Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+) (CHAMPS+)

Although global efforts have been made to end the HIV epidemic, there are still some gaps in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among people with HIV (PWH). These gaps are particularly prominent in the Deep South of the United States (US), where PWH face challenges in accessing healthcare services. In response, a team of experienced researchers has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention. This intervention uses mobile health (mHealth) technology and a team of community health workers (CHW) to design an intervention to improve ART adherence and VS. The CHAMPS+ intervention adds a CHW delivered supportive risk reduction counseling during periods of non-suppression to prevent HIV transmission. The study will engage the participants by developing culturally relevant materials and retention strategies, evaluating the clinical effectiveness and sustainability of the intervention in Deep South settings, and assessing regionalized implementation factors. Ultimately, the study will test the effectiveness of CHAMPS+ on ART adherence and viral load suppression for PWH in Alabama, Louisiana, and Mississippi.

Study Overview

• Status: Recruiting
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: CHW Sessions; Device: CleverCap

Detailed Description

Despite efforts to achieve UNAIDS 95-95-95 targets, marked deficits remain in HIV testing, antiretroviral therapy (ART) adherence, and viral suppression (VS) among a growing number of persons with HIV (PWH). Gaps in HIV treatment success are particularly pronounced in the United States (US) Deep South. 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 PWH. In this way, the development and evaluation of interventions using a resource-savvy cadre of community health workers (CHW) holds promise for addressing these challenges. Yet, gaps exist in the CHW literature, and research is needed to bring CHW interventions to scale to ameliorate the large gaps in the US HIV Care Continuum, particularly in Ending the HIV Epidemic (EHE) priority locations.

In response, the study team has developed and tested the Community Health Workers And MHealth to ImProve Viral Suppression (CHAMPS) intervention which leverages mobile health (mHealth) technology to create a multi-component intervention that targets multiple levels (individual, social and sexual networks, and community) to improve ART adherence and VS. The study team will build on the strong preliminary data of extant intervention work in PWH by leveraging the CHAMPS intervention which will be delivered by personnel from four HIV care settings in the Deep South. The CHAMPS+ intervention is delivered via an mHealth platform to support PWH to self-manage their ART regimens and adds to the extant CHAMPS intervention by adding a CHW-delivered supportive risk reduction counseling (sexual behavior and substance use) during periods of non-suppression to prevent HIV transmission. This study also builds upon mChoice (U01PS005229) and WiseApp (R01HS025071) studies to improve ART adherence and VS in the Deep South. This study design has a three-fold purpose of: 1) engaging the target population in the development of culturally relevant recruitment materials and retention strategies for the study, 2) assessing the clinical effectiveness and sustainability of the intervention in Deep South settings, and 3) evaluating regionalized implementation factors guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Ultimately, this study will test CHAMPS+ to promote ART adherence and suppressed viral load for PWH in in Alabama, Louisiana (Orleans Parish), and Mississippi, US EHE prioritized jurisdictions. Importantly, the multi-component intervention targets multiple levels to address HIV risk behaviors during periods of non-suppression--an innovative and impactful component likely to be of great public health import.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Schnall, PhD, MPH; Phone Number: 212-342-6886; Email: rb897@columbia.edu
• Study Contact Backup: Name: Maeve Brin; Phone Number: 212-305-8198; Email: mb4953@cumc.columbia.edu

Study Locations

• United States
  • Alabama
    • Hobson City, Alabama, United States, 36202
      • Recruiting
      • Health Services Center, Inc.
      • Contact: Kelly Turner, MS, ADC
    • Opelika, Alabama, United States, 36801
      • Recruiting
      • Unity Wellness Center
      • Contact: Tracy Wynne, MBA
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Tulane University
      • Contact: D. Scott Batey, PhD, MSW; Phone Number: (504) 862-3485; Email: dsbatey@tulane.edu
    • New Orleans, Louisiana, United States, 70112
      • Recruiting
      • Louisiana State University Health Sciences Center in New Orleans
      • Contact: Meredith Clement, MD
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Recruiting
      • University of Mississippi Medical Center
      • Contact: Mauda Monger, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Be able to speak, read, and write in English;
• Be above 18 years of age;
• Be willing to participate in any assigned arm of the intervention;
• Have an HIV-1 RNA level >200 copies/mL;
• Own a smartphone;
• Be able and willing to provide informed consent for study participation and consent for access to medical records.
• Live, work and or receive care in AL, LA, or MS

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; and
• Planning to move out of the area in the next 12 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; The control condition includes standard health services offered at each site. All participants receive referrals to mental health, drug/alcohol treatment, and/or other HIV services as necessary. Standard of care at each site follows the Dept. of Health and Human Services HIV guidelines.
Experimental: Intervention CHAMPS+; Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Additionally, participants will receive 10-12 sessions with CHWs, and sexual health log to keep track of their sexual behavior.	Behavioral: CHW Sessions; Sessions with a Community Health Worker (CHW).; Device: CleverCap; The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Viral Load	Using blood samples obtained during standard of care visits, viral load levels will be used to asses ART adherence.	Baseline, 6 month follow up, 12 month follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ART adherence - CleverCap.	The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data from participants in the intervention arm 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.
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. The total score range is 1(very poor) to 6 (excellent). A higher score indicates higher self-reported adherence.	Baseline, 6 month follow up, 12 month follow up.

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: University of Alabama at Birmingham; National Institute on Minority Health and Health Disparities (NIMHD); Tulane University; Louisiana State University Health Sciences Center in New Orleans; University of Mississippi Medical Center; Health Services Center, Inc.; Unity Wellness Center
• Investigators: Principal Investigator: Rebecca Schnall, PhD, MPH, Columbia University; Principal Investigator: Scott Batey, PhD, MSW, Tulane University

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): December 22, 2027

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: June 18, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: AAAU8885; R01MD019184 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes