Positive Health Check Evaluation Trial ((PHC))
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33607
- Hillsborough County Health Department
-
-
Georgia
-
Atlanta, Georgia, United States, 30033
- Atlanta VA Medical Center
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-
Louisiana
-
New Orleans, Louisiana, United States, 70119
- Crescent Care
-
-
New Jersey
-
Newark, New Jersey, United States, 07103
- Rutgers Infectious Disease Practice
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age or older;
- Diagnosed with human immunodeficiency virus (HIV);
- English-speaking;
- Attending one of the four clinical sites;
- Meet at least one of the following: a) Most recent viral load lab result of ≥ 200 copies/mL, b) Attended an initial human immunodeficiency virus human immunodeficiency virus (HIV) appointment with a provider at one of the four sites within the past 12 months; c) Out of care (last attended appointment at the clinic was more than 12 months ago);
- Not involved in any other intervention that would bias outcome assessment,
- Deemed mentally competent and able to engage with the intervention.
Exclusion Criteria:
- Under 18 years of age;
- Human immunodeficiency virus (HIV) negative;
- Does not speak English;
- Does not attend one of the four clinical sites for (HIV) primary care;
- Meets all of the following: a) Most recent viral load lab result of < 200 copies/mL, b) Did not attend an initial human immunodeficiency virus (HIV) appointment with a provider at one of the four sites within the past 12 months, c) Last attended appointment at the clinic was less than 12 months ago)
- Involved in an intervention that would bias outcome assessment;
- Deemed mentally incompetent to engage with the intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Receives the Positive Health Check intervention plus standard of care
|
Positive Health Check (PHC) is an online intervention that delivers tailored evidence-based prevention messages to human immunodeficiency virus (HIV) positive patients through a series of brief interactive videos designed to simulate a conversation with an human immunodeficiency virus (HIV) primary care provider.
|
|
Other: Control Group
Receives standard of care
|
Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Viral Load Suppression
Time Frame: Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
|
Viral load suppression was defined as having viral load < 200 copies/mL by the end of each participant's 12 months of follow-up assessment (with a window from start of 10 months through the end of 16 months post-randomization to accommodate timing of clinical visits).
|
Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants Retained in Care at 12-month Follow up
Time Frame: Up to 12 months post randomization
|
Retention in care is a patient defined as having at least one visit in each 6-month period within 12 months post-randomization separated by at least two months.
|
Up to 12 months post randomization
|
|
Retention in Care
Time Frame: 12 months of randomization
|
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
|
12 months of randomization
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Megan Lewis, PhD, RTI International
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- HIV Seropositivity
- Immunologic Deficiency Syndromes
Other Study ID Numbers
Other Study ID Numbers
- 1U18PS004967-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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