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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH118058-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| Medical University of South Carolina | OTHER |
| Wayne State University | OTHER |
| Rutgers University |
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AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.
AllyQuest (AQ) is a theory-informed smart phone application that supports HIV medication adherence for young men who have sex with men and young transgender women who have sex with men (YMSM/YTW) via behavior change, social support, and game-based mechanics. This study aims to evaluate the feasibility and acceptability of AQ and AQ plus medication adherence counseling in a Sequential Multiple Assignment Randomization Trial.
AllyQuest (AQ) is a smart phone application for Android and iOS (Apple) that supports HIV medication adherence. Intervention development was guided by health behavior change theories including Social Cognitive Theory (SCT), narrative communication (e.g. storytelling), and the Fogg Behavioral Model (FBM) of persuasive technology. AQ addresses key principles of SCT including: (1) observational learning by doing daily activities; (2) modeling and vicarious experiences (observing and participating in Daily Discussions, exploration of narrative "choose-your-own-adventure" stories); (3) self-efficacy and verbal persuasion from expert sources (multi-media knowledge center, tailored messages) and (4) reinforcements (virtual rewards, financial incentives, achievements). AQ incorporates principles of the FBM including triggers via app notifications and content, increasing ability via knowledge articles and identifying steps toward behavioral goals, and motivation via social support, rewards, goal setting, and achievement.
This study will test AQ and an enhanced version of AQ (AQ+) that adds two-way text based Next Step Counseling (NSC) for medication adherence. A sequential multiple assignment randomized trial (SMART) is a study design suited to development of adaptive interventions. An adaptive intervention is a sequence of decision rules that specify how the intensity or type of treatment should change depending on the patient's needs rather than applying a "one size fits all" approach. In a SMART, participants are randomized to an initial treatment, and, depending on how they respond, may be assigned or randomized to a new type or intensity of treatment. SMARTs are an efficient and rigorous way to study how the type or dose of treatment should be adjusted based on subject characteristics or response and thus maximize clinical utility and real-world applicability. In this SMART, participants are initially randomized to medication adherence support with one of two intervention approaches (AQ or AQ+NSC). At 3 months, based on protocol defined intervention responsiveness, participants are re-randomized or reassigned to continue their initial intervention approach or to change to the other intervention approach for months 4 - 6 of the trial.
Participants will complete viral load (VL) and web-based computer assisted survey instrument (CASI) assessments at baseline and 3- and 6- months. A sample of 20-25 users will complete a qualitative exit interview to evaluate their experience using AQ and AQ+ and their experience with the escalation/de-escalation intervention strategies.
The study will assess intervention feasibility, acceptability, and preliminary efficacy including: 1) frequency and total time spent on each AQ feature; 2) in-app daily adherence reports; and 3) user-contributed content (adherence counseling chat logs, user-entered daily discussion content and adherence strategies). Analyses will determine which treatment strategies embedded in the SMART (escalation, de-escalation, and maintenance combinations) result in sustained intervention app engagement, self-reported adherence, and viral suppression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AQ HIV Medication Adherence app-delivered intervention | Experimental | AQ: At minimum, intended app usage (dose) is for participant to complete a set of activities (record medication taking, complete a challenge, complete a forum post) one time per day (frequency) for 6 months (duration). The participant may or may not stay solely on AQ throughout the study. |
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| AQ HIV Medication Adherence app-delivered intervention + NSC | Experimental | AQ+NSC: At minimum, intended app usage (dose) is for participant to complete a set of activities (record medication taking, complete a challenge, complete a forum post) one time per day (frequency) for 6 months (duration). NSC sessions are scheduled approximately every other week (frequency) and last approximately 30 minutes per session (dose). The participant may or may not stay on AQ+NSC throughout the study. |
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| AQ followed by AQ+NSC | Experimental | At 3 months, those who were initially randomized to AQ who meet protocol defined definition for intervention non-responsiveness, are reassigned to AQ+NSC to complete months 4 - 6 of the trial. |
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| AQ+NSC followed by AQ | Experimental | At 3 months, those who were initially randomized to AQ+NSC who meet protocol defined definition for intervention responsiveness, may get re-randomized to AQ alone to complete months 4 - 6 of the trial. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AllyQuest HIV Medication Adherence app-delivered intervention | Behavioral | AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility: Average Proportion of Days of Any App Use | The average proportion of days of any app use during the trial across all participants as recorded by the app backend para data. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | 180 days |
| Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | The average proportion of days participants used the app to track their HIV medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | 180 Days |
| Intervention Acceptability: Mean Intervention Acceptability CSQ-8 Score | The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome). | 6 Months |
| Intervention Acceptability: Mean Intervention Acceptability Score | The mean composite score is calculated from the Acceptability of Health Apps among Adolescents (AHAA) scale, a 22-item validated scale measuring the construct of global intervention acceptability. Item response options include: Strongly Disagree, Disagree, Agree, Strongly Agree. Scale items are grouped into 6 sub-scales. Responses to the items in each sub-scale are averaged and the sub-scale averages are added to obtain a total possible composite score ranging from 6 (lowest acceptability, worst outcome) to 24 (highest acceptable, best outcome). A score of 18 or higher is consistent with overall high acceptability. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent of Past 30-Day ART Medication Adherence | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of ART doses taken in the past 30 days. | Month 6 follow-up time point |
| Mean Percent ART Medication Adherence Over Time |
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Inclusion Criteria:
Exclusion Criteria:
The study will enroll self identified men and transgender women.
