Community Health Worker And MHealth to ImProve Viral Suppression

HIV/AIDS Clinical Trial

— CHAMPS  

Official title:

Community Health Worker And MHealth to ImProve Viral Suppression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04562649
• Other study ID #: AAAT2430
• Secondary ID: R01NR019758
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 3, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Device:
• Wise App with medication adherence reminders
The Intervention group will receive the Wise App that delivers medication adherence reminders.

Behavioral:
• CHW Sessions
The Intervention group will complete sessions with a community health worker (CHW).

Locations

Country	Name	City	State
United States	Birmingham AIDS Outreach	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Viral Load	Using blood samples obtained during study visits, viral load levels will be used to asses ART adherence.	Baseline, 6 month follow up, 12 month follow up
Secondary	Change in ART adherence - CleverCap	The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 12 months), and it is a count response (number of times taking medication each day).	Up to 12 months
Secondary	Change in Score on the Self-Rating Scale Item (SRSI)	The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent).	6 month follow up, 12 month follow up