Antiretroviral Therapy Adherence Interventions Research Articles

The development of social capital in a peer-led mHealth cognitive behavioral antiretroviral therapy adherence intervention for HIV + adolescents and young adults

ABSTRACT Adherence Connection for Counseling, Education, and Support (ACCESS)-I is a peer-led mHealth antiretroviral therapy adherence intervention for adolescents and young adults living with HIV who are in treatment but have detectable viral loads. Participants received five online sessions with peer health coaches who followed a structured intervention manual. Peers maintained intervention fidelity but also engaged in casual discussion that was not directly related to ART adherence or HIV. We conducted a qualitative analysis of the casual interactions that occurred during the ACCESS I intervention. Sessions were transcribed and coded, and these casual interactions were then coded into 10 subcodes to document their content, and also coded for three types of social capital – emotional, informational, and instrumental. Emotional and Informational social capital codes were the most common, while instrumental codes were rare. Activities was the most common topic overall, while encouragement was more common in emotional social capital narratives and personal experience was more common in informational social capital narratives. These casual interactions may strengthen peer-participant relationships, building social capital that could then be used to encourage positive behavior change. Although social capital was not directly measured, these analyses illustrate the value of attending to seemingly casual interactions in peer-led interventions.

HTA23 Cost-Effectiveness of Antiretroviral Therapy Adherence Interventions in People Living with HIV/AIDS: A Systematic Review of Decision Analytical Models

Although safe and effective antiretrovirals (ARVs) are readily available, non-adherence to ARVs is prevalent among people living with HIV/AIDS (PLWHA). Different adherence-improving interventions have been developed and examined through decision-analytic models. This systematic review aimed to review and appraise the decision analytical models developed to improve ARVs adherence in PLWHA.

Feasibility and Acceptability of the Adherence Connection Counseling, Education, and Support (ACCESS) Proof of Concept: A Peer-Led, Mobile Health (mHealth) Cognitive Behavioral Antiretroviral Therapy (ART) Adherence Intervention for HIV-Infected (HIV+) Adolescents and Young Adults (AYA).

Effective antiretroviral therapy (ART) adherence strategies for HIV+ adolescents and young adults (AYA) are needed to prevent HIV-related morbidity, mortality, and onward transmission. In the Adherence Connection for Counseling, Education, and Support (ACCESS) pilot, an exploratory sequential mixed-methods design was used to develop and test a peer-led, mobile health (mHealth) cognitive behavioral ART adherence intervention. HIV+ AYA (ages 16-29years) with unsuppressed plasma HIV RNA (HIV viral load) were eligible for this five-session intervention directed to improving ART adherence and HIV viral load. A total of 78 peer-led remote videoconferencing sessions (via WebEx) were delivered to 16 participants. High completion rates (97.5%) and client satisfaction scores (mean = 29.13 of 32; SD = 2.45) were observed. Self-reported ART adherence improved (32% increase in doses taken; 95th CI 11.2-53.3) with an annualized average rate of 47.5% (0.28 log10) reduction in HIV viral load. We established proof of concept for the ACCESS peer-led, mHealth cognitive behavioral ART adherence intervention, with promising adherence and virologic outcome data.

Characteristics of psychosocial interventions to improve ART adherence in people living with HIV: A systematic review.

The HIV/AIDS pandemic continues to be a significant global public health crisis. The main HIV/AIDS treatment is the antiretroviral therapy (ART), which is highly effective but depends on the patient's adherence to be successful. However, the adherence to antiretroviral therapy remains unsatisfactory across different populations, which raises considerable difficulties at both individual and collective levels. Suboptimal adherence to ART can be overcome through multidisciplinary management that includes evidence-based psychosocial interventions. Existing reviews on these interventions have focused mainly on studies with experimental designs, overlooking valuable interventions whose evidence comes from different study designs. Here, we aimed to carry out a comprehensive review of the current research on psychosocial interventions for ART adherence and their characteristics including studies with different designs. We conducted a systematic review following PRISMA guidelines. We searched five databases (Pubmed, EBSCO, LILACS, WoS and SCIELO) for articles reporting a psychosocial intervention to improve treatment adherence for people living with HIV (adults). The quality of each study was analyzed with standardized tools, and data were summarized using a narrative synthesis method. Twenty-three articles were identified for inclusion, and they demonstrated good to fair quality. Individual counseling was the most frequent intervention, followed by SMS reminders, education, and group support. Most interventions combined different strategies and self-efficacy was the most common underlying theoretical framework. This review provides insight into the main characteristics of current psychosocial interventions designed to improve ART treatment adherence. PROSPERO number: CRD42021252449.

Addressing Treatment Outcomes and Substance Use Among Formerly Incarcerated Individuals Living with HIV

Incarcerated individuals, who are overrepresented among those infected with HIV, experience multiple barriers to optimal antiretroviral therapy (ART) adherence after incarceration. Substance use is highly prevalent among legal system-involved individuals and is commonly associated with suboptimal medication adherence. This manuscript describes the development and pilot test results of two interventions designed to improve ART adherence among formerly incarcerated individuals living with HIV (PLWH). Thirty participants were randomized and completed a multi-session ART adherence and risk reduction intervention or a brief ART adherence intervention. Participants were interviewed at baseline, 1-month, and 3-month follow-up. While past 30-day ART adherence improved in both groups, participants in the brief intervention group took a higher proportion of their ART medication. Multi-session intervention group participants experienced greater reductions in substance use and problematic experiences associated with drug use. ART medication adherence interventions can potentially improve treatment outcomes among PLWH who experience incarceration.

Implementation of a Dyad-Based Intervention to Improve Antiretroviral Therapy Adherence Among HIV-Positive People Who Inject Drugs in Kazakhstan: A Randomized Trial.

HIV-positive people who inject drugs (PWID) in Kazakhstan face many challenges to antiretroviral therapy (ART) adherence. Interventions that leverage social support from an intimate partner, family member, or friend may be effective in improving ART adherence among this population. The purpose of this paper is to describe the implementation process of a dyad-based intervention among HIV-positive PWID and their treatment support partners. Sixty-six HIV-positive PWID and 66 of their treatment support partners will be enrolled in this pilot randomized controlled trial in Almaty, Kazakhstan, and randomized as dyads to receive an adapted version of the SMART Couples intervention or standard of care. Several implementation strategies were used to facilitate intervention delivery, including remote delivery, training of staff, supervision, technical assistance, quality assurance, and collection of assessments through diverse sources. This trial responds to a need for dyad-based ART adherence interventions adapted specifically for HIV-positive PWID.

Virtual voices: examining social support exchanged through participant-generated and unmoderated content in a mobile intervention to improve HIV antiretroviral therapy adherence among GBMSM

ABSTRACT Antiretroviral therapy (ART) adherence is suboptimal among gay, bisexual, and other men who have sex with men (GBMSM). Online interventions that incorporate social support represent new opportunities to improve adherence. This study focused on how social support was provided and sought within a technology-based ART adherence intervention. We coded and analyzed 1,751 messages. Within the social support messages, half of the time participants sought social support and half of the time they provided social support. Emotional and informational support were the most frequently exchanged forms. The most frequent topic that participants sought support around was interpersonal relationships (29%), followed by HIV care and treatment (28%). Similarly, 31% and 27% of messages in which participants provided support was related to HIV treatment and care and interpersonal relationships, respectively. HIV treatment and care issues most salient were ART adherence, lab results and upcoming tests, ART side effects, changes in ART regimens, and relationships with healthcare providers. Participants used the messaging feature in this intervention to spontaneously discuss and exchange support around HIV treatment and care. This analysis provided an opportunity to understand how participants informally interact with one another, how they seek and provide social support online, and their salient personal issues.

Increased Depression during COVID-19 Lockdown Associated with Food Insecurity and Antiretroviral Non-Adherence among People Living with HIV in Uganda.

