An interventional study of Positive Health Check and Standard of Care in Human Immunodeficiency Virus (HIV) Positive, sponsored by RTI International. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by RTI International · Not applicable, Interventional, and Supportive care
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Among 83 studies in HIV Seropositivity with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. HIV Seropositivity · United States.
Among the 83 studies in HIV Seropositivity with a site in United States, this one is the 6th largest by enrollment of the 50 interventional ones that give a count, is one of 2 that started in 2018, is one of 25 with no phase, and was the 70th registered.
194 studies on the registry are indexed under HIV Seropositivity; 10 are open to participants now.
Browse HIV Seropositivity studies →4 of the 83 studies in HIV Seropositivity with a site in United States are open now. Recruiting first, the newest first:
American Laboratory Products Company · Sites in United States
Ages 13+ · Healthy volunteers
University of Chicago · Sites in United States
Ages 18–49 · Healthy volunteers
National Institute of Neurological Disorders and Stroke (NINDS) · Sites in United States
Ages 18–110 · Healthy volunteers
Henry Ford Health System · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 HIV Seropositivity studies recruiting now, 1 sets no upper age limit and 2 stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
83 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 11 · Phase 3 3 · Phase 4 5
First in 1996; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 799 is above the median of 105 across 114 interventional studies indexed under HIV Seropositivity.
Median enrollment 57 across the 50 interventional studies, 178 across the 30 observational. Of the 73 that completed or were terminated, 20 (27%) have results posted.
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11 of 83 have an industry lead sponsor. The 10 most frequent:
RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
RTI International has 1 study filed under HIV Seropositivity — fewer than ten, so there is no comparison to draw.
2 of the studies in HIV Seropositivity with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07089836American Laboratory Products CompanyThis Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests. | 2026-12 |
| NCT03519464National Institute of Allergy and Infectious Diseases (NIAID)Immunogenicity of the 9-Valent Human Papillomavirus Recombinant Vaccine in People With Idiopathic CD4 T Cell Lymphocytopenia | 2026-12-31 |
Add all 2 to your calendar (.ics) → With an account.
Among the 83 studies in HIV Seropositivity with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to evaluate the effect of Positive Health Check (PHC), an online intervention that delivers tailored, evidence-based prevention messages to HIV positive patients, on improving clinical outcomes and retention in care of people who are HIV positive and have unsuppressed viral loads. The costs and processes of implementation will also be assessed to inform future dissemination.
The Positive Health Check (PHC) Evaluation Trial uses a randomized trial to test if a brief web-based counseling intervention can improve clinical outcomes among people living with human immunodeficiency virus (HIV). The study will also assess implementation processes, collect data to determine cost effectiveness, and document the standard of care in each clinic. The study will take place in four locations including Atlanta Veterans Affairs (VA) Medical Center (Atlanta, GA), Hillsborough County Health Department (Tampa, FL), Rutgers Infectious Disease Practice (Newark, NJ) and Crescent Care (New Orleans, LA). The objectives of the PHC Evaluation Trial are four-fold: Objective 1) Implement a randomized trial to test if the PHC intervention improves clinical health outcomes, specifically viral load suppression and retention in care. While Positive Health Check (PHC) is designed to improve antiretroviral therapy (ART) initiation, ART adherence and retention in care as well as reduce unprotected sex and promote safe injection practices, the primary outcome on which the trial is powered is viral suppression; Objective 2) Conduct an implementation evaluation to determine effective implementation strategies and integration of Positive Health Check (PHC) into human immunodeficiency virus (HIV) primary care clinics; Objective 3) Collect and document data on the cost of the PHC intervention implementation; Objective 4) Document the standard of care at each participating site. Positive Health Check (PHC) is a web-based 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. Web-based interventions have been shown to be effective in improving adherence and reducing sexual risk. Eligible patients, who use the intervention, are given a tablet with a privacy screen, a set of headphones, a unique login identification (ID) and will be prompted to create their own private password. Once logged in, the intervention guides a patient through tailored messaging from a video doctor on patient-selected topics including treatment initiation or adherence, retention in care, sexual risk