Clinical trial NCT06370780: Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically
Official title: Exploring, Predicting, and Intervening on Long-term Viral Suppression Electronically
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Florida State University
name: University of California, Irvine
name: University of North Carolina, Chapel Hill
name: AIDS Healthcare Foundation
First posted: 2024-04-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Despite the widespread availability of effective antiretroviral therapy (ART) in the United States, there remains significant numbers of people living with HIV (PLWH) who fail to achieve and or maintain viral suppression (VS). Disparities persist with the lowest levels of VS among Black individuals, people who use drugs, youth ages 18-24 and people residing in rural areas. Investigators will examine the syndemics underlying these outcomes including substance use, mental health, and barriers to HIV care including racial discrimination, stigma and rural isolation.

Detailed description: This study will follow a digital cohort via the REMAIN App. The REMAIN App is adapted from the HealthMPowerment (HMP) platform and tailored to our focus population's unique needs. Digital cohorts, or eCohorts, utilize the flexibility and capacity of the internet to complement traditional approaches to epidemiological research, helping address some of the limitations and challenges associated with conventional cohort studies.

Aim 1 of this study is to recruit and retain a geographically and demographically diverse cohort of PLWH who are sub optimally engaged in care and with a history of, at high risk for, or not currently virally suppressed. Outcomes for this are levels of recruitment and retention to hit the study objectives to enroll 1,000 PLWH at risk for or experiencing VNS and follow them for up to 48 months. Aim 2 is to evaluate longitudinal patterns of care engagement within the cohort by modeling and advanced epidemiologic methods utilizing remote collection of biomarkers of HIV disease (e.g., viral load), online surveys, and brief, frequent app-based "check-ins". Outcomes include both those related to VS and engagement in care as well as engagement in the digital cohort.

Eligibility criteria: Inclusion Criteria:

* Have access to a personal smartphone device;
* Over 18 years of age;
* Speak English or Spanish;
* Living with HIV
* Are either 1) not currently virally suppressed, 2) not currently engaged in care, or 3) have one or more factors associated with viral non suppression including a history of missed appointments or viral non suppression;
* Active substance use or mental health disorder;
* Willing and able to provide written informed consent to take part in the study.

Exclusion Criteria:

* Unwilling or unable to provide reliable contact information;
* Unwilling to provide blood sample for HIV virology testing;
* Living with HIV and virally suppressed and not at risk of becoming unsuppressed in the near future.

Primary outcomes:
measure: Incidence of HIV Viral Suppression
timeFrame: past 3 months
measure: Level of Adherence to HIV medication
timeFrame: past 6 months
measure: Level of Adherence based on HIV appointments
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Pamina Gorbach, DrPh
role: PRINCIPAL_INVESTIGATOR
References: