Medication AdherenceNCT05762705
A Mobile Gaming App to Improve Adherence to PrEP
A study testing Multilevel Gaming Adherence Intervention and Treatment as Usual + in people with Medication Adherence and HIV/AIDS, run by Rhode Island Hospital at 3 sites in United States.
Trial summary
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Read more about this study
- Who is it for?
- Ages 15 to 34 yearsHealthy volunteers can take part
- Conditions the study is for
- Medication Adherence, HIV/AIDS
- What is being tested?
- Multilevel Gaming Adherence Intervention and Treatment as Usual +
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jun 2024to 3 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 34 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 15-34 years old
- English speaking
- Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month
- HIV negative as per clinician and clinical record
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Sharon Vuppula, MD, sharon.vuppula@bmc.org
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
James B Brock, MD, 601-984-5560, jbbrock@umc.edu
- Recruiting
Lifespan (The Miriam Hospital and Rhode Island Hospital)
Providence, Rhode Island, 02904
Larry K Brown, MD, 401-793-8808, lkbrown@lifespan.org
About this study
Official title: A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Read the detailed description
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Aim 1: To conduct formative evaluation interviews, guided by the i-PARHIS framework, with approximately 30 stakeholders (23 PrEP patients, 4 clinical staff, 3 clinic administrators) in order to adapt Viral Combat for diverse PrEP patient populations, and to identify individual, organizational, and structural factors associated with its implementation.
Aim 2: To evaluate, in a Hybrid Type 1 effectiveness-implementation randomized controlled trial with 200 participants taking PrEP (15-34 years of age), the effectiveness of Viral Combat compared to a control group that receives a non-PrEP related game.
The investigators will examine the impact of the intervention on:
2a: improving adherence to PrEP using a biological measure (tenofovir from DBS), clinic records, and self-report; 2b: the potential mediators of the intervention, such as knowledge, motivation, self-efficacy, and game metrics.
Aim 3: To conduct summative evaluation interviews, following the RCT phase, with an additional 30 stakeholders ((23 PrEP patients, 4 clinical staff, 3 clinic administrators). Interviews will assess and summarize the i-PARIHS constructs relevant to the intervention's future implementation success.
- Conditions
- Medication Adherence, HIV/AIDS
- Being tested
- Multilevel Gaming Adherence Intervention, Treatment as Usual +
- Medical subject headings
- Medication Adherence, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel Gaming Adherence InterventionBehavioural
Information-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages
Treatment as Usual +Behavioural
non-PrEP related mobile gaming application
| Study group | Role | What they receive |
|---|---|---|
| Multilevel Gaming Adherence | Experimental | Participants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Viral Combat on their mobile phones, and, for 24 weeks, game-related text messages guided by self-reported medication adherence. Receives: Behavioral: Multilevel Gaming Adherence Intervention |
| Treatment as Usual + | Active comparator | TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game. Receives: Behavioral: Treatment as Usual + |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tenofovir (TFV) blood concentration at 24 weeks
Tenofovir (TFV) concentration in blood from either venipuncture or dried blood spot labs immediately post-intervention (at 24 weeks follow-up).
Measured: 24 weeks
Secondary outcomes (5)
Tenofovir (TFV) blood concentration at 48 weeks
Tenofovir (TFV) concentration in blood from either venipuncture or dried blood spot labs at the end of study follow-up (at 48 weeks follow-up).
Measured: 48 weeks
Self-reported Medication Adherence at 24 weeks
Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month) immediately post-intervention (at 24 weeks follow-up).
Measured: 24 weeks
Self-reported Medication Adherence at 48 weeks
Proportion of days with missed doses via self-report: (reported missed doses in past month) / (total number of days in month) at the end of study follow-up (at 48 weeks follow-up).
Measured: 48 weeks
Medical appointment adherence at 24 weeks
Number of PrEP-related medical visits kept in the past 3 months based on clinic records at 24 weeks follow-up.
Measured: 24 weeks
Medical appointment adherence at 48 weeks
Number of PrEP-related medical visits kept in the past 3 months based on clinic records at 48 weeks follow-up.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start21 Jun 2024
- Primary completion3 Mar 2027 (estimated)
- Study completion3 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larry K Brock, MD, Study director, Rhode Island HospitalSharon Vuppula, MD, Study director, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762705
- Sponsor's protocol ID
- Pro00067477
- Status last verified
- May 2025
- First submitted
- 12 Feb 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multisite Randomized Trial of Viral Combat: A Mobile Gaming App to Improve Adherence to PrEP
- ClinicalTrials.gov ID
- NCT05762705
- Acronym / sponsor ID
- Pro00067477
- Conditions
- Medication Adherence, HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- 21 Jun 2024 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 3 Mar 2027 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Detailed description
In this study, the investigators will test the mobile game, Viral Combat, for efficacy and acceptability among diverse participants, ages 15-34 years, receiving PrEP care in clinical settings in New England and Mississippi. Formative evaluation interviews will be conducted with stakeholders (healthcare workers, clinic administrators, and patients taking PrEP) to inform intervention delivery. Data from the formative interviews will also be used to make necessary adaptations to the game and assess acceptability for diverse populations and clinics. Viral Combat will then be further tested with 200 participants ages 15-34 years, receiving PrEP care at clinical sites in the South (n=100 Jackson, MS) and New England (n=100, Providence, RI; Boston, MA) in a multisite Hybrid Type 1 effectiveness-implementation randomized controlled trial (RCT). This trial will test the efficacy of the intervention compared to a control condition (a non-PrEP related game) on biological and behavioral measures. At the end of the trial, a summative evaluation of the implementation context using the i-PARIHS framework will occur. These interviews with study participants and clinic staff will inform future implementation and dissemination of Viral Combat.
