HIV Infection PrimaryINSTACARENCT04663152
Integrated Navigation Services for Treatment Adherence, Counseling, and Research
A study testing INSTACARE in people with HIV Infection Primary, run by University of Miami at 1 site in United States.
Trial summary
The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection Primary
- What is being tested?
- INSTACARE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 31 May 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
- Ages 18 years or older
- Miami-Dade Resident at time of enrollment
- self-identify as Black
- Viral load > 200 mL within the last 6-months (VL must be verified via electronic medical record or lab report prior to enrollment)
Who cannot join
- Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Ashley Gray, MSPH, 305-243-1497, ajg2940@miami.edu
Sonjia Kenya, EdD, 3052438893, skenya@med.miami.edu
About this study
The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.
- Conditions
- HIV Infection Primary
- Being tested
- INSTACARE
- Keywords
- HIV viral suppression, community health worker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSTACAREBehavioural
CHWs will provide participants with support via phone calls, home-visits, and accompaniment to clinic visits to improve medication management and HIV viral suppression. CHWs will contact participants at least once per week for three months.
| Study group | Role | What they receive |
|---|---|---|
| INSTACARE arm | Experimental | Participants in this arm will receive the INSTACARE intervention for three months. Receives: Behavioral: INSTACARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication Preferences
Communication preferences will be reported as the number of participants who prefer any of the following intervention modes of administration: text messaging, phone calls, home visits, accompaniment to clinic visits, utilization of existing health portals and phone applications. Data will be collected via survey administered to participants by CHW.
Measured: 3 months
Number of CHW contacts
CHW contacts with participants will be extracted from CHW tracking logs.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start26 Jul 2023
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 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 Infection PrimaryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Sonjia Kenya, University of Miami
- Investigators
- Sonjia Kenya, EdD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663152
- Sponsor's protocol ID
- 20201234
- Other IDs
- R01MD018187
- Acronym
- INSTACARE
- Status last verified
- Jun 2026
- First submitted
- 3 Dec 2020
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kenya S, Young B, Escarfuller S, Jones-Weiss D, Carrasquillo O, Riccio A, Yue P. Improving HIV outcomes in Miami's Black populations with clinic-based community health workers protocol: The integrated navigation and support for treatment adherence, counseling, and research (INSTACARE) randomized controlled trial. PLoS One. 2025 Apr 7;20(4):e0316300. doi: 10.1371/journal.pone.0316300. eCollection 2025.
PubMed 40193336
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Navigation Services for Treatment Adherence, Counseling, and Research
- ClinicalTrials.gov ID
- NCT04663152
- Acronym / sponsor ID
- INSTACARE / 20201234
- Conditions
- HIV Infection Primary
- Keywords
- HIV viral suppression, community health worker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 10 Dec 2020 (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.
The goal of this research is to determine whether a Community Health Worker (CHW) intervention including a mobile telehealth (M-Health) component can help achieve long term viral suppression among Black people with poorly controlled HIV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INSTACARE arm | Experimental | Behavioral: INSTACAREParticipants in this arm will receive the INSTACARE intervention for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18 years or older
- Miami-Dade Resident at time of enrollment
- self-identify as Black
- Viral load > 200 mL within the last 6-months (VL must be verified via electronic medical record or lab report prior to enrollment)
Key exclusion criteria (1 listed)
- Any other condition(s) that the treating clinician determines would limit participant from meaningful study participation.
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 |
|---|---|---|
| INSTACARECHWs will provide participants with support via phone calls, home-visits, and accompaniment to clinic visits to improve medication management and HIV viral suppression. CHWs will contact participants at least once per week for three months. | Behavioural | INSTACARE arm |
Primary outcome
Communication Preferences
Time frame: 3 months
Communication preferences will be reported as the number of participants who prefer any of the following intervention modes of administration: text messaging, phone calls, home visits, accompaniment to clinic visits, utilization of existing health portals and phone applications. Data will be collected via survey administered to participants by CHW.
Number of CHW contacts
Time frame: 3 months
CHW contacts with participants will be extracted from CHW tracking logs.
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 29 Jun 2026.
- Derived from this study: PubMed 40193336Kenya S, Young B, Escarfuller S, Jones-Weiss D, Carrasquillo O, Riccio A, Yue P. Improving HIV outcomes in Miami's Black populations with clinic-based community health workers protocol: The integrated navigation and support for treatment adherence, counseling, and research (INSTACARE) randomized controlled trial. PLoS One. 2025 Apr 7;20(4):e0316300. doi: 10.1371/journal.pone.0316300. eCollection 2025.
- 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.
Sonjia Kenya, EdD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTACARE in people with HIV Infection Primary, run by University of Miami at 1 site 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 4 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 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Ashley J Gray, MPH (3052431497, ajg2940@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication Preferences (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04663152, 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 29 Jun 2026.