HIV InfectionsNCT05398185

WiseApp for Spanish Speakers Living With HIV

A study testing CleverCap in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by Columbia University at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Acquired Immune Deficiency Syndrome, Sexually Transmitted Diseases, Viral
What is being tested?: CleverCap
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 241 participants
Where: 2 sitesin 2 countries
Study dates: 1 Mar 2023to Jan 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Able to speak, read, and write in Spanish;
Aged ≥18 years;
Willing to participate in any assigned arm of the intervention;
Have an HIV-1 RNA level >50 copies/mL;
Own a smartphone (DR participants who are eligible but without access to a smartphone will get one as part of the study at the time of enrollment); and
Ability and willingness to provide informed consent for study participation and consent for access to medical records.

Who cannot join

Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
Terminal illness with life expectancy <6 months;
Planning to move out of the area in the next 12 months;
A cognitive state minimum score measured by the Mini-Mental State Examination (MMSE) to ensure participants are oriented to time and place.
Spouses/partners may not enroll in this study. The study will be limited to only 1 person from the same family/domestic household.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Columbia University Irving Medical Center
New York, New York, 10032

Other trials in United States

Dominican Republic1 site

Clinica de Familia La Romana
La Romana, Dominican Republic

Other trials in Dominican Republic

About this study

Official title: WiseApp for Spanish-Speaking Latino Persons Living With HIV (PLWH) in the United States (US) and the Dominican Republic (DR)

This study aims to conduct a 12-month randomized controlled trial to adapt the mobile app, WiseApp, and a smart pill dispenser for Spanish-speaking people living with HIV (PLWH) in the New York City (NYC) area and La Romana, Dominican Republic (DR). The study will assess the efficacy and sustainability of WiseApp as well as identify barriers with its widespread use among Spanish speakers. With disproportionately high rates of HIV in the New York City area and the Dominican Republic, this project seeks to identify distinct contextual factors related to Spanish speaking people living with HIV and increase the likelihood of engagement with technology and improvements in clinical outcomes.

Read the detailed description

While efforts have been made, deficits remain in antiretroviral therapy (ART) adherence and viral suppression among PLWH. There are gaps in HIV treatment success that are particularly present in racial and ethnic minority populations, especially among Latinos in the Northeast United States (US) and the Caribbean. The progression and premature deaths among PLWH have been attributed to insufficient engagement in medical care and adherence to HIV treatments. Access and adherence to ART are important to therapeutic success and help determine long-term health outcomes in PLWH. The investigators studied racial/ethnic minorities and their providers to identify the impact a mobile app can have to improve health outcomes. The Agency for Healthcare Research and Quality (AHRQ) helped create this app and integrated it with a smart pill box (CleverCap) which allows PLWH to monitor their medication adherence. The tool, WiseApp, is a better method than other ART adherence methods because the app is linked to the smart pill box and is currently being evaluated in random-control trials (RCT) in New York City. There is also a need to develop and test self-management interventions for Spanish speaking Latino PLWH because they are the largest and fastest growing ethnic minority group in the US and are disproportionately affected by HIV. The investigators suggest the transfer of WiseApp to Latinos in the US and the DR by translating it to Spanish and making it culturally accessible. The project will use health information technology to facilitate the collection of medication adherence, quality of life, and symptom burden data.

This study aims to adapt WiseApp for Spanish speaking PLWH and conduct RCT to assess the app's efficacy and sustainability. The study will identify barriers and facilitators to the widespread use of the app and builds on the strong linkage between Columbia University and Clínica de Familia in the DR. This project is also enhanced by utilizing the strong presence of Latinos in the Washington Heights neighborhood of NYC, the disproportionately high rates of HIV in the DR, and patterns of movement of people between NYC and the DR. Additionally, the study focuses on AHRQ priority populations such as chronically ill, inner-city, low-income, and racial/ethnic minority persons.

Conditions: HIV Infections, Acquired Immune Deficiency Syndrome, Sexually Transmitted Diseases, Viral
Being tested: CleverCap
Keywords: People living with HIV (PLWH), Antiretroviral therapy (ART), Mobile Health, Spanish Speakers, Latinos
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Viral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CleverCapDevice
The CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.

