Clinical trial NCT04562649: Community Health Worker And MHealth to ImProve Viral Suppression
Official title: Community Health Worker And MHealth to ImProve Viral Suppression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: ART
PLWH
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-09-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The overall goal of this study is to evaluate the effects of the CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Detailed description: Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy (ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition. Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PLWH are not fully benefitting from ART due to poor adherence. These suboptimal HIV health outcomes occur at a time when clinicians have limited time and the US healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as PLWH. Therefore, the development and evaluation of interventions using a cadre of community health workers (CHW) holds promise for addressing these challenges in the US. This study addresses limitations in current research on CHW interventions to improve viral suppression and ART adherence. The investigators propose to build on strong preliminary data to strengthen a community health worker (CHW) intervention using an existing mHealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Eligibility criteria: Inclusion Criteria:

* Be able to communicate and read in English or Spanish
* Willing to participate in any assigned arm of the intervention
* Diagnosed with HIV ≥6 months ago
* Have an HIV-1 RNA level \>200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
* Have ART adherence \<80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
* Own a smartphone

Exclusion Criteria:

* Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
* Terminal illness with life expectancy \<6 months
* Planning to move out of the area in the next 12 months

Primary outcomes:
measure: Number of Virally Suppressed Participants
timeFrame: 6 month follow up, 12 month follow up
Secondary outcomes:
measure: Antiretroviral Therapy (ART) Adherence - CleverCap
timeFrame: Up to 12 months
measure: Change in Score on the Self-Rating Scale Item (SRSI)
timeFrame: 6 month follow up and 12 month follow up
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham AIDS Outreach
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: