HIV Infection PrimaryNCT05947266
Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
A study testing an adaptation of the iENGAGE in people with HIV Infection Primary, run by Florida International University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are: Does this intervention result in measurable engagement and retention in care? Does this intervention result in measurable… 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?
- an adaptation of the iENGAGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 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
- Seropositive for HIV
- Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.
- Migrated to the US from Haiti
Who cannot join
- 1. Virally suppressed
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are:
- Does this intervention result in measurable engagement and retention in care?
- Does this intervention result in measurable viral suppression within 6 months?
Read more
Participants will
- participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment.
- Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.
Read the detailed description
Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.
Procedures to be used:
AIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.
AIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.
AIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.
- Conditions
- HIV Infection Primary
- Being tested
- an adaptation of the iENGAGE
- Keywords
- Viral suppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an adaptation of the iENGAGEBehavioural
Also called Haitian immigrant iENGAGE (H-iENGAGE)
Haitian immigrant iENGAGE (H-iENGAGE) is an adaptation of the iENGAGE intervention culturally adapted for Haitian immigrants with HIV that will be tested in a quasi-experimental pilot for preliminary efficacy among recently diagnosed or nonvirally suppressed adults across two Federally Qualified Health Centers (FQHCs) in Miami.
| Study group | Role | What they receive |
|---|---|---|
| Haitian immigrant iENGAGE (H-iENGAGE) intervention | Experimental | 1. Enrollment;
2. Baseline assessment;
3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4
4. Following Session 4, conduct Process evaluation;
5. Post-intervention assessment;
6. Six-month follow up assessment*
*Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods.
7. End of study participation Receives: Behavioral: an adaptation of the iENGAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Care of Engagement Index Score
Change in Engagement in Care score over time, including comfort and communication with provider
Measured: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up
Viral suppression
Change in HIV load measurement toward a target of less than 200 copies/ml
Measured: Baseline, 6-month post-baseline follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start3 Jun 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Infection PrimaryStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, quasi-experimental, single arm study
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947266
- Sponsor's protocol ID
- NIMH34133481
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening With Haitian Immigrants in the U.S. to Improve HIV Outcomes
- ClinicalTrials.gov ID
- NCT05947266
- Acronym / sponsor ID
- NIMH34133481
- Conditions
- HIV Infection Primary
- Keywords
- Viral suppression
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jul 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.
The goal of this clinical trial is to test a culturally tailored engagement and retention intervention for Haitian Immigrants Living With HIV (HILWH). The main questions it aims to answer are:
- Does this intervention result in measurable engagement and retention in care?
- Does this intervention result in measurable viral suppression within 6 months?
Participants will
- participate in a pilot health intervention entailing 4 individual meetings, approximately once monthly over a six-month period and completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment.
- Six participants who have completed the pilot intervention and agree to take part, will participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and take and display photographs.
Detailed description
Research design: The proposed study will test a culturally tailored engagement and retention intervention for Haitian immigrants living with HIV (HILWH). This is sequential mixed-methods formative pilot research that is designed to examine engagement and retention in care, and viral suppression (VS) for HILWH and adapt a promising intervention that will result in viral suppression between baseline and a 6 month follow-up assessment. The pilot will be conducted as a prospective, quasi-experimental single arm with a sample of newly diagnosed or nonvirally suppressed HIWLH adults drawn from 2 Federally Qualified Health Centers (FQHC) sites in Miami.
Procedures to be used:
AIM 1 mixed methods (quantitative and qualitative) data collection on barriers and facilitators to viral suppression among HILWH. Quantitative questionnaires will be completed by health care service providers and HILWH who will also participate in a Focus group. A sample of HILWH will participate in individual in-depth interviews.
AIM 2 consists of a pilot health intervention entailing completing research questionnaires at enrollment, post-intervention and at 6 months post-enrollment. In addition, participants will have 4 individual meetings, approximately once monthly over a six month period.
AIM 3 Photovoice participants will be 6 participants who have completed the pilot intervention (AIM 2) and agree to participate in the photovoice portion of the study. This activity will consist of 6 additional meetings where participants will be taught about using photographs to illustrate their experience participating in the study and taking photographs. This activity is expected to take approximately 8 additional hours over 2 and a half months. For these six participants, the total amount of time will be approximately 20 hours over 8 and 1/2 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, quasi-experimental, single arm study
| Arm | Type | Receives |
|---|---|---|
| Haitian immigrant iENGAGE (H-iENGAGE) intervention | Experimental | Behavioral: an adaptation of the iENGAGE1. Enrollment; 2. Baseline assessment; 3. Upon baseline completion, scheduling of H-iENGAGE sessions 1 through 4 4. Following Session 4, conduct Process evaluation; 5. Post-intervention assessment; 6. Six-month follow up assessment* *Six participants will complete AIM 3: Identify multi-level implementation factors contributing to intervention outcomes, using photovoice in mixed methods. 7. End of study participation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Seropositive for HIV
- Either a recent HIV diagnosis (within the last 2 months) or non-virally suppressed.
- Migrated to the US from Haiti
Key exclusion criteria (1 listed)
- 1. Virally suppressed
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 |
|---|---|---|
| an adaptation of the iENGAGEAlso: Haitian immigrant iENGAGE (H-iENGAGE)Haitian immigrant iENGAGE (H-iENGAGE) is an adaptation of the iENGAGE intervention culturally adapted for Haitian immigrants with HIV that will be tested in a quasi-experimental pilot for preliminary efficacy among recently diagnosed or nonvirally suppressed adults across two Federally Qualified Health Centers (FQHCs) in Miami. | Behavioural | Haitian immigrant iENGAGE (H-iENGAGE) intervention |
Primary outcome
Care of Engagement Index Score
Time frame: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up
Change in Engagement in Care score over time, including comfort and communication with provider
Viral suppression
Time frame: Baseline, 6-month post-baseline follow up
Change in HIV load measurement toward a target of less than 200 copies/ml
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 10 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing an adaptation of the iENGAGE in people with HIV Infection Primary, run by Florida International University 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 3 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 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?
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?
Care of Engagement Index Score (time frame: Baseline, post-intervention (week 12 to 14 post baseline), 6-month post-baseline follow up). 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?
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 10 Jul 2026.