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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention or CHAMPS | 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 |
|---|---|---|
| Viral Load | Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (>= 200 copies/mL in EHR; >= 500 copies/mL in DBS) and not detectable viral load (<200 copies/mL in EHR, <500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline. | 3 months |
| 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 3 months), and it is a count response (number of times taking medication each day). The percentage of their prescribed doses taken will be reported. | Up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Schnall, PhD, MPH, RN | Columbia University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University School of Nursing | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40173448 | Derived | Shourya S, Liu J, McInerney S, Casimir T, Kenniff J, Kershaw T, Batey D, Schnall R. A Remote Intervention Based on mHealth and Community Health Workers for Antiretroviral Therapy Adherence in People With HIV: Pilot Randomized Controlled Trial. JMIR Form Res. 2025 Apr 2;9:e67997. doi: 10.2196/67997. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard of care |
| FG001 | Intervention or CHAMPS | 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). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Standard of care |
| BG001 | Intervention or CHAMPS | 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 | Viral Load | Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (>= 200 copies/mL in EHR; >= 500 copies/mL in DBS) and not detectable viral load (<200 copies/mL in EHR, <500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline. | 17 analyzed as an insufficient sample was provided by n=1 (did not yield a result) | Posted | Count of Participants | Participants | 3 months |
|
3 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 | Control | Standard of care | 0 |
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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 | Mar 22, 2024 | Dec 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| CHW Sessions | Behavioral | The Intervention group will complete sessions with a community health worker (CHW). |
|
| Score on the Self-Rating Scale Item (SRSI) | The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent). | 3 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Relationship Status | Count of Participants | Participants |
|
| Children | Are a parent to a child or children. | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Viral Load | Using dried blood spot samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (>=200 copies/mL in electronic health record (EHR), >=500 copies/mL in DBS) and not detectable viral load (<200 copies/mL in EHR, <500 in dried blood spot (DBS)) will be reported. | Count of Participants | Participants |
|
| Score on the Self-Rating Scale Item | The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent). | Mean | Standard Deviation | units on a scale |
|
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).
|
|
|
| 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 3 months), and it is a count response (number of times taking medication each day). The percentage of their prescribed doses taken will be reported. | This outcome measures ART adherence using CleverCap. The control group is not reported in this outcome as they were not exposed to the intervention and therefore did not receive the CleverCap device. | Posted | Mean | Standard Deviation | percentage of prescribed doses | Up to 3 months |
|
|
|
| Secondary | Score on the Self-Rating Scale Item (SRSI) | The Self-Rating Scale Item is a single-item self-report adherence measure that uses a 6-point Likert scale to describe medication adherence over the past 4 weeks. Scores range from 1(very poor) to 6 (excellent). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Intervention or CHAMPS | 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). | 0 | 20 | 0 | 20 | 0 | 20 |
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| 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 |