N/A
N=799
Positive Health Check Evaluation Trial
Human Immunodeficiency Virus (HIV) Positive
Bottom Line
View on ClinicalTrials.gov: NCT03292913 ↗Enrolled (actual)
799
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Viral Load Suppression — 210; 213 Participants — p=0.220
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Positive Health Check (Behavioral); Standard of Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- RTI International
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Viral Load Suppression |
210; 213 | 0.220 |
| SECONDARY Number of Participants Retained in Care at 12-month Follow up |
257; 247 | 0.481 |
| SECONDARY Retention in Care |
113; 164 | 0.093 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03292913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.