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.

Use of technology for delivery of mental health and substance use services to youth living with HIV: a mixed-methods perspective.

Disparities in HIV treatment outcomes among youth living with HIV (YLWH) present a challenge for ending the HIV epidemic. Antiretroviral therapy (ART) adherence can be impacted by comorbidities such as mental health and substance use. Technology use has shown promise in increasing access to mental health and substance use services. Using a mixed-methods approach, we conducted formative research to describe the relationship between mental health, substance use, and medication adherence in 18-29 year-old YLWH, and explored technology use as an approach to supporting these services. Among 101 YLWH, ART adherence was significantly negatively associated with mental health measures such as depression, trauma, and adverse childhood experiences and marijuana and stimulants use. Depression had the highest level of relative importance in its association with ART adherence. During in-depth interviews with 29 participants, barriers to and facilitators of accessing and maintaining mental health services were identified. Most participants favored technology use for mental health and substance use service delivery, including videoconferencing with a counselor. Provision of ongoing mental health and substance use treatment is an important mechanism to achieving HIV treatment engagement. Technology, particularly videoconferencing, may have the capacity to overcome many barriers to care by increasing accessibility of these services.

Feasibility and acceptability of novel methods to estimate antiretroviral adherence: A longitudinal study.

Due to marked reductions in morbidity and mortality, antiretroviral (ARV) adherence monitoring is of high interest. Researchers and clinicians often resort to the most feasible and cost-effective adherence methods possible, which may result in biased or inaccurate estimates and require the physical presence of a participant at a research or clinic site. The objective of our study was to evaluate the feasibility and acceptability of three objective, innovative, and remote methods to estimate ARV adherence which may be conducted with less time and financial resources in a wide range of clinic and research settings. These three methods included: (a) text-messaged photographs of pharmacy refill dates to measure refill-based adherence, (b) text-messaged photographs of ARV medications to estimate pill-count-based adherence, and (c) home-collected hair samples for the measurement of ARV concentration to determine pharmacologic-based adherence. We conducted a pilot study from March through October 2017 to examine the feasibility and acceptability of these three adherence measures and the remotely conducted study procedures in 93 adults living with HIV nationwide. From our diverse national sample of participants, 95.7% were retained until the end of the study, 89.9% sent all text messages, and 84.3% sent all hair samples. Approximately 74.2% of participants reported excellent overall experience with the study, 60.2% were very or extremely satisfied with participating in a hair collection study, and 76.3% noted extremely high likelihood of participating in a similar study including text messaging pictures of medications or refill dates. We noted high levels of feasibility and acceptability with the remote study methodology, collection of photographed and text messaged pharmacy refill dates and pill counts, and home-collected hair samples. Here we describe the feasibility and acceptability metrics, results from the exit qualitative interviews with the participants, and lessons learned. These adherence measures represent innovative approaches to expand monitoring tools for HIV treatment and prevention adherence in future research.

Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol.

INTRODUCTION: Youth and young adults living with HIV (YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy. This study in the San Francisco Bay area aims to evaluate the feasibility, acceptability and preliminary clinical outcomes of a 12-session telehealth counselling series provided to 80 YLWH, including education, motivational enhancement and problem-solving around HIV care, mental health, substance use and other challenges. Findings will provide information about benefits and challenges of telehealth counselling for YLWH and will guide the development of new technology-based strategies for care. METHODS AND ANALYSIS: The Youth to Telehealth and Text to Improve Engagement in Care study is a pilot randomised, crossover trial examining the feasibility and acceptability of a telehealth counselling intervention consisting of twelve 20-30 min weekly sessions focused on identifying and problem-solving around barriers to HIV care access and adherence and on addressing mental health, substance use and/or other issues. Participants also receive text messages for check-ins, appointment reminders and to improve engagement. Participants complete quantitative online surveys at baseline, 4 and 8 months and qualitative exit interviews. Clinical outcomes, including plasma HIV RNA and CD4+ cell count, are collected from medical records. Study staff will explore outcomes of the intervention using quantitative and qualitative methods. ETHICS AND DISSEMINATION: This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the community, participants and the academic community. TRIAL REGISTRATION: NCT03681145.

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

BACKGROUND: There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. METHODS: The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. DISCUSSION: Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation.