Pressure to Use HIV Self-Tests Among Men Who Have Sex With Men, United States, 2015-2016.

To assess whether pressuring others to use HIV self-tests is prevalent among US men who have sex with men (MSM), we analyzed data from a randomized controlled trial of HIV self-testing. Among 752 online-recruited MSM who received HIV self-tests and responded to a 12-month survey, 8.5% (60/709) reported pressuring someone to use an HIV self-test: 29 pressured a friend, 28 pressured a sexual partner, and 1 pressured a family member. Conversely, 2.1% (15/715) reported being pressured to self-test: 12 by a sexual partner and 3 by a friend. No physical harm was reported. HIV prevention programs that use HIV self-tests to reach populations at risk for HIV may be reassured by our findings because, despite reports of pressure to use HIV self-tests, no physical abuse was reported between sex partners. These programs should, however, include messages emphasizing the voluntary use of HIV self-tests and be prepared to address concerns of persons who have been pressured to use HIV self-tests. This trial is registered at www.clinicaltrials.gov (NCT02067039) and the date of registration is February 5, 2014.

RESUMEN: Analizamos los datos de un ensayo controlado aleatorio (ECA) de 12 meses para evaluar si presionar a alguien a que utilice la autoprueba del VIH es una ocurrencia frecuente entre hombres estadounidenses que tienen sexo con hombres (HSH) reclutados via el internet. Entre 752 HSH que recibieron por correo autopruebas del VIH y que respondieron a una encuesta a los 12 meses del ECA, el 8.5% (60/709) informó haber presionado a alguien a que usara una autoprueba del VIH: 29 presionaron a un amigo, 28 presionaron a una pareja sexual y uno presionó a un miembro de su familia. Por el contrario, el 2.1% (15/715) informó haber sido presionado a usar la autoprueba: 12 por una pareja sexual y 3 por un amigo. Ningun participante reporto daños físicos. Los programas de prevención del VIH que utilizan autopruebas del VIH para alcanzar a poblaciones a riesgo de contraer el VIH, pueden sentirse tranquilizados por nuestros hallazgos porque, a pesar de los reportes de presión para usar las autopruebas del VIH, no se reporto abuso físico entre parejas sexuales. Sin embargo, los programas deben incluir mensajes que enfaticen el uso voluntario de las autopruebas del VIH y estar preparados para calmar las preocupaciones de las personas que han sido presionadas a usar las autopruebas del VIH. El ensayo está registrado en www.clinicaltrials.gov (NCT02067039) y la fecha de registro es el 5 de febrero de 2014.

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study.

BACKGROUND: Mobile health apps are important interventions that increase the scale and reach of prevention services, including HIV testing and prevention counseling, pre-exposure prophylaxis, condom distribution, and education, of which all are required to decrease HIV incidence rates. The use of these web-based apps as well as fully web-based intervention trials can be challenged by the need to remove fraudulent or duplicate entries and authenticate unique trial participants before randomization to protect the integrity of the sample and trial results. It is critical to ensure that the data collected through this modality are valid and reliable. OBJECTIVE: The aim of this study is to discuss the electronic and manual authentication strategies for the iReach randomized controlled trial that were used to monitor and prevent fraudulent enrollment. METHODS: iReach is a randomized controlled trial that focused on same-sex attracted, cisgender males (people assigned male at birth who identify as men) aged 13-18 years in the United States and on enrolling people of color and those in rural communities. The data were evaluated by identifying possible duplications in enrollment, identifying potentially fraudulent or ineligible participants through inconsistencies in the data collected at screening and survey data, and reviewing baseline completion times to avoid enrolling bots and those who did not complete the baseline questionnaire. Electronic systems flagged questionable enrollment. Additional manual reviews included the verification of age, IP addresses, email addresses, social media accounts, and completion times for surveys. RESULTS: The electronic and manual strategies, including the integration of social media profiles, resulted in the identification and prevention of 624 cases of potential fraudulent, duplicative, or ineligible enrollment. A total of 79% (493/624) of the potentially fraudulent or ineligible cases were identified through electronic strategies, thereby reducing the burden of manual authentication for most cases. A case study with a scenario, resolution, and authentication strategy response was included. CONCLUSIONS: As web-based trials are becoming more common, methods for handling suspicious enrollments that compromise data quality have become increasingly important for inclusion in protocols. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/10174.

Detection of SARS-CoV-2 RNA and Antibodies in Diverse Samples: Protocol to Validate the Sufficiency of Provider-Observed, Home-Collected Blood, Saliva, and Oropharyngeal Samples.

BACKGROUND: The response in the United States to the coronavirus disease (COVID-19) pandemic has been hampered by a lack of aggressive testing for the infection. Testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cornerstone of an effective public health response. However, efforts to test have been hampered by limited reagents, limitations in the availability of swabs used for the collection of nasopharyngeal swab (NPS) specimens, limitations in personal protective equipment (PPE) for health care providers collecting the NPS specimens, and limitations in viral transport media for transporting the specimens. Therefore, more flexible options for screening for SARS-CoV-2 RNA and serologic responses are critical to inform clinical and public health responses. OBJECTIVE: We aim to document the ability of patients to self-collect sufficient specimens for SARS-CoV-2 viral detection and serology. METHODS: Patient self-collection of samples will be done with observation by a health care provider during a telemedicine session. Participants will be mailed a specimen collection kit, engage in a telehealth session with a provider through a HIPPA (Health Insurance Portability and Accountability Act of 1996)-compliant video meeting, and collect specimens while being observed by the provider. Providers will record whether they are confident in the suitability of the specimen for laboratory testing that would inform clinical decision making. We will objectively assess the sufficiency of biological material in the mailed-in specimens. RESULTS: The protocol was approved by the Emory University Institutional Review Board (IRB) on March 30, 2020 (Protocol number 371). To date, we have enrolled 159 participants. CONCLUSIONS: Defining a conceptual framework for assessing the sufficiency of patient-collected samples for the detection of SARS-CoV-2 RNA and serologic responses to infection is critical for facilitating public health responses and providing PPE-sparing options to increase testing. Validation of alternative methods of specimen collection should include objective measures of the sufficiency of specimens for testing. A strong evidence base for diversifying testing modalities will improve tools to guide public health responses to the COVID-19 pandemic.

University of North Carolina/Emory Center for Innovative Technology (iTech) for Addressing the HIV Epidemic Among Adolescents and Young Adults in the United States: Protocol and Rationale for Center Development.

BACKGROUND: Over a fifth of all new HIV infections in the United States occur among persons aged 13 24 years, with most of these diagnoses occurring among gay and bisexual males (81%). While the epidemic of HIV in the United States has leveled off for many age groups, the annual number of new HIV diagnoses among young men who have sex with men (YMSM; 13-24 years old) remains high. Traditional approaches to continuum improvement for youth have been insufficient, and targeted interventions are urgently needed for young people at risk for or infected with HIV. Interventions delivered through mobile health technology represent a promising approach for improving outcomes in this population. Mobile phones have nearly reached saturation among youth, making mobile technology a particularly promising tool for reaching this population. OBJECTIVE: The University of North Carolina/Emory Center for Innovative Technology (iTech) is a National Institutes of Health cooperative agreement as part of the Adolescent Medicine Trials Network for HIV/AIDS Interventions. iTech aims to impact the HIV epidemic by conducting innovative, interdisciplinary research on technology-based interventions across the HIV prevention and care continuum for adolescents and young adults in the United States, particularly YMSM, by providing the following: (1) evaluation of novel approaches to identifying youth with undiagnosed HIV infections; (2) evaluation of multilevel, combination prevention approaches, particularly relevant to gender- and sexual-minority youth facing co-occurring health risks; (3) evaluation of uptake of and adherence to biomedical prevention modalities; and 4) evaluation of interventions designed to promote or optimize engagement in care and antiretroviral therapy adherence in HIV-positive youth, to optimize viral load suppression. METHODS: iTech brings together multidisciplinary experts in the fields of adolescent HIV treatment and prevention, development and evaluation of technology-based interventions, HIV surveillance and epidemiology, and intervention design and evaluation. This initiative will support 8 efficacy trials and 2 exploratory projects, each led by 2 principal investigators. Taken together, the studies address all of the key steps of the HIV prevention and care continuum for youth in the United States. Each proposal uses technology in a scientifically rigorous and innovative way to access, engage, and impact at-risk or infected youth. Nine iTech subject recruitment venues are spread across 8 US cities. Three cores (management, analytic, and technology) support all iTech activities and form the research network's infrastructure, facilitating all aspects of study implementation and evaluation. RESULTS: Formative work has already begun on many of the above-mentioned iTech trials. We expect the first randomized controlled trials to begin in mid-2018. Additional details can be found in the individual intervention protocol papers in this issue. CONCLUSIONS: Through its comprehensive research portfolio, iTech aims to effectively advance HIV prevention and care for youth through technology-based, youth-relevant interventions that maximize adaptability and sustainability. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10365.

Reducing HIV Vulnerability Through a Multilevel Life Skills Intervention for Adolescent Men (The iREACH Project): Protocol for a Randomized Controlled Trial.

