HIVHEICA-HIV-2025NCT07105007
Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
A study testing Exercise Intervention, Tailored Education sessions and Behavioral coaching in people with HIV and Heart Failure, run by University of Washington at 2 sites in 2 countries.
Trial summary
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- HIV, Heart Failure
- What is being tested?
- Exercise Intervention, Tailored Education sessions and Behavioral coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Aug 2025to 1 Jul 2026
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed HIV infection (verified on medical record)
- Age ≥40 years
- Classified as heart failure stage A or B (American Heart Association Guidelines)
- On antiretroviral therapy (ART) for ≥12 months
- HIV RNA <200 copies/mL in the past 12 months
- Not engaged in a structured exercise or weight loss program in the past 6 months
Show all 9Show fewer
- Physically inactive, defined as an activity level of less than 400 METs measured with the Global Physical Activity Questionnaire (GPAQ)
- Independent in basic activities of daily living
- Able to ambulate independently
Who cannot join
- Heart failure stage C or D (AHA Guidelines)
- Participating in structured exercise or weight loss program in the past 6 months
- Exercising ≥3 times per week (≥20 minutes per session)
- Do not report fatigue
- Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
- Pregnant or postmenopausal women
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Vitor Oliveira, PhD, 2066160488, vitorhfo@uw.edu
Vitor Oliveira
Brazil1 site, 1 recruiting
- Recruiting
Londrina State University
Londrina, Paraná, 86055
Rafael Deminice, +55 43 3371-4248, rdeminice@uel.br
Rafael Deminice
About this study
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population.
Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
- Conditions
- HIV, Heart Failure
- Being tested
- Exercise Intervention, Tailored Education sessions, Behavioral coaching, Mobile health support, General education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. Sessions at the exercise center will be supervised by experienced exercise trainers in a 1:1 ratio. The intervention is designed to meet the recommendation of at least 150 minutes of MVPA per week and the recommendations on exercise intensity and volume from the ACSM. Each exercise session will be composed of aerobic and resistance exercises at moderate intensity (i.e., combined exercise training), which is the best exercise model for the needs of PLWH. Additionally, poor muscle strength has been associated with lower VO2peak among PLWH, suggesting that appropriate muscle-strengthening exercises can improve the aerobic performance of these patients. The aerobic exercise will be performed in a continuous manner and prescribed using the heart rate reserve.
Tailored Education sessionsBehavioural
At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. The material for the education sessions will be developed by the study team (a diverse team including exercise scientists, nurse, cardiologist, and infectious disease specialist). The focus of the sessions will be to increase the participants' knowledge and self-efficacy. The education sessions will occur prior to the start of the exercise intervention, to teach the participants how to safely perform the home-based exercises. An interventionist, who will possess a degree in a health profession, will present the content following the completion of standard training using material and guidance developed for this purpose. The content of the sessions will include a self-assessment on exercise and physical activity, and incorporate the ACSM recommendations for quantity and quality of exercise
Behavioral coachingBehavioural
At the end of their weekly in-person exercise sessions, the participants will receive a 20 minute coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. During the sessions, the trainers will be taught to use motivational interviewing, an evidence-based communication strategy that identifies and enhances patients' own motivations and reasons for health behavior change. Motivational interviewing is an approach to assessment and intervention based on the Stages of Motivational Readiness for Change model, which has been shown to increase physical activity in people with chronic health conditions. According to the Stages of Motivational Readiness for Change Model, individuals move through a series of stages (i.e., Precontemplation, Contemplation, Preparation, Action, and Maintenance) as they adopt and maintain a new habit. The coaching session will also address barriers from the home-based sessions, discuss HIV-specific barriers
Mobile health supportBehavioural
At the beginning of the program the participants will receive a fitness activity tracker (e.g., Fitbit or similar) to help in achieving their PA goals. Contemporary activity trackers provide reliable information on heart rate, steps count, and amount of PA performed, that will help the participants to monitor the intensity and amount during the home-base sessions. Heart rate monitoring will also be used to assess compliance with the home-based exercise prescription. Trackers also include gamification, awarding badges and trophies when goals are attained, that is demonstrated to be motivating.
General educationBehavioural
Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations consistent with professional society guidelines (e.g., American College of Sports Medicine). Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent (physical activity, education, behavioral coaching, mobile health) | Experimental | HEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals Receives: Behavioral: Exercise Intervention; Behavioral: Tailored Education sessions; Behavioral: Behavioral coaching; Behavioral: Mobile health support |
| Control group | Other | Participants randomized allocated to the control group will receive a standardized, guideline-based exercise counseling comparator designed to reflect best-practice health education rather than the multicomponent HEICA-HIV program. Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations. Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support. Although formal exercise prescription is not routinely provided in standard HIV care, inclusion of general exercise counseling in the control condition is ethically appropriate, given the well-established benefits of physical activity. Receives: Behavioral: General education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Adherence
Description: Number of exercise and education sessions attended by each participant during the intervention.