The health and economic threats posed by the COVID-19 pandemic can be sources of great distress among people living with HIV, which in turn can impact the management of their HIV disease. We examined change in depression from pre- to post-lockdown restrictions and correlates of elevated depressive symptoms, including antiretroviral therapy (ART) adherence. Participants enrolled in a randomized controlled trial of an ART adherence intervention in Uganda. The month-12 follow-up assessment was fully administered just prior to the start of the pandemic-related lockdown in March 2020; at the conclusion of the lockdown three months later, we administered a mixed-methods phone-based assessment. ART adherence was electronically monitored throughout the study period, including during and after the lockdown. Depression was assessed with the 8-item Patient health questionnaire (PHQ-8), on which scores > 9 signify a positive screen for elevated depressive symptoms. A sample of 280 participants completed both the month-12 and post-lockdown assessments. Rates of elevated depressive symptoms nearly tripled from month 12 (n = 17, 6.1%) to the post-lockdown assessment (n = 50, 17.9%; McNemar test < .001). Elevated depressive symptoms at post-lockdown were associated with being female, indicators of economic struggles at month 12 (unemployment, low income, high food insecurity), and lower ART adherence during the 3-month lockdown period [mean of 71.9% (SD = 27.9) vs. 80.8% (SD = 24.1) among those not depressed; p = .041] in bivariate analysis. In multiple regression analysis, higher food insecurity [adj. OR (95% CI) = 4.64 (2.16–9.96)] and perception that the pandemic negatively impacted ART adherence [adj. OR (95% CI) = 1.96 (1.22–3.16)] remained associated with a greater likelihood of elevated depressive symptoms, when other correlates were controlled for. Qualitative data suggested that economic stressors (lack of food, work, and money) were key contributors to elevated depressive symptoms, and these stressors led to missed ART doses because of lack of food and stress induced forgetfulness. Elevated depressive symptoms significantly increased during the COVID-19 lockdown and was associated with food insecurity and reduced ART adherence. Mechanisms for identifying and treating depression and food insecurity are needed to help PLHIV cope with and mitigate the harmful effects of unexpected crises that may impede disease management and access to food.

A Systematic Review of Nurse-Led Antiretroviral Medication Adherence Intervention Trials: How Nurses Have Advanced the Science.

Antiretroviral therapy (ART) is essential to achieving viral suppression and improving health and clinical outcomes in persons living with HIV. Despite the effectiveness of ART and many promising evidence-based ART adherence interventions, viral suppression rates continue to be less than optimal. Nurses play pivotal roles in HIV care management, yet their role in the development and delivery of evidence-based adherence interventions has received little attention. Therefore, this review examined the contributions of nurses to ART adherence research and delivery. We found that nurse-led and nurse-facilitated interventions can be effective in fostering ART adherence in persons living with HIV. Considering the role nurses play in HIV care management and the effectiveness of interventions involving nurses, more nurse-led and nurse-facilitated interventions to address ART adherence are indicated. However, there is a need for further research to examine multilevel interventions and comparative cost and effectiveness of nurse-delivered ART interventions with other forms of delivery.

Interventions to Improve Adherence to Antiretroviral Therapy (ART) in Sub-Saharan Africa: An Updated Systematic Review

Optimal adherence to antiretroviral therapy (ART) remains the bedrock of effective therapy and management of human immunodeficiency virus (HIV). This systematic review examines the effect of interventions in improving ART adherence in sub-Saharan Africa (SSA), which bears the largest global burden of HIV infection. In accordance with PRISMA guidelines, and based on our inclusion and exclusion criteria, PUBMED, MEDLINE, and Google Scholar databases were searched for published studies on ART adherence interventions from 2010 to 2019. Thirty-one eligible studies published between 2010 to 2019 were identified, the categories of interventions were structural, behavioral, biological, cognitive, and combination. Study characteristics varied across design, intervention type, intervention setting, country, and outcome measurements. Many of the studies were behavioral interventions conducted in hospitals with more studies being randomized controlled trial (RCT) interventions. Despite the study variations, twenty-four studies recorded improvements. Notwithstanding, more quality studies such as RCTs should be conducted, especially among key affected populations (KAPs) to control transmission of resistant strains of the virus. Reliable objective measures of adherence should replace the conventional subjective self-report. Furthermore, long-term interventions with longer duration should be considered when evaluating the effectiveness of interventions.

PEERNaija: A Gamified mHealth Behavioral Intervention to Improve Adherence to Antiretroviral Treatment Among Adolescents and Young Adults in Nigeria.

Background:HIV is the leading cause of death for youth in Sub-Saharan Africa (SSA). The rapid proliferation of smart phones in SSA provides an opportunity to leverage novel approaches to promote adherence to life-saving antiretroviral therapy (ART) for adolescents and young adults living with HIV (AYA-HIV) that go beyond simple medication reminders.Methods:Guided by the Integrate, Design, Assess and Share (IDEAS) framework, our multidisciplinary team developed a peer-based mHealth ART adherence intervention—PEERNaija. Grounded in Social Cognitive Theory, and principles of contingency management and supportive accountability, PEERNaija delivers a multi-faceted behavioral intervention within a smartphone application to address important obstacles to adherence.Results:PEERNaija was developed as a gamified Android-based mHealth application to support the behavioral change goal of improving ART adherence among AYA-HIV within Nigeria, a low- and middle- income country (LMIC). Identified via foundational interviews with the target population and review of the literature, key individual (forgetfulness and poor executive functioning), environmental (poor social support) and structural (indirect cost of clinic-based interventions) barriers to ART adherence for AYA-HIV informed application features. Further informed by established behavioral theories and principles, the intervention aimed to improve self-efficacy and self-regulation of AYA-HIV, leverage peer relationships among AYA to incentivize medication adherence (via contingency management, social accountability), provide peer social support through an app-based chat group, and allow for outreach of the provider team through the incorporation of a provider application. Gamification mechanics incorporated within PEERNaija include: points, progress bar, leaderboard with levels, achievements, badges, avatars and targeted behavior change messages. PEERNaija was designed as a tethered mobile personal health record application, sharing data to the widely deployed OpenMRS electronic health record application. It also uses the secure opensource Nakama gamification platform, in line with Principles of Digital Development that emphasize use of opensource systems within LMICs.Conclusions:Theory-based gamified mHealth applications that incorporate social incentives have the potential to improve adherence to AYA-HIV. Ongoing evaluations of PEERNaija will provide important data for the potential role for a gamified, smartphones application to deliver multifaceted adherence interventions for vulnerable AYA-HIV in SSA.

HIV treatment cascade among people who inject drugs in Ukraine.

The HIV treatment cascade is an effective tool to track progress and gaps in the HIV response among key populations. People who inject drugs (PWID) remain the most affected key population in Ukraine with HIV prevalence of 22% in 2015. We performed secondary analysis of the 2017 Integrated Bio-Behavioral Surveillance (IBBS) survey data to construct the HIV treatment cascade for PWID and identify correlates of each indicator achievement. The biggest gap in the cascade was found in the first "90", HIV status awareness: only 58% [95% CI: 56%-61%] of HIV-positive PWID reported being aware of their HIV-positive status. Almost 70% [67%-72%] of all HIV-infected PWID who were aware of their status reported that they currently received antiretroviral therapy (ART). Almost three quarters (74% [71%-77%]) of all HIV-infected PWID on ART were virally suppressed. Access to harm reduction services in the past 12 months and lifetime receipt of opioid agonist treatment (OAT) had the strongest association with HIV status awareness. Additionally, OAT patients who were aware of HIV-positive status had 1.7 [1.2-2.3] times the odds of receiving ART. Being on ART for the last 6 months or longer increased odds to be virally suppressed; in contrast, missed recent doses of ART significantly decreased the odds of suppression. The HIV treatment cascade analysis for PWID in Ukraine revealed substantial gaps at each step and identified factors contributing to achievement of the outcomes. More intensive harm reduction outreach along with targeted case finding could help to fill the HIV awareness gap among PWID in Ukraine. Scale up of OAT and community-level linkage to care and ART adherence interventions are viable strategies to improve ART coverage and viral suppression among PWID.

Interventions to improve daily medication use among adolescents and young adults: what can we learn for youth pre-exposure prophylaxis services?

Objective:Oral pre-exposure prophylaxis (PrEP) is an important HIV prevention method and studies have shown that young people ages 15–24 have difficulty adhering to daily PrEP. The field of PrEP delivery for young people is relatively nascent and lessons about potential PrEP adherence interventions could be learned from the larger evidence base of adherence interventions for other daily medications among youth.Design:Systematic review of adherence support interventions for adolescents.Methods:We searched PubMed, CINAHL, EMBASE, and PsycINFO through January 2020 for oral contraceptive pill (OCP), antiretroviral therapy (ART), asthma, and diabetes medication adherence interventions. We reviewed primary articles about OCP adherence interventions and reviewed systematic reviews for ART, asthma, and diabetes medication adherence interventions. Studies were retained if they included participants’ ages 10–24 years; measured OCP, ART, asthma, or diabetes medication adherence; and were systematic reviews, randomized trials, or quasi-experimental studies.Results:Fifteen OCP articles and 26 ART, diabetes, and asthma systematic reviews were included. Interventions that improved medication adherence for OCPs, ART, asthma, and diabetes treatment included reminder text messages, computer-based and phone-based support, and enhanced counseling. Multi-month prescriptions and same-day pill starts also were found to improve OCP adherence and continuation. Adolescent-friendly clinics and peer-based counseling significantly improved ART adherence, and telemedicine interventions improved diabetes medication adherence.Conclusion:Interventions that improve medication adherence among youth include enhanced counseling, extended pill supply, adolescent-friendly services, and text message reminders. PrEP programs could incorporate and evaluate such interventions for their impact on PrEP adherence and continuation among at-risk adolescents.

