Deanna Kerrigan

We developed a pre-exposure prophylaxis (PrEP) shared decision-making tool to support people who could benefit from PrEP in reaching their prevention goals and preferences when considering two effective PrEP modalities, oral or long-acting injectable (LAI) PrEP, in partnership with their healthcare providers (HCPs). This 2-phase study included formative research to develop a PrEP shared decision-making tool prototype followed by a pilot study to determine prototype acceptability. For the formative phase, we conducted semi-structured qualitative in-depth interviews with a diverse sample of people who could benefit from PrEP (n = 41) and HCPs (n = 20) in two community-based sites in Washington, DC, prior to and shortly after LAI PrEP became available in December 2021. Insights from in-depth interviews informed development of a PrEP shared decision-making tool prototype in both English and Spanish. This prototype was piloted in one-on-one mock clinical encounters with 37 people who could benefit from PrEP and 11 HCPs, in the two DC sites and at a university-affiliated clinic in Chapel Hill, North Carolina. After these encounters, people who could benefit from PrEP and HCPs were interviewed independently about acceptability of the prototype’s language, visuals, content and flow as well as the usability, utility, and feasibility of the prototype to support informed shared decision-making. In the formative phase, people who could benefit from PrEP had low awareness of and high interest in LAI PrEP. They and HCPs agreed that side effects and efficacy should be a primary focus of a PrEP shared decision-making tool. Participants in the mock clinical encounters found that the prototype filled information gaps, supported shared decision-making regardless of an individual’s experience with PrEP, and systematized, streamlined and normalized conversations around PrEP choice. Testing the effectiveness of the prototype in a larger-scale evaluation is highly warranted as the field seeks to address ongoing inequities in PrEP uptake.

Background: HIV outcomes in people with HIV (PWH) are suboptimal and inequitably distributed in the United States. Long-acting injectable antiretroviral therapy (LAI-ART) has potential to make important contributions to improving HIV outcomes and quality of life for PWH. Methods: The SELIGO Study used a 1-time, 20-minute survey of 801 PWH from the Center for AIDS Research Network of Integrated Clinical Systems cohort in 3 US cities (Boston, MA; Chapel Hill, NC; San Diego, CA) that included 54 items. Using multinomial and binary logistic regression, we assessed factors associated with LAI-ART versus daily oral ART preferences. Results: Most participants were cisgender men (82.3%); 57.0% identified as racial and/or ethnic minorities; mean years of age, 52.2; mean years living with HIV, 18.1; 2.8% were using LAI-ART. Compared with daily oral ART, 56.9% preferred LAI-ART administered monthly, and 68.0% preferred LAI-ART administered every 2 months. Factors associated with greater odds of LAI-ART preference included medication/contraception injection experience, pill burden, no medication other than ART, 4 or more clinic visits per year, detectable viral load, reporting a higher number of HIV treatment considerations, and identifying as Black. Factors associated with decreased odds of LAI-ART preference included older age, identifying as neither gay nor straight, living > 1 hour from the clinic, and considerable/extreme needle fear. Conclusions: Findings demonstrate that although there is considerable interest in LAI-ART, HIV treatment modality preferences are multifaceted. Shared decision making can ensure that conversations about ART options consistently address specific factors across diverse groups to facilitate equitable LAI-ART uptake.

Introduction: Diagnosing and treating tuberculosis (TB) infection are critical to reducing TB mortality among people with HIV (PLHIV). Blood-based screening using QuantiFERON-TB Gold Plus (QFT+) and shorter-course TB preventive therapy (TPT) regimens such as 3-month weekly isoniazid and rifapentine (3HP) hold promise to improve TB outcomes. Methods: We conducted 38 qualitative interviews to explore implementation challenges and solutions related to QFT+ use and TPT uptake among PLHIV participating in the PREVINE-TB study in Brazil and utilized thematic analysis. Results: Clinic and provider implementation innovations and examples of positive deviance helped explain quantitative differences in QFT+ use and TPT uptake between cities including predetermination of eligible patients for QFT+ screening based on nurse review of electronic medical records, specialized TB clinics, the use of TPT Champions, and digital communication. Conclusions: Clinic and provider innovations can support QFT+ use and TPT uptake to improve TB outcomes, including in the context of health systems challenges.

Objectives: The purpose of this study was to determine the prevalence of type 2 diabetes, hypertension, and mental health conditions among female sex workers with HIV in Santo Domingo, Dominican Republic. Methods: We conducted a cross-sectional survey, blood draw, and medical exam with women (n = 200) recruited by peer navigators. We determined prevalence and used multivariable logistic regression to assess the relationship between conditions. Results: Mean participant age was 46.1 years (SD: 9.15). Most participants (89.0%) were virally suppressed. Diabetes prevalence was 7.0% and hypertension was 63.0%. Nearly half reported moderate-to-severe depressive symptoms (46.0%) and over half (65.8%) anxiety. Women with moderate-to-severe depressive symptoms were over 4 times more likely to be virally unsuppressed (adjusted odds ratio [aOR]=4.17 [95% CI: 1.37-12.68]) and over 3 times more likely to have diabetes (aOR=3.45 [95% CI: 1.00-11.91]). Conclusion: Findings indicate the need for holistic, integrated healthcare models to address multiple health conditions and support overall wellbeing.

Background: Cisgender women account for 23% of new HIV diagnoses in the United States, but there are significant socio-structural barriers to engagement and retention in the preexposure prophylaxis (PrEP) cascade, particularly for women of color. Objective: In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we developed and piloted a clinic-based, socio-structural intervention to measure (1) the feasibility of delivering the adapted intervention and (2) clinic team and patient perspectives on the intervention, in preparation for a future trial on engagement and retention in the PrEP cascade among women. Methods: We previously applied the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing) model to develop a culturally appropriate, evidence-based intervention, responsive to Black women’s HIV prevention needs. In the present study, we set out to complete the Training and Testing phases: namely, to hire and train a PrEP navigator and to train clinic staff to deliver the adapted intervention. We completed a 4-month pilot to assess the feasibility of delivering the intervention and collecting outcomes of interest and initial outcome trends (compared to baseline). We further assessed the clinic team and patient perspectives on the intervention to understand the potential for future scale and delivery. Results: The clinic team participants found the adapted Women’s PrEP project (W-PrEP) intervention both highly feasible and relevant to patients, with minimal impact on clinic flow. Patient participants reported that the W-PrEP intervention was highly relevant and appreciated the education and counseling from the PrEP navigator—many learning about PrEP for the first time from the navigator and health care provider. The outcome measures were both feasible to collect and appropriate to capture the primary outcomes of interest. Finally, the W-PrEP intervention increased the proportion of patients counseled about PrEP from 65% to 76% of patients seen ( P <.001). Conclusions: The intervention and outcome data collection was feasible, and open-ended clinic team and patient perspectives showed positive feedback about the intervention and relevance. The associated increase in PrEP counseling is promising but necessitates further evaluation of the effects of the W-PrEP intervention on the PrEP cascade (eg, initiation, persistence, adherence) in a larger randomized trial.

BACKGROUND Cisgender women account for 23% of new HIV diagnoses in the United States (US), but there are significant socio-structural barriers to engagement and retention in the PrEP cascade, particularly for women of color. In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we developed and piloted a clinic-level, socio-structural intervention to measure the preliminary outomes and the feasibility and acceptability of the the adapted intervention, in preparation for a future trial on engagement and retention in the PrEP cascade among women. OBJECTIVE To evaluate the adoption, reach, preliminary effectiveness, and implementation of the W-PrEP intervention, as well as the study instrumentation. METHODS We previously applied the Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, Testing (ADAPT-ITT) model to develop a culturally-appropriate, evidence-based intervention, responsive to Black women’s HIV prevention needs. In the present study we set out to complete Training and Testing: namely to hire and train a PrEP navigator and to train clinic staff to deliver the adapted intervention. We completed a four-month pilot to assess the acceptability and feasibility of the intervention to the clinic-team and patients, the feasibility of collecting the outcome measures, and initial outcome trends (compared to baseline). RESULTS The intervention training was attended by 100% of the clinic team, with significant improvement in knowledge of HIV prevention and PrEP; combined knowledge test scores improved from a mean of 65% to 89% between the pre- and post-test. The clinic team participants found the adapted W-PrEP intervention both highly feasible and acceptable, with minimal impact on clinic flow. Patient participants reported that the W-PrEP intervention was highly acceptable and appreciated the education and counseling from the PrEP navigator—many learning about PrEP for the first time from the navigator and/or health care provider. The outcome measures were both feasible to collect and appropriate to capture the primary outcomes of interest. Lastly, the W-PrEP intervention increased the proportion of patients counseled about PrEP from 65% to 76% of patients seen (p<0.001). CONCLUSIONS The intervention was both acceptable and feasible to the clinic team and intended patient population. The associated increase in PrEP counseling is promising, but necessitates further evaluation of the effects of the W-PrEP intervention on the PrEP cascade (e.g., initiation, persistence, adherence) in a larger randomized trial. CLINICALTRIAL N/A

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: Cisgender women (subsequently referred to as women) account for 23% of new HIV diagnoses in the United States (US), but there are significant socio-structural barriers to engagement and retention in the PrEP cascade, particularly for women of color. Objective: In response to the lack of evidence-based interventions to improve PrEP initiation, adherence, and persistence among women in the United States, we set out to develop a clinic-based, socio-structural intervention focused on engagement and retention in the PrEP cascade among women. Methods: We utilized the ADAPT-ITT (Assessment, Decision, Adaptation, Production, Topical Experts, Integration, Training, Testing) model to create a culturally-appropriate, evidence-based intervention responsive to Black women’s HIV prevention needs. In this manuscript we focus on the first six steps of iterative adaptation in preparation for pilot testing. We conducted semi-structured interviews and focus group discussions with key populations to inform and guide intervention development and employed Theater Testing to evaluate the mock-up of the prototype. We conducted rapid qualitative analysis (RQA) to identify key themes around delivering PrEP to the intended population, and engaged subject matter experts to refine the prototype. Results: Assessment: We conducted n=10 in-depth interviews with key informants from community-based and HIV-prevention organizations, and led n=7 focus group discussions (participant n range 4 to 8) to guide intervention development among medical providers (n=2 groups), PrEP navigators and educators (n=1 group), and female patients (n=4 groups). Key themes included population specific barriers to PrEP utilization, namely accessibility/availability, perceived risk, and stigma. Additionally, participants advised on model adaptation specific to PrEP navigation, clinic-level training and social support. Decision: We selected two evidence based-interventions from the Centers for Disease Control Compendium of Best Practices in HIV Prevention. Adaptation: We adapted and theater tested a preliminary intervention for feedback. Production: Using feedback from theater testing, we created a prototype of “the Women’s PrEP Project (W-PrEP)” designed to address patient-, provider-, and clinic-level barriers to provision of PrEP for women though a clinic-wide intervention delivering education, resources, and support (including PrEP navigation). Topical Experts & Integration: We collected iterative feedback from our advisory board and subject matter experts and integrated feedback into the final prototype. Conclusions: The adaptation of the W-PrEP program integrated key elements of the local context for cisgender women with potential exposure to HIV, as well as medical providers, clinic-staff, and PrEP navigators. Next steps include training clinic staff in a real-world setting to pilot test the acceptability, feasibility, and preliminary effectiveness of the intervention. Clinical Trial: N/A

