NCT03292913: (PHC)

Positive Health Check Evaluation Trial

Completed NA Results posted Last updated 2 August 2022

What this trial tests

NA trial testing Positive Health Check in Human Immunodeficiency Virus (HIV) Positive in 799 participants. Completed in 31 October 2020.

Timeline

27 February 2018

Primary endpoint
31 October 2020

31 October 2020

Quick facts

Lead sponsor	RTI International
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	799
Start date	27 February 2018
Primary completion	31 October 2020
Estimated completion	31 October 2020
Sites	4 locations across United States

Drugs / interventions tested

• Positive Health Check
• Standard of Care

Conditions studied

• Human Immunodeficiency Virus (HIV) Positive — all drugs for Human Immunodeficiency Virus (HIV) Positive →

Sponsor

RTI International — full company profile →

Who can join

18 and older, any sex, with Human Immunodeficiency Virus (HIV) Positive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Viral Load Suppression Primary · 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).

Group	Value	95% CI
Intervention Group	210
Control Group	213

Number of Participants Retained in Care at 12-month Follow up Secondary · 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.

Group	Value	95% CI
Intervention Group	257
Control Group	247

Retention in Care Secondary · 12 months of randomization

A 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.

Group	Value	95% CI
Intervention Group	113
Control Group	164

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Identifying Implementation Strategies That Address Barriers and Facilitate Implementation of Digital Interventions in HIV Primary Care Settings: Results from the Pilot Implementation of Positive Health Check.
   Zulkiewicz BA, Burrus O, Harshbarger C, Ortiz A, et al · · 2021 · cited 9× · PMID 32594271 · DOI 10.1007/s10461-020-02944-9
2. 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.
   Lewis MA, Harshbarger C, Bann C, Marconi VC, et al · · 2022 · cited 6× · PMID 35972854 · DOI 10.1097/qai.0000000000003045