Aim 1: To conduct formative evaluation interviews, guided by the i-PARHIS framework, with approximately 30 stakeholders (23 PrEP patients, 4 clinical staff, 3 clinic administrators) in order to adapt Viral Combat for diverse PrEP patient populations, and to identify individual, organizational, and structural factors associated with its implementation.
Aim 2: To evaluate, in a Hybrid Type 1 effectiveness-implementation randomized controlled trial with 200 participants taking PrEP (15-34 years of age), the effectiveness of Viral Combat compared to a control group that receives a non-PrEP related game.
The investigators will examine the impact of the intervention on:
2a: improving adherence to PrEP using a biological measure (tenofovir from DBS), clinic records, and self-report; 2b: the potential mediators of the intervention, such as knowledge, motivation, self-efficacy, and game metrics.
Aim 3: To conduct summative evaluation interviews, following the RCT phase, with an additional 30 stakeholders ((23 PrEP patients, 4 clinical staff, 3 clinic administrators). Interviews will assess and summarize the i-PARIHS constructs relevant to the intervention's future implementation success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multilevel Gaming Adherence | Experimental | Behavioral: Multilevel Gaming Adherence InterventionParticipants in the intervention arm will receive Multilevel Gaming Adherence Intervention. Participants receive Viral Combat on their mobile phones, and, for 24 weeks, game-related text messages guided by self-reported medication adherence. |
| Treatment as Usual + | Active comparator | Behavioral: Treatment as Usual +TAU+ participants will receive the Treatment As Usual + intervention, which includes receiving a non-HIV related mobile game. |
Who may qualify
- Ages
- 15 to 34 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 15-34 years old
- English speaking
- Initiated PrEP in the last 30 days or re-initiated PrEP after not taking PrEP for at least 1 month
- HIV negative as per clinician and clinical record
- Able to give consent/assent and not impaired by cognitive or medical limitations as per clinical assessment.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Multilevel Gaming Adherence InterventionInformation-Motivation-Behavior based mobile gaming application tailored for those taking PrEP and adherence-based text messages | Behavioural | Multilevel Gaming Adherence |
| Treatment as Usual +non-PrEP related mobile gaming application | Behavioural | Treatment as Usual + |
Primary outcome
Tenofovir (TFV) blood concentration at 24 weeks
Time frame: 24 weeks
Tenofovir (TFV) concentration in blood from either venipuncture or dried blood spot labs immediately post-intervention (at 24 weeks follow-up).
5 secondary outcomes
Tenofovir (TFV) blood concentration at 48 weeks
Time frame: 48 weeks
Self-reported Medication Adherence at 24 weeks
Time frame: 24 weeks
Self-reported Medication Adherence at 48 weeks
Time frame: 48 weeks
Medical appointment adherence at 24 weeks
Time frame: 24 weeks
Medical appointment adherence at 48 weeks
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
Related trials for Medication Adherence
Not yet recruiting
A Hybrid Effectiveness-Implementation and Cost-Utility Evaluation of a Support Programme for Informal Carers of People With Dementia in Primary Care (EsCuidar2)
Quality of Life
Active, not recruitingPhase 3
Outcomes of the PLHIV With Suboptimal Viral Suppression to Injectable Long-acting Antiretrovirals
HIV-1-infection, Non-Adherence, Medication
Recruiting
IMB-Guided Health Education Intervention for Medication Adherence and Blood Pressure Control in Non-adherent Hypertensive Patients
Hypertension
Enrolling by invitation
Investigation of a Patient Support Intervention for Statin Medication Adherence
Medication Adherence
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
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.
Larry K Brock, MD study director
Rhode Island Hospital
Sharon Vuppula, MD study director
Boston Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel Gaming Adherence Intervention and Treatment as Usual + in people with Medication Adherence and HIV/AIDS, run by Rhode Island Hospital at 3 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Whiteley, MD ((401)-455-6375, laura_whiteley@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tenofovir (TFV) blood concentration at 24 weeks (time frame: 24 weeks). 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 14 May 2025.