reduction, pregnancy, and intravenous drug use. Throughout the intervention patients answer tailoring questions about themselves and based on their answers, are given tailored messages from their chosen video doctor. Positive Health Check (PHC) is designed to facilitate patient-provider communication on these topics. In the intervention, patients can select which questions they have for their doctor on the topics covered and which health promotion strategies they want to practice before their next visit. The questions and chosen health promotion strategies ("tips") automatically populate to a handout which is given to the patient after logging off. Patients also have access to another module that provides other information about human immunodeficiency virus (HIV) management, how to prevent transmission, and living a healthy lifestyle while being human immunodeficiency virus (HIV) positive. The intervention will be considered implemented with fidelity if a patient completes the intervention in the clinic before or after seeing their primary care provider, or before or after a blood draw or ancillary appointment in advance of their appointment with their clinical provider. A patient may also begin the intervention in the clinic and complete it after the appointment or at home within 21 days. Evaluation of the intervention will include comparisons of the intervention and control arms on the primary outcome using data abstracted via electronic medical records, with the 12- month viral load value considered the primary outcome measure.
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.
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.
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.
Receives the Positive Health Check intervention plus standard of care
Behavioral: Positive Health Check
Receives standard of care
Behavioral: 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.
Standard of care for patients with human immunodeficiency virus (HIV) (this includes standard of care practices around antiretroviral therapy (ART) initiation, adherence and retention)
Number of Participants With Viral Load Suppression
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).
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.
Number of Participants Retained in Care at 12-month Follow up
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.
Time frame: Up to 12 months post randomization
Retention in Care
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
Time frame: 12 months of randomization
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 397 | 402 |
| Completed | 315 | 314 |
| Not completed | 82 | 88 |
| Withdrew: Death | 9 | 3 |
| Withdrew: Lost to follow-up | 49 | 49 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Clinic closed due to covid | 22 | 36 |
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).
| Participants | Intervention Group | Control Group |
|---|---|---|
| Number of Participants With Viral Load Suppression | 210 | 213 |
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.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Number of Participants Retained in Care at 12-month Follow up | 257 | 247 |
A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
| Participants | Intervention Group | Control Group |
|---|---|---|
| Retention in Care | 113 | 164 |
Collected over Baseline to 12 months post randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 9/397 (2.3%) | 0/397 (0%) | 0/397 (0%) |
| Control Group | 3/402 (0.7%) | 0/402 (0%) | 0/402 (0%) |
One of the 397 participants in the Positive Health Check and Standard of Care group and one of the 402 participants in the Standard of Care group were missing data for age because it was not included in their patient charts.
| Age, Categorical(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Participants — <=18 years | 0 | 0 | 0 |
| Participants — Between 18 and 65 years | 376 | 383 | 759 |
| Participants — >=65 years | 20 | 18 | 38 |
| Age, Continuous(years) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Mean | 45.4 ± 13.0 | 44.5 ± 12.6 | 44.9 ± 12.8 |
| Sex: Female, Male(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Participants — Female | 303 | 306 | 609 |
| Participants — Male | 94 | 95 | 189 |
| Ethnicity (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 31 | 32 | 63 |
| Not Hispanic or Latino | 359 | 365 | 724 |
| Unknown or Not Reported | 7 | 5 | 12 |
| Race (NIH/OMB)(Participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 299 | 301 | 600 |
| White | 85 | 88 | 173 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 7 | 9 | 16 |
| Region of Enrollment(participants) | Intervention Group | Control Group | Total |
|---|---|---|---|
| United States | 397 | 402 | 799 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Oct 2020, 32 months.
Results were first posted in Aug 2022, 1 year 9 months after primary completion.
Of 28 non-industry interventional studies with no phase under HIV Seropositivity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 46. This study's 32 months is above that.
Counting every sponsor, half of 29 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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RTI International