Clinical trial NCT05938413: Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
Official title: Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Keywords: ART
PLWH
HIV Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goal of this study is to evaluate the feasibility of a remotely delivered CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.

Detailed description: Persons living with HIV (PLWH) now achieve a near-normal life expectancy due to antiretroviral therapy (ART) which has transformed HIV from a terminal diagnosis to a manageable chronic condition. Despite widespread availability of ART in the United States (US), many of the country's approximate 1.1 million PLWH are not fully benefitting from ART due to poor adherence. 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 PLWH. Therefore, the development and evaluation of interventions using a cadre of community health workers (CHW) holds promise for addressing these challenges in the US. This study addresses limitations in current research on CHW interventions to improve viral suppression and ART adherence. The ubiquitous nature of mHealth technologies in daily life creates opportunities for health behavior management tools that were not previously possible and has the potential to address many of the healthcare needs of PLWH. The investigators propose to build on strong preliminary data to strengthen a community health worker (CHW) intervention using an existing mHealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Eligibility criteria: Inclusion Criteria:

1. Able to speak, read, and write in English or Spanish;
2. Aged ≥18 years;
3. Willing to provide a valid form of identification for verification;
4. Willing to participate in any assigned arm of the intervention;
5. Having been diagnosed with HIV ≥6 months ago;
6. Have an HIV-1 RNA level \>200 copies/mL as verified by provision of medical records, or have a detectable load of \>500 copies/mL, as measured by dried blood spot (DBS) sample kits, or report either not being virally suppressed in the past 12 months or being virally unsuppressed in the past 12 months;
7. Own a smartphone;
8. Ability and willingness to provide informed consent for study participation and consent for access to medical records; and
9. Live in the United States

Exclusion Criteria:

1. Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
2. Terminal illness with life expectancy \<3 months;
3. Planning to move out of the country in the next 3months.

Primary outcomes:
measure: Viral Load
timeFrame: 3 months
Secondary outcomes:
measure: Antiretroviral Therapy (ART) Adherence - CleverCap
timeFrame: Up to 3 months
measure: Score on the Self-Rating Scale Item (SRSI)
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University School of Nursing
state: New York
Study officials:
affiliation: Columbia University School of Nursing
name: Rebecca Schnall, PhD, MPH, RN
role: PRINCIPAL_INVESTIGATOR
References: