Trial Outcomes & Findings for Positive Health Check Evaluation Trial (NCT NCT03292913)
NCT ID: NCT03292913
Last Updated: 2022-08-02
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
799 participants
Primary outcome timeframe
Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.
Results posted on
2022-08-02
Participant Flow
Participant milestones
| Measure |
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 HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider.
|
Control Group
Receives standard of care
Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention)
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
402
|
|
Overall Study
COMPLETED
|
315
|
314
|
|
Overall Study
NOT COMPLETED
|
82
|
88
|
Reasons for withdrawal
| Measure |
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 HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider.
|
Control Group
Receives standard of care
Standard of Care: Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention)
|
|---|---|---|
|
Overall Study
Death
|
9
|
3
|
|
Overall Study
Lost to Follow-up
|
49
|
49
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Clinic closed due to COVID
|
22
|
36
|
Baseline Characteristics
2 participants, 1 from each group did not declare their age.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=397 Participants
Positive Health Check and Standard of Care
Participants with HIV diagnosis received Positive Health Check intervention and standard of care
|
Control Group
n=402 Participants
Standard of care
Participants with HIV diagnosis received standard of care only
|
Total
n=799 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Participants · <=18 years
|
0 Participants
n=396 Participants • 2 participants, 1 from each group did not declare their age.
|
0 Participants
n=401 Participants • 2 participants, 1 from each group did not declare their age.
|
0 Participants
n=797 Participants • 2 participants, 1 from each group did not declare their age.
|
|
Age, Categorical
Participants · Between 18 and 65 years
|
376 Participants
n=396 Participants • 2 participants, 1 from each group did not declare their age.
|
383 Participants
n=401 Participants • 2 participants, 1 from each group did not declare their age.
|
759 Participants
n=797 Participants • 2 participants, 1 from each group did not declare their age.
|
|
Age, Categorical
Participants · >=65 years
|
20 Participants
n=396 Participants • 2 participants, 1 from each group did not declare their age.
|
18 Participants
n=401 Participants • 2 participants, 1 from each group did not declare their age.
|
38 Participants
n=797 Participants • 2 participants, 1 from each group did not declare their age.
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 13.0 • n=396 Participants • 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.
|
44.5 years
STANDARD_DEVIATION 12.6 • n=401 Participants • 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.
|
44.9 years
STANDARD_DEVIATION 12.8 • n=797 Participants • 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.
|
|
Sex: Female, Male
Participants · Female
|
303 Participants
n=397 Participants • 1 participant did not declare gender/sex
|
306 Participants
n=401 Participants • 1 participant did not declare gender/sex
|
609 Participants
n=798 Participants • 1 participant did not declare gender/sex
|
|
Sex: Female, Male
Participants · Male
|
94 Participants
n=397 Participants • 1 participant did not declare gender/sex
|
95 Participants
n=401 Participants • 1 participant did not declare gender/sex
|
189 Participants
n=798 Participants • 1 participant did not declare gender/sex
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=397 Participants
|
32 Participants
n=402 Participants
|
63 Participants
n=799 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
359 Participants
n=397 Participants
|
365 Participants
n=402 Participants
|
724 Participants
n=799 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=397 Participants
|
5 Participants
n=402 Participants
|
12 Participants
n=799 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=397 Participants
|
0 Participants
n=402 Participants
|
1 Participants
n=799 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=397 Participants
|
1 Participants
n=402 Participants
|
2 Participants
n=799 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=397 Participants
|
1 Participants
n=402 Participants
|
1 Participants
n=799 Participants
|
|
Race (NIH/OMB)
Black or African American
|
299 Participants
n=397 Participants
|
301 Participants
n=402 Participants
|
600 Participants
n=799 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=397 Participants
|
88 Participants
n=402 Participants
|
173 Participants
n=799 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=397 Participants
|
2 Participants
n=402 Participants
|
6 Participants
n=799 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=397 Participants
|
9 Participants
n=402 Participants
|
16 Participants
n=799 Participants
|
|
Region of Enrollment
United States
|
397 participants
n=397 Participants
|
402 participants
n=402 Participants
|
799 participants
n=799 Participants
|
PRIMARY outcome
Timeframe: Targeted time frame is 12 months post-randomization with a possible range of 10-16 months to account for variable timing of clinic visits.Population: All participants with a viral load measurement at baseline.
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).
Outcome measures
| Measure |
Intervention Group
n=368 Participants
Positive Health Check intervention plus standard of care
|
Control Group
n=372 Participants
Standard of care only
|
|---|---|---|
|
Number of Participants With Viral Load Suppression
|
210 Participants
|
213 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post randomizationPopulation: All participants
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.
Outcome measures
| Measure |
Intervention Group
n=397 Participants
Positive Health Check intervention plus standard of care
|
Control Group
n=402 Participants
Standard of care only
|
|---|---|---|
|
Number of Participants Retained in Care at 12-month Follow up
|
257 Participants
|
247 Participants
|
SECONDARY outcome
Timeframe: 12 months of randomizationA 6-month visit gap was defined as having at least 189 days between two sequentially kept visits, post-randomization.
Outcome measures
| Measure |
Intervention Group
n=397 Participants
Positive Health Check intervention plus standard of care
|
Control Group
n=402 Participants
Standard of care only
|
|---|---|---|
|
Retention in Care
|
113 Participants
|
164 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 9 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place