RecruitingNot ApplicableNCT06472206

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


Sponsor

Columbia University

Enrollment

420 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria3

  • 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.

Interventions

BEHAVIORALCHW Sessions

Sessions with a Community Health Worker (CHW).

DEVICECleverCap

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.


Locations(5)

Health Services Center, Inc.

Hobson City, Alabama, United States

Unity Wellness Center

Opelika, Alabama, United States

Louisiana State University Health Sciences Center in New Orleans

New Orleans, Louisiana, United States

Tulane University

New Orleans, Louisiana, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

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NCT06472206


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