mHealth · 2026
The results of a web-based randomized controlled intervention trial to improve antiretroviral therapy (ART) adherence among Youth with HIV (YouTHrive, ATN 135) during the COVID-19 pandemic.
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Horvath Keith J, Miller-Perusse Michael, MacLehose Richard, Sullivan Patrick S, Hightow-Weidman Lisa L, Amico K Rivet
Аннотация
BACKGROUND: Two-thirds of youth with human immunodeficiency virus (HIV) (YWH) were virally suppressed at the end of 2022 in the United States. We developed and evaluated the YouTHrive intervention in a multi-site 2-arm randomized controlled trial (RCT) for effects on viral suppression. Additionally, we evaluated the impact of the coronavirus disease 2019 (COVID-19) pandemic on participants.
METHODS: The 5-month mHealth intervention included participant interaction features, adherence information and monitoring, goal setting, and gamification, and was compared to an HIV information-only control condition. Viral suppression was defined as viral load <50 copies/mL, with secondary outcomes including examining viral load <200 copies/mL, viral load as a continuous outcome, and self-reported adherence using a visual analog scale (VAS). At baseline and 5-month follow-up, log-binomial regression models were used to estimate rate ratios (RRs) between study arms for viral suppression outcomes, and ordinary least squares linear regression models estimated mean differences (MDs) between study arms for antiretroviral therapy (ART) adherence and continuous viral load. The impacts of COVID-19 on different aspects of youth's lives were examined for the full sample and by intervention group. We also compared the responses of youth who were enrolled pre- vs. post-COVID-19 on self-reported adherence and treatment engagement outcomes.
RESULTS: From August 2019 to December 2022, 208 youth across 8 recruiting sites were enrolled. The trial was stopped in March 2020 due to the COVID-19 pandemic, during which study procedures were modified before reopening in October 2020. Over half of participants (64%) were between 21 and 24 years of age, and 29% were between 18 and 20 years of age. Most were cisgender males (68%), Black/African American (66%), non-Hispanic (76%), and identified as gay (50%). Of the 120 participants with complete viral load data at both time points, most were virally suppressed at baseline and at the 5-month follow-up (67%). No significant group differences in primary or secondary outcomes were found in either the complete case models or models that used multiple imputation to account for missing variables. Youth reported that the COVID-19 pandemic overall reduced their quality of life, with the greatest impacts on anxiety levels, finances, and reducing opportunities for sex, although relatively few participants reported that it negatively impacted access to HIV treatment and care services.
CONCLUSIONS: The YouTHrive intervention did not improve ART adherence or HIV viral load in this sample of youth. However, substantial changes to study procedures made in response to the COVID-19 pandemic may have contributed to these findings. Teams conducting similar studies in the future should consider ways of mitigating the impacts of possible future pandemics or similar disruptions early in their timeline to consider the impacts of changes to the study.Trial Registration: The study is registered as a clinical trial (clinicaltrials.gov, NCT03149757).
METHODS: The 5-month mHealth intervention included participant interaction features, adherence information and monitoring, goal setting, and gamification, and was compared to an HIV information-only control condition. Viral suppression was defined as viral load <50 copies/mL, with secondary outcomes including examining viral load <200 copies/mL, viral load as a continuous outcome, and self-reported adherence using a visual analog scale (VAS). At baseline and 5-month follow-up, log-binomial regression models were used to estimate rate ratios (RRs) between study arms for viral suppression outcomes, and ordinary least squares linear regression models estimated mean differences (MDs) between study arms for antiretroviral therapy (ART) adherence and continuous viral load. The impacts of COVID-19 on different aspects of youth's lives were examined for the full sample and by intervention group. We also compared the responses of youth who were enrolled pre- vs. post-COVID-19 on self-reported adherence and treatment engagement outcomes.
RESULTS: From August 2019 to December 2022, 208 youth across 8 recruiting sites were enrolled. The trial was stopped in March 2020 due to the COVID-19 pandemic, during which study procedures were modified before reopening in October 2020. Over half of participants (64%) were between 21 and 24 years of age, and 29% were between 18 and 20 years of age. Most were cisgender males (68%), Black/African American (66%), non-Hispanic (76%), and identified as gay (50%). Of the 120 participants with complete viral load data at both time points, most were virally suppressed at baseline and at the 5-month follow-up (67%). No significant group differences in primary or secondary outcomes were found in either the complete case models or models that used multiple imputation to account for missing variables. Youth reported that the COVID-19 pandemic overall reduced their quality of life, with the greatest impacts on anxiety levels, finances, and reducing opportunities for sex, although relatively few participants reported that it negatively impacted access to HIV treatment and care services.
CONCLUSIONS: The YouTHrive intervention did not improve ART adherence or HIV viral load in this sample of youth. However, substantial changes to study procedures made in response to the COVID-19 pandemic may have contributed to these findings. Teams conducting similar studies in the future should consider ways of mitigating the impacts of possible future pandemics or similar disruptions early in their timeline to consider the impacts of changes to the study.Trial Registration: The study is registered as a clinical trial (clinicaltrials.gov, NCT03149757).