Identifying Key Factors to PrEP Initiation and Persistence Among YMSM Through Focus Groups and Surveys in Two High-Priority Settings.

Cisgender men are diagnosed with HIV at a rate four times greater than cisgender women, with 71% of infections attributed to male-male sexual contact. Despite expanding accessibility, pre-exposure prophylaxis (PrEP) for HIV prevention is initiated by only 30% of people with PrEP indications. Five focus groups with 42 young men who have sex with men from New York and Alabama were conducted to identify key factors to PrEP initiation and persistence. Thirty focus group participants completed a survey on demographics, PrEP choices and health care attitudes. Findings suggest provider competency significantly influences PrEP use due to stigmatization in medical settings. Participants noted benefits of PrEP including HIV protection and sexual empowerment, yet barriers like cost and side effects were prevalent. Our findings outline barriers and facilitators to PrEP use among young men who have sex with men in two high priority settings that will inform PrEP care updates in participating clinics.

Preexposure Prophylaxis Uptake Among Spanish-Speaking Transgender Women: A Randomized Controlled Trial in North and South Carolina, 2019-2022.

Objectives. To evaluate Chicas Creando Acceso a la Salud (Girls Creating Access to Health; ChiCAS), a Spanish-language, small-group intervention designed to increase preexposure prophylaxis (PrEP) use, consistent condom use, and medically supervised gender-affirming hormone therapy use among Spanish-speaking transgender Latinas who have sex with men. Methods. Participants were 144 HIV-negative Spanish-speaking transgender Latinas, aged 18 to 59 years, living in North and South Carolina. From July 2019 to July 2021, we screened, recruited, and randomized them to the 2-session ChiCAS intervention or the delayed-intervention waitlist control. Participants completed assessments at baseline and 6-month follow-up. Follow-up retention was 94.4%. Results. At follow-up, relative to control participants, ChiCAS participants reported increased PrEP use (adjusted odds ratio [AOR] = 4.64; 95% confidence interval [CI] = 1.57, 13.7; P < .006). However, ChiCAS participants did not report increased use of condoms or medically supervised gender-affirming hormone therapy. ChiCAS participants reported increases in knowledge of HIV (P < .001), sexually transmitted infections (P < .001), and gender-affirming hormone therapy (P = .01); PrEP awareness (P < .001), knowledge (P < .001), and readiness (P < .001); condom use skills (P < .001); and community attachment (P < .001). Conclusions. The ChiCAS intervention was efficacious in increasing PrEP use among Spanish-speaking, transgender Latinas in this trial. (Am J Public Health. 2024;114(1):68-78. https://doi.org/10.2105/AJPH.2023.307444).

Cost Analysis of the Positive Health Check Intervention to Suppress HIV Viral Load and Retain Patients in HIV Clinical Care.

CONTEXT: Digital video-based behavioral interventions are effective tools for improving HIV care and treatment outcomes. OBJECTIVE: To assess the costs of the Positive Health Check (PHC) intervention delivered in HIV primary care settings. DESIGN, SETTING, AND INTERVENTION: The PHC study was a randomized trial evaluating the effectiveness of a highly tailored, interactive video-counseling intervention delivered in 4 HIV care clinics in the United States in improving viral suppression and retention in care. Eligible patients were randomized to either the PHC intervention or the control arm. Control arm participants received standard of care (SOC), and intervention arm participants received SOC plus PHC. The intervention was delivered on computer tablets in the clinic waiting rooms. The PHC intervention improved viral suppression among male participants. A microcosting approach was used to assess the program costs, including labor hours, materials and supplies, equipment, and office overhead. PARTICIPANTS: Persons with HIV infection, receiving care in participating clinics. MAIN OUTCOME MEASURES: The primary outcome was the number of patients virally suppressed, defined as having fewer than 200 copies/mL by the end of their 12-month follow-up. RESULTS: A total of 397 (range across sites [range], 95-102) participants were enrolled in the PHC intervention arm, of whom 368 participants (range, 82-98) had viral load data at baseline and were included in the viral load analyses. Of those, 210 (range, 41-63) patients were virally suppressed at the end of their 12-month follow-up visit. The overall annual program cost was $402 274 (range, $65 581-$124 629). We estimated the average program cost per patient at $1013 (range, $649-$1259) and the cost per patient virally suppressed at $1916 (range, $1041-$3040). Recruitment and outreach costs accounted for 30% of PHC program costs. CONCLUSIONS: The costs of this interactive video-counseling intervention are comparable with other retention in care or reengagement interventions.

Positive Health Check intervention tool usage during a feasibility pilot in HIV primary care clinics.

