HIV/AIDSNCT06274632
ADELANTE: A Randomized Controlled Trial to Improve Engagement in Care for Latinos With HIV
A study testing ADELANTE in people with HIV/AIDS, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- ADELANTE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 May 2024to 28 Feb 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
- Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 3 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System, University of Miami's Continuity Clinic, or another HIV primary care clinic in Miami/Dade County; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.
Who cannot join
- Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Thomas P Giordano, MD, 713 798 8918, tpg@bcm.edu
- Recruiting
University of Miami
Miami, Florida, 33146
Allan Rodriguez, MD, 305-243-3711, arodriguez2@miami.edu
About this study
Official title: ADELANTE: A Randomized Controlled Trial of an Intervention to Improve Engagement in Care for Latinos With HIV
The goal of this study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.
Read the detailed description
Participants will be Latinx/Hispanic individuals age ≥18 years who are at least 3 months since initiation of HIV treatment and have evidence of viral non-suppression (HIV RNA ≥200 cpm). Participants will be recruited from two Ryan White-funded clinics in geographic priority areas in the US Ending the HIV Epidemic (EHE) Plan due to high HIV incidences and prevalence. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver a manualized problem-solving intervention that is framed around an HIV-focused telenovela, or drama-based film. The CHW will deliver five sessions within 6 months. The CHW will assist in problem-solving to improve behavioral activation and self-management skills and help participants adhere to HIV treatment and attend medical appointments. The CHW will also link patients to resources. In the enhanced care condition, participants will receive 5 phone calls. They will not receive the intervention or access to navigation beyond routine care. Measurements will occur at baseline, month-3, month-6, and month-12 post randomization by study staff blinded to the allocation status of participants. Participants will be remunerated for each assessment.
- Conditions
- HIV/AIDS
- Being tested
- ADELANTE
- Keywords
- Latino, Hispanic, HIV/AIDS, health outcomes, community health worker
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADELANTEBehavioural
A manualized problem-solving intervention that addresses barriers to viral suppression in Latinos with HIV. At the patient-level, CHWs use motivational interviewing to facilitate problem-solving skill development around attending HIV care and adherence and establish an individually tailored goal-setting plan. We target emotional well-being and self-management through a rapport with CHW and the integration of an HIV-centered telenovela to facilitate participant reflection on difficult topics for skill-building. The CHW will also link the participant to needed services.
| Study group | Role | What they receive |
|---|---|---|
| ADELANTE | Experimental | Participants will receive 5, individualized problem solving sessions delivered by a community health worker over 6 months. The intervention content is framed around a bi-lingual film about HIV. Receives: Behavioral: ADELANTE |
| Enhanced Care Condition | No intervention | Participants in the enhanced care control group will receive 5 locator phone calls confirming contact information at the same interval as CHW sessions in the ADELANTE group. They will be offered routine HIV health promotion materials as is available in the clinic. If a participant requests support for navigation or case management, they will be encouraged to contact their HIV team |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month viral suppression
Viral suppression is defined as number of participants with HIV RNA less than 200 cpm. Response determined by viral load values in the medical record closest to the scheduled 12-month date, allowing for a range of three months before or after the scheduled 12-month date.
Measured: month-12
Secondary outcomes (4)
Number of Emergency department visits
All-cause emergency department visits
Measured: 12 months
Number of Hospitalizations
All-cause hospitalizations defined as number of different times stayed in any hospital overnight or longer
Measured: 12 months
6-month viral suppression
Viral suppression is defined as number of participants with HIV RNA less than 200 cpm. Response determined by viral load values in the medical record closest to the scheduled 6-month date, allowing for a range between 4 and 8 months.
Measured: month-6
Retention in care
A dichotomized outcome (yes/no) with yes defined as at least one visit to the clinic providing HIV treatment at both time periods (months 0-6 and months 7-12) with the two visits at least 90 days apart and no defined as no HIV visit from at least one time period. Attendance determined by review of the medical record.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start22 May 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, University of Miami
- Responsible party
- Principal investigator, Julie H Levison, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274632
- Sponsor's protocol ID
- 2023P001913
- Status last verified
- Sep 2026
- First submitted
- 16 Feb 2024
- Last updated
- 22 Sep 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADELANTE: A Randomized Controlled Trial of an Intervention to Improve Engagement in Care for Latinos With HIV
- ClinicalTrials.gov ID
- NCT06274632
- Acronym / sponsor ID
- 2023P001913
- Conditions
- HIV/AIDS
- Keywords
- Latino, Hispanic, HIV/AIDS, health outcomes, community health worker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, University of Miami
- Study start
- 22 May 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 23 Feb 2024 (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 study is to test the effectiveness of ADELANTE on viral suppression among Latinos with HIV and viral non-suppression. Participants will receive ADELANTE (5-session, community health worker-delivered, problem-solving intervention) or enhanced care condition (ECC, 5 reminder phone calls). We will evaluate the overall effectiveness of ADELANTE compared with ECC on rates of viral suppression and emergency room visits and hospitalizations. Our hypothesis is that ADELANTE participants will achieve higher rates of viral suppression and will have lower rates of emergency room visits and hospitalizations compared with ECC at 12 months post-randomization.