COVID-19 Related Medical Mistrust, Health Impacts, and Potential Vaccine Hesitancy Among Black Americans Living With HIV.

Background:Medical mistrust, a result of systemic racism, is prevalent among Black Americans and may play a role in COVID-19 inequities. In a convenience sample of HIV-positive Black Americans, we examined associations of COVID-19-related medical mistrust with COVID-19 vaccine and COVID-19 treatment hesitancy and negative impacts of COVID-19 on antiretroviral therapy (ART) adherence.Methods:Participants were 101 HIV-positive Black Americans (age: M = 50.3 years; SD = 11.5; 86% cisgender men; 77% sexual minority) enrolled in a randomized controlled trial of a community-based ART adherence intervention in Los Angeles County, CA. From May to July 2020, participants completed telephone interviews on negative COVID-19 impacts, general COVID-19 mistrust (eg, about the government withholding information), COVID-19 vaccine and treatment hesitancy, and trust in COVID-19 information sources. Adherence was monitored electronically with the Medication Event Monitoring System.Results:Nearly all participants (97%) endorsed at least one general COVID-19 mistrust belief, and more than half endorsed at least one COVID-19 vaccine or treatment hesitancy belief. Social service and health care providers were the most trusted sources. Greater COVID-19 mistrust was related to greater vaccine and treatment hesitancy [b (SE) = 0.85 (0.14), P < 0.0001 and b (SE) = 0.88 (0.14), P < 0.0001, respectively]. Participants experiencing more negative COVID-19 impacts showed lower ART adherence, assessed among a subset of 49 participants [b (SE) = −5.19 (2.08), P = 0.02].Discussion:To prevent widening health inequities, health care providers should engage with communities to tailor strategies to overcome mistrust and deliver evidence-based information, to encourage COVID-19 vaccine and treatment uptake.

Childhood Sexual Trauma and Antiretroviral Therapy Adherence: A Mixed-Methods Systematic Review.

Childhood sexual abuse (CSA) has been shown to be more prevalent among populations living with HIV. Antiretroviral therapy (ART) adherence is crucial for populations living with HIV as it significantly increases the likelihood of attaining and maintaining viral suppression. Previous findings on the association between CSA and ART adherence have been mixed. The current mixed-methods systematic review aimed to identify quantitative and qualitative studies from CINAHL, PsycInfo, PubMed, and Web of Science examining the relationship between CSA and ART adherence. Authors were also contacted if relevant data were unpublished. Studies had to be published from January 1, 2000 to April 1, 2019, written in English, and examined CSA as an exposure and ART adherence as an outcome. Four domains were combined: 1) childhood sexual abuse; 2) child; 3) antiretroviral; and 4) adherence. Eight quantitative and two qualitative studies were retained. The results showed that four quantitative studies found no association while the other four found factors such as timing of victimization, mental health and gender influenced the association between CSA and ART adherence. Themes emerging from the qualitative studies included use of ART evoking memories of CSA; CSA impacting mental health; and mental health treatment improving ART adherence. Mixed insights included the intricate links between CSA and ART adherence and the role of external factors on the relationship. ART adherence intervention programs may be needed for people who have experienced CSA. However, future studies are needed that will examine the association between CSA and ART adherence and include subgroup analyses.

Perceived risks and amelioration of harm in research using mobile technology to support antiretroviral therapy adherence in the context of methamphetamine use: a focus group study among minorities living with HIV

BackgroundMethamphetamine use poses a barrier to antiretroviral therapy (ART) adherence. Black and Hispanic men who have sex with men living with HIV (PLWH) shoulder much of the health burden resulting from the methamphetamine and HIV syndemic. Smartphones are nearly ubiquitous in the USA and may be promising vehicles for delivering interventions for ART adherence and drug use cessation. However, the acceptability of using applications to collect sensitive information and deliver feedback in this population has not been adequately explored.ObjectiveThis study examined minority PLWH’s appraisals of the risks of participating in smartphone-based research to promote ART adherence in the context of methamphetamine use and explored their views on appropriate steps to mitigate perceived risks of participation.MethodsThree focus groups were conducted among Black and Hispanic PLWH who use methamphetamine. Of the 13 participants, 5 had previously participated in a smartphone-based observational study of ART adherence and substance use. Discussants provided feedback on smartphone-based research, including receiving probes for HIV medication adherence, mood, and substance use as well as feedback on passive location-tracking for personalized messages. Transcribed audio-recordings were thematically coded and analyzed using the qualitative software MAXQDA.ResultsParticipants expressed confidentiality concerns related to potential unintentional disclosure of their HIV status and methamphetamine use and to possible legal consequences. They additionally expressed concerns around the invasiveness of daily assessments and the potential of methamphetamine use questions to trigger cravings. To mitigate these concerns, they suggested maintaining participant privacy by indirectly asking sensitive questions, focusing on positive behaviors (e.g., number of days sober), allowing user-initiated reporting of location to tailor messages, and ensuring adequate data protections. In addition to financial compensation, participants cited altruism (specifically, continuing a tradition of volunteerism in HIV research) as a motivator for potentially engaging in such research.ConclusionsMinority PLWH have concerns regarding the use of smartphones for ART adherence and methamphetamine sobriety intervention research. However, minority PLWH are likely to participate if studies include appropriate protections against risks to confidentiality and experimental harm and are designed to offer future benefit to themselves and other PLWH.

Improving Medication Adherence Among Drug-Using HIV-Infected Formerly Incarcerated Individuals: A Pilot Test of Two Interventions.

Incarcerated individuals in the United States are reportedly four times more likely to be infected with HIV than members of the general population, and a substantial proportion have a history of drug use. Postincarceration, many struggle to maintain their antiretroviral therapy (ART) regimen. This pilot study tested the potential performance of two ART adherence interventions, Project ADHerence Education and Risk Evaluation (ADHERE) and Medication Adherence and Care Engagement (MACE) among drug-using HIV-infected formerly incarcerated individuals in New York City. Thirty participants were randomized and completed the ADHERE or MACE intervention. Participants were interviewed and had their blood drawn for viral load testing at baseline and 3 months postintervention. Our findings suggest that drug-using HIV-infected formerly incarcerated individuals can benefit from brief ART adherence interventions. They also suggest that marijuana use may not have a negative impact on ART adherence.

Using Real-Time Adherence Feedback to Enhance Communication About Adherence to Antiretroviral Therapy: Patient and Clinician Perspectives.

New technologies for real-time adherence monitoring hold the potential to enhance antiretroviral therapy adherence interventions by providing objective information about daily medication-taking behavior. To realize this potential, we need to understand how to integrate real-time adherence feedback into existing best practices to promote antiretroviral therapy adherence at the point of care. Using in-depth interviews with 30 HIV-infected patients and 29 HIV care clinicians, our primary aims were to understand patients' and clinicians' perceptions of anticipated benefits and preferred uses of objective feedback to enhance conversations about adherence and to identify concerns about the impact of objective monitoring on patient-clinician relationships and communication. Both patients and clinicians suggested that identifying patterns of nonadherence with real-time feedback could (a) facilitate collaborative adherence problem-solving, (b) motivate patient adherence, and (c) reinforce the importance of optimal adherence. Some clinicians worried that delivery of real-time feedback could imply mistrust of patient-reported adherence and suggested careful framing of monitoring results. A few patients and clinicians were concerned that negative reactions to monitoring could discourage retention in care and reduce adherence motivation. These results indicate the potential of real-time feedback to enhance existing evidence-based adherence interventions targeting the key adherence precursors of adherence information, motivation, and behavioral skills. Guidance for the delivery of real-time adherence feedback should focus on both optimizing adherence and mitigating negative perceptions of adherence monitoring.

