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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR019758 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Wise App that delivers medication adherence reminders and community health worker sessions |
|
| Control | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wise App with medication adherence reminders | Device | The Intervention group will receive the Wise App that delivers medication adherence reminders. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Virally Suppressed Participants | The number of virally suppressed participants. Viral suppression defined as viral load of <200 copies/mL. | 6 month follow up, 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH, RN | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham AIDS Outreach | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40634827 | Derived | 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. | |
| 37226141 | Derived | Wood 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Wise App that delivers medication adherence reminders and community health worker sessions Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders. CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW). |
| FG001 | Control | Standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Wise App that delivers medication adherence reminders and community health worker sessions Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders. CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Virally Suppressed Participants | The number of virally suppressed participants. Viral suppression defined as viral load of <200 copies/mL. | N=123 intervention (CHAMPS) participants completed the 6 month visit. Of the 123 samples collected, four samples could not be processed by the laboratory, resulting in 119 analyzed. N=113 intervention participants completed the 12 month visit. Of the 113 completers, seven samples could not be processed by the laboratory, resulting in 106 analyzed in the intervention arm. N=116 analyzed in the control arm at month 12, as six samples could not be processed by the laboratory. | Posted | Count of Participants | Participants | 6 month follow up, 12 month follow up |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Wise App that delivers medication adherence reminders and community health worker sessions Wise App with medication adherence reminders: The Intervention group will receive the Wise App that delivers medication adherence reminders. CHW Sessions: The Intervention group will complete sessions with a community health worker (CHW). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Schnall, PhD, MPH, RN | Columbia University | 212-342-6886 | rb897@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2023 | Jan 30, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2021 | Jan 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| CHW Sessions | Behavioral | The Intervention group will complete sessions with a community health worker (CHW). |
|
| 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). |
| 6 month follow up and 12 month follow up |
| Birmingham |
| Alabama |
| 35294 |
| United States |
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| BG001 |
| Control |
Standard of care |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education Level | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| Viral Suppression | Viral suppression defined as an HIV viral load ≤200 copies/mL | Count of Participants | Participants |
|
| OG001 | Control | Standard of care |
|
|
| Secondary | 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. | 141 participants analyzed as 141 participants used the CleverCap device and app. Nine participants never used the CleverCap device and app. | Posted | Mean | Standard Deviation | Days | Up to 12 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Error | score on a scale | 6 month follow up and 12 month follow up |
|
|
|
| 1 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
| EG001 | Control | Standard of care | 5 | 150 | 0 | 150 | 0 | 150 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |