younger youth, those not using condoms, youth with greater education, that possessed a primary health care provider, and youth diagnosed with HIV. Vaccinations were lower among youth that were out-of-home due to mental health inpatient hospitalization, drug treatment, homelessness, or incarceration. Conclusions: Special programs are required to target youth experiencing multiple life stressors, especially out-of-home experiences, those with less education, and without the safety net of health insurance or a provider

Development of an Electronic Data Collection System to Support a Large-Scale HIV Behavioral Intervention Trial: Protocol for an Electronic Data Collection System.

BACKGROUND:Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances for electronic data capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants, deliver intervention directly to participants' mobile devices, monitor staff activity, and facilitate near real-time decision making during study implementation. OBJECTIVE:This paper presents the infrastructure of an EDC system designed to support a multisite HIV biobehavioral intervention trial in Los Angeles and New Orleans: the Adolescent Medicine Trials Network "Comprehensive Adolescent Research & Engagement Studies" (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. METHODS:The CARES EDC system is designed to monitor and document multiple study functions, including, screening, recruitment, retention, intervention delivery, and outcome assessment. Text messaging (short message service, SMS) and nearly all data collection are supported by the EDC system. The system functions on mobile phones, tablets, and Web browsers. RESULTS:ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. Besides data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality, and field staff supervision. The system is supporting both incoming and outgoing text messages (SMS) and offers high-level data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using EDC systems are addressed through programming updates and training on how to improve data quality. CONCLUSIONS:There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided whether the flexibility provided by the development of a study-specific, in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, text messaging (SMS) interventions, and case management and a separate Web-based platform to support an online peer support intervention. Decisions need to be made regarding the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering text messages (SMS) to study participants' mobile phones. EDC data security protocols should be developed under guidance from security experts and with formative consulting with the target study population as to their perceptions and needs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10777

Correlation Between Use of Antiretroviral Adherence Devices by HIV-Infected Youth and Plasma HIV RNA and Self-Reported Adherence

Our objective was to investigate antiretroviral adherence device use by HIV-infected youth and assess associations of device use with viral suppression and self-reported adherence. This cross-sectional, multisite, clinic-based study included data from 1,317 HIV-infected individuals 12-24 years of age that were prescribed antiretroviral therapy. Mean adherence in the past 7 days was 86.1 % and 50.5 % had an undetectable HIV RNA. Pillbox was the most commonly endorsed device. No specific device was independently associated with higher odds of 100 % adherence. Paradoxically, having an undetectable HIV RNA was inversely associated with use of adherence devices (OR 0.80; p = 0.04); however, among those with <100 % adherence, higher adherence was associated with use of one or more adherence devices (coefficient = 7.32; p = 0.003). Our data suggest that adolescents who experienced virologic failure often used adherence devices which may not have been sufficiently effective in optimizing adherence. Therefore, other tailored adherence-enhancing methods need to be considered to maximize virologic suppression and decrease drug resistance and HIV transmission. © 2014 Springer Science+Business Media New York

Development of an Electronic Data Collection System to Support a Large-Scale HIV Behavioral Intervention Trial: Protocol for an Electronic Data Collection System.

BACKGROUND:Advancing technology has increased functionality and permitted more complex study designs for behavioral interventions. Investigators need to keep pace with these technological advances for electronic data capture (EDC) systems to be appropriately executed and utilized at full capacity in research settings. Mobile technology allows EDC systems to collect near real-time data from study participants, deliver intervention directly to participants' mobile devices, monitor staff activity, and facilitate near real-time decision making during study implementation. OBJECTIVE:This paper presents the infrastructure of an EDC system designed to support a multisite HIV biobehavioral intervention trial in Los Angeles and New Orleans: the Adolescent Medicine Trials Network "Comprehensive Adolescent Research & Engagement Studies" (ATN CARES). We provide an overview of how multiple EDC functions can be integrated into a single EDC system to support large-scale intervention trials. METHODS:The CARES EDC system is designed to monitor and document multiple study functions, including, screening, recruitment, retention, intervention delivery, and outcome assessment. Text messaging (short message service, SMS) and nearly all data collection are supported by the EDC system. The system functions on mobile phones, tablets, and Web browsers. RESULTS:ATN CARES is enrolling study participants and collecting baseline and follow-up data through the EDC system. Besides data collection, the EDC system is being used to generate multiple reports that inform recruitment planning, budgeting, intervention quality, and field staff supervision. The system is supporting both incoming and outgoing text messages (SMS) and offers high-level data security. Intervention design details are also influenced by EDC system platform capabilities and constraints. Challenges of using EDC systems are addressed through programming updates and training on how to improve data quality. CONCLUSIONS:There are three key considerations in the development of an EDC system for an intervention trial. First, it needs to be decided whether the flexibility provided by the development of a study-specific, in-house EDC system is needed relative to the utilization of an existing commercial platform that requires less in-house programming expertise. Second, a single EDC system may not provide all functionality. ATN CARES is using a main EDC system for data collection, text messaging (SMS) interventions, and case management and a separate Web-based platform to support an online peer support intervention. Decisions need to be made regarding the functionality that is crucial for the EDC system to handle and what functionality can be handled by other systems. Third, data security is a priority but needs to be balanced with the need for flexible intervention delivery. For example, ATN CARES is delivering text messages (SMS) to study participants' mobile phones. EDC data security protocols should be developed under guidance from security experts and with formative consulting with the target study population as to their perceptions and needs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/10777

Exchange of Sex for Drugs or Money in Adolescents and Young Adults: An Examination of Sociodemographic Factors, HIV-Related Risk, and Community Context.

The goal of this research was to examine associations among sociodemographic factors, HIV risk, and community context (e.g., economic insecurity, job training, housing instability, crime victimization, and perceived community norms) in adolescents and young adults who ever exchanged sex for drugs or money. Anonymous survey data were collected using ACASIs at community venues where adolescents and young adults congregate in resource-challenged, STI prevalent, urban, US neighborhoods. Conventional descriptive statistics, Fisher's exact tests, and generalized estimating equations approaches were used to examine associations. Participants (1818, 95.5 % of those screened eligible) were, on average, aged 21.0 years; 42.2 % were males, and 4.6 % were transgender. Almost one-third (32.1 %) identified as gay or lesbian, 18.1 % identified as bisexual; 66.2 % were Black and 21.0 % were Hispanic; 1.3 % was 'living on the street'. A sizeable proportion reported HIV-related risk: 16.3 % exchanged sex, 12.6 % had sex with someone they knew to be HIV-infected, 7.8 % had sex with someone who injected drugs, and 1.3 % injected drugs. Multivariate comparisons identified a number of variables (e.g., being male or transgender, homelessness, sex with a partner who has HIV, STI history, unemployment, job training access, housing instability, crime victimization, perceived community norms) that were significantly associated with exchange of sex (p < 0.05). This research contributes to the knowledge-base regarding exchange of sex among adolescents and young adults, particularly as it relates to community context. Longitudinal studies to describe the trajectory of social, health, and physical risks and consequences are needed for development of effective evidence-based prevention strategies