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SteadyRx: Smartphone ART Adherence Intervention for Drug Users
NA trial testing SteadyRx in HIV in 51 participants. Completed in 30 April 2018.
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 2 May 2016 |
| Primary completion | 30 April 2018 |
| Estimated completion | 30 April 2018 |
| Sites | 1 location across United States |
Johns Hopkins University
Adults 18 to 100, any sex, with HIV or Medication Adherence. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The MEMS cap is a device that records the date and time whenever a patient opens a vial to monitor medication adherence. Percentage of participant to achieve 95% adherence will then be recorded.
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 52.2 | |
| Usual Care | 27.2 |
Measured twice in six months to assess the percentage of participants to achieve a viral load \<400 HIV-RNA/mL (Y/N)
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 88.1 | |
| Usual Care | 100 |
This measure is calculated for each participant in each study month. The number of days in the month in which the participant correctly consumed their antiretroviral medication is divided by the number of days in the month. The measure is collected by an electronic pill bottle cap (a.k.a. "MEMS cap").
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 87.97 | ± 1.64 |
| Usual Care | 73.88 | ± 2.4 |
Actual HIV-RNA levels, measured at the same time as the undetectable viral load outcome measure
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 248.17 | ± 182.64 |
| Usual Care | 23.38 | ± 1.37 |
The 35-item questionnaire includes ten dimensions (health perceptions, pain, physical, role, social and cognitive functioning, mental health, energy, health distress and quality of life (QoL). Subscales are scored on a 0-100 scale (a higher score indicates better health) and separate physical and mental health summary scores are calculated. Summary scores for these items are transforms with a mean of 50 and a standard deviation of 10. Thus, for both scores, being of average (physical or mental) health leads to a score of 50, with a range of 20 to 80.
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 54.6 | ± 8.33 |
| Usual Care | 51.4 | ± 12.36 |
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 45.63 | ± 11.41 |
| Usual Care | 42.75 | ± 12.95 |
Measured using monthly self-report. Response will be binary (Yes/No). The percentage of the participants that reported yes will be recorded for each month and then an average for the 6 month period calculated.
| Group | Value | 95% CI |
|---|---|---|
| SteadyRx | 20.0 | ± 9.0 |
| Usual Care | 22.8 | ± 4.9 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | SteadyRx | Usual Care |
|---|---|---|---|
| Death | Immune system disorders | — | — |
| Hospitalization | Immune system disorders | — | — |
Most-reported serious reactions: Death, Hospitalization.
Data from ClinicalTrials.gov NCT02317614 adverse events section.
Antiretroviral therapy (ART) increases life expectancy and quality of life for individuals infected with HIV, and can reduce the chance of HIV transmission, but a high degree of adherence to ART is required to achieve these benefits. Unfortunately, only 59% of patients in North America report ART adherence \>90%. Thus, ART adherence interventions are a critical part of the fight against HIV/AIDS. Injection drug use and crack cocaine use are major factors in the transmission of HIV, and are associated with non-adherence to ART. Several types of interventions, most notably directly administered antiretroviral therapy (direct observation of antiretroviral administration and patient supports) and contingency management (the provision of incentives contingent upon objective evidence of adherence) have been effective in promoting ART adherence in drug users. However, a core problem with all ART adherence interventions is that their effects do not last after the interventions are discontinued. The common finding of post-intervention dissipation of effects suggests that ART adherence interventions may need to be long-term or even permanent adjuncts to ART for drug users. The investigators intend to develop an intensive intervention that incorporates the most effective techniques for promoting ART adherence in drug users, and delivers them in a manner that allows for their large-scale implementation as long-term or even permanent adjuncts to ART. Thus, we will bundle a targeted group of effective component interventions into a smartphone application that is easy for patients to use, simple to manage, and maximally convenient for all stakeholders. Our ultimate goal is to produce an intervention that is highly effective and scalable. Toward that end, the SteadyRX intervention to be developed under this project will be largely automated and will (1) facilitate consultation with care providers (2) provide reminders when a dose is overdue, (3) provide electronic remote observation of medication-taking, and (4) reward ART adherence. In addition to developing this smartphone-based intervention, a pilot study will be conducted in 50 HIV+ adults with a history of problem drug use. In this study, participants will be randomly assigned to receive usual care, or usual care plus the SteadyRX intervention.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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