Detailed description
Participants will be Latinx/Hispanic individuals age ≥18 years who are at least 3 months since initiation of HIV treatment and have evidence of viral non-suppression (HIV RNA ≥200 cpm). Participants will be recruited from two Ryan White-funded clinics in geographic priority areas in the US Ending the HIV Epidemic (EHE) Plan due to high HIV incidences and prevalence. In the intervention, a bilingual (English-Spanish speaking) community health worker (CHW) will deliver a manualized problem-solving intervention that is framed around an HIV-focused telenovela, or drama-based film. The CHW will deliver five sessions within 6 months. The CHW will assist in problem-solving to improve behavioral activation and self-management skills and help participants adhere to HIV treatment and attend medical appointments. The CHW will also link patients to resources. In the enhanced care condition, participants will receive 5 phone calls. They will not receive the intervention or access to navigation beyond routine care. Measurements will occur at baseline, month-3, month-6, and month-12 post randomization by study staff blinded to the allocation status of participants. Participants will be remunerated for each assessment.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADELANTE | Experimental | Behavioral: ADELANTEParticipants will receive 5, individualized problem solving sessions delivered by a community health worker over 6 months. The intervention content is framed around a bi-lingual film about HIV. |
| Enhanced Care Condition | No intervention | –Participants in the enhanced care control group will receive 5 locator phone calls confirming contact information at the same interval as CHW sessions in the ADELANTE group. They will be offered routine HIV health promotion materials as is available in the clinic. If a participant requests support for navigation or case management, they will be encouraged to contact their HIV team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-identify as Latino/Latina/Latinx/Hispanic; adults 18 years and over; with HIV infection confirmed by standard laboratory results available in the medical record; 3 or more months from initial entry into care with a medical provider who can prescribe HIV antiretroviral treatment; receiving HIV primary care at Jackson Memorial Hospital or Thomas Street at Quentin Mease Health Center/Harris Health System, University of Miami's Continuity Clinic, or another HIV primary care clinic in Miami/Dade County; and medical record evidence with last viral load (VL) indicating viral non-suppression (HIV RNA ≥200 cpm) within 12 months prior to assessment of eligibility, as it is typical for providers to obtain laboratories prior to a clinic visit in preparation for counseling.
Key exclusion criteria (1 listed)
- Lacks capacity to consent (measured by a validated screener), plans to move out of the county in the next 6 months, or currently participating in an HIV intervention study with ongoing follow-up.
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 |
|---|---|---|
| ADELANTEA manualized problem-solving intervention that addresses barriers to viral suppression in Latinos with HIV. At the patient-level, CHWs use motivational interviewing to facilitate problem-solving skill development around attending HIV care and adherence and establish an individually tailored goal-setting plan. We target emotional well-being and self-management through a rapport with CHW and the integration of an HIV-centered telenovela to facilitate participant reflection on difficult topics for skill-building. The CHW will also link the participant to needed services. | Behavioural | ADELANTE |
Primary outcome
12-month viral suppression
Time frame: month-12
Viral suppression is defined as number of participants with HIV RNA less than 200 cpm. Response determined by viral load values in the medical record closest to the scheduled 12-month date, allowing for a range of three months before or after the scheduled 12-month date.
4 secondary outcomes
Number of Emergency department visits
Time frame: 12 months
Number of Hospitalizations
Time frame: 12 months
6-month viral suppression
Time frame: month-6
Retention in care
Time frame: 12 months
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 22 Sep 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADELANTE in people with HIV/AIDS, run by Massachusetts General Hospital at 2 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 1 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 22 Sep 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. 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 Julie H Levison, MD (617-724-4698, jlevison@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12-month viral suppression (time frame: month-12). 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 22 Sep 2026.