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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21DA039842-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| University at Albany | OTHER |
| University of Connecticut | OTHER |
| National Institute on Drug Abuse (NIDA) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No feedback | Experimental | For participants in the control group (Group A), no feedback from the TowerView Health® smart pill box or clinical nurse will be given. |
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| Automated feedback | Experimental | 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. |
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| Automated feedback + Clinician feedback | Experimental | 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. |
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| Automated feedback + Social Network feedback | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A_No feedback | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in HIV 1 RNA, QN PCR (Copies/ML) | HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection. | End of intervention (Week 12) |
| Percent Change in CD4 Count From Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Altice, M.D., M.A. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Clinical Research | New Haven | Connecticut | 06510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35254270 | Derived | Ranjit YS, Krishnan A, Ghosh D, Cravero C, Zhou X, Altice FL. mHealth Intervention to Improve Treatment Outcomes Among People With HIV Who Use Cocaine: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 7;11(3):e28332. doi: 10.2196/28332. |
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All data will be kept confidential.
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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 were recruited from two sites--New Haven and Hartford, CT. Recruitment started in June 2017 and concluded in January 1st 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of times pills taken | Week 12 |
|
Up to 16 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Kil | Associate Director Domestic Projects | 203.737.2883 | natalie.kil@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 13, 2020 | Jul 2, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2020 | Jul 1, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| NIH |
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| Group B_Automated feedback | Device | 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. |
|
| Group C_Automated feedback + Clinician feedback | Device | 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. |
|
| Group D_Automated feedback + Social Network feedback | Device | 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. |
|
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.
| 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). | up to End of the study (week 16) |
| Lost to Follow-up |
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| Withdrawal by Subject |
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| Dropped out after receiving pillbox and phone |
|
| BG001 |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Health literacy | It includes three Likert scale questions on a scale of 1 to 5. The scores of each question were averaged to obtain an average score. Higher score indicates higher level of health literacy. | Mean | Standard Deviation | units on a scale |
|
| Mental health (CESD-D10) | The CES-D Scale: A self-report depression scale for research in the general population. It includes 10 questions, measured from 0 to 3, where higher score indicates higher level of depression. All of the questions are totaled, thus minimal is 0 and maximum is 30. | Mean | Standard Deviation | units on a scale |
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| Alcohol screening AUDIT C | Scales measure substance use using multiple choices. Questions were coded as 0, 1 to 4. The results were summed up for each participant. If the sum >=2, then presence of substance use, else no substance use. Answers are summed up, 0 is the minimal and 12 is the maximum. | Mean | Standard Deviation | units on a scale |
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| Presence of cocaine use disorder | Count of Participants | Participants |
|
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.
| OG002 | 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. |
| OG003 | 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | percentage of times pills taken | Week 16 |
|
|
|
| Secondary | Changes in HIV 1 RNA, QN PCR (Copies/ML) | HIV RNA (viral load) and HIV disease progression to manage and monitor HIV infection. | 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. | Posted | Count of Participants | Participants | End of intervention (Week 12) |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of CD4 (helper cells) | Baseline and End of intervention (Week 12) |
|
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| 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). | These data were not collected due to changes in the research plan. | Posted | up to End of the study (week 16) |
|
|
| 1 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | 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. | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
|
| Viral load increase |
|
| No change and remained max suppression |
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| No change and remained viral suppression or no viral suppression |
|