An interventional study of Immediate Fast-Track Care and Deferred Fast-Track Care in HIV/AIDS, sponsored by Brigham and Women's Hospital. Completed at 1 site in Haiti. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 149 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Deferred fast-track care
Behavioral: Deferred Fast-Track Care
Immediate fast-track care
Behavioral: Immediate Fast-Track Care
Eligible for fast-track care at enrollment
Eligible for fast-track care after 6 months on ART
Viral Suppression; cut-off <200 copies/ml
HIV-1 RNA \<200 copies/ml
Time frame: 48 weeks after enrollment
Viral Suppression; cut-off <50 copies/ml
HIV-1 RNA \<50 copies/ml
Time frame: 48 weeks after enrollment
Viral Suppression; cut-off <1000 copies/ml
HIV-1 RNA \<1000 copies/ml
Time frame: 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)
Time frame: 48 weeks after enrollment
Cost-effectiveness
Cost per patients with undetectable viral load
Time frame: 48 weeks after enrollment
Connectedness to Treatment Setting Scale
Mean score; range 10-60; a higher score indicates greater connection to treatment setting
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 2, 24, and 48 after enrollment
Plan to share: Yes — We will post an anonymized dataset after the study is complete.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available at the time of publication of the primary study results.
Access criteria: Information will be posted online.
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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