HIV/AIDS
Conditions
Keywords
ART, PLWH
Brief 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) 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.
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
National Institute of Nursing Research (NINR)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Virally Suppressed Participants | 6 month follow up, 12 month follow up | The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antiretroviral Therapy (ART) Adherence - CleverCap | Up to 12 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 12 months) and report the number of days used. |
| Change in Score on the Self-Rating Scale Item (SRSI) | 6 month follow up and 12 month follow up | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 150 |
| Control Standard of care | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 20 |
| Overall Study | Withdrawal by Subject | 11 | 8 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 11.7 | 46.8 years STANDARD_DEVIATION 11.4 | 49.4 years STANDARD_DEVIATION 11.9 |
| Education Level Greater than high school | 127 Participants | 58 Participants | 69 Participants |
| Education Level High school education/(General Education Development (GED) | 88 Participants | 47 Participants | 41 Participants |
| Education Level Less than high school | 84 Participants | 45 Participants | 39 Participants |
| Education Level Unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 39 Participants | 22 Participants | 17 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 219 Participants | 104 Participants | 115 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 10 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 28 Participants | 17 Participants | 11 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 300 participants | 150 participants | 150 participants |
| Sex/Gender, Customized Female | 134 Participants | 66 Participants | 68 Participants |
| Sex/Gender, Customized Male | 146 Participants | 74 Participants | 72 Participants |
| Sex/Gender, Customized Other | 19 Participants | 10 Participants | 9 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 0 Participants | 1 Participants |
| Sexual Orientation Heterosexual | 153 Participants | 76 Participants | 77 Participants |
| Sexual Orientation Homosexual | 98 Participants | 52 Participants | 46 Participants |
| Sexual Orientation Other | 45 Participants | 22 Participants | 23 Participants |
| Sexual Orientation Unknown | 4 Participants | 0 Participants | 4 Participants |
| Viral Suppression No | 78 Participants | 41 Participants | 37 Participants |
| Viral Suppression Unknown | 13 Participants | 5 Participants | 8 Participants |
| Viral Suppression Yes | 209 Participants | 104 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 150 | 5 / 150 |
| other Total, other adverse events | 0 / 150 | 0 / 150 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
Number of Virally Suppressed Participants
The number of virally suppressed participants. Viral suppression defined as viral load of \<200 copies/mL.
Time frame: 6 month follow up, 12 month follow up
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Virally Suppressed Participants | 6 months | 97 Participants |
| Intervention | Number of Virally Suppressed Participants | 12 months | 79 Participants |
| Control | Number of Virally Suppressed Participants | 6 months | 94 Participants |
| Control | Number of Virally Suppressed Participants | 12 months | 89 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 12 months) and report the number of days used.
Time frame: Up to 12 months
Population: 141 participants analyzed as 141 participants used the CleverCap device and app. Nine participants never used the CleverCap device and app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Antiretroviral Therapy (ART) Adherence - CleverCap | 244 Days | Standard Deviation 124 |
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).
Time frame: 6 month follow up and 12 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Change in Score on the Self-Rating Scale Item (SRSI) | 0.04 score on a scale | Standard Error 0.13 |
| Control | Change in Score on the Self-Rating Scale Item (SRSI) | -0.08 score on a scale | Standard Error 0.13 |