Results From a Pilot Study of an Automated Directly Observed Therapy Intervention Using Artificial Intelligence With Conditional Economic Incentives Among Young Adults With HIV.

BACKGROUND: Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. SETTING: We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. METHODS: We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. RESULTS: Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. CONCLUSIONS: Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.

Estimating The Impact Of Out-Of-Pocket Cost Changes On Abandonment Of HIV Pre-Exposure Prophylaxis.

Oral HIV pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV. Several different developments in the US either threaten to increase or promise to decrease PrEP out-of-pocket costs and access in the coming years. In a sample of 58,529 people with a new insurer-approved PrEP prescription, we estimated risk-adjusted percentages of patients who abandoned (did not fill) their initial prescription across six out-of-pocket cost categories. We then simulated the percentage of patients who would abandon PrEP under hypothetical changes to out-of-pocket costs, ranging from $0 to more than $500. PrEP abandonment rates of 5.5 percent at $0 rose to 42.6 percent at more than $500; even a small increase from $0 to $10 doubled the rate of abandonment. Conversely, abandonment rates that were 48.0 percent with out-of-pocket costs of more than $500 dropped to 7.3 percent when those costs were cut to $0. HIV diagnoses were two to three times higher among patients who abandoned PrEP prescriptions than among those who filled them. These results imply that recent legal challenges to the provision of PrEP with no cost sharing could substantially increase PrEP abandonment and HIV rates, upending progress on the HIV/AIDS epidemic.

Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV.

BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.

Pharmacy Deserts and Pharmacies' Roles Post-Extreme Weather and Climate Events in the United States: A Scoping Review.

BACKGROUND: The effects of climate change are seen with a rise of extreme weather and climate events (EWCEs) which lead to the closures of many healthcare facilities, such as community pharmacies. Pharmacists in community pharmacies are seen as the most accessible healthcare professional to the public and are responsible for the continued delivery of care to patients. However, amid closures due to EWCEs and the emergence of pharmacy deserts, there is decreased access to pharmacies and a disruption of care. OBJECTIVE: It is important to address the preparedness and accessibility of pharmacies post-EWCEs to guide future research and policy. Additionally, to tackle health disparities that arise due to pharmacy deserts, the populations most affected by a decreased access to pharmacies should be identified. We conducted a scoping review to assess the preparedness and accessibility of pharmacies post-EWCEs and to identify populations most affected by pharmacy deserts. METHODS: We searched PubMed, Embase, and Web of Science from January 1, 2012 to September 30, 2022 and included all English-language, peer-reviewed primary literature that examined the preparedness and accessibility of community pharmacies in the United States post-EWCEs and addressed disparities within pharmacy deserts. Studies meeting these criteria were screened of their titles and abstracts by the first author and discrepancies were resolved with co-authors. We used Covidence for data extraction. RESULTS: A total of 472 studies were identified (196 duplicates removed) and after screening, 53 studies were assessed for eligibility. The results of included publications (N = 26) showed that pharmacists and pharmacies are not equipped with the necessary emergency protocols which could lead to decreased access of pharmacies in the wake of EWCEs. Pharmacy deserts disproportionately affect residents living in rural, lower income, and Black/African American and Hispanic/Latino neighborhoods. The lack of preparedness of pharmacies post-EWCEs could worsen medication access. CONCLUSION: This scoping review addresses challenges impacting pharmacies and patients post-EWCEs and within pharmacy deserts. In times of increased need, these challenges implicate the well-being of communities affected by EWCEs by breaking the continuum of care and access to medications. Here we offer suggestions for future research and directions for policy change.

Facilitators and barriers of 2-1-1 HIV pre-exposure prophylaxis.

An alternative strategy for men who have sex with men (MSM) experiencing challenges with daily HIV pre-exposure prophylaxis (PrEP) includes 2-1-1 dosing. Understanding 2-1-1 PrEP facilitators and barriers, especially during the SARS-CoV-2 pandemic, may guide researchers and healthcare providers in future studies and clinical preparedness. We conducted a national cross-sectional study of MSM in the US who had taken 2-1-1 PrEP to examine facilitators and barriers of this on-demand PrEP dosing option. With the shelter-in-place orders in March 2020, this study was adapted to include questions on how the SARS-CoV-2 pandemic affected participants' PrEP use. A total of 140 individuals participated in the survey, 106 of which completed questions pertaining to the SARS-CoV-2 pandemic. The most common reasons for switching from once-daily to 2-1-1 PrEP included having sex less frequently (63.6%) and wanting to take fewer pills (46.4%). Participants reported high medication adherence based on each component of 2-1-1 PrEP dosing (>84%). The most common barriers with 2-1-1 PrEP dosing included unplanned sexual encounters resulting in missing the double-dose pre-sex (43.6%) and trouble remembering doses post-sex (29.3%). Facilitators of the 2-1-1 PrEP dosing strategy included reductions in sexual encounters (63.6%), preference to take fewer pills (46.4%), need to reduce cost (22.1%), and desire to reduce side effects (19.3%). Challenges to receiving PrEP services during the pandemic included obtaining laboratory testing (25.5%) and PrEP refills (either receipt of a refill authorization from a healthcare provider or processing of a refill from the pharmacy) (18.9%). 2-1-1 PrEP is an effective HIV prevention method; therefore, understanding facilitators and barriers of this dosing strategy can result in continuous provision of HIV prevention efforts, particularly during a pandemic.

The LAIs Are Coming! Implementation Science Considerations for Long-Acting Injectable Antiretroviral Therapy in the United States: A Scoping Review.

Long-acting injectable antiretroviral therapy (LAI-ART) is one of the latest advancements in HIV control with the potential to overcome oral ART barriers to adherence. The objective of this article is to anticipate and examine implementation considerations for LAI-ART using components of the PRISM model, a Practical, Robust Implementation and Sustainability Model for integrating research findings into practice. We conducted a scoping review from January to August 2020 of the growing literature on LAI-ART implementation and other fields using LAI therapies. Key considerations regarding LAI-ART were parsed from the searches and entered into the PRISM implementation science framework. The PRISM framework posed multiple questions for consideration in the development of an optimal implementation strategy for LAI-ART in the United States. These questions revealed the necessity for more data, including acceptability of LAI-ART among many different subgroups of people living with HIV (PLWH), cost effectiveness, patient satisfaction, and patient-reported outcomes, as well as more detailed information related to the external environment for optimal LAI-ART implementation. Ethical considerations of LAI-ART will also need to be considered. The anticipation of, and excitement for, LAI-ART represent the hope for a new direction for HIV treatment that reduces adherence barriers and improves prognoses for PLWH. We have a unique window of opportunity to anticipate implementation considerations for LAI-ART, so this new therapy can be used to its fullest potential. Outstanding questions remain, however, that need to be addressed to help achieve HIV suppression goals in diverse populations.

Findings From a Probability-Based Survey of United States Households About Prevention Measures Based on Race, Ethnicity, and Age in Response to Severe Acute Respiratory Syndrome Coronavirus 2.

We investigated individual behaviors taken by white, African American, and Latino United States (US) households in response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and likelihood of using digital tools for symptom surveillance/reporting. We analyzed cross-sectional week 1 data (April 2020) of the coronavirus disease 2019 (COVID-19) Impact Survey in a large, nationally representative sample of US adults. In general, all groups engaged in the same prevention behaviors, but whites reported being more likely to use digital tools to report/act on symptoms and seek testing, compared with African Americans and Latinos. Individual behaviors may not explain COVID-19 case disparities, and digital tools for tracking should focus on uptake among race/ethnic minorities.

We are family: designing and developing a mobile health application for the San Francisco bay area House Ball and Gay Family communities.

BACKGROUND: The House Ball community (HBC) and its affiliated Gay Families (GFs) consist of predominantly African American and Latinx sexual, gender, and ethnic minorities (SGEM), who form chosen families often as a way to provide support, and in the case of the HBC, to constitute houses that then compete in performative categories in balls. Members of both communities are disproportionately impacted by HIV. Although public health professionals have engaged with the HBC and GFs to improve HIV testing and clinical care, most intervention activities have relied on in-person modes of outreach and delivery. Little research has been conducted with the members of the HBC and GFs to develop and produce culturally-informed mobile health (mHealth) applications that would enable them to increase HIV-related knowledge, connect to HIV-related resources, receive HIV health support, and to celebrate their unique identities and communities in a safe space. METHODS: We conducted 45 in-depth interviews with HBC and GF members who attended balls. Topics included HIV-related health needs, suggestions for mHealth components, current usage of apps and desirable features, and wishes around privacy and security. Following analysis of the interview data, we convened a series of four workshops with N=15 participants who were split into two groups. The purpose of the workshops was to co-design a digital tool to help provide information, reduce HIV-related stigma, and locate HIV resources for participants. Each group attended two workshops. Data were analyzed by a team of social scientists, community members, and mobile health experts. Findings were used to design an mHealth app related to HIV prevention and care. RESULTS: Participants requested an app that clearly reflected the community. The desired features of the app included accurate information and education on HIV transmission; links to resources such as HIV testing, lube and condoms, PrEP, and other health-related services; and the ability to rate and review local resources. In workshops, participants proposed several design elements and functions for the app. It had to be 'Mobile and Modern', 'Relatable, Raw, and "Reflective of Me"', 'Positive and Fun', feature community-generated content, and provide a safe space for users. Using these clear directives, the team designed an mHealth tool to be fielded as part of the larger "We Are Family" intervention that would provide HIV-specific information, resources, and support in a platform that was congruent with community norms and expectations. CONCLUSIONS: Designing and fielding an mHealth app as part of a larger HIV prevention intervention that reflects the social support and relationships within existing House Ball and Gay Family communities allows those youth most at risk for HIV-related health disparities to gain access to HIV testing, or link and re-engage young people to care.

Moving Antiretroviral Adherence Assessments to the Modern Era: Correlations Among Three Novel Measures of Adherence.

There is no gold standard for estimating antiretroviral therapy (ART) adherence. Feasible, acceptable, and objective measures that are cost- and time-effective are needed. US adults (N = 93) on ART for ≥ 3 months, having access to a mobile phone and internet, and willing to mail in self-collected hair samples, were recruited into a pilot study of remote adherence data collection methods. We examined the correlation of self-reported adherence and three objective remotely collected adherence measures: text-messaged photographs of pharmacy refill dates for pharmacy-refill-based adherence, text-messaged photographs of pills for pill-count-based adherence, and assays of home-collected hair samples for pharmacologic-based adherence. All measures were positively correlated. The strongest correlation was between pill-count- and pharmacy-refill-based adherence (r = 0.68; p < 0.001), and the weakest correlation was between self-reported adherence and hair drug concentrations (r = 0.14, p = 0.34). The three measures provide objective adherence data, are easy to collect, and are viable candidates for future HIV treatment and prevention research.

Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial.

BACKGROUND: In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services. METHODS/DESIGN: We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors. DISCUSSION: The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address. TRIAL REGISTRATION: NCT02417233, registered 12 December 2014.

Using online social media for recruitment of human immunodeficiency virus-positive participants: a cross-sectional survey.

BACKGROUND: There are many challenges in recruiting and engaging participants when conducting research, especially with HIV-positive individuals. Some of these challenges include geographical barriers, insufficient time and financial resources, and perceived HIV-related stigma. OBJECTIVE: This paper describes the methodology of a recruitment approach that capitalized on existing online social media venues and other Internet resources in an attempt to overcome some of these barriers to research recruitment and retention. METHODS: From May through August 2013, a campaign approach using a combination of online social media, non-financial incentives, and Web-based survey software was implemented to advertise, recruit, and retain participants, and collect data for a survey study with a limited budget. RESULTS: Approximately US $5,000 was spent with a research staff designated at 20% of full-time effort, yielding 2034 survey clicks, 1404 of which met the inclusion criteria and initiated the survey, for an average cost of US $3.56 per survey initiation. A total of 1221 individuals completed the survey, yielding 86.97% retention. CONCLUSIONS: These data indicate that online recruitment is a feasible and efficient tool that can be further enhanced by sophisticated online data collection software and the addition of non-financial incentives.

Correlates of antiretroviral adherence and viral load among transgender women living with HIV.

Transgender women are 49 times more likely to become HIV infected than other groups, yet they are drastically underserved by current treatment efforts and report lower rates of treatment adherence then other groups. The objective of this study was to explore correlates of antiretroviral (ART) adherence and viral load among HIV-positive transgender women on ART utilizing a cross-sectional survey of a convenience sample of 59 transgender women. In multivariate models of ART adherence, correlates were age, stress appraisal of transphobic experiences, importance of gender affirmation, and adherence to hormone therapy. In multivariate models of self-reported viral load, correlates were stress appraisal of transphobic experiences and being in a relationship. This study provides preliminary evidence of transgender-relevant correlates of ART adherence and viral load.

Immunologic benefits of enfuvirtide in patients enrolled in a drug assistance program.

BACKGROUND: Randomized clinical trials have demonstrated that enfuvirtide plus an optimized background regimen can cause a significant increase in CD4+ cell counts and a reduction in HIV RNA levels. OBJECTIVE: To describe and analyze CD4+ cell count and HIV RNA changes in HIV-infected patients receiving enfuvirtide and a prescribed background regimen (PBR) in a primarily clinical setting. METHODS: A retrospective review from September 1998 through August 2005 of CD4+ cell counts and HIV RNA changes from baseline was conducted in patients receiving enfuvirtide. Data were stratified and analyzed according to baseline CD4+ cell count and HIV RNA. RESULTS: A mean CD4+ cell count increase of approximately 102 cells/mm(3)was observed, regardless of baseline CD4+ cell count, in 187 patients receiving enfuvirtide during a mean of 19.4 months of follow-up. During 3 years of follow-up, patients initiating enfuvirtide at CD4+ cell counts less than 100 cells/mm(3)never achieved absolute CD4+ cell counts comparable to the counts in patients starting enfuvirtide at CD4+ cell counts of 100 cells/mm(3)or more. In 38.3% of patients achieving an undetectable HIV RNA level, a mean CD4+ cell count increase of 185 cells/mm(3)was observed. An unexpected finding was that a mean CD4+ cell count increase of 76 cells/mm(3)occurred in 61.7% of patients not achieving complete viral suppression. CONCLUSIONS: Immunologic benefits were observed in subjects continuing enfuvirtide plus a PBR irrespective of baseline CD4+ cell count, complete viral suppression, or antiretroviral susceptibility data. Data suggest that initiation of enfuvirtide at CD4+ cell counts greater than 100 cells/mm(3)may be immunologically advantageous and independent of complete virologic response.