A Mixed-Methods Study Examining Adherence to and Acceptability of Intravaginal Rings for HIV Prevention: Behavioral Results of MTN-027.

Intravaginal rings (IVR) containing antiretroviral drugs are a promising method for HIV prevention. We triangulated quantitative and qualitative assessments to evaluate the acceptability of four IVRs used continuously for 28 days as part of a Phase I trial (N = 48 HIV-negative women; ages 18-45). Adherence was high throughout the trial, yet 30% of participants reported involuntary IVR expulsions followed by re-insertion. Most participants (93.6%) felt comfortable with the IVR being inside their body. Participants reported liking the IVR more (36.2%) or the same amount (55.3%) since starting the study. When given the option of choosing between the IVR and/or a male condom for HIV-prevention, most reported preferring the IVR (n = 29, 63.0%), and over a quarter of the sample reported liking them equally (n = 12, 26.1%). We observed no differences in IVR acceptability across the study arms. High adherence and acceptability underscores the promise of an IVR as a female-controlled, sustained mechanism for HIV prevention.

Internet and Social Media Access Among Youth Experiencing Homelessness: Mixed-Methods Study.

BACKGROUND: Youth experiencing homelessness are at a risk for a variety of adverse outcomes. Given the widespread use of the internet and social media, these new technologies may be used to address their needs and for outreach purposes. However, little is known about how this group uses these resources. OBJECTIVE: This study investigated how homeless adolescents use these technologies for general and health-related purposes, whether the scope of their use changes with housing status, and their interest in a website dedicated to youth experiencing homelessness. METHODS: A convenience sample of youth aged 18 to 21 years was recruited from a youth-specific homeless shelter. All participants completed a 47-item survey, with 10 individuals completing a semistructured interview. Descriptive statistics, exact testing, logistic regression, and generalized estimating equation modeling was performed for quantitative data analysis. Interviews were transcribed verbatim, and NVivo 10 (QSR International) was employed to facilitate double coding and thematic analysis. RESULTS: A total of 87 participants completed the survey with a mean age of 19.4 (SD 1.1) years. While experiencing homelessness, 56% (49/87) accessed the internet at least once a day, with 86% (75/87) accessing once a week. Access to a smartphone was associated with a 3.03 greater odds of accessing the internet and was the most frequently used device (66% of participants, 57/87). While experiencing homelessness, subjects reported a 68% decreased odds in internet access frequency (odds ratio [OR] 0.32, P<.001), 75% decreased odds in spending greater amounts of time on the internet (OR 0.25, P<.001), and an 87% decreased odds of social media use (OR 0.13, P=.01). Ten participants completed the semistructured interview. Several themes were identified, including (1) changes in internet behaviors while experiencing homelessness, (2) health status as a major concern and reason for Internet use, and (3) interest in a website dedicated to youth experiencing homelessness. While experiencing homelessness, participants indicated their behaviors were more goal-oriented and less focused on leisure or entertainment activities. CONCLUSIONS: While homeless youth experience changes in the frequency, amount of time, and specific uses of the internet and social media, study participants were able to access the internet regularly. The internet was used to search health-related topics. Given the importance of smartphones in accessing the internet, mobile-optimized websites may be an effective method for reaching this group.

Online recruitment of youth for mHealth studies.

BACKGROUND: Social networking sites and apps have emerged as an opportunity to engage in research young men who have sex with men (YMSM) at risk of HIV infection who may not be otherwise reached by in-person recruitment efforts. This paper highlights lessons learned, best practices and on-going recruitment challenges in the iTech network of the NIH Adolescent Trials Network for HIV Interventions. METHODS: Recruitment was conducted for four randomized controlled trials (RCTs) of mHealth HIV prevention interventions for YMSM living in 10 US cities. Advertising was purchased on Facebook, Instagram, Snapchat, Twitter and Grindr. Users who clicked on banner ads were taken directly to a study-specific eligibility screener and if eligible, were asked to provide contact information for follow-up by respective study site staff. Ad and screening metrics (impressions, clicks, cost per click (CPC), click-through rate (CTR), number screened, number eligible, number who provided contact information and cost per eligible contact) were compared across platforms, studies and geographic areas (where available). Screening metrics were also calculated for in-person recruitment efforts. RESULTS: Grindr and Snapchat ads produced the highest CTRs as compared to Facebook ads. However, these ads had the lowest proportions of users who initiated eligibility screeners and ultimately Facebook ads yielded the lowest cost per eligible contact across studies. Instagram ads yielded the highest proportions of eligible contacts who were racial/ethnic minorities and under the age of 18. Geographic variability in cost per eligible contact was observed for studies with identical eligibility criteria running concurrently in different regions, driven by both advertising costs and the screening and eligibility rates. Despite lower eligibility rates, the total numbers of eligible contacts were higher for online advertising campaigns, as compared to other recruitment efforts, for all studies except P3. Ads recruiting for P3 had the highest cost per eligible contact, likely due to this study having the most stringent eligibility criteria of the studies described. CONCLUSIONS: We implemented a successful online advertising strategy to recruit YMSM at high risk for HIV infection into four RCTs of mHealth interventions. This report provides a framework for evaluation of data from future online recruitment efforts across platforms and geographic areas, regardless of inevitable changes in the digital marketing space.

Adapting technology-based HIV prevention and care interventions for youth: lessons learned across five U.S. Adolescent Trials Network studies.

BACKGROUND: U.S. sexual and gender minority youth experience individual, interpersonal, and structural-level barriers to HIV prevention and care. Innovative, youth-driven approaches to mobile and electronic interventions that support use of new biomedical prevention, testing, and treatment options may address these barriers. Adapting evidence-based interventions for youth must balance core intervention components with responsiveness to the distinct needs of end-users. METHODS: The UNC/Emory Center for Innovative Technology (iTech) adapts and evaluates technology-based interventions for youth living with or at risk for HIV. We analyzed formative research (focus groups and individual usability sessions) across five iTech studies: two apps promoting HIV testing and pre-exposure prophylaxis (PrEP), one app promoting behavioral risk reduction and PrEP, one PrEP adherence app, and one mobile-optimized website for increasing viral suppression, with the aim of informing best practices for technology-based intervention development. Each study presented prototypes of adapted mHealth interventions to samples of their target end-user population for use and/or evaluation. RESULTS: One hundred and thirty-eight youth across seven geographically diverse sites provided feedback during the intervention adaptation process. We found high interest in and acceptability of all five intervention prototypes. Cross-study themes included: (I) Desire for multiple privacy protections (e.g., password, fingerprint) to keep HIV status, sexual identity, and sexual behavior confidential. (II) Strong but varied preferences for the look and feel of platforms. Imagery should be discrete but representative. Participants valued customizable platforms and positive themes, motivational language, and humor. Youth wanted information presented using multiple modalities (e.g., text, video, image) to increase engagement. (III) Youth preferred engagement features and functions consistent with familiar platforms (e.g., Snapchat, Instagram). Gamification features that resulted in tangible versus virtual rewards were predicted to increase engagement. Intervention messaging functions were perceived as useful; customization was desired as a way to control frequency, mode (e.g., SMS, in-app message, push notification), and content. (IV) Youth voiced varied preferences for platform content including: featuring young role models from the lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ) community, incorporating mental health resources, and maintaining a holistic health-focus (not HIV-centric). CONCLUSIONS: We found high acceptability and consistent feedback in youths' evaluations of these mHealth interventions; divergence was most commonly found in preferred content versus features and functions. Identifying broadly accepted aspects of mHealth interventions for youth supports the feasibility of adaptation (versus de novo creation) and should guide the focus of future formative research phases. Continued research is needed to better understand how to balance usability preferences with finite resources for customization.

Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial.

