HIV/AIDSNCT03358927
Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti
A study testing Immediate Fast-Track Care and Deferred Fast-Track Care in people with HIV/AIDS, run by Brigham and Women's Hospital at 1 site in Haiti.
Trial summary
In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. 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?
- Immediate Fast-Track Care and Deferred Fast-Track Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteHaiti
- Study dates
- 27 Nov 2018to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Men and women of ≥18 years of age
- Ability and willingness to give written informed consent
- Documentation of positive HIV status (test conducted at GHESKIO), and initiation of same-day ART prior to enrollment
- Physician-confirmed WHO Stage 1 or 2 disease
- Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
- Access to a phone, or able to provide a contact person with a phone (this does not require disclosure of HIV status to the contact person)
- Agreement to provide a contact phone number and address, and to accept home visits from a CHW.
Who cannot join
- Any use of ART in the past
- Pregnancy or breastfeeding at the screening visit
- WHO Stage 3 or 4 disease
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
- Score of <3 for any of the 7 questions on the ART readiness survey
- Planning to transfer care to another clinic during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study
In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. All participants will receive same-day HIV testing and ART initiation prior to study enrollment. The intervention group will receive immediate fast-track care, which is conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1 RNA <200 copies/ml). The standard group will be eligible to start fast-track care at 24 weeks, if they are on time for that visit and have an undetectable viral load. Participants in either group who are >3 days late for any fast-track visit will lose fast-track care for that visit; those in either group with detectable viremia on their 24-week viral load test will be evaluated by a physician, with follow-up visits every 4 weeks until they have an undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot study, the investigators aim to conduct the formative work that is necessary to successfully implement a future clinical trial with the same primary outcome. The investigators hypothesize that immediate fast-track care will result in higher retention with viral suppression.
Read the detailed description
This study is a randomized, open-label pilot study comparing immediate fast-track vs. standard care for patients with WHO Stage 1 or 2 disease at HIV diagnosis. Participants will be enrolled on the day of HIV diagnosis, and will be followed for 48 weeks. The total sample size will be 254 participants; of these, 56 will be patients or providers enrolled in one-time focus groups, 20 will be enrolled for testing the manuals and study procedures, and 178 will be enrolled in the pilot RCT.
The study site is GHESKIO (Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections) in Port-au-Prince, Haiti. The study population includes men and women who are at least 18 years of age who are ART-naïve, and who present with WHO Stage 1 or 2 diseases at HIV diagnosis.
Participants in both groups will initiate ART on the day of HIV testing, prior to enrollment and randomization. They will then be randomized to immediate versus standard (deferred fast-track) care. Those in the immediate group will start fast-track care on the day of HIV testing. Those in the standard group will start fast-track care if they are on time for their 24-week visit, with HIV-1 RNA <200 copies/ml. Participants in both groups will receive identical care from weeks 24 to 48.
Once a patient qualifies for fast-track care, it is provided in the same manner for both groups.
- Reminder phone call and point-of-service dispensing of ART: The CHW calls patient one day in advance, to ensure they can attend visit. If patient responds in the affirmative, then their ART and prophylactic medications are packaged in advance.
- Minimal waiting time to see clinician, with short, focused visits: Total visit time is about 30 minutes.
- Less frequent clinic visits: Other than the first 3 months for the immediate group, fast-track care includes quarterly nurse visits, with CHW phone calls during months when no clinic visit is scheduled;
- Nurse-led care: Fast-track visits are all staffed by nurses, except in the case that a patient has a new symptom; in that case, the patient receives a fast-track physician evaluation, with appropriate fast-track follow-up care. For example, in the rare case that a patient develops active TB, they will receive fast-track care with physician and nurse visits as appropriate.
- Conditions
- HIV/AIDS
- Being tested
- Immediate Fast-Track Care, Deferred Fast-Track Care
- Keywords
- HIV/AIDS, Fast-track care, Behavioral economics, Differentiated care
- 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.
