HIV/AIDS
Conditions
Keywords
ART, PLWH, HIV Infections, Acquired Immunodeficiency Syndrome
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.
Interventions
The Intervention group will receive the Wise App that delivers medication adherence reminders.
BEHAVIORALCHW Sessions
The Intervention group will complete sessions with a community health worker (CHW).
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Therapy (ART) Adherence - CleverCap | Up to 3 months | 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. |
| Score on the Self-Rating Scale Item (SRSI) | 3 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Standard of care | 20 |
| 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). | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 7 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Control | Intervention or CHAMPS |
|---|---|---|---|
| Age, Continuous | 47.85 years STANDARD_DEVIATION 12.64 | 49.2 years STANDARD_DEVIATION 13.52 | 46.5 years STANDARD_DEVIATION 11.89 |
| Children No | 27 Participants | 12 Participants | 15 Participants |
| Children Yes | 13 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 18 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Highest Level of Education Associate degree or technical degree | 7 Participants | 4 Participants | 3 Participants |
| Highest Level of Education Bachelor/college degree | 5 Participants | 2 Participants | 3 Participants |
| Highest Level of Education Elementary School | 0 Participants | 0 Participants | 0 Participants |
| Highest Level of Education High school diploma or equivalent | 10 Participants | 5 Participants | 5 Participants |
| Highest Level of Education None | 0 Participants | 0 Participants | 0 Participants |
| Highest Level of Education Professional or graduate degree | 3 Participants | 1 Participants | 2 Participants |
| Highest Level of Education Some college | 10 Participants | 6 Participants | 4 Participants |
| Highest Level of Education Some high school, no diploma | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants | 10 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 40 participants | 20 participants | 20 participants |
| Relationship Status Divorced/separated from a man | 1 Participants | 1 Participants | 0 Participants |
| Relationship Status Divorced/separated from a woman | 1 Participants | 1 Participants | 0 Participants |
| Relationship Status In a relationship with a man | 9 Participants | 6 Participants | 3 Participants |
| Relationship Status In a relationship with a woman | 1 Participants | 1 Participants | 0 Participants |
| Relationship Status Other | 3 Participants | 1 Participants | 2 Participants |
| Relationship Status Single | 24 Participants | 10 Participants | 14 Participants |
| Relationship Status Widowed | 1 Participants | 0 Participants | 1 Participants |
| Score on the Self-Rating Scale Item | 4.85 units on a scale STANDARD_DEVIATION 1.33 | 4.80 units on a scale STANDARD_DEVIATION 1.34 | 4.9 units on a scale STANDARD_DEVIATION 1.35 |
| Sex/Gender, Customized Female | 15 Participants | 7 Participants | 8 Participants |
| Sex/Gender, Customized Male | 24 Participants | 12 Participants | 12 Participants |
| Sex/Gender, Customized Something Else | 1 Participants | 1 Participants | 0 Participants |
| Viral Load Viral Load Detectable | 12 Participants | 3 Participants | 9 Participants |
| Viral Load Viral Load Not Detectable | 28 Participants | 17 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 months
Population: 17 analyzed as an insufficient sample was provided by n=1 (did not yield a result)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control | Viral Load | Viral Load Not Detectable | 15 Participants |
| Control | Viral Load | Viral Load Detectable | 2 Participants |
| Intervention or CHAMPS | Viral Load | Viral Load Not Detectable | 11 Participants |
| Intervention or CHAMPS | Viral Load | Viral Load Detectable | 1 Participants |
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.
Time frame: Up to 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Antiretroviral Therapy (ART) Adherence - CleverCap | 60.08 percentage of prescribed doses | Standard Deviation 19.15 |
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).
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Score on the Self-Rating Scale Item (SRSI) | 5.27 score on a scale | Standard Deviation 1.23 |
| Intervention or CHAMPS | Score on the Self-Rating Scale Item (SRSI) | 5.25 score on a scale | Standard Deviation 1.17 |