Clinical trial NCT06472206: Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
Official title: Community Health Workers And MHealth to ImProve Viral Suppression Plus (CHAMPS+)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: University of Alabama at Birmingham
name: Health Services Center, Inc.
name: Unity Wellness Center
name: Louisiana State University Health Sciences Center in New Orleans
name: University of Mississippi Medical Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Tulane University
First posted: 2024-06-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Change in Viral Load
timeFrame: Baseline, 6 month follow up, 12 month follow up.
Secondary outcomes:
measure: Change in ART adherence - CleverCap.
timeFrame: Up to 12 months.
measure: Change in Score on the Self-Rating Scale Item (SRSI).
timeFrame: Baseline, 6 month follow up, 12 month follow up.
Other outcomes:
Locations:
city: Hobson City
country: United States
facility: Health Services Center, Inc.
state: Alabama
city: Opelika
country: United States
facility: Unity Wellness Center
state: Alabama
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center in New Orleans
state: Louisiana
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Columbia University
name: Rebecca Schnall, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tulane University
name: Scott Batey, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: