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.

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.

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.

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.

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.