HivAQ2NCT03916484
AllyQuest Adherence App Intervention for HIV-positive Men Who Have Sex With Men and Transgender Women: Pilot Trial
A study testing AllyQuest HIV Medication Adherence app-delivered intervention and AllyQuest HIV Medication Adherence app-delivered intervention + NSC in people with Hiv and HIV/AIDS, run by University of North Carolina, Chapel Hill at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 29 years, men only
- Conditions the study is for
- Hiv, HIV/AIDS, Medication Adherence
- What is being tested?
- AllyQuest HIV Medication Adherence app-delivered intervention and AllyQuest HIV Medication Adherence app-delivered intervention + NSC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 6 sitesUnited States
- Study dates
- 8 Jul 2020to 4 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- younger than 15, or older than 29
- assigned female at birth
- HIV negative or status unknown
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Alabama
Birmingham, Alabama, 35294
UNC-Chapel Hill
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
RAIN
Charlotte, North Carolina, 28201
Wayne State University
Detroit, Michigan, 48202
Rutgers University
Newark, New Jersey, 07103
About this study
Official title: Piloting a Sequential Multiple-Assignment Randomization Trial to Evaluate AllyQuest: an mHealth Intervention for HIV-positive Young MSM and TWSM to Optimize HIV Medication Adherence and Care Outcomes
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.
Read the 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.
- Conditions
- Hiv, HIV/AIDS, Medication Adherence, Sexual Behavior, Sexually Transmitted Infections (Not HIV or Hepatitis)
- Being tested
- AllyQuest HIV Medication Adherence app-delivered intervention, AllyQuest HIV Medication Adherence app-delivered intervention + NSC
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Medication Adherence, Sexual Behavior, Sexually Transmitted Diseases, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllyQuest HIV Medication Adherence app-delivered interventionBehavioural
Also called AQ
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 + NSCBehavioural
Also called AQ+
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention |
| 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. Receives: Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC |
| 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. Receives: Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention; Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC |
| 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. Receives: Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention; Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 6 Months
Secondary outcomes (5)
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.
Measured: Month 6 follow-up time point
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start8 Jul 2020
- Primary completion4 Jun 2022
- Study completion4 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Kate Muessig, PhD, Principal investigator, UNC-Chapel HillLisa Hightow-Weidman, MD, MPH, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916484
- Sponsor's protocol ID
- 18-2061
- Other IDs
- 1R34MH118058-01
- Acronym
- AQ2
- Status last verified
- Mar 2023
- First submitted
- 10 Apr 2019
- Last updated
- 24 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting a Sequential Multiple-Assignment Randomization Trial to Evaluate AllyQuest: an mHealth Intervention for HIV-positive Young MSM and TWSM to Optimize HIV Medication Adherence and Care Outcomes
- ClinicalTrials.gov ID
- NCT03916484
- Acronym / sponsor ID
- AQ2 / 18-2061
- Conditions
- Hiv, HIV/AIDS, Medication Adherence, Sexual Behavior, Sexually Transmitted Infections (Not HIV or Hepatitis)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- 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
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 4 Jun 2022 (actual)
- Study completion
- 4 Jun 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 24 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| AQ HIV Medication Adherence app-delivered intervention | Experimental | Behavioral: AllyQuest HIV Medication Adherence app-delivered interventionAQ: 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. |
| AQ HIV Medication Adherence app-delivered intervention + NSC | Experimental | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSCAQ+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. |
| AQ followed by AQ+NSC | Experimental | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention, Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSCAt 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. |
| AQ+NSC followed by AQ | Experimental | Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention, Behavioral: AllyQuest HIV Medication Adherence app-delivered intervention + NSCAt 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. |
Who may qualify
- Ages
- 15 to 29 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- younger than 15, or older than 29
- assigned female at birth
- HIV negative or status unknown
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllyQuest HIV Medication Adherence app-delivered interventionAlso: AQAQ 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. | Behavioural | AQ HIV Medication Adherence app-delivered intervention, AQ followed by AQ+NSC, AQ+NSC followed by AQ |
| AllyQuest HIV Medication Adherence app-delivered intervention + NSCAlso: AQ+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. | Behavioural | AQ HIV Medication Adherence app-delivered intervention + NSC, AQ followed by AQ+NSC, AQ+NSC followed by AQ |
Primary outcome
Intervention Feasibility: Average Proportion of Days of Any App Use
Time frame: 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
Time frame: 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
Time frame: 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).
Intervention Acceptability: Mean Intervention Acceptability Score
Time frame: 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.
5 secondary outcomes
Mean Percent of Past 30-Day ART Medication Adherence
Time frame: Month 6 follow-up time point
Mean Percent ART Medication Adherence Over Time
Time frame: up to 6 months
Number of Participants With Viral Suppression
Time frame: Month 6 follow-up time point
Percent of Participants With Viral Suppression Over Time
Time frame: up to 3 months
Percent of Participants With Viral Suppression Over Time
Time frame: up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Muessig, PhD principal investigator
UNC-Chapel Hill
Lisa Hightow-Weidman, MD, MPH principal investigator
UNC-Chapel Hill
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AllyQuest HIV Medication Adherence app-delivered intervention and AllyQuest HIV Medication Adherence app-delivered intervention + NSC in people with Hiv and HIV/AIDS, run by University of North Carolina, Chapel Hill at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility: Average Proportion of Days of Any App Use (time frame: 180 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.