BACKGROUND: Stigma and discrimination related to sexuality, race, ethnicity, and HIV status negatively impact HIV testing, engagement in care, and consistent viral suppression (VS) among young Black and Latinx men who have sex with men and transgender women who have sex with men (YBLMT). Few interventions address the effects of intersectional stigma among youth living with HIV and those at risk for HIV within the same virtual space. OBJECTIVE: Building on the success of the HealthMpowerment (HMP) mobile health (mHealth) intervention (HMP 1.0) and with the input of a youth advisory board, HMP 2.0 is an app-based intervention that promotes user-generated content and social support to reduce intersectional stigma and improve HIV-related outcomes among YBLMT. The primary objective of this study is to test whether participants randomized to HMP 2.0 report improvement in HIV prevention and care continuum outcomes compared with an information-only control arm. We will also explore whether participant engagement, as measured by paradata (data collected as users interact with an mHealth intervention, eg, time spent using the intervention), mediates stigma- and HIV care-related outcomes. Finally, we will assess whether changes in intersectional stigma and improvements in HIV care continuum outcomes vary across different types of social networks formed within the intervention study arms. METHODS: We will enroll 1050 YBLMT aged 15 to 29 years affected by HIV across the United States. Using an HIV-status stratified, randomized trial design, participants will be randomly assigned to 1 of the 3 app-based conditions (information-only app-based control arm, a researcher-created network arm of HMP 2.0, or a peer-referred network arm of HMP 2.0). Behavioral assessments will occur at baseline, 3, 6, 9, and 12 months. For participants living with HIV, self-collected biomarkers (viral load) are scheduled for baseline, 6, and 12 months. For HIV-negative participants, up to 3 HIV self-testing kits will be available during the study period. RESULTS: Research activities began in September 2018 and are ongoing. The University of Pennsylvania is the central institutional review board for this study (protocol #829805) with institutional reliance agreements with the University of North Carolina at Chapel Hill, Duke University, and SUNY Downstate Health Sciences University. Study recruitment began on July 20, 2020. A total of 205 participants have been enrolled as of November 20, 2020. CONCLUSIONS: Among a large sample of US-based YBLMT, this study will assess whether HMP 2.0, an app-based intervention designed to ameliorate stigma and its negative sequelae, can increase routine HIV testing among HIV-negative participants and consistent VS among participants living with HIV. If efficacious and brought to scale, this intervention has the potential to significantly impact the disproportionate burden of HIV among YBLMT in the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03678181; https://clinicaltrials.gov/ct2/show/study/NCT03678181. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24043.

Testing the Testers: Are Young Men Who Have Sex With Men Receiving Adequate HIV Testing and Counseling Services?

BACKGROUND: The United States Centers for Disease Control and Prevention promote HIV testing every 6 months among young men who have sex with men (YMSM) to facilitate entry into the HIV prevention and care continuum. Willingness to be tested may be influenced by testing services' quality. Using a novel mystery shopper methodology, we assessed YMSM's testing experiences in 3 cities and recommend service delivery improvements. METHODS: We assessed YMSM's experiences at HIV testing sites in Philadelphia (n = 30), Atlanta (n = 17), and Houston (n = 19). YMSM (18-24) were trained as mystery shoppers and each site was visited twice. After each visit, shoppers completed a quality assurance survey to evaluate their experience. Data were pooled across sites, normed as percentages, and compared across cities. RESULTS: Across cites, visits averaged 30 minutes (SD = 25.5) and were perceived as welcoming and friendly (70.9%). YMSM perceived most sites respected their privacy and confidentiality (84.3%). YMSM noted deficiencies in providers' competencies with sexual minorities (63.4%) and comfort during the visit (65.7%). Sites underperformed on Lesbian, Gay, Bisexual, Transgender visibility (49.6%) and medical forms inclusivity (57.95%). Sites on average did not discuss YMSM's relationship context (49.8%) nor provide risk reduction counseling (56.8%) or safer sex education (24.3%). Sites delivered pre-exposure prophylaxis information and counseling inconsistently (58.8%). CONCLUSIONS: Testing sites' variable performance underscores the importance of improving HIV testing services for YMSM. Strategies are recommended for testing sites to promote cultural sensitivity: funding staff trainings, creating systems to assess adherence to testing guidelines and best practices, and implementing new service delivery models.

Paradata Analysis of an eHealth HIV Testing Intervention for Young Men Who Have Sex With Men.

Little is known about users' intervention engagement and use patterns within eHealth interventions. We describe these patterns among young men who have sex with men (YMSM) who participated in a brief eHealth intervention designed to increase HIV testing. We merged pilot trial participants' survey data (N = 86) with their paradata (e.g., system data recorded during interaction with the intervention). We created engagement (time spent on components) and use (interaction with features) metrics, and explored whether they differed by participant characteristics. Racial/ethnic minorities clicked on fewer features (mean = 8.30) than non-Hispanic White men (mean = 12.00). Use was associated with older age (r = .19), greater educational attainment (r = .25), and a greater number of methods to connect online (r = .38). Paradata can help researchers understand how users interact with eHealth interventions, and inform which components to retain or redesign. Efforts to systematically collect, analyze, and report paradata in eHealth HIV prevention and care interventions are warranted.

A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial.

BACKGROUND: HIV epidemic among young men who have sex with men (YMSM) is characterized by strong racial disparities and concerns about the availability and access to culturally appropriate HIV prevention and care service delivery. Get Connected, a Web-based intervention that employs individual- and system-level tailoring technology to reduce barriers to HIV prevention care (eg, HIV or sexually transmitted infection [STI] testing, pre-exposure prophylaxis [PrEP]), was developed for YMSM (age 15-24 years). This protocol details the design and procedures of a 2-phase project that includes mystery shopping and a randomized controlled trial (RCT) to test the efficacy of Get Connected among YMSM in Philadelphia, Atlanta, and Houston. OBJECTIVE: The objective of mystery shopping is to examine the quality of HIV test counseling and PrEP-related referrals for YMSM within local HIV or STI testing sites. The objective of the RCT is to test the efficacy of Get Connected for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (eg, routine HIV or STI testing), PrEP awareness, and likelihood to start PrEP (PrEP willingness), compared with those in the control condition, over a 12-month period. METHODS: For Phase 1, we will create a master list of HIV and STI testing sites in each city. We will enroll and train 10-15 mystery shoppers per city; each testing site will be separately visited and assessed by 2 mystery shoppers. After each site visit, the mystery shoppers will complete a site evaluation to record their perceptions of various measures including lesbian, gay, bisexual, transgender, queer visibility and inclusivity, privacy and confidentiality, provider-patient interactions, and clinic environment. For Phase 2, we will enroll 480 YMSM for 12 months across the 3 iTech cities into a 2-arm prospective RCT. Participants randomized to the control condition are directed to the AIDSVu.org testing site locator. Participants randomized to the intervention condition will be granted access to a Web app with content tailored to their specific demographic characteristics (eg, age, race or ethnicity, location, and relationship status), HIV and STI risk behaviors (eg, HIV and STI testing history, substance use, communication with partners regarding status) and sociocultural context (eg, homelessness, incarceration). Study assessments will occur at enrollment and at 1, 3, 6, 9, and 12 months postenrollment. RESULTS: Get Connected research activities began in September 2016 and are ongoing. To date, institutional review board (IRB) submission is complete and IRB authorization agreements are pending at several other universities. CONCLUSIONS: The deployment of Get Connected through a mobile-optimized Web app seeks to optimize the intervention's acceptability, accessibility, availability, and long-term affordability among YMSM. TRIAL REGISTRATION: ClinicalTrials.gov (NCT03132415); https://clinicaltrials.gov/ct2/show/NCT03132415 (Archived by WebCite at http://www.webcitation.org/70j4gSFbZ). REGISTERED REPORT IDENTIFIER: RR1-10.2196/10444.

Addressing engagement in technology-based behavioural HIV interventions through paradata metrics.

PURPOSE OF REVIEW: The goal of this review was to examine how often researchers report participants' online engagement using paradata (i.e. intervention usage metrics) when describing the outcomes of online behavioural HIV prevention and care interventions. We also highlight the utility of paradata collection and analysis in future technology-based trials. RECENT FINDINGS: We focused on studies indexed on PubMed and published between 1 January 2016 and 31 March 2017 that reported the development and testing of online behavioural interventions for HIV prevention and/or care. Of the 705 extracted citations, six met study criteria. SUMMARY: Only one study reported paradata reflecting participants' engagement with a technology-based intervention. Researchers should systematically collect and analyse paradata to strengthen the evidence base for technology-based interventions (do they work?), advance the use of behaviour change theory across modalities and platforms (how/why do they work?) and inform reach and scale-up efforts (for whom do they work?). Researchers may also rely on paradata to examine dose-response relationships due to user engagement, to identify replicable core components linked to behaviour change outcomes, to allocate resources judiciously and drive down development costs, and to pool these metrics for use in future meta-analyses.