BACKGROUND Cisgender women (subsequently referred to as women) account for 23% of new HIV diagnoses in the United States. There are significant sociostructural barriers to engagement and retention in the pre-exposure prophylaxis (PrEP) cascade, particularly for Black women. OBJECTIVE In response to the lack of evidence-based interventions (EBIs) to improve PrEP initiation, adherence, and persistence among women in the United States, we developed a clinic-based, sociostructural intervention focused on engagement and retention in the PrEP cascade for women. METHODS We used the Assessment, Decision, Adaptation, Production, Topical experts, Integration, Training, and Testing (ADAPT-ITT) model to adapt two Centers for Disease Control and Prevention (CDC) best practices in HIV prevention: HIV PrEP Services for Urban Women and Project Shikamana to create a culturally appropriate EBI responsive to Black women’s HIV prevention needs. In this paper, we focus on the first 6 steps of iterative adaptation in preparation for pilot testing. We conducted semistructured interviews and focus group discussions with key populations to inform and guide intervention development and used theater testing to evaluate the mock-up of the prototype. We conducted rapid qualitative analysis to identify key themes related to delivering PrEP to the intended population and engaged subject matter experts to refine the prototype. RESULTS For the Assessment phase, we conducted 10 in-depth interviews with key informants from community-based and HIV-prevention organizations and led 7 focus group discussions (n=4-8) to guide intervention development among health care providers (n=2 groups), PrEP navigators and educators (n=1 group), and female patients (n=4 groups). Key themes included population-specific barriers to PrEP use, namely accessibility and availability, perceived risk, and stigma. In addition, participants advised on model adaptation specific to PrEP navigation, clinic-level training, and social support. For the Decision phase, we selected 2 EBIs from the CDC HIV Compendium of Best Practices. For the Adaptation phase, we adapted and theater tested a preliminary intervention for feedback. For the Production phase, using feedback from theater testing, we created a prototype of the Women’s PrEP Project (W-PrEP) designed to address patient-, provider-, and clinic-level barriers to the provision of PrEP for women through a clinic-wide intervention delivering education, resources, and support (including PrEP navigation). For the Topical experts and Integration phases, we collected iterative feedback from our advisory board and subject matter experts and integrated feedback into the final prototype. CONCLUSIONS The adaptation of the W-PrEP integrated key elements of the local context for women with potential exposure to HIV, as well as health care providers, clinic staff, and PrEP navigators. Next steps include training clinic staff in a real-world setting to pilot-test the acceptability, feasibility, and preliminary effectiveness of the intervention.

Intersecting forms of stigma including both HIV and sex work stigma have been known to impede HIV prevention and optimal treatment outcomes among FSW. Recent research has indicated that intersectional stigma can be resisted at the community and individual level. We assessed pathways between HIV stigma, sex work stigma, social cohesion and viral suppression among a cohort of 210 FSW living with HIV in the Dominican Republic. Through Poisson regression we explored the relationship between HIV outcomes and internalized, anticipated and enacted HIV and sex work stigma, and resisted sex work stigma. We employed structural equation modeling to explore the direct effect of various forms of stigma on HIV outcomes, and the mediating effects of multi-level stigma resistance including social cohesion at the community level and occupational dignity at the individual level. 76.2% of FSW were virally suppressed and 28.1% had stopped ART at least once in the last 6 months. ART interruption had a significant negative direct effect on viral suppression (OR = 0.26, p < 0.001, 95% CI: 0.13–0.51). Social cohesion had a significant positive direct effect on viral suppression (OR = 2.07, p = 0.046, 95% CI: 1.01–4.25). Anticipated HIV stigma had a significant negative effect on viral suppression (OR = 0.34, p = 0.055, 95% CI: 0.11–1.02). This effect was mediated by the interaction between cohesion and dignity which rendered the impact of HIV stigma on viral suppression not significant. Findings demonstrate that while HIV stigma has a negative impact on viral suppression among FSW, it can be resisted through individual and collective means. Results reinforce the importance of community-driven, multi-level interventions.