NOT_YET_RECRUITING
Community Health Workers And MHealth to ImProve Viral Suppression Plus (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.
Conditions:
🦠 HIV/AIDS
🗓️ Study Start (Actual) 22 July 2024
🗓️ Primary Completion (Estimated) 22 July 2027
✅ Study Completion (Estimated) 22 December 2027
👥 Enrollment (Estimated) 420
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Hobson City, Alabama, United States
📍 Opelika, Alabama, United States
📍 New Orleans, Louisiana, United States
📍 New Orleans, Louisiana, United States
📍 Jackson, Mississippi, United States
📍 New York, New York, United States

📋 Eligibility Criteria

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;
    • * Have below 80% ART adherence as measured through the Single-Item Self-Rating Adherence Scale;
    • * Own a smartphone;
    • * Be able and willing to provide informed consent for study participation and consent for access to medical records.

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 18 June 2024
  • First Submitted that Met QC Criteria 18 June 2024
  • First Posted 25 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 1 July 2024
  • Last Update Posted 3 July 2024
  • Last Verified July 2024