Immediate Fast-Track CareBehavioural
Eligible for fast-track care at enrollment
Deferred Fast-Track CareBehavioural
Eligible for fast-track care after 6 months on ART
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Active comparator | Deferred fast-track care Receives: Behavioral: Deferred Fast-Track Care |
| Immediate Fast-Track Group | Experimental | Immediate fast-track care Receives: Behavioral: Immediate Fast-Track Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression; cut-off <200 copies/ml
HIV-1 RNA <200 copies/ml
Measured: 48 weeks after enrollment
Secondary outcomes (9)
Viral Suppression; cut-off <50 copies/ml
HIV-1 RNA <50 copies/ml
Measured: 48 weeks after enrollment
Viral Suppression; cut-off <1000 copies/ml
HIV-1 RNA <1000 copies/ml
Measured: 48 weeks after enrollment
Adherence by pharmacy refill records
ART dispensed by the pharmacy for at least 90% of the days in the study period (302 days of ART dispensed during the 336-day study period)
Measured: 48 weeks after enrollment
Cost-effectiveness
Cost per patients with undetectable viral load
Measured: 48 weeks after enrollment
Connectedness to Treatment Setting Scale
Mean score; range 10-60; a higher score indicates greater connection to treatment setting
Measured: Day of enrollment, and 24 weeks and 48 weeks after enrollment
State Hope Scale
Mean score; range 6 to 30; a higher score indicates greater hopefulness
Measured: Day of enrollment, and 24 weeks and 48 weeks after enrollment
Patient Satisfaction Survey
Mean score; range 5 to 25; a higher score indicates greater satisfaction
Measured: Weeks 2, 24, and 48 after enrollment
Social Provisions Scale
Mean score; range 24 to 96; a higher score indicates greater degree of perceived support
Measured: Day of enrollment, and 24 and 48 weeks after enrollment
Coping Survey
Mean score; range 38 to 152; a higher score indicates a greater sense of being able to cope with a situation
Measured: Weeks 2, 24, and 48 after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start27 Nov 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
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 Brigham and Women's 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, Duke University, Florida International University, Analysis Group, Inc.
- Responsible party
- Principal investigator, Serena Patricia Koenig, Brigham and Women's Hospital
- Investigators
- Serena Koenig, MD, Principal investigator, Brigham and Women's Hospital/GHESKIOJean Pape, MD, Study director, GHESKIO; Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03358927
- Sponsor's protocol ID
- R34MH114739
- Status last verified
- Apr 2021
- First submitted
- 27 Nov 2017
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will post an anonymized dataset after the study is complete.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Fast-Track Versus Standard Care for Persons Living With HIV in Haiti: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT03358927
- Acronym / sponsor ID
- R34MH114739
- Conditions
- HIV/AIDS
- Keywords
- HIV/AIDS, Fast-track care, Behavioral economics, Differentiated care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, Duke University, Florida International University, Analysis Group, Inc.
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 2 Dec 2017 (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.
In the proposed R34 grant, the investigators will develop and test a strategy of immediate fast-track care. The study population will include adult patients with early HIV infection. Participants will be randomized to immediate fast-track or standard (deferred fast-track) care. All participants will receive same-day HIV testing and ART initiation prior to study enrollment. The intervention group will receive immediate fast-track care, which is conditional upon timely visits, and after 24 weeks in care, an undetectable viral load (HIV-1 RNA <200 copies/ml). The standard group will be eligible to start fast-track care at 24 weeks, if they are on time for that visit and have an undetectable viral load. Participants in either group who are >3 days late for any fast-track visit will lose fast-track care for that visit; those in either group with detectable viremia on their 24-week viral load test will be evaluated by a physician, with follow-up visits every 4 weeks until they have an undetectable viral load. Participants will be followed for 48 weeks. With the proposed pilot study, the investigators aim to conduct the formative work that is necessary to successfully implement a future clinical trial with the same primary outcome. The investigators hypothesize that immediate fast-track care will result in higher retention with viral suppression.
Detailed description
This study is a randomized, open-label pilot study comparing immediate fast-track vs. standard care for patients with WHO Stage 1 or 2 disease at HIV diagnosis. Participants will be enrolled on the day of HIV diagnosis, and will be followed for 48 weeks. The total sample size will be 254 participants; of these, 56 will be patients or providers enrolled in one-time focus groups, 20 will be enrolled for testing the manuals and study procedures, and 178 will be enrolled in the pilot RCT.
The study site is GHESKIO (Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic Infections) in Port-au-Prince, Haiti. The study population includes men and women who are at least 18 years of age who are ART-naïve, and who present with WHO Stage 1 or 2 diseases at HIV diagnosis.
Participants in both groups will initiate ART on the day of HIV testing, prior to enrollment and randomization. They will then be randomized to immediate versus standard (deferred fast-track) care. Those in the immediate group will start fast-track care on the day of HIV testing. Those in the standard group will start fast-track care if they are on time for their 24-week visit, with HIV-1 RNA <200 copies/ml. Participants in both groups will receive identical care from weeks 24 to 48.
Once a patient qualifies for fast-track care, it is provided in the same manner for both groups.
- Reminder phone call and point-of-service dispensing of ART: The CHW calls patient one day in advance, to ensure they can attend visit. If patient responds in the affirmative, then their ART and prophylactic medications are packaged in advance.
- Minimal waiting time to see clinician, with short, focused visits: Total visit time is about 30 minutes.
- Less frequent clinic visits: Other than the first 3 months for the immediate group, fast-track care includes quarterly nurse visits, with CHW phone calls during months when no clinic visit is scheduled;
- Nurse-led care: Fast-track visits are all staffed by nurses, except in the case that a patient has a new symptom; in that case, the patient receives a fast-track physician evaluation, with appropriate fast-track follow-up care. For example, in the rare case that a patient develops active TB, they will receive fast-track care with physician and nurse visits as appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Active comparator | Behavioral: Deferred Fast-Track CareDeferred fast-track care |
| Immediate Fast-Track Group | Experimental | Behavioral: Immediate Fast-Track CareImmediate fast-track care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women of ≥18 years of age
- Ability and willingness to give written informed consent
- Documentation of positive HIV status (test conducted at GHESKIO), and initiation of same-day ART prior to enrollment
- Physician-confirmed WHO Stage 1 or 2 disease
- Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
Key exclusion criteria (6 listed)
- Any use of ART in the past
- Pregnancy or breastfeeding at the screening visit
- WHO Stage 3 or 4 disease
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
- Score of <3 for any of the 7 questions on the ART readiness survey
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 |
|---|---|---|
| Immediate Fast-Track CareEligible for fast-track care at enrollment | Behavioural | Immediate Fast-Track Group |
| Deferred Fast-Track CareEligible for fast-track care after 6 months on ART | Behavioural | Standard Group |
Primary outcome
Viral Suppression; cut-off <200 copies/ml
Time frame: 48 weeks after enrollment
HIV-1 RNA <200 copies/ml
9 secondary outcomes
Viral Suppression; cut-off <50 copies/ml
Time frame: 48 weeks after enrollment
Viral Suppression; cut-off <1000 copies/ml
Time frame: 48 weeks after enrollment
Adherence by pharmacy refill records
Time frame: 48 weeks after enrollment
Cost-effectiveness
Time frame: 48 weeks after enrollment
Connectedness to Treatment Setting Scale
Time frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
State Hope Scale
Time frame: Day of enrollment, and 24 weeks and 48 weeks after enrollment
Patient Satisfaction Survey
Time frame: Weeks 2, 24, and 48 after enrollment
Social Provisions Scale
Time frame: Day of enrollment, and 24 and 48 weeks after enrollment
Coping Survey
Time frame: Weeks 2, 24, and 48 after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Individual participant dataSharing planned: Yes. We will post an anonymized dataset after the study is complete.
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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.
Serena Koenig, MD principal investigator
Brigham and Women's Hospital/GHESKIO
Jean Pape, MD study director
GHESKIO; Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Fast-Track Care and Deferred Fast-Track Care in people with HIV/AIDS, run by Brigham and Women's Hospital at 1 site in Haiti.
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 7 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: finished, as of the sponsor's last update on 9 Apr 2021. 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 Haiti. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Viral Suppression; cut-off <200 copies/ml (time frame: 48 weeks after enrollment). 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 9 Apr 2021.