Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.

BACKGROUND: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance. OBJECTIVE: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines. METHODS: Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements. RESULTS: Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites. CONCLUSIONS: The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

Optimizing Individual HIV Testing and Counseling for Emerging Adult Sexual Minority Men (Aged 18 to 24) in Relationships: A Pilot Randomized Controlled Trial of Adjunct Communication Components.

The majority of new HIV infections in the US occur among sexual minority men (SMM) with older adolescent and emerging adult SMM at the highest risk. Those in relationships face unique HIV prevention challenges. Existing sexual HIV transmission risk interventions for male couples often encounter implementation challenges and engaging younger SMM early in relationships may be particularly difficult. This pilot randomized controlled trial evaluated the acceptibility and feasibility of We Test HIV testing - a behavioral health intervention tailored for younger SMM in realtionships - and generated preliminary estimates of effect size. The intervention comprises two adjunct moduls - video-based communication skills training as well as communication goal setting and planning - delivered in conjunction with routine HIV testing and counseling in individual or dyadic formats. A sample of 69 SMM aged 17 to 24 were recruited online. Following baseline assessment, youth were randomized to receive either the experimental, We Test, intervention or routine HIV testing (the control condition). Follow-up assessments were completed 3 and 6 months post-baseline. Results suggested the study was feasible and the individually delivered format was acceptible. We Test HIV testing was associated with significant improvements in communication skills. In addition, youth who remained in a relationship experienced an increase in communal coping to reduce HIV infection risk and relationship power. While groups did not differ with respect to condomless anal sex with casual partners, these psycho-social constructs (communication, communal coping with HIV prevention, and relationship power) may serve as mediators of intervention effects on sexual risk reduction in a larger study.

Information, Motivation, Behavioral Skills Model in Youth Newly Starting Antiretroviral Treatment.

An understanding of adherence among youth newly starting antiretroviral therapy (ART) is critical but understudied. The information-motivation-behavioral skills (IMB) model is often used to understand health behaviors, but has rarely been studied in youth with HIV. In a multi-site sample of 153 youth newly starting ART, structural equation modeling was utilized to test this model. The model was generally supported with information and behavioral skills directly related to the decision to adhere, while motivation was indirectly related through behavioral skills. Results suggest that interventions focusing on improving IMB constructs for medication adherence are important for preventing non-adherence in youth newly starting ART.

RESUMEN: El entendimiento de la adherencia en jóvenes que recién comienzan ART es fundamental, pero se ha estudiado poco. El modelo de información-motivación-habilidades conductuales (IMB, por sus siglas en inglés) se usa a menudo para comprender los comportamientos de salud, pero rara vez se ha estudiado en jóvenes que viven con el VIH. En una muestra de múltiples sitios de 153 jóvenes que recién comenzaban ART, se utilizó el análisis de ecuaciones estructurales para probar este modelo. En general, el modelo fue apoyado con información y habilidades conductuales directamente relacionadas con la decisión de adherirse, mientras que la motivación se relacionó indirectamente a través de las habilidades conductuales. Los resultados sugieren que las intervenciones que se enfocan en mejorar los aspectos del modelo IMB para la adherencia al medicamento son importantes para prevenir la falta de adherencia en los jóvenes que recién comienzan ART.

Executive functions mediate the association between alcohol use and declarative memory symptoms in daily life.

Alcohol use is associated with memory problems in young adults with HIV, but the cognitive mechanisms of that association are not known. Sixty adults (aged 19-24 years) living with HIV were administered the Alcohol, Smoking, and Substance Involvement Screening Test to assess alcohol use, Behavior Rating Inventory of Executive Function for self-reported executive functions, and the Prospective and Retrospective Memory Questionnaire (PRMQ) for dailiy memory functioning. Controlling for mood, self-reported executive functions fully mediated the relationship between alcohol use and memory (indirect effect b=.568, 95%CI [.209,.888]). Findings suggest that self-reported executive dysregulation of memory processes (e.g., Strategic encoding and retrieval) may drive the effects of alcohol use on daily memory symptoms.

Cannabis and complementary/alternative self-treatment approaches for symptom management among African American persons living with HIV.

Persons living with HIV (PLWH) experience symptoms from disease progression and side effects of antiretroviral treatment. This study examines in African American PLWH (N = 259) commonly-endorsed symptoms, types and self-rated efficacy of therapies for symptom alleviation. Analyses were stratified by gender (n = 178 males, n = 81 females) and cannabis use typology: non-users (n = 90), mostly recreational use (n = 46), mixed recreational/therapeutic use (n = 51), or mostly therapeutic use (n = 72). Females reported greater severity for pain, fatigue, depression, weight change and tingling in extremities, but there were no gender differences for ratings of poor sleep, anxiety, poor appetite, or headache. Both marijuana (used therapeutically by females more than males) and medication(s) were among the 3 top methods for managing pain, poor sleep, anxiety, and headache. Marijuana was most often used for poor appetite, and medications for depression. Perceived efficacy of self-treatment approaches was moderately good. Among African American PLWH, symptom severity was higher for females and for therapeutic users of cannabis. Marijuana and medicine were often used to self-treat symptoms, but many participants did nothing. These results highlight the need for careful evaluation and management of symptoms in this underserved population.

Adapting a Motivational Interviewing Intervention to Improve HIV Prevention Among Young, Black, Sexual Minority Men in Alabama: Protocol for the Development of the Kings Digital Health Intervention.

BACKGROUND: African American or Black young men who have sex with men (BYMSM) are at a disproportionate risk for contracting HIV and have high rates of undiagnosed, and therefore untreated, HIV infection. In the southern United States, BYMSM face region-specific hurdles to HIV prevention, such as limited access to care and high levels of racism and intersectional stigma, necessitating HIV testing and pre-exposure prophylaxis interventions that address sociocultural and structural barriers while motivating BYMSM to engage in prevention. Brothers Saving Brothers (BSB) is a motivational interviewing behavioral intervention that successfully and simultaneously increased community-based HIV testing and prevention counseling and education among BYMSM in the midwestern United States. OBJECTIVE: The aim of this protocol is to detail the process for the adaption of the BSB intervention for midwestern BYMSM to the Kings intervention for southern BYMSM. During the adaptation process, the intervention will be modernized to include rapid HIV testing, as opposed to HIV testing that requires BYMSM to return for test results, pre-exposure prophylaxis, and the provision of structural supports, and for relevance in the southern United States. METHODS: Aim 1 is to gather qualitative data through focus groups and in-depth interviews with BYMSM aged 18 to 29 years in Alabama and in-depth interviews with prevention and outreach workers who routinely work with BYMSM in Alabama. NVivo qualitative software (QSR International) will be used for the coding and analysis of the transcripts via a thematic analysis approach. For aim 2, intervention mapping will guide the adaptation process, intervention content, components, and design. Both aims 1 and 2 will leverage the Exploration, Preparation, Implementation, Sustainment implementation science framework, with emphasis on the exploration and preparation phases of this model. By applying these frameworks, the original midwestern BSB intervention will be scientifically adapted to the southern BYMSM Kings intervention. RESULTS: This study is ongoing as of 2022 and is expected to conclude in 2024, with aims 1 and 2 being completed in 2023. Qualitative data will offer insight into the current real-world experiences and preferences of BYMSM in Alabama. Feedback will be collected through the adaptation process to inform intervention refinement. Institutional review board approvals have been received. CONCLUSIONS: The findings will inform next steps, that is, testing the Kings intervention for feasibility, acceptability, and preliminary effectiveness in a pilot hybrid type 1 effective-implementation randomized controlled trial. The study results will provide insights about important considerations for HIV prevention among BYMSM in the southern United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT03680729; https://clinicaltrials.gov/ct2/show/NCT03680729. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/36655.

"Do I Have a Memory Problem? I Can't Recall": An Evaluation of Measurement Invariance in Subjective Reporting of Memory Symptoms among Persons with and without Objective HIV-Associated Memory Impairment.

OBJECTIVE: Memory symptoms and objective impairment are common in HIV disease and are associated with disability. A paradoxical issue is that objective episodic memory failures can interfere with accurate recall of memory symptoms. The present study assessed whether responses on a self-report scale of memory symptoms demonstrate measurement invariance in persons with and without objective HIV-associated memory impairment. METHOD: In total, 505 persons with HIV completed the Prospective and Retrospective Memory Questionnaire (PRMQ). Objective memory impairment (n = 141) was determined using a 1-SD cutoff on clinical tests of episodic memory. PRMQ measurement invariance was assessed by confirmatory factor analyses examining a one-factor model with increasing cross-group equality constraints imposed on factor loadings and item thresholds (i.e., configural, weak, and strong invariance). RESULTS: Configural model fit indicated that identical items measured a one-factor model for both groups. Comparison to the weak model indicated that factor loadings were equivalent across groups. However, there was evidence of partial strong invariance, with two PRMQ item thresholds differing across memory impairment groups. Post hoc analyses using a 1.5-SD memory impairment cutoff (n = 77) revealed both partial weak and partial strong invariance, such that PRMQ item loadings differed across memory groups for three items. CONCLUSIONS: The PRMQ demonstrated a robust factor structure among persons with and without objective HIV-associated memory impairment. However, on select PRMQ items, individuals with memory impairment reported observed scores that were relatively higher than their latent score, while items were more strongly associated with the memory factor in a group with greater memory impairment.

Student characteristics and substance use as predictors of self-reported HIV testing: the youth risk behavior survey (YRBS) 2013-2015.

Many adolescents and young adults (AYAs; ages 13-24) are unaware of their HIV status despite participating in behavior that places them at risk for contracting HIV. This study examined possible predictors of self-reported HIV testing for high school students (grades 9-12) who completed the Youth Risk Behavior Survey (YRBS). Three sex-stratified, stepwise multivariable logistic models were used to estimate odds of having received a HIV test being associated with student characteristics and substance use. The likelihood of being tested for HIV was associated with students who were a racial/ethnic minority and age 18 and older. HIV testing was also associated with male students who reported same sex partners (males) or same sex partners (males) and different sex partners (females). Female students who reported same sex partners (females) and different sex partners (males) were more likely to have been tested for HIV. Male and female students were more likely to have been tested for HIV if they reported illicit drug and/or marijuana use, while prescription drug use was also associated with HIV testing for female students. Knowledge of the predictors of HIV testing for adolescents can guide efforts for the effective scale up of testing for this vulnerable population.

Marijuana and illicit drugs: Correlates of condomless anal sex among adolescent and emerging adult sexual minority men.

The association between "illicit drugs" (e.g., cocaine/crack, methamphetamine, gamma-hydroxybutyrate-GHB, ketamine, and ecstasy) and condomless anal sex (CAS) with casual partners is well established for sexual minority men (SMM). Recent evidence from adult SMM has indicated that marijuana is associated with the occurrence of CAS with casual partners above and beyond illicit drug use. The purpose of the current study was to evaluate associations between CAS and the use of marijuana and illicit drugs in a sample of young SMM (aged 15-24). Participants (n = 578) completed an online survey assessing demographics, current PrEP prescription, age, marijuana use, as well as drug use and sexual behavior in the past 90 days. A hurdle model simultaneously predicted the occurrence of CAS as well as the frequency of CAS among those reporting it. Illicit drug use was associated with both the occurrence (OR = 2.26; p = .01) and frequency of CAS (RR = 1.63; p = .02). In contrast, marijuana use was associated with the occurrence (OR = 1.69; p = .01), but not the frequency of CAS (RR = 1.07; p = .74). Findings mirror recent observations in large samples of adult SMM. While the effect size of marijuana is more modest than illicit drug use, marijuana does have significant and unique associations with the occurrence of CAS. HIV prevention services for young SMM may therefore benefit from assessing and addressing marijuana use in the context of HIV sexual behavior.