Positive Health Check (PHC), an interactive, web-based intervention, provides tailored behavioral health messages to support people with HIV in their HIV care. Users interact with a virtual doctor and based on responses to tailoring questions, PHC delivers relevant content modules addressing treatment initiation, medication adherence, retention in care, sexual risk reduction, mother-to-child transmission, and injection drug use. During a one-month feasibility pilot of PHC, patients in four HIV primary care clinics were invited to use PHC and tool usage metrics were collected and assessed. Descriptive analyses were conducted to characterize how the tool was used based on behavioral risk scenarios presented.Ninety-seven patients accessed PHC as part of the pilot, with 68 (70.1%) completing the intervention on average in 15 min. Out of 85 patients who viewed behavioral tips and commitments, 66 (77.7%) selected at least one tip to practice and 41 (48.2%) made at least one commitment to ask their provider a question. Patients spent the most time with adherence and sexual risk reduction content. The high level of tool engagement suggests that PHC was acceptable to patients regardless of length of time since diagnosis. PHC can be completed within a single visit and is a promising tool for PWH.

Expanding PrEP Services for Men Who Have Sex With Men and Transgender Persons Through Health Department Programs: Key Processes and Outcomes From Project PrIDE, 2015-2019.

OBJECTIVE: Pre-exposure prophylaxis (PrEP) Implementation, Data to Care, and Evaluation (PrIDE) was a demonstration project implemented by 12 state and local health departments during 2015-2019 to expand PrEP services for men who have sex with men (MSM) and transgender persons at risk for HIV infection. We describe findings from the cross-jurisdictional evaluation of the project. METHODS: We analyzed work plans, annual progress reports, and aggregate quantitative program data submitted by funded health departments (n = 12) to identify key activities implemented and summarize key project outcomes. RESULTS: PrIDE jurisdictions implemented multiple health equity-focused activities to expand PrEP services to priority populations, including building program capacity, conducting knowledge and awareness campaigns, providing PrEP support services, and addressing barriers to PrEP use. Overall, PrIDE jurisdictions identified 44 813 persons with PrEP indications. Of these, 74.8% (n = 33 500) were referred and 33.1% (n = 14 821) were linked to PrEP providers, and 25.3% (n = 11 356) were prescribed PrEP. Most persons prescribed PrEP were MSM or transgender persons (87.9%) and persons from racial and ethnic minority groups (65.6%). However, among persons with PrEP indications, non-Hispanic Black/African American persons (14.9% of 18 782) were less likely than non-Hispanic White persons (31.0% of 11 633) to be prescribed PrEP (z = -33.57; P < .001). CONCLUSIONS: PrIDE jurisdictions successfully expanded PrEP services for MSM, transgender persons, and racial and ethnic minority groups by implementing health equity-focused activities that addressed barriers to PrEP services. However, PrEP prescription was generally low, with significant disparities by demographic characteristics. Additional targeted interventions are needed to expand PrEP services, achieve equity in PrEP use, and contribute to ending the HIV epidemic in the United States.

Expanding Data to Care Programs to Improve HIV Care Continuum Among Men Who Have Sex With Men and Transgender Persons: Key Processes and Outcomes From Project PrIDE, 2015-2019.

OBJECTIVES: During 2015-2019, five local and state health department jurisdictions implemented Data to Care (D2C) programs supported by Project PrIDE (Pre-exposure prophylaxis, Implementation, Data to Care, and Evaluation) to improve linkage or reengagement in HIV medical care among persons with HIV (PWH) who had gaps in care, particularly among men who have sex with men (MSM) and transgender persons. We describe findings from the cross-jurisdiction evaluation of the project. METHODS: We conducted a qualitative analysis of the final progress reports submitted by PrIDE jurisdictions to the Centers for Disease Control and Prevention to identify key D2C activities implemented and challenges encountered. We also conducted descriptive analysis on aggregate quantitative data to summarize key D2C program outcomes. RESULTS: PrIDE jurisdictions implemented multiple activities to build their D2C capacity, identify PWH who were not in care or virally suppressed, provide linkage/reengagement services, and monitor outcomes. Overall, 11 463 PWH were selected for follow-up, 45% of whom were MSM or transgender persons. Investigations were completed for 8935 (77.9%) PWH. Only 2323 (26.0%) PWH were confirmed not in care or virally suppressed; 1194 (51.4%) were subsequently linked/reengaged in care; among those, 679 (56.9%) were virally suppressed at last test. PrIDE jurisdictions identified data-related (eg, incomplete or delayed laboratory results), program capacity (eg, insufficient staff), and social and structural (eg, unstable housing) challenges that affected their D2C implementation. CONCLUSIONS: PrIDE jurisdictions successfully enhanced their D2C capacity, reached priority populations who were not in care or virally suppressed, and improved their engagement in care and health outcomes. Data-related and non-data-related challenges limited the efficiency of D2C programs. Findings can help inform other D2C programs and contribute to national HIV prevention goals.

Adapting a Group-Level PrEP Promotion Intervention Trial for Transgender Latinas During the COVID-19 Pandemic.

The COVID-19 pandemic has profoundly affected the conduct of community-based and community-engaged research. Prior to the pandemic, our community-based participatory research partnership was testing ChiCAS, an in-person, group-level behavioral intervention designed to promote uptake of pre-exposure prophylaxis (PrEP), condom use, and medically supervised gender-affirming hormone therapy among Spanish-speaking transgender Latinas. However, the pandemic required adaptations to ensure the safe conduct of the ChiCAS intervention trial. In this article, we describe adaptations to the trial within five domains. Transgender women are disproportionately affected by HIV, and it is essential to find ways to continue research designed to support their health within the context of the COVID-19 pandemic and future infectious disease outbreaks, epidemics, and pandemics. These adaptations offer guidance for ongoing and future community-based and community-engaged research during the COVID-19 pandemic and/or potential subsequent outbreaks (e.g., monkeypox), epidemics, and pandemics, particularly within under-served marginalized and minoritized communities.

Evaluating Locally Developed Interventions to Promote PrEP Among Racially/Ethnically Diverse Transgender Women in the United States: A Unique CDC Initiative.

In the United States, transgender women are disproportionately affected by HIV. However, few evidence-based prevention interventions exist for this key population. We describe two promising, locally developed interventions that are currently being implemented and evaluated through the Centers for Disease Control and Prevention Combination HIV Prevention for Transgender Women Project: (a) ChiCAS, designed to promote the uptake of pre-exposure prophylaxis (PrEP), condom use, and medically supervised hormone therapy among Spanish-speaking transgender Latinas, and (b) TransLife Care, designed to address the structural drivers of HIV risk through access to housing, employment, legal services, and medical services, including HIV preventive care (e.g., PrEP use) among racially/ethnically diverse urban transgender women. If the evaluation trials determine that these interventions are effective, they will be among the first such interventions for use with transgender women incorporating PrEP, thereby contributing to the evidence-based resources that may be used to reduce HIV risk among this population.

Challenges of and Solutions for Developing Tailored Video Interventions That Integrate Multiple Digital Assets to Promote Engagement and Improve Health Outcomes: Tutorial.

BACKGROUND: Video is a versatile and popular medium for digital health interventions. As mobile device and app technology advances, it is likely that video-based interventions will become increasingly common. Although clinic waiting rooms are complex and busy environments, they offer the opportunity to facilitate engagement with video-based digital interventions as patients wait to see their providers. However, to increase efficiency in public health, leverage the scalability and low cost of implementing digital interventions, and keep up with rapidly advancing technology and user needs, more design and development guidance is needed for video-based tailored interventions. OBJECTIVE: We provide a tutorial for digital intervention researchers and developers to efficiently design and develop video-based tailored digital health interventions. We describe the challenges and solutions encountered with Positive Health Check (PHC), a hybrid app used to deliver a brief, interactive, individually tailored video-based HIV behavioral counseling intervention. PHC uses video clips and multimedia digital assets to deliver intervention content, including interactive tailored messages and graphics, a repurposed animated video, and patient and provider handouts generated in real time by PHC. METHODS: We chronicle multiple challenges and solutions for the following: (1) using video as a medium to enhance user engagement, (2) navigating the complexity of linking a database of video clips with other digital assets, and (3) identifying the main steps involved in building an app that will seamlessly deliver to users individually tailored messages, graphics, and handouts. RESULTS: We leveraged video to enhance user engagement by featuring "video doctors," full-screen video, storyboards, and streamlined scripts. We developed an approach to link the database of video clips with other digital assets through script coding and flow diagrams of algorithms to deliver a tailored user experience. We identified the steps to app development by using keyframes to design the integration of video and digital assets, using agile development methods to gather iterative feedback from multidisciplinary teams, and creating an intelligent data-driven back-end solution to tailor message delivery to individual users. CONCLUSIONS: Video-based digital health interventions will continue to play an important role in the future of HIV prevention and treatment, as well as other clinical health practices. However, facilitating the adoption of an HIV video intervention in HIV clinical settings is a work in progress. Our experience in designing and developing PHC presented unique challenges due to the extensive use of a large database of videos tailored individually to each user. Although PHC focuses on promoting the health and well-being of persons with HIV, the challenges and solutions presented in this tutorial are transferable to the design and development of video-based digital health interventions focused on other areas of health.

Positive Health Check evaluation: A type 1 hybrid design randomized trial to decrease HIV viral loads in patients seen in HIV primary care.

