HIV/AIDSCHAMPSNCT04562649
Community Health Worker And MHealth to ImProve Viral Suppression
A study testing Wise App with medication adherence reminders and CHW Sessions in people with HIV/AIDS, run by Columbia University at 3 sites in United States.
Trial summary
The overall goal of this study is to evaluate the effects of the 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Wise App with medication adherence reminders and CHW Sessions
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 May 2021to 19 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to communicate and read in English or Spanish
- Willing to participate in any assigned arm of the intervention
- Diagnosed with HIV ≥6 months ago
- Have an HIV-1 RNA level >200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
- Have ART adherence <80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
- Own a smartphone
Who cannot join
- Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
- Terminal illness with life expectancy <6 months
- Planning to move out of the area in the next 12 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Birmingham AIDS Outreach
Birmingham, Alabama, 35233
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Columbia University Irving Medical Center
New York, New York, 10032
About this study
The overall goal of this study is to evaluate the effects of the 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.
Read the 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 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.
- Conditions
- HIV/AIDS
- Being tested
- Wise App with medication adherence reminders, CHW Sessions
- Keywords
- ART, PLWH
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wise App with medication adherence remindersDevice
The Intervention group will receive the Wise App that delivers medication adherence reminders.
CHW SessionsBehavioural
The Intervention group will complete sessions with a community health worker (CHW).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Wise App that delivers medication adherence reminders and community health worker sessions Receives: Device: Wise App with medication adherence reminders; Behavioral: CHW Sessions |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Virally Suppressed Participants
The number of virally suppressed participants. Viral suppression defined as viral load of <200 copies/mL.
Measured: 6 month follow up, 12 month follow up
Secondary outcomes (2)
Antiretroviral Therapy (ART) Adherence - CleverCap
The CleverCapTM dispenser will automatically record each time a participant opens the dispenser. The investigators will collect adherence data each day from the start to the end of trial (day 1 to 12 months) and report the number of days used.
Measured: Up to 12 months
Change in Score on the Self-Rating Scale Item (SRSI)
The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 5-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent).
Measured: 6 month follow up and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start3 May 2021
- Primary completion19 Apr 2024
- Study completion19 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rebecca Schnall, RN, MPH, PhD, Columbia University
- Investigators
- Rebecca Schnall, PhD, MPH, RN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562649
- Sponsor's protocol ID
- AAAT2430
- Other IDs
- R01NR019758
- Acronym
- CHAMPS
- Status last verified
- Jan 2025
- First submitted
- 18 Sep 2020
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Schnall R, Jia H, Brin M, Kay ES, Wood OR, Abua J, Batey DS. Efficacy of CHAMPS for Improving Viral Suppression: A Randomised Clinical Trial. AIDS Behav. 2025 Nov;29(11):3703-3713. doi: 10.1007/s10461-025-04811-x. Epub 2025 Jul 10.
PubMed 40634827Wood OR, Schnall R, Kay ES, Jia H, Abua JA, Nichols TK, Olender SA, Mugavero MJ, Batey DS. A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol. BMC Public Health. 2023 May 24;23(1):942. doi: 10.1186/s12889-023-15616-9.
PubMed 37226141
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Health Worker And MHealth to ImProve Viral Suppression
- ClinicalTrials.gov ID
- NCT04562649
- Acronym / sponsor ID
- CHAMPS / AAAT2430
- Conditions
- HIV/AIDS
- Keywords
- ART, PLWH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 3 May 2021 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 19 Apr 2024 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 17 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to evaluate the effects of the 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Wise App with medication adherence reminders, Behavioral: CHW SessionsWise App that delivers medication adherence reminders and community health worker sessions |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to communicate and read in English or Spanish
- Willing to participate in any assigned arm of the intervention
- Diagnosed with HIV ≥6 months ago
- Have an HIV-1 RNA level >200 copies/mL, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months
- Have ART adherence <80%, as measured through Single-Item Self-Rating Adherence Scale (SRSI)
Key exclusion criteria (3 listed)
- Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment
- Terminal illness with life expectancy <6 months
- Planning to move out of the area in the next 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wise App with medication adherence remindersThe Intervention group will receive the Wise App that delivers medication adherence reminders. | Device | Intervention |
| CHW SessionsThe Intervention group will complete sessions with a community health worker (CHW). | Behavioural | Intervention |
Primary outcome
Number of Virally Suppressed Participants
Time frame: 6 month follow up, 12 month follow up
The number of virally suppressed participants. Viral suppression defined as viral load of <200 copies/mL.
2 secondary outcomes
Antiretroviral Therapy (ART) Adherence - CleverCap
Time frame: Up to 12 months
Change in Score on the Self-Rating Scale Item (SRSI)
Time frame: 6 month follow up and 12 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40634827Schnall R, Jia H, Brin M, Kay ES, Wood OR, Abua J, Batey DS. Efficacy of CHAMPS for Improving Viral Suppression: A Randomised Clinical Trial. AIDS Behav. 2025 Nov;29(11):3703-3713. doi: 10.1007/s10461-025-04811-x. Epub 2025 Jul 10.
- Derived from this study: PubMed 37226141Wood OR, Schnall R, Kay ES, Jia H, Abua JA, Nichols TK, Olender SA, Mugavero MJ, Batey DS. A community health worker and mobile health app intervention to improve adherence to HIV medication among persons with HIV: the CHAMPS study protocol. BMC Public Health. 2023 May 24;23(1):942. doi: 10.1186/s12889-023-15616-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Schnall, PhD, MPH, RN principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wise App with medication adherence reminders and CHW Sessions in people with HIV/AIDS, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Virally Suppressed Participants (time frame: 6 month follow up, 12 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04562649, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.