Utilizing Alternative Testing Technology for Human Immunodeficiency Virus (HIV) in the COVID era.

PURPOSE OF REVIEW: With the onset of the Coronavirus disease 2019 (COVID-19) pandemic, in-person human immunodeficiency virus (HIV) testing is no longer easily accessible. Therefore, alternative testing technologies must be considered and implemented on a large scale to continue prevention efforts. This review seeks to describe the benefits of utilizing at-home HIV testing technologies, traditionally deemed an alternative form of testing. RECENT FINDINGS: Utilizing at-home testing technology during the COVID-19 pandemic overcomes novel and previously identified barriers to HIV testing. SUMMARY: Ensuring access to HIV testing is imperative to long-term prevention goals. With the Ending the HIV Epidemic (EHE) initiative in the USA targeting achievement by 2030, obstacles to HIV testing must be addressed to ensure its success. Implementing alternative testing technology more broadly allows for continued prevention efforts for HIV in light of COVID era restrictions.

Associations Between Internalized HIV Stigma and Tobacco Smoking Among Adolescents and Young Adults Living with HIV: The Moderating Role of Future Orientations.

HIV stigma and future orientations impact the health of adolescents and young adults living with HIV (AYALWH); however, little is known about how these factors may impact tobacco use, and thereby long-term health status. This study examined associations between internalized HIV stigma, future orientations, and smoking behavior using a cross sectional survey of AYALWH ages 18 to 29 (N = 109). Greater levels of stigma were associated with increased odds of smoking, and greater future orientations were associated with a reduced odds of smoking. The interaction was significant, illustrating that stigma was significantly associated with an increased odds of smoking among AYALWH who reported low levels of future orientations, but not for those with high levels of future orientations. Findings underscore the importance of understanding how HIV stigma may undermine future aspirations of AYALWH. Interventions that target HIV stigma and future orientations may be critical for tobacco prevention and cessation.

Calendaring and alarms can improve naturalistic time-based prospective memory for youth infected with HIV.

Individuals with HIV disease often evidence deficits in prospective memory (PM), which interfere with daily functioning and increase the risk of suboptimal health behaviours. This study examined the benefits of simple encoding and cueing supports on naturalistic time-based PM in 47 HIV-positive young adults. All participants completed a naturalistic time-based PM task in which they were instructed to text the examiner once per day for seven days at a specified time. Participants were randomised into (1) a Calendaring condition in which they created a calendar event in their mobile telephone for the specified texting time; (2) an Alarm condition in which they programmed an alarm into their mobile telephone for the specified texting time; (3) a Combined calendaring and alarm condition; and (4) a Control condition. Participants in the Combined condition demonstrated significantly better naturalistic PM performance than participants in the Control and Calendaring conditions. Findings indicate that HIV-positive young people may benefit from a combined calendaring and alarm supportive strategy for successful execution of future intentions in daily life.

Promoting resilience through neurocognitive functioning in youth living with HIV.

Using a phased model of intervention development, we developed an intervention to promote resilience in youth living with HIV via improved neurocognitive resources. First, youth completed a naturalistic prospective memory (PM) task and were randomized into a visualization condition or control condition. Next, 47 of these participants completed another naturalistic PM task and were randomized into Calendaring condition, an Alarm condition, a Combined condition, or a Control condition. Youth with low PM demonstrated observable gains from the visualization technique. Youth in the Combined Calendaring and Alarm condition demonstrated significantly better performance than participants in the Control and Calendaring conditions. In a Proof-of-Concept study with 16 youth, the previous findings were translated into a single session in-person intervention followed by tailored text messaging to improve adherence and viral load via improved neurocognitive resources. The resulting intervention showed a signal of effect with viral load reductions in youth with available data. Targeting compensatory strategies to enhance neurocognitive functioning may promote resilience and health outcomes. A randomized pilot study with a control condition is the next step.

Visualisation of future task performance improves naturalistic prospective memory for some younger adults living with HIV disease.

Human immunodeficiency virus (HIV) disease is commonly associated with deficits in prospective memory (PM), which increase the risk of suboptimal health behaviours, like medication non-adherence. This study examined the potential benefits of a brief future visualisation exercise during the encoding stage of a naturalistic PM task in 60 young adults (aged 19-24 years) with HIV disease. Participants were administered a brief clinical neuropsychological assessment, which included a standardised performance-based measure of time- and event-based PM. All participants were also given a naturalistic PM task in which they were asked to complete a mock medication management task when the examiner showed them the Grooved Pegboard Test during their neuropsychological evaluation. Participants were randomised into: (1) a visualisation condition in which they spent 30 sec imagining successfully completing the naturalistic PM task; or (2) a control condition in which they repeated the task instructions. Logistic regression analyses revealed significant interactions between clinical neurocognitive functions and visualisation. HIV positive (HIV+) participants with intact retrospective learning and/or low time-based PM demonstrated observable gains from the visualisation technique, while HIV+ participants with impaired learning and/or intact time-based PM did not evidence gains. Findings indicate that individual differences in neurocognitive ability moderate the response to visualisation in HIV+ young adults. The extent to which such cognitive supports improve health-related PM outcomes (e.g., medication adherence) remains to be determined.

Allowing brief delays in responding improves event-based prospective memory for young adults living with HIV disease.

Event-based prospective memory (PM) tasks require individuals to remember to perform an action when they encounter a specific cue in the environment, and they have clear relevance for daily functioning for individuals with HIV. In many everyday tasks, not only must the individual maintain the intent to perform the PM task, but the PM task response also competes with the alternative and more habitual task response. The current study examined whether event-based PM can be improved by slowing down the pace of the task environment. Fifty-seven young adults living with HIV performed an ongoing lexical decision task while simultaneously performing a PM task of monitoring for a specific word (which was focal to the ongoing task of making lexical decisions) or syllable contained in a word (which was nonfocal). Participants were instructed to refrain from making task responses until after a tone was presented, which occurred at varying onsets (0-1600 ms) after each stimulus appeared. Improvements in focal and nonfocal PM accuracy were observed with response delays of 600 ms. Furthermore, the difference in PM accuracy between the low-demand focal PM task and the resource-demanding nonfocal PM task was reduced by half across increasingly longer delays, falling from 31% at 0-ms delay to only 14% at 1600-ms delay. The degree of ongoing task response slowing for the PM conditions, relative to a control condition that did not have a PM task and made lexical decisions only, also decreased with increased delay. Overall, the evidence indicates that delaying the task responses of younger HIV-infected adults increased the probability that the PM relevant features of task stimuli were adequately assessed prior to the ongoing task response, and by implication that younger HIV infected adults can more adequately achieve PM goals when the pace of the task environment is slowed down.

Task importance affects event-based prospective memory performance in adults with HIV-associated neurocognitive disorders and HIV-infected young adults with problematic substance use.

Two experiments were conducted to examine the effects of task importance on event-based prospective memory (PM) in separate samples of adults with HIV-associated neurocognitive disorders (HAND) and HIV-infected young adults with substance use disorders (SUD). All participants completed three conditions of an ongoing lexical decision task: (1) without PM task requirements; (2) with PM task requirements that emphasized the importance of the ongoing task; and (3) with PM task requirements that emphasized the importance of the PM task. In both experiments, all HIV+ groups showed the expected increase in response costs to the ongoing task when the PM task's importance was emphasized. In Experiment 1, individuals with HAND showed significantly lower PM accuracy as compared to HIV+ subjects without HAND when the importance of the ongoing task was emphasized, but improved significantly and no longer differed from HIV+ subjects without HAND when the PM task was emphasized. A similar pattern of findings emerged in Experiment 2, whereby HIV+ young adults with SUD (especially cannabis) showed significant improvements in PM accuracy when the PM task was emphasized. Findings suggest that both HAND and SUD may increase the amount of cognitive attentional resources that need to be allocated to support PM performance in persons living with HIV infection.

Experiences of community and parental violence among HIV-positive young racial/ethnic minority men who have sex with men.

Adolescents and young adults (ages 13-24) in the USA are frequently exposed to violence in their community and home. While studies have examined the prevalence and impact of violence exposure among adolescents, there is a lack of data focusing specifically on adolescent men of color who have sex with men. Eight demonstration sites funded through a Special Projects of National Significance (SPNS) Initiative recruited 363 HIV-positive racial/ethnic minority young men who have sex with men (YMSM) for a longitudinal study between 2006 and 2009. Over two-thirds of participants (83.8%) had witnessed community violence, 55.1% in the prior three months. Witnessing violence committed with a deadly weapon was significantly associated with being African-American, having ever used drugs, and drinking alcohol in the prior two weeks. Fear of violence in the community was significantly associated with depressive symptomatology, having less than a high school degree, not possessing health insurance, and site of enrollment. Having been emotionally or physically abused by a parent or caretaker was significantly associated with depressive symptomatology, attempting suicide, site of enrollment, and increased age. Witnessing violence with a deadly weapon was significantly associated with alcohol and drug use but not with high-risk sexual behaviors. As this was one of the first studies on the prevalence and correlates of violence exposure among racial/ethnic minority YMSM living with HIV, the findings can be used to inform the development of culturally appropriate resilience-focused interventions to address the aftereffects of violence exposures and help develop social support systems outside of the family.

The initial feasibility of a computer-based motivational intervention for adherence for youth newly recommended to start antiretroviral treatment.

Young people represent the largest number of new HIV infections, thus youth living with HIV (YLH) are likely to be the largest group to initiate antiretroviral treatment (ART). Adherence patterns for behaviorally infected YLH are not adequate to effectively manage the disease; therefore, novel interventions are needed to improve medication adherence. The purpose of the current study, which will precede a randomized controlled trial, was to assess the initial feasibility of an individually tailored computer-based two-session interactive motivational interviewing (MI) intervention for YLH newly recommended to start ART. Intervention development occurred in collaboration with three youth advisory groups. Ten youth (ages 18-24) were recruited to participate in this study. Participants completed the intervention online. Intervention components focused on medication adherence (rating perceived importance and confidence, and goal setting). Retention was 100% for both intervention sessions. All participants (n=10) felt medication adherence was important, but 80% felt confident they could manage their adherence to HIV medications. Ninety percent of participants set the goal of taking their HIV medications exactly as prescribed and reported success achieving this goal at follow-up. Additionally, participants were satisfied with the quality of the sessions and the amount of assistance they received for managing their adherence to HIV medications (90% participants for Session 1; 89% for Session 2). Per exit interview responses, participants felt that the intervention made them think more about their health and was a motivator for them to take better care of their health. In conclusion, the intervention was feasible for YLH enrolled in the study.

Motivational Enhancement System for Adherence (MESA): pilot randomized trial of a brief computer-delivered prevention intervention for youth initiating antiretroviral treatment.

OBJECTIVE: To pilot test a two-session computer-delivered motivational intervention to facilitate adherence among youth with HIV newly prescribed antiretroviral treatment (ART). METHODS: Youth (N = 76) newly prescribed ART were recruited from 8 sites, and were randomized to the intervention or an active nutrition and physical activity control. Primary outcomes were HIV-1 viral load at baseline, 3 months, and 6 months, and self-reported adherence at 3 and 6 months. RESULTS: Satisfaction ratings were high. Effect sizes suggested that the intervention group showed a greater drop than controls in viral load from baseline to 6 months (Cohen's d = 0.39 at 3 months; d = 0.19 at 6 months), and had greater percent undetectable by 6 months (d = 0.28). Effects sizes were medium to large for 7-day and weekend adherence. CONCLUSIONS: A brief computer-delivered motivational intervention showed promise for youth starting ART and is ready to be tested in a full-scale clinical trial.