Cocaine Use, HIV/AIDS
Conditions
Brief summary
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).
Detailed description
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).
Interventions
DEVICEGroup A_No 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.
DEVICEGroup B_Automated feedback
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.
DEVICEGroup C_Automated feedback + Clinician feedback
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.
DEVICEGroup D_Automated feedback + Social Network feedback
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.
Sponsors
National Institutes of Health (NIH)
University at Albany
University of Connecticut
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age equal to or greater than 18 years * Clinic-confirmed HIV diagnosis * Currently prescribed or eligible for ART * Currently has insurance * Self-reported cocaine use in the past 30 days * Willing and able to use a cell phone and electronic pill box for the 12-week intervention
Exclusion criteria
* Unable to provide informed consent * Verbally or physically threatening to research staff * Unable to communicate in either English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | Week 12 | 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. |
| Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in HIV 1 RNA, QN PCR (Copies/ML) | End of intervention (Week 12) | HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection. |
| Percent Change in CD4 Count From Baseline to Week 12 | Baseline and End of intervention (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. |
| Retention in Care | up to End of the study (week 16) | 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). |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two sites--New Haven and Hartford, CT. Recruitment started in June 2017 and concluded in January 1st 2020.
Pre-assignment details
This study required participants to change their pharmacy for delivery of HIV medication , so that the medication blister pack could be inserted into the TowerView smart pillbox. In some cases, participants who had severe opioid use disorder were prevented by their provider from participating in this study; they prefer close monitoring. Other factors preventing participants from continuing included co-morbidities (cancer, severe SUD), incarceration, and difficulty with transportation.
Participants by arm
| Arm | Count |
|---|---|
| No Feedback For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given.
Group A\_No 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. | 19 |
| Automated 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.
Group B\_Automated feedback: 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. | 20 |
| Automated Feedback + Clinician 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.
Group C\_Automated feedback + Clinician feedback: 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. | 16 |
| Automated Feedback + Social Network 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.
Group D\_Automated feedback + Social Network feedback: 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. | 23 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 | 0 |
| Overall Study | Dropped out after receiving pillbox and phone | 2 | 0 | 2 | 3 |
| Overall Study | Lost to Follow-up | 2 | 5 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Total | No Feedback | Automated Feedback | Automated Feedback + Clinician Feedback | Automated Feedback + Social Network Feedback |
|---|---|---|---|---|---|
| Age, Continuous | 54.65 years STANDARD_DEVIATION 6.95 | 55.91 years STANDARD_DEVIATION 7.7 | 54.78 years STANDARD_DEVIATION 6.81 | 51.45 years STANDARD_DEVIATION 6.45 | 55.94 years STANDARD_DEVIATION 6.35 |
| Alcohol screening AUDIT C | 4.45 units on a scale STANDARD_DEVIATION 3.17 | 5.50 units on a scale STANDARD_DEVIATION 3.09 | 3.46 units on a scale STANDARD_DEVIATION 3.13 | 5.10 units on a scale STANDARD_DEVIATION 3.64 | 4.00 units on a scale STANDARD_DEVIATION 2.88 |
| Health literacy | 3.93 units on a scale STANDARD_DEVIATION 0.94 | 4.04 units on a scale STANDARD_DEVIATION 0.99 | 3.92 units on a scale STANDARD_DEVIATION 0.92 | 3.92 units on a scale STANDARD_DEVIATION 0.85 | 3.86 units on a scale STANDARD_DEVIATION 1.02 |
| Mental health (CESD-D10) | 10.50 units on a scale STANDARD_DEVIATION 6.77 | 10.89 units on a scale STANDARD_DEVIATION 6.67 | 9.80 units on a scale STANDARD_DEVIATION 7.13 | 9.56 units on a scale STANDARD_DEVIATION 6.18 | 11.43 units on a scale STANDARD_DEVIATION 7.2 |
| Presence of cocaine use disorder No | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Presence of cocaine use disorder Yes | 75 Participants | 19 Participants | 19 Participants | 16 Participants | 21 Participants |
| Race/Ethnicity, Customized Black | 50 Participants | 10 Participants | 13 Participants | 10 Participants | 17 Participants |
| Race/Ethnicity, Customized Hispanic or Puerto Rican | 10 Participants | 3 Participants | 2 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 6 Participants | 5 Participants | 5 Participants | 2 Participants |