Unit of Measure: Number of sessions attended
Measured: From enrollment to the end of treatment at 8 weeks
Time Spent in Sedentary Behavior
Description: Exploratory analysis of the average time spent in sedentary behavior per week.
Unit of Measure: Minutes per week
Measured: From enrollment to the end of treatment at 8 weeks
Daily Step Count
Description: Exploratory outcome assessing the average daily number of steps. Unit of Measure: Steps per day
Measured: From enrollment to the end of treatment at 8 weeks
Moderate to Vigorous Physical Activity (MVPA) Time
Description: The primary outcome will be the objectively measured amount of time (in minutes) spent in moderate to vigorous physical activity (MVPA) per week.
Assessment Method: Using the wGT3X-BT ActiGraph accelerometer (ActiGraph, LLC, Fort Walton Beach, FL), participants will wear the device for 7 consecutive days during waking hours. Data will be considered valid with at least 10 hours/day of wear time for at least 4 days.
Data Processing: Data will be reduced using ActiLife software and MVPA will be classified based on Sasaki et al. adult cutpoints.
Unit of Measure: Minutes per week
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (3)
High-sensitivity C-reactive Protein (hs-CRP)
Description: Change in serum levels of hs-CRP from baseline to end of intervention.
Unit of Measure: mg/L
Measured: From enrollment to the end of treatment at 8 weeks
B-type Natriuretic Peptide (BNP)
Description: Change in serum levels of BNP from baseline to end of intervention.
Unit of Measure: pg/mL
Measured: From enrollment to the end of treatment at 8 weeks
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Description: Change in serum levels of NT-proBNP from baseline to end of intervention.
Unit of Measure: pg/mL
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Aug 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, non-randomized, pilot trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, State University of Londrina
- Responsible party
- Principal investigator, Vitor Oliveira, University of Washington
- Investigators
- Vitor Oliveira, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105007
- Sponsor's protocol ID
- STUDY00022246
- Acronym
- HEICA-HIV-2025
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2025
- Last updated
- 16 Mar 2026
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV
- ClinicalTrials.gov ID
- NCT07105007
- Acronym / sponsor ID
- HEICA-HIV-2025 / STUDY00022246
- Conditions
- HIV, Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, State University of Londrina
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population.
Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, non-randomized, pilot trial
| Arm | Type | Receives |
|---|---|---|
| Multicomponent (physical activity, education, behavioral coaching, mobile health) | Experimental | Behavioral: Exercise Intervention, Behavioral: Tailored Education sessions, Behavioral: Behavioral coaching, Behavioral: Mobile health supportHEICA-HIV components will include: a) education sessions; b) exercise intervention; c) individual coaching; d) mobile health support. COMPONENT 1: Education Sessions. At the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. COMPONENT 2: Exercise Intervention. After completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. COMPONENT 3: Individual Coaching. At the end of their weekly in-person exercise sessions, the participants will receive a 20 min coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. COMPONENT 4: Mobile health support. At the beginning of the program, participants will receive a fitness activity tracker to help in achieving goals |
| Control group | Other | Behavioral: General educationParticipants randomized allocated to the control group will receive a standardized, guideline-based exercise counseling comparator designed to reflect best-practice health education rather than the multicomponent HEICA-HIV program. Control participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations. Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support. Although formal exercise prescription is not routinely provided in standard HIV care, inclusion of general exercise counseling in the control condition is ethically appropriate, given the well-established benefits of physical activity. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Confirmed HIV infection (verified on medical record)
- Age ≥40 years
- Classified as heart failure stage A or B (American Heart Association Guidelines)
- On antiretroviral therapy (ART) for ≥12 months
- HIV RNA <200 copies/mL in the past 12 months
Key exclusion criteria (6 listed)
- Heart failure stage C or D (AHA Guidelines)
- Participating in structured exercise or weight loss program in the past 6 months
- Exercising ≥3 times per week (≥20 minutes per session)
- Do not report fatigue
- Significant comorbidities (e.g., uncontrolled hypertension, severe musculoskeletal/neurological conditions)
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 |
|---|---|---|
| Exercise InterventionAfter completing the education sessions, the participants will start 8 weeks of a hybrid exercise intervention, three days/week, being one supervised session in the exercise center and two unsupervised sessions at home. Sessions at the exercise center will be supervised by experienced exercise trainers in a 1:1 ratio. The intervention is designed to meet the recommendation of at least 150 minutes of MVPA per week and the recommendations on exercise intensity and volume from the ACSM. Each exercise session will be composed of aerobic and resistance exercises at moderate intensity (i.e., combined exercise training), which is the best exercise model for the needs of PLWH. Additionally, poor muscle strength has been associated with lower VO2peak among PLWH, suggesting that appropriate muscle-strengthening exercises can improve the aerobic performance of these patients. The aerobic exercise will be performed in a continuous manner and prescribed using the heart rate reserve. | Behavioural | Multicomponent (physical activity, education, behavioral coaching, mobile health) |