Antiretroviral adherence for adolescents growing up with HIV: understanding real life, drug delivery and forgiveness.

Poorer adherence to medication is normal in adolescence and is one of a range of risk-taking behaviours common during a developmental stage that encompasses enormous cognitive, physical, sexual, social and emotional change. For adolescents living with human immunodeficiency virus (HIV) infection, poor adherence to antiretroviral therapy (ART) confers two significant challenges: poor health, but also the specific additional burden of onward transmission to partners. Late adolescence (15–19 years) is the only age group where HIV-associated mortality is rising, driven by poor adherence to ART and lack of access to second-line therapy, particularly amongst surviving perinatally infected young people. A previous lack of well-powered randomised multimodal behavioural ART adherence interventions specifically targeting adolescents is now being addressed and ongoing studies registered to ClinicalTrials.gov are described in the context of previous data. Accepting that despite enhanced support, some adolescents will continue to struggle with adherence, we must address how best to use existing ART agents to reduce mortality and allow adolescents the time to mature into adult life. Single-tablet regimens with a high genetic barrier to resistance based on integrase inhibitors and boosted protease inhibitors exist, but global access, in resource limited settings of young people living with HIV reside, is limited. Pragmatically, such regimens tolerate the intermittent adherence so characteristic of adolescence, preserving immune function, without the rapid evolution of resistance. The potential role of long-acting injectable ART, specifically cabotegravir and rilpivirine, is discussed and future strategies including ultra-long-acting drug-delivery systems and broadly neutralising monoclonal antibodies explored.

Connecting Youth and Young Adults to Optimize Antiretroviral Therapy Adherence (YouTHrive): Protocol for a Randomized Controlled Trial.

BackgroundDespite intensive efforts to engage people living with HIV in the United States, less than half of the youth aged 13 to 24 years achieve viral suppression. There is a clear and continued need for innovative behavioral programs that support optimizing adherence among young persons with HIV.ObjectiveThere are 3 phases of this project. Phase 1 involves conducting focus groups to obtain feedback from youth about an existing technology-based antiretroviral therapy (ART) adherence intervention. Phase 2 will be used to conduct beta testing with youth to refine and finalize the YouTHrive (YT) intervention. Phase 3 is a randomized controlled trial (RCT) to test the efficacy of the YT intervention among youth living with HIV (YLWH).MethodsIn phase 1, we will conduct 6 focus groups with approximately 8 youths (aged 15-19 years) and young adults (aged 20-24 years), each in 3 US cities to obtain (1) feedback from YLWH about the look and feel and content of an existing adult-focused Web-based ART adherence intervention and (2) suggestions for adapting the intervention for YLWH similar to themselves. Phase 2 will involve updating the existing intervention to include features and functionality recommended by YLWH in phase 1; it will conclude with beta testing with 12 participants to gain feedback on the overall design and ensure proper functionality and ease of navigation. For phase 3, we will enroll 300 YLWH in 6 US cities (Atlanta, Chicago, Houston, New York City, Philadelphia, and Tampa) into a 2-arm prospective RCT. Participants will be randomized 1:1 to YT intervention or control group. The randomization sequence will be stratified by city and use random permuted blocks of sizes 2 and 4. Participants randomized to the control condition will view a weekly email newsletter on topics related to HIV, with the exception of ART adherence, for 5 months. Participants randomized to the YT intervention condition will be given access to the YT site for 5 months. Study assessments will occur at enrollment and 5, 8, and 11 months post enrollment. The primary outcome that will be assessed is sustained viral load (VL), defined as the proportion of participants in each study arm who have suppressed VL at both the 5- and 11-month assessment; the secondary outcome that will be assessed is suppressed VL at both the 5- and 11-month assessment between drug-using and nondrug-using participants assigned to the YT intervention arm.ResultsParticipant recruitment began in May 2017 for phase 1 of the study. The data collection for aim 3 is anticipated to end in April 2020.ConclusionsThe efficacy trial of the YT intervention will help to fill gaps in understanding the efficacy of mobile interventions to improve ART adherence among at-risk populations.Trial RegistrationClinicalTrials.gov NCT03149757; https://clinicaltrials.gov/ct2/show/NCT03149757 (Archived by WebCite at http://www.webcitation.org/73pw57Cf1)International Registered Report Identifier (IRRID)DERR1-10.2196/11502