An interventional study of Group A_No feedback and Group B_Automated feedback in HIV/AIDS and Cocaine Use, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by Yale University · Not applicable, Interventional, and Other
The aim of this study is to examine the effect of mHealth tools on antiretroviral (ART) adherence and persistence among HIV-infected individuals with co-occurring cocaine use disorders (CUDs).
To conduct qualitative assessments using focus groups of people living with HIV (PLH) who use cocaine and healthcare providers that will assess the acceptability, feasibility, facilitators and barriers of implementing mHealth interventions; and will aid in developing the final design and content of both automated and clinician feedback in preparation for designing a pilot feasibility study.
To conduct a 12-week pilot feasibility RCT among PLH with co-occurring CUDs that will examine the impact of mHealth tools (cellular-enabled smart pill boxes and cell phones) and feedback (no feedback vs. automated feedback vs. automated + clinician feedback) on primary (ART adherence and persistence) and secondary outcomes (HIV viral suppression, cocaine use, retention in HIV care).
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Exclusion Criteria:
For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Device: Group A_No feedback
For participants in Group B (automated feedback), automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages.
Device: Group B_Automated feedback
For participants in Group C, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, clinical nurse will also send personalized feedback and suggestions to the participants in this group.
Device: Group C_Automated feedback + Clinician feedback
For participants in Group D, automated feedback will be generated from the TowerView Health® smart pill box and sent to participants' smartphone as text messages. In addition, a weekly text reminder will be sent to each participant from a social network designee chosen by the participant.
Device: Group D_Automated feedback + Social Network feedback
In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period
Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
Time frame: Week 12
Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period)
This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.
Time frame: Week 16
Changes in HIV 1 RNA, QN PCR (Copies/ML)
HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
Time frame: End of intervention (Week 12)
Percent Change in CD4 Count From Baseline to Week 12
CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.
Time frame: Baseline and End of intervention (Week 12)
Retention in Care
Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).
Time frame: up to End of the study (week 16)
Participants were recruited from two sites--New Haven and Hartford, CT. Recruitment started in June 2017 and concluded in January 1st 2020.
| Milestone | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|
| Started | 19 | 20 | 16 | 23 |
| 9 participants had complete lab results at 16 weeks | 1 | 3 | 4 | 1 |
| 57 participants completed 12 weeks | 15 | 15 | 11 | 16 |
| Completed | 13 | 15 | 12 | 17 |
| Not completed | 6 | 5 | 4 | 6 |
| Withdrew: Death | 1 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 2 | 5 | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 1 |
| Withdrew: Dropped out after receiving pillbox and phone | 2 | 0 | 2 | 3 |
Adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder based on the real time record of the behavior provided by the electronic pill box.
| percentage of times pills taken | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|
| Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | 91.07 ± 25.58 | 96.00 ± 12.98 | 99.82 ± .60 | 94.81 ± 13.48 |
This is a follow up period where participants adherence will be measured in percentage of times pills taken in time or within 90 mins of reminder after being the study for 16 weeks. The information will be based on the real time record of the behavior provided by the electronic pill box.
| percentage of times pills taken | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|
| Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | 96.31 ± 7.49 | 93.00 ± 25.76 | 92.75 ± 21.53 | 93.24 ± 24.15 |
HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection.
| Participants | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|
| Changed to maximum viral suppression | 0 | 2 | 2 | — |
| Viral load decreased but not achieve max viral suppression | 0 | 0 | 2 | — |
| Viral load increase | 3 | 3 | 1 | — |
| No change and remained max suppression | 5 | 4 | 3 | — |
| No change and remained viral suppression or no viral suppression | 0 | 1 | 0 | — |
CD4 T lymphocyte (CD4) cell count are markers of antiretroviral treatment (ART) responses. Participants will be asked to perform testing including CD4 lymphocyte count at the end of intervention (Week 12). The value is calculated by the percentage of CD4 at Week 12 minus the percentage of CD4 at baseline.
| percentage of CD4 (helper cells) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|
| Percent Change in CD4 Count From Baseline to Week 12 | 27.00 ± 13.33 | 26.09 ± 12.75 | 28.8 ± 9.96 | 30.81 ± 6.56 |
Participants medical chart review will be reviewed to look at the number of doctor's visit for for the duration of the study (4 months).
No measurements were reported for this outcome.
Collected over Up to 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Feedback | 1/19 (5.3%) | 0/19 (0%) | 0/19 (0%) |
| Automated Feedback | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Automated Feedback + Clinician Feedback | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Automated Feedback + Social Network Feedback | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Age, Continuous(years) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Mean | 55.91 ± 7.70 | 54.78 ± 6.81 | 51.45 ± 6.45 | 55.94 ± 6.35 | 54.65 ± 6.95 |
| Sex/Gender, Customized(Participants) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Male | 12 | 8 | 6 | 13 | 39 |
| Female | 7 | 9 | 9 | 9 | 34 |
| Transgender (male to female) | 0 | 3 | 1 | 1 | 5 |
| Transgender (female to male) | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| White | 6 | 5 | 5 | 2 | 18 |
| Black | 10 | 13 | 10 | 17 | 50 |
| Hispanic or Puerto Rican | 3 | 2 | 1 | 4 | 10 |
| Health literacy(units on a scale) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Mean | 4.04 ± .99 | 3.92 ± .92 | 3.92 ± .85 | 3.86 ± 1.02 | 3.93 ± .94 |
| Mental health (CESD-D10)(units on a scale) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Mean | 10.89 ± 6.67 | 9.80 ± 7.13 | 9.56 ± 6.18 | 11.43 ± 7.20 | 10.50 ± 6.77 |
| Alcohol screening AUDIT C(units on a scale) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Mean | 5.50 ± 3.09 | 3.46 ± 3.13 | 5.10 ± 3.64 | 4.00 ± 2.88 | 4.45 ± 3.17 |
| Presence of cocaine use disorder(Participants) | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback | Total |
|---|---|---|---|---|---|
| Yes | 19 | 19 | 16 | 21 | 75 |
| No | 0 | 1 | 0 | 2 | 3 |
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Plan to share: No — All data will be kept confidential.
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