Hiv, HIV/AIDS, Medication Adherence, Sexual Behavior, Sexually Transmitted Infections (Not HIV or Hepatitis)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAllyQuest 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.
BEHAVIORALAllyQuest 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.
Sponsors
National Institute of Mental Health (NIMH)
Medical University of South Carolina
Wayne State University
Rutgers University
University of Alabama at Birmingham
North Carolina State University
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
15 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
* Living with HIV * Assigned male at birth * currently identify as male or transgender woman * anal sex with another male or transgender woman(lifetime) * access to a smart phone with data plan * English literacy * prescribed ART * At least one of the following: Having failed to show up for or missed 1 or more scheduled HIV care appointment in the past 12 months OR Last HIV care visit was more than 6 months ago OR Self-reporting less than 90% ART adherence in the past 4 weeks OR have a detectable viral load measure in the past 12 months OR recently diagnosed with HIV (past 3 months)
Exclusion criteria
* younger than 15, or older than 29 * assigned female at birth * HIV negative or status unknown
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Acceptability: Mean Intervention Acceptability Score | 6 Months | 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. |
| Intervention Feasibility: Average Proportion of Days of Any App Use | 180 days | 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. |
| Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 180 Days | 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. |
| Intervention Acceptability: Mean Intervention Acceptability CSQ-8 Score | 6 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Viral Suppression | Month 6 follow-up time point | 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. |
| Percent of Participants With Viral Suppression Over Time | up to 3 months | 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. |
| Mean Percent of Past 30-Day ART Medication Adherence | Month 6 follow-up time point | HIV Antiretroviral (ART) Medication Adherence is measured by CASI as percent of ART doses taken in the past 30 days. |
| Mean Percent ART Medication Adherence Over Time | up to 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 6 clinical recruitment sites in Birmingham, AL; Chapel Hill and Charlotte, NC; Charleston, SC; Detroit, MI and Newark, NJ.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 41 |
| 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. | 15 |
| 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. | 8 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Stage 1 Intervention (Months 1-3) | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Stage 2 Intervention (Months 4-6) | Lost to Follow-up | 2 | 11 | 4 | 1 |
Baseline characteristics
| Characteristic | Total | AQ HIV Medication Adherence App-delivered Intervention | AQ HIV Medication Adherence App-delivered Intervention + NSC | AQ Followed by AQ+NSC | AQ+NSC Followed by AQ |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 6 Participants | 39 Participants | 14 Participants | 8 Participants |
| Age, Continuous | 22.54 years | 24.28 years | 22.43 years | 22.13 years | 22.37 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 1 Participants | 5 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants | 6 Participants | 35 Participants | 13 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Mean Percent of Past 30-Day ART medication adherence | 83.69 percentage of doses taken STANDARD_DEVIATION 25.98 | 98.00 percentage of doses taken STANDARD_DEVIATION 2.73 | 81.05 percentage of doses taken STANDARD_DEVIATION 28.37 | 78.09 percentage of doses taken STANDARD_DEVIATION 28.59 | 94.00 percentage of doses taken STANDARD_DEVIATION 12.67 |
| Participants with viral suppression | 29 Participants | 2 Participants | 14 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 49 Participants | 6 Participants | 27 Participants | 8 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 13 Participants | 0 Participants | 8 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 71 Participants | 7 Participants | 41 Participants | 15 Participants | 8 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 71 Participants | 7 Participants | 41 Participants | 15 Participants | 8 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 | 0 / 22 | 0 / 49 | 0 / 15 | 0 / 55 |
| other Total, other adverse events | 0 / 22 | 0 / 49 | 0 / 15 | 0 / 55 |
| serious Total, serious adverse events | 0 / 22 | 0 / 49 | 0 / 15 | 0 / 55 |
Outcome results
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).
Time frame: 6 Months
Population: 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.
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.
Time frame: 6 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Intervention Acceptability: Mean Intervention Acceptability Score | 20.95 score on a scale | Standard Deviation 1.37 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Intervention Acceptability: Mean Intervention Acceptability Score | 19.97 score on a scale | Standard Deviation 2.32 |
| AQ Followed by AQ+NSC | Intervention Acceptability: Mean Intervention Acceptability Score | 18.36 score on a scale | Standard Deviation 0.61 |
| AQ+NSC Followed by AQ | Intervention Acceptability: Mean Intervention Acceptability Score | 17.06 score on a scale | Standard Deviation 4.23 |
| Total Sample | Intervention Acceptability: Mean Intervention Acceptability Score | 19.48 score on a scale | Standard Deviation 2.6 |
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.
Time frame: 180 days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Intervention Feasibility: Average Proportion of Days of Any App Use | 0.64 proportion of days | Standard Deviation 0.17 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Intervention Feasibility: Average Proportion of Days of Any App Use | 0.40 proportion of days | Standard Deviation 0.33 |
| AQ Followed by AQ+NSC | Intervention Feasibility: Average Proportion of Days of Any App Use | 0.27 proportion of days | Standard Deviation 0.14 |
| AQ+NSC Followed by AQ | Intervention Feasibility: Average Proportion of Days of Any App Use | 0.64 proportion of days | Standard Deviation 0.16 |
| Total Sample | Intervention Feasibility: Average Proportion of Days of Any App Use | 0.42 proportion of days | Standard Deviation 0.29 |
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.
Time frame: 180 Days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 0.80 proportion of days | Standard Deviation 0.15 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 0.50 proportion of days | Standard Deviation 0.33 |
| AQ Followed by AQ+NSC | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 0.38 proportion of days | Standard Deviation 0.2 |
| AQ+NSC Followed by AQ | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 0.81 proportion of days | Standard Deviation 0.13 |
| Total Sample | Intervention Feasibility: Average Proportion of Days of HIV Medication Tracked | 0.54 proportion of days | Standard Deviation 0.31 |
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.
Time frame: up to 6 months
Population: Analysis population includes all those who answered this question on both the Baseline and the Month 6 follow-up surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Mean Percent ART Medication Adherence Over Time | Baseline | 98.75 percentage of medication taken | Standard Deviation 2.5 |
| AQ HIV Medication Adherence App-delivered Intervention | Mean Percent ART Medication Adherence Over Time | Month 6 Follow-up | 98.75 percentage of medication taken | Standard Deviation 1.89 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Mean Percent ART Medication Adherence Over Time | Baseline | 80.77 percentage of medication taken | Standard Deviation 31.1 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Mean Percent ART Medication Adherence Over Time | Month 6 Follow-up | 87.16 percentage of medication taken | Standard Deviation 23.53 |
| AQ Followed by AQ+NSC | Mean Percent ART Medication Adherence Over Time | Baseline | 73.00 percentage of medication taken | Standard Deviation 32.34 |
| AQ Followed by AQ+NSC | Mean Percent ART Medication Adherence Over Time | Month 6 Follow-up | 96.85 percentage of medication taken | Standard Deviation 5.17 |
| AQ+NSC Followed by AQ | Mean Percent ART Medication Adherence Over Time | Month 6 Follow-up | 84.42 percentage of medication taken | Standard Deviation 25.35 |
| AQ+NSC Followed by AQ | Mean Percent ART Medication Adherence Over Time | Baseline | 98.42 percentage of medication taken | Standard Deviation 2.07 |
| Total Sample | Mean Percent ART Medication Adherence Over Time | Baseline | 84.69 percentage of medication taken | Standard Deviation 27.31 |
| Total Sample | Mean Percent ART Medication Adherence Over Time | Month 6 Follow-up | 89.80 percentage of medication taken | Standard Deviation 20.31 |
p-value: 1Wilcoxon (Mann-Whitney)
p-value: 0.43Wilcoxon (Mann-Whitney)
p-value: 0.06Wilcoxon (Mann-Whitney)
p-value: 0.06Wilcoxon (Mann-Whitney)
p-value: 0.48Wilcoxon (Mann-Whitney)
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.
