In an ongoing study, researchers seek to determine whether a staggered, "step up" intervention model could be more successful and cost-effective than standard care for achieving viral suppression in youths living with HIV.
A staggered intervention model may prove to be a cost-effective method to help youths living with HIV (YLH) achieve viral suppression, according to an ongoing randomized clinical trial (RTC) in JMIR Research Protocols. The model initially provides a low level of intervention and gradually adds new methods if results are not shown in periodic increments.
YLH who have not achieved viral suppression are being identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, California, and New Orleans, Louisiana. Recruitment began in 2017, and researchers hope to enroll 220 participants. They estimate data collection will be complete by the end of 2020.
The study is the first to apply this method to help YLH achieve viral suppression. In the RTC, youth were assigned to either standard or stepped care intervention. The Enhanced Standard Care model included typical clinical care with automated messaging and monitoring intervention (AMMI) while the Enhanced Stepped Care model included 3 levels of intervention, including AMMI, peer support through social media with AMMI, or coaching with peer support and AMMI. Researchers conducted the study to examine how standard and staggered care models differed, in both effectiveness and price, raising rates of viral suppression in YLH.
The population of YLH has reached approximately 60,900 individuals between the ages of 12 and 24, who account for one-fourth of new HIV infections. Currently, only 30% to 40% of YLH in the United States are virally suppressed, according to CDC data. Achieving viral suppression extends length of life, increases quality of life, and reduces the chances the infection could be transmitted to others. Among diagnosed YLH, 81% are gay, bisexual, or transgender and rates of infection disproportionately occur in black and Hispanic populations.
Stepped care has previously been used to manage chronic diseases and mental health problems but has only recently been applied to YLH in 1 trial. In the study’s staggered care model, treatment providers implemented the least intensive intervention needed to reach the goal of viral suppression and intensified it until the goal was achieved. A portion of YLH demonstrated that they required little intervention to adhere to treatment regimens, showing that even low levels of intervention could be successful in helping individuals reach viral suppression. However, some YLH proved that they needed more tailored intervention to achieve the same results.
The primary outcome of the RTC was viral suppression of HIV. YLH were examined at 4-month intervals for 24 months. In the Enhanced Stepped Care intervention group, YLH who did not achieve viral suppression at any 4-month assessment would “step up” to the next level of intervention. Secondary outcomes included retention in care, antiretroviral therapy adherence, alcohol and substance use, mental health symptoms, and sexual behavior.
Researchers will use intent-to-treat analyses to compare viral suppression as primary and secondary outcomes between study participants assigned to either model. They will use bivariate-outcome multilevel models to examine relationships between primary and secondary outcomes. They will also conduct cost-effectiveness analyses to assess the benefits of intervention on primary and secondary outcomes against costs to implement intervention beyond those incurred through standard care. These analyses will compare the additional average cost required to obtain an additional unit of outcome in the Enhanced Stepped Care intervention by calculating the cost effectiveness ratio, which is the difference in total costs of providing staggered opposed to standard care intervention, divided by the difference in outcomes of both intervention models.
Researchers believe that Enhanced Stepped Care can be essential for achieving viral suppression in the YLH population as funding and resources for HIV care have not increased in recent years. If the staggered model proves to be more cost-effective than the standard model, it may change the way professionals apply evidence-based interventions.
There is a 94% chance that transmission of an HIV infection can be prevented if an individual living with HIV achieves viral suppression to a point where their viral load becomes undetectable. Achieving viral suppression among YLH requires establishment of cohesive, trusting relationships, care retention, and antiretroviral therapy (ART) adherence. However, YLH currently underutilize scientifically improved treatments for HIV.
As HIV is treated across the lifespan, individuals must overcome barriers to care and adhere daily to ART. In the past, 95% ART adherence was required to achieve an undetectable viral load. However, it has been found that rates as low as 80% may lead to viral suppression as pills are currently combined in regimens and ART is more powerful. Even with regimens consisting of a single daily pill and lower ART adherence rates required, most YLH don’t seek or receive the care they need to achieve viral suppression. While 41% of YLH are aware of their infection, only 62% receive medical care within 12 months after being diagnosed. Retention rates are low and just one-fourth of YLH are retained in care 3 years after they begin treatment.
“Without a dramatic reversal, HIV incidence among adolescents is expected to increase, and each additional infection costs $379,668 (in 2010). The Enhanced Stepped Care model proposed in this study is expected to result in better outcomes and cost savings for society by preventing HIV secondary transmission and postponing disease progression,” researchers concluded.
Arnold EM, Swendeman D, Harris D, et al. The stepped care intervention to suppress viral load in youth living with HIV: protocol for a randomized controlled trial. JMIR Res Protoc. 2019;8(2). doi: 10.2196/10791.