NCT06472206 Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
| NCT ID | NCT06472206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | HIV/AIDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2027-07-22 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2024-09-23 with a primary completion date of 2027-07-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Rebecca Schnall, PhD, MPH
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06472206 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HIV/AIDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06472206 currently recruiting?
Yes, NCT06472206 is actively recruiting participants. Contact the research team at rb897@columbia.edu for enrollment information.
Where is the NCT06472206 trial being conducted?
This trial is being conducted at Hobson City, United States, Opelika, United States, New Orleans, United States, New Orleans, United States and 1 additional location.
Who is sponsoring the NCT06472206 clinical trial?
NCT06472206 is sponsored by Columbia University. The principal investigator is Rebecca Schnall, PhD, MPH at Columbia University. The trial plans to enroll 420 participants.
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