Time frame: Month 6 follow-up time point
Population: Data are reported for all participants who completed this question on the 6-month follow-up survey
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Mean Percent of Past 30-Day ART Medication Adherence | 99.00 percentage of doses taken | Standard Deviation 1.73 |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Mean Percent of Past 30-Day ART Medication Adherence | 88.15 percentage of doses taken | Standard Deviation 22.47 |
| AQ Followed by AQ+NSC | Mean Percent of Past 30-Day ART Medication Adherence | 97.09 percentage of doses taken | Standard Deviation 4.32 |
| AQ+NSC Followed by AQ | Mean Percent of Past 30-Day ART Medication Adherence | 84.42 percentage of doses taken | Standard Deviation 25.35 |
| Total Sample | Mean Percent of Past 30-Day ART Medication Adherence | 91.09 percentage of doses taken | Standard Deviation 18.8 |
p-value: 0.33Kruskal-Wallis
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.
Time frame: Month 6 follow-up time point
Population: All participants with an available viral load lab measure for the 6-month follow-up time point.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Number of Participants With Viral Suppression | 3 Participants |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Number of Participants With Viral Suppression | 19 Participants |
| AQ Followed by AQ+NSC | Number of Participants With Viral Suppression | 8 Participants |
| AQ+NSC Followed by AQ | Number of Participants With Viral Suppression | 3 Participants |
| Total Sample | Number of Participants With Viral Suppression | 33 Participants |
p-value: 0.45Fisher Exact
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.
Time frame: up to 3 months
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Percent of Participants With Viral Suppression Over Time | Baseline | 40.00 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention | Percent of Participants With Viral Suppression Over Time | Month 3 follow-up | 80.00 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Percent of Participants With Viral Suppression Over Time | Baseline | 33.33 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Percent of Participants With Viral Suppression Over Time | Month 3 follow-up | 75.76 percent of participants |
| AQ Followed by AQ+NSC | Percent of Participants With Viral Suppression Over Time | Baseline | 35.42 percent of participants |
| AQ Followed by AQ+NSC | Percent of Participants With Viral Suppression Over Time | Month 3 follow-up | 77.08 percent of participants |
p-value: <0.001McNemar
p-value: 0.07McNemar
p-value: 0.003McNemar
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.
Time frame: up to 6 months
Population: Population includes all participants with an available clinical viral load measure at both the baseline and month 6 follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AQ HIV Medication Adherence App-delivered Intervention | Percent of Participants With Viral Suppression Over Time | Baseline | 0.00 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention | Percent of Participants With Viral Suppression Over Time | Month 6 follow-up | 60.00 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Percent of Participants With Viral Suppression Over Time | Baseline | 28.00 percent of participants |
| AQ HIV Medication Adherence App-delivered Intervention + NSC | Percent of Participants With Viral Suppression Over Time | Month 6 follow-up | 76.00 percent of participants |
| AQ Followed by AQ+NSC | Percent of Participants With Viral Suppression Over Time | Baseline | 45.45 percent of participants |
| AQ Followed by AQ+NSC | Percent of Participants With Viral Suppression Over Time | Month 6 follow-up | 72.73 percent of participants |
| AQ+NSC Followed by AQ | Percent of Participants With Viral Suppression Over Time | Month 6 follow-up | 42.86 percent of participants |
| AQ+NSC Followed by AQ | Percent of Participants With Viral Suppression Over Time | Baseline | 71.43 percent of participants |
| Total Sample | Percent of Participants With Viral Suppression Over Time | Baseline | 35.42 percent of participants |
| Total Sample | Percent of Participants With Viral Suppression Over Time | Month 6 follow-up | 68.75 percent of participants |
p-value: 0.25McNemar
p-value: 0.002McNemar
p-value: 0.453McNemar
p-value: 0.5McNemar
p-value: 0.003McNemar