Trial Outcomes & Findings for Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs (NCT NCT03282890)
NCT ID: NCT03282890
Last Updated: 2025-08-17
Results Overview
The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.
COMPLETED
NA
237 participants
This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.
2025-08-17
Participant Flow
Participant milestones
| Measure |
CHRP-BB (Experimental Condition)
Community-friendly health recovery program - bio-behavioral
|
Active Control Condition
Treatment as usual - active control group condition
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
117
|
|
Overall Study
Post-test
|
105
|
104
|
|
Overall Study
3-month Follow-up
|
102
|
101
|
|
Overall Study
6-month Follooup
|
74
|
75
|
|
Overall Study
9-month Follow-up
|
68
|
64
|
|
Overall Study
COMPLETED
|
68
|
64
|
|
Overall Study
NOT COMPLETED
|
52
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
Baseline characteristics by cohort
| Measure |
CHRP-BB
n=120 Participants
Community-friendly health recovery program - bio-behavioral
|
Active Control Condition
n=117 Participants
Treatment as usual group condition
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
96 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
76 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
120 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
n=5 Participants
|
44 years
n=7 Participants
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Gender · Female
|
58 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Sex: Female, Male
Gender · Male
|
62 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
117 participants
n=7 Participants
|
237 participants
n=5 Participants
|
|
Currently unemployed
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.The Pre-exposure prophylaxis (PrEP) adherence behavior scale is an 11-item categorical self-report measure designed to assess how confident a participant is about properly taking their PrEP medication (e.g., "How confident are you that you could make PrEP part of your daily routine?"). The scale requires participants to respond to each of the 11 items about adherence by selecting whether they are either 'Not at all confident', 'Somewhat confident', 'Moderately confident', 'Very confident', or 'Completely confident' about the behavior. The 11 items are summed to create a total score, with higher scores indicating a better PrEP adherence behavior outcome. The possible range of total scores is 0-44.
Outcome measures
| Measure |
CHRP-BB (Experimental Condition)
n=120 Participants
community-friendly health recovery program - bio-behavioral (CHRP-BB)
|
Active Control Condition
n=117 Participants
time and attention matched control condition
|
|---|---|---|
|
Pre-exposure Prophylaxis (PrEP) Adherence Behavior
|
25.9 score
Interval 20.4 to 31.3
|
22.8 score
Interval 18.9 to 26.7
|
SECONDARY outcome
Timeframe: This was assessed immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months.HIV risk reduction behavior was assessed using a 4-item categorical self-report measure designed to assess the participant's self-efficacy about engaging in behaviors to reduce their HIV risk (e.g., 'How hard would it be for you to always use condoms or latex protection if you have oral, vaginal, or anal sex?"). The measure requires participants to select one of five possible responses for each of the four items, indicating whether a behavior would be either 'Very hard to do', 'Fairly hard to do', 'Neither hard nor easy to do', 'Somewhat easy to do', or 'Very easy to do'. Responses to the four items were summed and reversed to create a total score, with higher scores indicating a better HIV risk reduction outcome.The possible range of total HIV risk reduction behavior scores is 4 to 20.
Outcome measures
| Measure |
CHRP-BB (Experimental Condition)
n=120 Participants
community-friendly health recovery program - bio-behavioral (CHRP-BB)
|
Active Control Condition
n=117 Participants
time and attention matched control condition
|
|---|---|---|
|
HIV Risk Reduction Behavior
|
17.5 score
Interval 16.8 to 18.1
|
16.2 score
Interval 15.3 to 17.0
|
Adverse Events
CHRP-BB
Control Condition
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