| Sex/Gender, Customized Female | 34 Participants | 7 Participants | 9 Participants | 9 Participants | 9 Participants |
| Sex/Gender, Customized Male | 39 Participants | 12 Participants | 8 Participants | 6 Participants | 13 Participants |
| Sex/Gender, Customized Transgender (female to male) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Transgender (male to female) | 5 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 19 | 0 / 20 | 0 / 16 | 0 / 23 |
| other Total, other adverse events | 0 / 19 | 0 / 20 | 0 / 16 | 0 / 23 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 | 0 / 16 | 0 / 23 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | 91.07 percentage of times pills taken | Standard Deviation 25.58 |
| Automated Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | 96.00 percentage of times pills taken | Standard Deviation 12.98 |
| Automated Feedback + Clinician Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | 99.82 percentage of times pills taken | Standard Deviation 0.6 |
| Automated Feedback + Social Network Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 12-Week Intervention Period | 94.81 percentage of times pills taken | Standard Deviation 13.48 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | 96.31 percentage of times pills taken | Standard Deviation 7.49 |
| Automated Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | 93.00 percentage of times pills taken | Standard Deviation 25.76 |
| Automated Feedback + Clinician Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | 92.75 percentage of times pills taken | Standard Deviation 21.53 |
| Automated Feedback + Social Network Feedback | Adherence to Anti-Retroviral Therapy (ART) at the End of 16 Weeks (4-week Post-intervention Period) | 93.24 percentage of times pills taken | Standard Deviation 24.15 |
Secondary
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)
Population: If there is a change from viral suppression or not viral suppression to maximum viral suppression between baseline and intervention end date. Maximum viral suppression is \<20, viral suppression is \<200, not viral suppression is \>200 copies/ML. Only 26 participants whose labs are complete. Thus we were only able to analyze this outcome on 26 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained max suppression | 5 Participants |
| No Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load increase | 3 Participants |
| No Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Changed to maximum viral suppression | 0 Participants |
| No Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load decreased but not achieve max viral suppression | 0 Participants |
| No Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained viral suppression or no viral suppression | 0 Participants |
| Automated Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load increase | 3 Participants |
| Automated Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Changed to maximum viral suppression | 2 Participants |
| Automated Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load decreased but not achieve max viral suppression | 0 Participants |
| Automated Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained max suppression | 4 Participants |
| Automated Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained viral suppression or no viral suppression | 1 Participants |
| Automated Feedback + Clinician Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained viral suppression or no viral suppression | 0 Participants |
| Automated Feedback + Clinician Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | No change and remained max suppression | 3 Participants |
| Automated Feedback + Clinician Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Changed to maximum viral suppression | 2 Participants |
| Automated Feedback + Clinician Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load increase | 1 Participants |
| Automated Feedback + Clinician Feedback | Changes in HIV 1 RNA, QN PCR (Copies/ML) | Viral load decreased but not achieve max viral suppression | 2 Participants |
Secondary
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)
Population: 18 lab results were missing or lost and not available. 60 participants submitted their CD4 data (summarized here) vs. 57 participants completed all data measures at week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Feedback | Percent Change in CD4 Count From Baseline to Week 12 | 27.00 percentage of CD4 (helper cells) | Standard Deviation 13.33 |
| Automated Feedback | Percent Change in CD4 Count From Baseline to Week 12 | 26.09 percentage of CD4 (helper cells) | Standard Deviation 12.75 |
| Automated Feedback + Clinician Feedback | Percent Change in CD4 Count From Baseline to Week 12 | 28.8 percentage of CD4 (helper cells) | Standard Deviation 9.96 |
| Automated Feedback + Social Network Feedback | Percent Change in CD4 Count From Baseline to Week 12 | 30.81 percentage of CD4 (helper cells) | Standard Deviation 6.56 |
Secondary
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)
Population: These data were not collected due to changes in the research plan.