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| Name | Affiliation | Role |
|---|---|---|
| Kate Muessig, PhD | UNC-Chapel Hill | Principal Investigator |
| Lisa Hightow-Weidman, MD, MPH | UNC-Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Wayne State University |
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Enrollment and randomization to stage 1 interventions took place directly following confirmation of eligibility and completion of informed consent. All enrolled participants were randomized and assigned to a stage 1 intervention condition.
Participants were recruited from 6 clinical recruitment sites in Birmingham, AL; Chapel Hill and Charlotte, NC; Charleston, SC; Detroit, MI and Newark, NJ.
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| ID | Title | Description |
|---|---|---|
| FG000 | AQ HIV Medication Adherence App-delivered Intervention | Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6. AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 Intervention (Months 1-3) |
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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 | Feb 1, 2023 |
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| OTHER |
| University of Alabama at Birmingham | OTHER |
| North Carolina State University | OTHER |
Sequential multiple assignment randomized trials (SMART) are adaptive interventions. An adaptive intervention is a sequence of decision rules that specify how the intensity or type of treatment should change depending on the patient's needs rather than applying a "one size fits all" approach. The type or dose of the intervention is adjusted based on participant characteristics or response. SMARTs are an efficient and rigorous way to maximize clinical utility and real-world applicability. In this SMART, participants are initially randomized to medication adherence support with one of two intervention approaches (AQ or AQ+NSC). At 3 months, based on protocol defined intervention responsiveness, participants are re-randomized or reassigned to continue their initial intervention approach or to change to the other intervention approach for months 4 - 6 of the trial.
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| AllyQuest HIV Medication Adherence app-delivered intervention + NSC | Behavioral | In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week. |
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HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of prescribed ART doses taken in the past 30 days. Assessed at Baseline and Month 6 follow-up time point.
| up to 6 months |
| Number of Participants With Viral Suppression | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. The study will report the number of participants who are virally suppressed at 6 month follow-up. | Month 6 follow-up time point |
| Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 3 follow-up time point. | up to 3 months |
| Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 6 follow-up. | up to 6 months |
| Detroit |
| Michigan |
| 48202 |
| United States |
| Rutgers University | Newark | New Jersey | 07103 | United States |
| UNC-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| RAIN | Charlotte | North Carolina | 28201 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| FG001 | AQ HIV Medication Adherence App-delivered Intervention + NSC | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6. AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week. |
| FG002 | AQ Followed by AQ+NSC | Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness. AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app. AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week. |
| FG003 | AQ+NSC Followed by AQ | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. AllyQuest HIV Medication Adherence app-delivered intervention: AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app "account" rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app. AllyQuest HIV Medication Adherence app-delivered intervention + NSC: In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week. |
| COMPLETED |
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| NOT COMPLETED |
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| Stage 2 Intervention (Months 4-6) |
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| ID | Title | Description |
|---|---|---|
| BG000 | AQ HIV Medication Adherence App-delivered Intervention | Participants in this arm received the intervention approach starting with AQ for the first 3 months and remaining with AQ for months 4 - 6. |
| BG001 | AQ HIV Medication Adherence App-delivered Intervention + NSC | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and remaining with AQ+NSC for months 4 - 6. |
| BG002 | AQ Followed by AQ+NSC | Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness. |
| BG003 | AQ+NSC Followed by AQ | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| BG004 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Mean Percent of Past 30-Day ART medication adherence | HIV Antiretroviral (ART) Medication Adherence is measured by computer-assisted self interview (CASI) as percent of prescribed ART doses taken in the past 30 days. | This survey question was optional for participants. The number analyzed includes all participants who answered this question. | Mean | Standard Deviation | percentage of doses taken |
| ||||||||
| Participants with viral suppression | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||
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| Primary | Intervention Feasibility: Average Proportion of Days of Any App Use | The average proportion of days of any app use during the trial across all participants as recorded by the app backend para data. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | Per the pre-specified analysis plan, this outcome compares how effective each intervention sequence performed as measured by participants' daily use of the intervention app with the 4 sequences offering different intervention intensity variations. | Posted | Mean | Standard Deviation | proportion of days | 180 days |
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| Primary | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | The average proportion of days participants used the app to track their HIV medication taking. Total possible range: 0 - 1. Higher proportion indicates higher intervention feasibility. | Per the pre-specified analysis plan, this outcome compares how effective each intervention sequence performed as measured by participants' daily use of the intervention app to track daily medication with the 4 sequences offering different intervention intensity variations. | Posted | Mean | Standard Deviation | proportion of days | 180 Days |