Study groups in NCT05398185
Study group	Role	What they receive
Control	No intervention	The control includes standard health services offered at each site (e.g., mental health services, case-management, referral to clinical care) and a brief adherence educational session.
Intervention	Experimental	Participants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp. Receives: Device: CleverCap

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in self-reported ART adherence
Self-reported ART adherence is a single-item self-report measure on a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.
Measured: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up

Secondary outcomes (3)

Change in cluster of differentiation 4 (CD4) Count
Using blood samples obtained during study visits, CD4 count will be used to assess ART adherence.
Measured: Baseline, 3 month follow up, and 6 month follow up
Change in Viral Load
Using blood samples obtained during study visits, viral load levels will be used to assess ART adherence.
Measured: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Change In Participant's Self-reported Health-related Quality of Life Score
Health-related quality of life will be measured with the Patient-Reported Outcomes Measurement Information System® (PROMIS)-29 measure, which measures 7 domains of health-related quality of life with 4 questions in each section pertaining to how that participant's health influences their life. In general, each question has five response options ranging in values from 1-5. To find the total raw score for this form with all the questions answered, the values from the responses of each question are summed. Raw scores are then translated into a T-score for each participant, which rescales the raw score into a standardized T-score with a mean of 50 and standard deviation (SD) of 10. Consequently, a person with a T-score of 40 would be one SD below the mean.
Measured: Baseline and 12 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 2023Jan 2027

First posted31 May 2022
Study start1 Mar 2023
Primary completion1 Nov 2026 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by Columbia UniversityThe 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: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 241 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05398185
Sponsor's protocol ID: AAAT8632
Other IDs: 1R18HS028523-01
Status last verified: Aug 2026
First submitted: 25 May 2022
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Olaya F, Brin M, Caraballo PB, Halpern M, Jia H, Ramirez SO, Padilla JJ, Stonbraker S, Schnall R. A randomized controlled trial of the dissemination of an mHealth intervention for improving health outcomes: the WiseApp for Spanish-speakers living with HIV study protocol. BMC Public Health. 2024 Jan 17;24(1):201. doi: 10.1186/s12889-023-17538-y.
PubMed 38233908

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: WiseApp for Spanish-Speaking Latino Persons Living With HIV (PLWH) in the United States (US) and the Dominican Republic (DR)
ClinicalTrials.gov ID: NCT05398185
Acronym / sponsor ID: AAAT8632
Conditions: HIV Infections, Acquired Immune Deficiency Syndrome, Sexually Transmitted Diseases, Viral
Keywords: People living with HIV (PLWH), Antiretroviral therapy (ART), Mobile Health, Spanish Speakers, Latinos
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 241 participants (actual)
Lead sponsor: Columbia UniversityUniversity, hospital or other
Collaborators: Clínica de Familia La Romana, Dominican Republic
Study start: 1 Mar 2023 (actual)
Primary completion: 1 Nov 2026 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 31 May 2022 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Control	No intervention	–The control includes standard health services offered at each site (e.g., mental health services, case-management, referral to clinical care) and a brief adherence educational session.
Intervention	Experimental	Device: CleverCapParticipants randomized to intervention will receive the CleverCap pill bottle, an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Able to speak, read, and write in Spanish;
Aged ≥18 years;
Willing to participate in any assigned arm of the intervention;
Have an HIV-1 RNA level >50 copies/mL;
Own a smartphone (DR participants who are eligible but without access to a smartphone will get one as part of the study at the time of enrollment); and

Key exclusion criteria (5 listed)

Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment;
Terminal illness with life expectancy <6 months;
Planning to move out of the area in the next 12 months;
A cognitive state minimum score measured by the Mini-Mental State Examination (MMSE) to ensure participants are oriented to time and place.
Spouses/partners may not enroll in this study. The study will be limited to only 1 person from the same family/domestic household.

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
CleverCapThe CleverCap pill bottle is an innovative technology that dispenses only the prescribed amount of medication, keeps track of medications dispensed, and communicates wirelessly with the WiseApp to deliver medication adherence reminders.	Device	Intervention

Primary outcome

Change in self-reported ART adherence
Time frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Self-reported ART adherence is a single-item self-report measure on a linear scale of 0-100 with zero indicating lowest adherence and 100 indicating highest adherence.

3 secondary outcomes

Change in cluster of differentiation 4 (CD4) Count
Time frame: Baseline, 3 month follow up, and 6 month follow up
Change in Viral Load
Time frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up
Change In Participant's Self-reported Health-related Quality of Life Score
Time frame: Baseline and 12 month follow up

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 6 Aug 2026.
Derived from this study: PubMed 38233908Olaya F, Brin M, Caraballo PB, Halpern M, Jia H, Ramirez SO, Padilla JJ, Stonbraker S, Schnall R. A randomized controlled trial of the dissemination of an mHealth intervention for improving health outcomes: the WiseApp for Spanish-speakers living with HIV study protocol. BMC Public Health. 2024 Jan 17;24(1):201. doi: 10.1186/s12889-023-17538-y.
Individual participant dataSharing planned: No

Related trials for HIV Infections

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Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
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Recruiting
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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.

Rebecca Schnall, PhD, MPH principal investigator

Columbia University

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CleverCap in people with HIV Infections and Acquired Immune Deficiency Syndrome, run by Columbia University 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Aug 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, Dominican Republic. 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?

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?

Change in self-reported ART adherence (time frame: Baseline, 3 month follow up, 6 month follow up, and 12 month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05398185, which also lists 1 linked publication.

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 6 Aug 2026.