| Tailored Education sessionsAt the beginning of the program, the participants will receive two face-to-face group education sessions, consisting of 90 minutes of exercise and cardiovascular health education. The material for the education sessions will be developed by the study team (a diverse team including exercise scientists, nurse, cardiologist, and infectious disease specialist). The focus of the sessions will be to increase the participants' knowledge and self-efficacy. The education sessions will occur prior to the start of the exercise intervention, to teach the participants how to safely perform the home-based exercises. An interventionist, who will possess a degree in a health profession, will present the content following the completion of standard training using material and guidance developed for this purpose. The content of the sessions will include a self-assessment on exercise and physical activity, and incorporate the ACSM recommendations for quantity and quality of exercise | Behavioural | Multicomponent (physical activity, education, behavioral coaching, mobile health) |
| Behavioral coachingAt the end of their weekly in-person exercise sessions, the participants will receive a 20 minute coaching session to address their attitudes, self-efficacy, and behavioral self-management skills towards exercise. During the sessions, the trainers will be taught to use motivational interviewing, an evidence-based communication strategy that identifies and enhances patients' own motivations and reasons for health behavior change. Motivational interviewing is an approach to assessment and intervention based on the Stages of Motivational Readiness for Change model, which has been shown to increase physical activity in people with chronic health conditions. According to the Stages of Motivational Readiness for Change Model, individuals move through a series of stages (i.e., Precontemplation, Contemplation, Preparation, Action, and Maintenance) as they adopt and maintain a new habit. The coaching session will also address barriers from the home-based sessions, discuss HIV-specific barriers | Behavioural | Multicomponent (physical activity, education, behavioral coaching, mobile health) |
| Mobile health supportAt the beginning of the program the participants will receive a fitness activity tracker (e.g., Fitbit or similar) to help in achieving their PA goals. Contemporary activity trackers provide reliable information on heart rate, steps count, and amount of PA performed, that will help the participants to monitor the intensity and amount during the home-base sessions. Heart rate monitoring will also be used to assess compliance with the home-based exercise prescription. Trackers also include gamification, awarding badges and trophies when goals are attained, that is demonstrated to be motivating. | Behavioural | Multicomponent (physical activity, education, behavioral coaching, mobile health) |
| General educationControl participants will complete one brief education session delivered at baseline, covering exercise safety and general physical activity recommendations consistent with professional society guidelines (e.g., American College of Sports Medicine). Following education, participants will receive a non-individualized, generic home-based exercise recommendation emphasizing aerobic and resistance activities, without supervised training, structured progression, individualized feedback, or behavioral coaching. Control participants will not receive motivational interviewing support. | Behavioural | Control group |
Primary outcome
Intervention Adherence
Time frame: From enrollment to the end of treatment at 8 weeks
Description: Number of exercise and education sessions attended by each participant during the intervention. Unit of Measure: Number of sessions attended
Time Spent in Sedentary Behavior
Time frame: From enrollment to the end of treatment at 8 weeks
Description: Exploratory analysis of the average time spent in sedentary behavior per week. Unit of Measure: Minutes per week
Daily Step Count
Time frame: From enrollment to the end of treatment at 8 weeks
Description: Exploratory outcome assessing the average daily number of steps. Unit of Measure: Steps per day
Moderate to Vigorous Physical Activity (MVPA) Time
Time frame: From enrollment to the end of treatment at 8 weeks
Description: The primary outcome will be the objectively measured amount of time (in minutes) spent in moderate to vigorous physical activity (MVPA) per week. Assessment Method: Using the wGT3X-BT ActiGraph accelerometer (ActiGraph, LLC, Fort Walton Beach, FL), participants will wear the device for 7 consecutive days during waking hours. Data will be considered valid with at least 10 hours/day of wear time for at least 4 days. Data Processing: Data will be reduced using ActiLife software and MVPA will be classified based on Sasaki et al. adult cutpoints. Unit of Measure: Minutes per week
3 secondary outcomes
High-sensitivity C-reactive Protein (hs-CRP)
Time frame: From enrollment to the end of treatment at 8 weeks
B-type Natriuretic Peptide (BNP)
Time frame: From enrollment to the end of treatment at 8 weeks
N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Time frame: From enrollment to the end of treatment at 8 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 16 Mar 2026.
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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.
Vitor Oliveira, PhD principal investigator
University of Washington
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Tailored Education sessions and Behavioral coaching in people with HIV and Heart Failure, run by University of Washington at 2 sites in 2 countries.
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 9 inclusion and 6 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Brazil. 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 André Pereira dos Santos, PhD (206-380-3048, andreps@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Adherence (time frame: From enrollment to the end of treatment at 8 weeks). 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 16 Mar 2026.