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| Primary | Intervention Acceptability: Mean Intervention Acceptability CSQ-8 Score | The mean composite score calculated from the Client Satisfaction Questionnaire (CSQ-8), an 8-item validated scale measuring the construct of global intervention satisfaction. Total possible composite score range: 8 (lowest acceptability, worst outcome) to 32 (highest acceptable, best outcome). | The protocol was amended to utilize a more precise scale for this measure (see outcome #4). The CSQ-8® was not administered and no data were collected using this tool. | Posted | 6 Months |
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| Primary | Intervention Acceptability: Mean Intervention Acceptability Score | The mean composite score is calculated from the Acceptability of Health Apps among Adolescents (AHAA) scale, a 22-item validated scale measuring the construct of global intervention acceptability. Item response options include: Strongly Disagree, Disagree, Agree, Strongly Agree. Scale items are grouped into 6 sub-scales. Responses to the items in each sub-scale are averaged and the sub-scale averages are added to obtain a total possible composite score ranging from 6 (lowest acceptability, worst outcome) to 24 (highest acceptable, best outcome). A score of 18 or higher is consistent with overall high acceptability. | Participants could choose to decline to answer some or all of the self-reported CASI responses to intervention acceptability measures. This analysis includes all participants who answered half or more (>=11) of the 22 items on the AHAA scale. | Posted | Mean | Standard Deviation | score on a scale | 6 Months |
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| Secondary | Mean Percent of Past 30-Day ART Medication Adherence | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of ART doses taken in the past 30 days. | Data are reported for all participants who completed this question on the 6-month follow-up survey | Posted | Mean | Standard Deviation | percentage of doses taken | Month 6 follow-up time point |
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| Secondary | Mean Percent ART Medication Adherence Over Time | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of prescribed ART doses taken in the past 30 days. Assessed at Baseline and Month 6 follow-up time point. | Analysis population includes all those who answered this question on both the Baseline and the Month 6 follow-up surveys. | Posted | Mean | Standard Deviation | percentage of medication taken | up to 6 months |
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| Secondary | Number of Participants With Viral Suppression | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. The study will report the number of participants who are virally suppressed at 6 month follow-up. | All participants with an available viral load lab measure for the 6-month follow-up time point. | Posted | Count of Participants | Participants | Month 6 follow-up time point |
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| Secondary | Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 3 follow-up time point. | Includes all participants who had available clinical viral load measures at both baseline and month 3 follow-up. This outcome reports on viral suppression at the end of Stage 1 of the intervention (Month 3 follow-up visit). | Posted | Number | percent of participants | up to 3 months |
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| Secondary | Percent of Participants With Viral Suppression Over Time | Viral suppression is defined as having an HIV viral load below the lower limit of detection per assay used. Assessed at Baseline and Month 6 follow-up. | Population includes all participants with an available clinical viral load measure at both the baseline and month 6 follow-up. | Posted | Number | percent of participants | up to 6 months |
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From time of initial consent through 6-month Follow-Up, a total of approximately 6 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: (Months 1-3) AQ HIV Medication Adherence App-delivered Intervention | Participants in this arm received the intervention approach starting with AQ for the first 3 months. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG001 | Stage 1: (Months 1-3) AQ+NSC HIV Medication Adherence App-delivered Intervention + NSC | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months. | 0 | 49 | 0 | 49 | 0 | 49 |
| EG002 | Stage 2: (Months 4-6) AQ HIV Medication Adherence App-delivered Intervention | Participants in this arm received the intervention approach of AQ for months 4 - 6. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG003 | Stage 2: (Months 4-6) AQ HIV Medication Adherence App-delivered Intervention + NSC | Participants in this arm received the intervention approach of AQ+NSC for months 4 - 6. | 0 | 55 | 0 | 55 | 0 | 55 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kate Muessig, PhD | University of North Carolina at Chapel Hill | 850-644-3299 | kmuessig@fsu.edu |
| Apr 26, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 23, 2021 | Mar 22, 2023 | ICF_002.pdf |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D055118 | Medication Adherence |
| D012725 | Sexual Behavior |
| D012749 | Sexually Transmitted Diseases |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| 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 |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| OG003 | AQ+NSC Followed by AQ | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | This group includes all enrolled participants |
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| OG003 | AQ+NSC Followed by AQ | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
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| OG002 | AQ Followed by AQ+NSC | Participants in this arm received the intervention approach starting with AQ for the first 3 months and escalated to AQ+NSC for months 4 - 6, having met the protocol definition for intervention non-responsiveness. |
| OG003 | AQ+NSC Followed by AQ | Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | All enrolled participants |
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| AQ+NSC Followed by AQ |
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | This group includes all enrolled participants |
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| OG003 |
| AQ+NSC Followed by AQ |
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | This group includes all enrolled participants |
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| OG003 |
| AQ+NSC Followed by AQ |
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | This group includes all enrolled participants |
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| Participants |
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| AQ+NSC Followed by AQ |
Participants in this arm received the intervention approach starting with AQ+NSC for the first 3 months and de-escalated to AQ for months 4 - 6, having met the protocol definition for intervention responsiveness. |
| OG004 | Total Sample | This group includes all enrolled participants |
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