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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
| Hunter College of City University of New York | OTHER |
| Wayne State University | OTHER |
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The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.
The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS).
The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPS-Rsp-T | Active Comparator | After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC. |
|
| CPS-Rsp-SC | Active Comparator | After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only |
|
| CPS-NRsp-I | Active Comparator | After 3 months of intervention, this group of CPS NRsp will receive 3 months of CPS-I followed by 3 months of CPS-T and 3 months of SC. |
|
| CPS-NRsp-SMS-I | Active Comparator | After 3 months of intervention, this group of CPS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC |
|
| SMS-Rsp-T | Active Comparator | After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC. |
|
| SMS-Rsp-SC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPS | Behavioral | Assessment of participant's medication adherence and barrier problem solving via phone conversation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Undetectable Viral Load | Percent of participants that have an undetectable HIV Viral Load. | baseline, month 3, month 6, month 9, and month 12 |
| Medication Adherence Rate - 7 Day | Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups. | baseline, month 3, month 6, month 9, and month 12 |
| Medication Adherence - 30 Days | Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups. | baseline, month 3, month 6, month 9, and month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The City University of New York | New York | New York | 10018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30573448 | Derived | Belzer ME, MacDonell KK, Ghosh S, Naar S, McAvoy-Banerjea J, Gurung S, Cain D, Fan CA, Parsons JT. Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART). JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 Cell Phone Support | CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation |
| FG001 | Stage 1 Short Message Service (SMS) | SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response. |
| FG002 | Stage 2 Cell Phone Support CPS-I | Cell Phone Support Non-responder re-randomized to cell phone support incentivized |
| FG003 | Stage 2 Cell Phone Support SMS-I | Cell phone support non-responder, re-randomized to SMS incentivized |
| FG004 | Stage 2 Cell Phone Support CPS-T | Cell phone support responder, re-randomized to cell phone support tapered |
| FG005 | Stage 2 Cell Phone Support SC | Cell phone support responder, re-randomized to standard of care |
| FG006 | Stage 2 Short Message Service SMS-T | Short message service (SMS) responder, re-randomized to SMS tapered |
| FG007 | Stage 2 Short Message Service SC | Short message service responder, re-randomized to standard of care |
| FG008 | Stage 2 Short Message Service CPS-I | Short message service non-responder, re-randomized to cell phone support incentivized |
| FG009 | Stage 2 Short Message Service SMS-I | Short message service non-responder, re-randomized to SMS incentivized |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 Randomization |
| |||||||||||||
| Stage 2 Randomization |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 Cell Phone Support | CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation |
| BG001 | Stage 1 Short Message Service (SMS) |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Undetectable Viral Load | Percent of participants that have an undetectable HIV Viral Load. | Significant attrition at follow-ups for viral load testing. Therefore the overall model would not converge. | Posted | Number | percentage of participants | baseline, month 3, month 6, month 9, and month 12 |
|
Every 1 Year, for up to 3 years and 9 months.
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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 | Stage 1 Cell Phone Support | CPS: Assessment of participant's medication adherence and barrier problem solving via phone conversation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sylvie Naar, PhD; Distinguished Endowed Professor | Florida State University | 18506442334 | sylvie.naar@med.fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 17, 2021 | Apr 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 8, 2021 | May 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2020 | Apr 5, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Multiple Assignment Randomized Trial
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| Active Comparator |
After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only |
|
| SMS-NRsp-CPS-I | Active Comparator | After 3 months of intervention, this group of SMS NRsp will receive 3 months of CPS-I followed by 3 months CPS-T and 3 months SC |
|
| SMS-NRsp-I | Active Comparator | After 3 months of intervention, this group of SMS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC |
|
| SMS | Behavioral | Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region | Count of Participants | Participants |
|
| Employed | Count of Participants | Participants |
|
| Education | Count of Participants | Participants |
|
| Sexual Identity | Count of Participants | Participants |
|
| OG002 | Stage 2 Cell Phone Support CPS-I | Cell phone support non-responder re-randomized to cell phone support incentivized |
| OG003 | Stage 2 Cell Phone Support SMS-I | Cell Phone Support non-responder, re-randomized to SMS Incentivized |
| OG004 | Stage 2 Cell Phone Support CPS-T | Cell phone support responder, re-randomized to cell phone support tapered |
| OG005 | Stage 2 Cell Phone Support SC | Cell phone support responder, re-randomized to standard of care |
| OG006 | Stage 2 Short Message Service SMS-T | Short message service (SMS) responder, re-randomized to SMS tapered |
| OG007 | Stage 2 Short Message Service SC | Short message service responder, re-randomized to standard of care |
| OG008 | Stage 2 Short Message Service CPS-I | Short message service non-responder, re-randomized to cell phone support incentivized |
| OG009 | Stage 2 Short Message Service SMS-I | Short message service non-responder, re-randomized to SMS incentivized |
|
|
| Primary | Medication Adherence Rate - 7 Day | Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups. | Numbers are different due to attrition. | Posted | Mean | Standard Deviation | percentage of medication adherence | baseline, month 3, month 6, month 9, and month 12 |
|
|
|
|
| Primary | Medication Adherence - 30 Days | Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups. | Numbers are different due to attrition. | Posted | Mean | Standard Deviation | percentage of medication adherence | baseline, month 3, month 6, month 9, and month 12 |
|
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Stage 1 Short Message Service (SMS) | SMS: Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response. | 0 | 43 | 0 | 43 | 0 | 43 |
| EG002 | Stage 2 Cell Phone Support CPS-I | Cell Phone Support Non-responder re-randomized to cell phone support incentivized | 0 | 2 | 0 | 2 | 0 | 2 |
| EG003 | Stage 2 Cell Phone Support SMS-I | Cell phone support non-responder, re-randomized to SMS incentivized | 0 | 4 | 0 | 4 | 0 | 4 |
| EG004 | Stage 2 Cell Phone Support CPS-T | Cell phone support responder, re-randomized to cell phone support tapered | 0 | 11 | 0 | 11 | 0 | 11 |
| EG005 | Stage 2 Cell Phone Support SC | Cell phone support responder, re-randomized to standard of care | 0 | 16 | 0 | 16 | 0 | 16 |
| EG006 | Stage 2 Short Message Service SMS-T | Short message service (SMS) responder, re-randomized to SMS tapered | 0 | 14 | 0 | 14 | 0 | 14 |
| EG007 | Stage 2 Short Message Service SC | Short message service responder, re-randomized to standard of care | 0 | 14 | 0 | 14 | 0 | 14 |
| EG008 | Stage 2 Short Message Service CPS-I | Short message service non-responder, re-randomized to cell phone support incentivized | 0 | 3 | 0 | 3 | 0 | 3 |
| EG009 | Stage 2 Short Message Service SMS-I | Short message service non-responder, re-randomized to SMS incentivized | 0 | 5 | 0 | 5 | 0 | 5 |
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| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| 3 month |
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| 6 month |
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| 9 month |
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| 12 month |
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| 3 Month |
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| 6 Month |
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| 9 Month |
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| 12 Month |
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