For people with HIV, important transmission prevention strategies include early initiation and adherence to antiretroviral therapy and retention in clinical care with the goal of reducing viral loads as quickly as possible. Consequently, at this point in the HIV epidemic, innovative and effective strategies are urgently needed to engage and retain people in health care to support medication adherence. To address this gap, the Positive Health Check Evaluation Trial uses a type 1 hybrid randomized trial design to test whether the use of a highly tailored video doctor intervention will reduce HIV viral load and retain people with HIV in health care. Eligible and consenting patients from four HIV primary care clinical sites are randomly assigned to receive either the Positive Health Check intervention in addition to the standard of care or the standard of care only. The primary aim is to determine the effectiveness of the intervention. A second aim is to understand the implementation potential of the intervention in clinic workflows, and a third aim is to assess the costs of intervention implementation. The trial findings will have important real-world applicability for understanding how digital interventions that take the form of video doctors can be used to decrease viral load and to support retention in care among diverse patients attending HIV primary care clinics.

Implementing Web-Based Interventions in HIV Primary Care Clinics: Pilot Implementation Evaluation of Positive Health Check.

BACKGROUND: Web-based interventions can help people living with HIV achieve better clinical outcomes and behaviors, but integrating them into clinical practice remains challenging. There is a gap in understanding the feasibility of implementing these interventions in HIV clinic settings from the clinicians' perspective. OBJECTIVE: The goal of the research was to determine whether Positive Health Check (PHC)-a Web-based, tailored video counseling tool focused on increasing patient adherence and retention in care and reducing HIV risk among HIV-positive patients-was acceptable, appropriate, and feasible for HIV primary care clinic staff to implement in clinic workflows. METHODS: A multiple-case study design was used to evaluate the pilot implementation. Four primary care clinics located in the southeastern United States implemented PHC over a 1-month period. Nine clinic staff across the clinics participated in structured interviews before, during, and after the implementation. In total, 54 interviews were conducted. We used a framework analysis approach to code the data and identify themes related to implementation outcomes, including acceptability, appropriateness, and feasibility. We also analyzed patient intervention use metrics (n=104) to quantify patient intervention completion rates (n=68). RESULTS: Overall, clinicians viewed PHC as acceptable and appropriate. Themes that emerged related to these implementation outcomes include the ability for PHC to increase provider-patient communication and its ability to engage patients due to the tailored and interactive design. While generally feasible to implement, challenges to the clinic workflow and physical environment were areas that clinics needed to manage to make PHC work in their clinics. CONCLUSIONS: Findings from this pilot implementation suggest that clinical staff viewed PHC as acceptable and appropriate, especially as more patients used the intervention over the pilot period. Feasibility of implementation was challenging in some cases, and lessons learned from this pilot implementation can provide information for larger scale tests of the intervention that include assessment of both implementation outcomes and clinical outcomes.

Lessons Learned From the Field-Testing of Healthy Love: An HIV Prevention Intervention for Black Women.

BACKGROUND: Healthy Love is a brief, highly interactive, single-session, group-level HIV prevention intervention designed for African American women that is effective at reducing sex risk behaviors and increasing condom use and HIV testing among participants. The Centers for Disease Control and Prevention, through a contract, developed a user-friendly intervention package that would allow organizations to adopt and implement Healthy Love with fidelity. METHOD: Training and implementation materials were developed to support original research protocols, and piloted and revised to conduct field-testing with case study agencies (CSAs). Three CSAs were selected to deliver the intervention over a 3-month period to test the utility of intervention materials and feasibility of implementation. RESULTS: All CSAs were able to successfully deliver 10 sessions with a total of 185 women ranging from 18 to 59 years of age. Successes and challenges encountered in training, preimplementation activities, and intervention delivery are described. DISCUSSION: Lessons learned from training, technical assistance, and process monitoring and evaluation informed final package revisions. Research to practice recommendations are shared as is guidance for future implementations of Healthy Love. The research to practice process used is a model approach for developing a comprehensive intervention package and will support the adoption of Healthy Love by other organizations.

Shifting Resources and Focus to Meet the Goals of the National HIV/AIDS Strategy: The Enhanced Comprehensive HIV Prevention Planning Project, 2010-2013.

In September 2010, CDC launched the Enhanced Comprehensive HIV Prevention Planning (ECHPP) project to shift HIV-related activities to meet goals of the 2010 National HIV/AIDS Strategy (NHAS). Twelve health departments in cities with high AIDS burden participated. These 12 grantees submitted plans detailing jurisdiction-level goals, strategies, and objectives for HIV prevention and care activities. We reviewed plans to identify themes in the planning process and initial implementation. Planning themes included data integration, broad engagement of partners, and resource allocation modeling. Implementation themes included organizational change, building partnerships, enhancing data use, developing protocols and policies, and providing training and technical assistance for new and expanded activities. Pilot programs also allowed grantees to assess the feasibility of large-scale implementation. These findings indicate that health departments in areas hardest hit by HIV are shifting their HIV prevention and care programs to increase local impact. Examples from ECHPP will be of interest to other health departments as they work toward meeting the NHAS goals.