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CompletedNCT03292913(PHC)Updated Aug 2, 2022Results posted

Positive Health Check Evaluation Trial

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

Phase
Not applicable
Study type
Interventional
Enrollment
799
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Human Immunodeficiency Virus (HIV) Positive

Keywords

  • Human Immunodeficiency Virus (HIV)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 18 years of age or older;
  2. Diagnosed with human immunodeficiency virus (HIV);
  3. English-speaking;
  4. Attending one of the four clinical sites;
  5. 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);
  6. Not involved in any other intervention that would bias outcome assessment,
  7. Deemed mentally competent and able to engage with the intervention.

Exclusion criteria

Exclusion Criteria:

  1. Under 18 years of age;
  2. Human immunodeficiency virus (HIV) negative;
  3. Does not speak English;
  4. Does not attend one of the four clinical sites for (HIV) primary care;
  5. 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)
  6. Involved in an intervention that would bias outcome assessment;
  7. Deemed mentally incompetent to engage with the intervention.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
799 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Receives the Positive Health Check intervention plus standard of care

    Behavioral: Positive Health Check

  • Other
    Control Group

    Receives standard of care

    Behavioral: Standard of Care

Interventions

  • BehavioralPositive Health Check

    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.

  • BehavioralStandard 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)

05

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

06

Results

Posted Aug 2, 2022

Participant flow

Participant flow — Overall Study
MilestoneIntervention GroupControl Group
Started397402
Completed315314
Not completed8288
Withdrew: Death93
Withdrew: Lost to follow-up4949
Withdrew: Withdrawal by subject20
Withdrew: Clinic closed due to covid2236

Outcome measures

PrimaryNumber 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.
Reported as:
Count of participants · Participants
Number of Participants With Viral Load Suppression
ParticipantsIntervention GroupControl Group
Number of Participants With Viral Load Suppression210213
Statistical analysis
  • Intervention Group vs Control Group · Mixed Models Analysis · p = 0.220 · Risk ratio (rr): 1.07 · 95% CI 0.96 to 1.21Risk ratio is adjusted for sex, age, race, site, viral load suppression at baseline, and new to care.
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants Retained in Care at 12-month Follow up
ParticipantsIntervention GroupControl Group
Number of Participants Retained in Care at 12-month Follow up257247
Statistical analysis
  • Intervention Group vs Control Group · Mixed Models Analysis · p = 0.481 · Risk ratio (rr): 1.04 · 95% CI 0.94 to 1.15Risk ratio is adjusted for sex, age, race, site, and new to care.
SecondaryRetention 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
Reported as:
Count of participants · Participants
Retention in Care
ParticipantsIntervention GroupControl Group
Retention in Care113164
Statistical analysis
  • Intervention Group vs Control Group · Mixed Models Analysis · p = 0.093 · Risk ratio (rr): 0.86 · 95% CI 0.72 to 1.03Risk ratio is adjusted for sex, age, race, site, and new to care.

Adverse events

Collected over Baseline to 12 months post randomization. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Group9/397 (2.3%)0/397 (0%)0/397 (0%)
Control Group3/402 (0.7%)0/402 (0%)0/402 (0%)

Baseline characteristics

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
Age, Categorical(Participants)Intervention GroupControl GroupTotal
Participants — <=18 years000
Participants — Between 18 and 65 years376383759
Participants — >=65 years201838
Age, Continuous
Age, Continuous(years)Intervention GroupControl GroupTotal
Mean45.4 ± 13.044.5 ± 12.644.9 ± 12.8
Sex: Female, Male
Sex: Female, Male(Participants)Intervention GroupControl GroupTotal
Participants — Female303306609
Participants — Male9495189
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Intervention GroupControl GroupTotal
Hispanic or Latino313263
Not Hispanic or Latino359365724
Unknown or Not Reported7512
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Intervention GroupControl GroupTotal
American Indian or Alaska Native101
Asian112
Native Hawaiian or Other Pacific Islander011
Black or African American299301600
White8588173
More than one race426
Unknown or Not Reported7916
Region of Enrollment
Region of Enrollment(participants)Intervention GroupControl GroupTotal
United States397402799
07

Study locations

4 sites
  • Hillsborough County Health Department
    Tampa, Florida 33607, United States
  • Atlanta VA Medical Center
    Atlanta, Georgia 30033, United States
  • Crescent Care
    New Orleans, Louisiana 70119, United States
  • Rutgers Infectious Disease Practice
    Newark, New Jersey 07103, United States
08

References and documents

Publications

  • Lewis MA, Harshbarger C, Bann C, Marconi VC, Somboonwit C, Piazza MD, Swaminathan S, Burrus O, Galindo C, Borkowf CB, Marks G, Karns S, Zulkiewicz B, Ortiz A, Abdallah I, Garner BR, Courtenay-Quirk C; Positive Health Check Study Team. Effectiveness of an Interactive, Highly Tailored "Video Doctor" Intervention to Suppress Viral Load and Retain Patients With HIV in Clinical Care: A Randomized Clinical Trial. J Acquir Immune Defic Syndr. 2022 Sep 1;91(1):58-67. doi: 10.1097/QAI.0000000000003045. Epub 2022 Jun 27. PubMed 35972854 ↗

Study documents

  • Study protocol · Mar 24, 2022
  • Statistical analysis plan · Mar 3, 2022
  • Informed consent form · May 22, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03292913
Lead sponsor
RTI International
Collaborators
Centers for Disease Control and Prevention
Responsible party
Sponsor
First posted
Sep 26, 2017
Start date
Feb 27, 2018
Primary completion
Oct 31, 2020
Completion
Oct 31, 2020
Results posted
Aug 2, 2022
Last update
Aug 2, 2022

Study contacts

Megan Lewis, PhD
principal investigator · RTI International

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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