October 10, 2017 - CARES Protocols ATN 147, 148, and 149 Initiate Enrollment
CARES ATN protocols 147, 148, and 149 began enrollment in May. ATN 147 aims to identify recently infected/ recently diagnosed HIV-1 infected youth between the ages of 13 to 24 years in the greater Los Angeles area and in New Orleans. ATN 148 tests a Stepped Care Model to achieve viral suppression – by increasing adherence to the HIV Treatment Continuum. ATN 149 screens seronegative youth at highest risk for HIV in homeless shelters and gay-identified community-based organizations (CBO). Enrollment in all three studies commenced in May in Los Angeles and in June at the New Orleans site.
ATN 147, Early Treatment for Acutely Infected Youth, aims to rapidly initiate prompt, potent antiretroviral therapy (ARV) upon immediate identification of an HIV-infected subject. The study aims to evaluate HIV viral reservoir load over time in patients with acute/ recent HIV infection. Determination of length of HIV infection in each subject is assessed by Feibig staging. Participants in Study One are referred from the community or from Study 3 (which follows a cohort of youth at risk for HIV acquisition) following diagnosis of HIV infection. Following written informed consent participants are enrolled, evaluated and prescribed user friendly, once daily ART. Participants are paired with coaches for support and encouragement of adherence to the ART regimen. Study sites include the UCLA CARE4Youth Clinic (Division of Pediatric Infectious Diseases), the Los Angeles LGBT center, and Tulane University in New Orleans, Division of Adolescent Medicine.
ATN 148, Stepped Care for Youth Living with HIV, utilizes a strategy used in managing other chronic diseases, not yet applied to HIV. In a stepped care design, providers implement the least intensive intervention needed to achieve the treatment goal and intensify the intervention until the treatment goal is achieved. The Stepped Care arm has three levels of intervention:
- Level 1: Standard Care is a daily text messaging (automated messaging) and a weekly query in six areas of the youth’s life (a monitoring survey). This is called automated messaging and monitoring (AMMI).
- Level 2: A Peer Support and AMMI (PS-AMMI) plus the Standard Care; and
- Level 3: A Coach plus PS-AMMI plus the Standard Care.
YLH with established HIV infection (N=220) are identified by screening each youth seeking services at five homeless shelters and gay-identified community based organizations in Los Angeles and 5 parallel agencies in New Orleans. The YLH are randomly assigned during the recruitment process when it is determined that the YLH has an established HIV infection. Over 24 months, viral load is monitored at 4-month intervals as the primary outcomes by assessing ARV in the blood. Secondary outcomes are sexually transmitted infection (STI), serious substance abuse, and retention in care and antiretroviral (ARV) therapy adherence. The study examines the mediating effect of reducing substance use and reducing depression on viral suppression, as well document the frequency and type of life challenges and barriers YLH experience to achieve viral suppression and how the quality of the peer support and coaching may impact outcomes.
ATN 149, Cost-efficient Interventions for Youth at Risk for HIV, is a randomized controlled trial (RCT) of seronegative youth at highest risk for HIV using four intervention conditions:
- an Automated Messaging and Monitoring Intervention (AMMI), which uses texts to diffuse prevention messages daily and to monitor risk behaviors weekly (n=900);
- a Peer Support intervention on a social media platform (i.e., Facebook) in which young people post messages and stories about their experiences preventing HIV, plus the AMMI (n=200);
- a coaching. intervention in which a B.A.-level staff supports youth, primarily through texting and social media, but also in-person meetings, to provide support in crisis situations, refer to treatment, and assist in gaining access to health care and other services, plus Peer Support and AMMI (n=200); and,
- a combined intervention of coaching., Peer Support, and AMMI (n=200).
A single outcome is composed of six key behaviors (access to medical care, accessing and adherence to PrEP or PEP, treatment of all STI, and 100% condom use). In addition to evaluating the added benefit of increasing levels of intervention, the brief 7-item weekly text-messaging monitoring surveys provide approximately 100,000 weekly reports of indicators of primary and secondary outcomes that can inform our understandings about the relationships between risk and comorbid states.