BACKGROUND: Few HIV interventions have demonstrated efficacy in reducing HIV risk among adolescent men who have sex with men (AMSM), and fewer still have recognized the unique needs of AMSM based on race/ethnicity or geographical setting. Recognizing that youths' HIV vulnerability is intricately tied to their development and social context, delivering life skills training during adolescence might delay the onset or reduce the consequences of risk factors for HIV acquisition and equip AMSM with the skills to navigate HIV prevention. This protocol describes the development and testing of iREACH, an online multilevel life skills intervention for AMSM. OBJECTIVE: This randomized controlled trial (RCT) aims to test the efficacy of an online-delivered life skills intervention, iREACH, on cognitive and behavioral HIV-related outcomes for AMSM. METHODS: iREACH is a prospective RCT of approximately 600 cisgender adolescent males aged 13 to 18 years who report same-sex attractions. The intervention will be tested with a racial/ethnically diverse sample (≥50% racial/ethnic minority) of AMSM living in four regions in the United States: (1) Chicago to Detroit, (2) Washington, DC to Atlanta, (3) San Francisco to San Diego, and (4) Memphis to New Orleans. RESULTS: This project is currently recruiting participants. Recruitment began in March 2018. CONCLUSIONS: iREACH represents a significant innovation in the development and testing of a tailored life skills-focused intervention for AMSM, and has the potential to fill a significant gap in HIV prevention intervention programming and research for AMSM. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10174.

Perceptions of HIV Self-Testing Among Men Who Have Sex With Men in the United States: A Qualitative Analysis.

HIV testing is the gateway into both prevention and treatment services. It is important to understand how men who have sex with men (MSM) perceive HIV self-tests. We conducted focus groups and individual interviews to collect feedback on two HIV self-tests, and on a dried blood spot (DBS) specimen collection kit. Perceptions and attitudes around HIV self-testing (HIVST), and willingness to distribute HIV self-tests to others were assessed. MSM reported HIVST to be complementary to facility-based testing, and liked this approach because it offers privacy and convenience, does not require counseling, and could lead to linkage to care. However, they also had concerns around the accuracy of HIV self-tests, their cost, and receiving a positive test result without immediate access to follow-up services. Despite these issues, they perceived HIVST as a positive addition to their HIV prevention toolbox.

Pilot Evaluation of the Ability of Men Who Have Sex with Men to Self-Administer Rapid HIV Tests, Prepare Dried Blood Spot Cards, and Interpret Test Results, Atlanta, Georgia, 2013.

In the United States, an estimated 67% of new HIV diagnoses are among men who have sex with men (MSM), however 25% of HIV-positive MSM in the 2014 National HIV Behavioral Surveillance Survey were unaware of their infection. HIV self-testing (HIVST) with rapid diagnostic tests (RDTs) may facilitate access to HIV testing. We evaluated the ability of 22 MSM to conduct two HIV RDTs (OraQuick ® In-Home HIV Test and a home-use prototype of Sure Check ® HIV 1/2 Assay), interpret sample images of test results, and collect a dried blood spot (DBS) specimen. While some participants did not follow every direction, most participants were able to conduct HIVST and correctly interpret their results. Interpretation of panels of RDT images was especially difficult when the "control" line was missing, and 27% of DBS cards produced were rated as of bad quality. Modifications to the DBS instructions were necessary prior to evaluating the performance of these tests in real-world settings.

Willingness to distribute free rapid home HIV test kits and to test with social or sexual network associates among men who have sex with men in the United States.

Peer-driven HIV prevention strategies can be effective in identifying high-risk persons with undiagnosed infections. Besides individual self-testing, other potential uses of rapid home HIV test kits include distributing them, and testing with others within one's social or sexual networks. We sought to identify factors associated with the willingness to engage in these alternative activities among men who have sex with men (MSM) in the United States. From May to October 2014, we surveyed 828 HIV-negative or unknown status MSM about multiple aspects of rapid home HIV testing. A greater proportion indicated being likely to distribute free oral fluid (OF) tests compared to free finger-stick blood (FSB) tests (91% versus 79%), and almost three-fourths (72%) reported being likely to test with their friends or sex partners in the future. MSM not identifying as homosexual/gay were less willing to distribute OF tests, and those with lower educational attainment were more willing to distribute FSB tests. MSM unaware of their HIV status were less likely to report potentially testing with others using free rapid home HIV tests compared to those who were HIV-negative. Finally, MSM willing to self-test were more likely to report future test kit distribution, and those willing to distribute kits were more likely to report potentially testing with others. Engaging individuals with positive attitudes towards these strategies in prevention efforts could help increase HIV testing levels among MSM. A greater understanding of the potential public health impact of rapid home HIV test kits is necessary.

Asymmetric frontal cortical activity and negative affective responses to ostracism.

Ostracism arouses negative affect. However, little is known about variables that influence the intensity of these negative affective responses. Two studies fill this void by incorporating work on approach- and withdrawal-related emotional states and their associated cortical activations. Study 1 found that following ostracism anger related directly to relative left frontal cortical activation. Study 2 used unilateral hand contractions to manipulate frontal cortical activity prior to an ostracizing event. Right-hand contractions, compared to left-hand contractions, caused greater relative left frontal cortical activation during the hand contractions as well as ostracism. Also, right-hand contractions caused more self-reported anger in response to being ostracized. Within-condition correlations revealed patterns of associations between ostracism-induced frontal asymmetry and emotive responses to ostracism consistent with Study 1. Taken together, these results suggest that asymmetrical frontal cortical activity is related to angry responses to ostracism, with greater relative left frontal cortical activity being associated with increased anger.