Trial Outcomes & Findings for The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project (NCT NCT04687917)
NCT ID: NCT04687917
Last Updated: 2025-11-13
Results Overview
The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
428 participants
Primary outcome timeframe
Assessed at the end of month 12
Results posted on
2025-11-13
Participant Flow
Unit of analysis: HIV Service Organizations (HSOs)
Participant milestones
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC)
A multilevel implementation strategy
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI)
A multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
|---|---|---|
|
Overall Study
STARTED
|
161 13
|
267 13
|
|
Overall Study
HSO Staff Participants
|
44 13
|
43 13
|
|
Overall Study
HSO Client Participants
|
117 13
|
224 13
|
|
Overall Study
COMPLETED
|
67 13
|
113 13
|
|
Overall Study
NOT COMPLETED
|
94 0
|
154 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Baseline characteristics by cohort
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
n=44 Participants
A multilevel implementation strategy provided to staff
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, and Consultation (FTFC) Clients
n=117 Participants
A multilevel implementation strategy that client participants are cluster-randomized
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
n=43 Participants
An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients
n=224 Participants
An enhanced version of the multilevel implementation strategy that client participants are cluster-randomized.
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
Total
n=428 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=171 Participants
|
79 Participants
n=23 Participants
|
33 Participants
n=306 Participants
|
171 Participants
n=2186 Participants
|
310 Participants
n=181 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=2186 Participants
|
0 Participants
n=181 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
44 Participants
n=171 Participants
|
109 Participants
n=23 Participants
|
40 Participants
n=306 Participants
|
206 Participants
n=2186 Participants
|
399 Participants
n=181 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=171 Participants
|
8 Participants
n=23 Participants
|
3 Participants
n=306 Participants
|
18 Participants
n=2186 Participants
|
29 Participants
n=181 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=171 Participants
|
20 Participants
n=23 Participants
|
27 Participants
n=306 Participants
|
74 Participants
n=2186 Participants
|
152 Participants
n=181 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=171 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
0 Participants
n=2186 Participants
|
0 Participants
n=181 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=171 Participants
|
97 Participants
n=23 Participants
|
16 Participants
n=306 Participants
|
150 Participants
n=2186 Participants
|
276 Participants
n=181 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=171 Participants
|
38 Participants
n=23 Participants
|
10 Participants
n=306 Participants
|
53 Participants
n=2186 Participants
|
118 Participants
n=181 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=171 Participants
|
3 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
8 Participants
n=2186 Participants
|
12 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=171 Participants
|
1 Participants
n=23 Participants
|
2 Participants
n=306 Participants
|
3 Participants
n=2186 Participants
|
7 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=171 Participants
|
4 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
6 Participants
n=2186 Participants
|
11 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=171 Participants
|
51 Participants
n=23 Participants
|
21 Participants
n=306 Participants
|
129 Participants
n=2186 Participants
|
212 Participants
n=181 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=171 Participants
|
51 Participants
n=23 Participants
|
16 Participants
n=306 Participants
|
73 Participants
n=2186 Participants
|
163 Participants
n=181 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=171 Participants
|
3 Participants
n=23 Participants
|
0 Participants
n=306 Participants
|
3 Participants
n=2186 Participants
|
7 Participants
n=181 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=171 Participants
|
4 Participants
n=23 Participants
|
4 Participants
n=306 Participants
|
2 Participants
n=2186 Participants
|
16 Participants
n=181 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=171 Participants
|
117 Participants
n=23 Participants
|
43 Participants
n=306 Participants
|
224 Participants
n=2186 Participants
|
428 Participants
n=181 Participants
|
PRIMARY outcome
Timeframe: Assessed at the end of month 12The cumulative number of brief interventions that each HSO staff participant implemented with HSO client participants during the implementation phase.
Outcome measures
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
n=44 Participants
A multilevel implementation strategy
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
n=43 Participants
An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
|---|---|---|
|
Staff-level Implementation Consistency
|
.73 client participants
Standard Deviation 1.55
|
2.35 client participants
Standard Deviation 6.67
|
PRIMARY outcome
Timeframe: Assessed at the end of month 12The cumulative sum quality score that each HSO staff participant demonstrated during the implementation phase. Each motivational interviewing brief intervention (MIBI) is rated on a scale from 0 (zero quality) to 12 (highest quality possible). Each individual MIBI quality score is summed to create a cumulative sum quality score. Higher scores indicated higher quality (i.e. motivational interviewing fidelity). The lower limit is zero. There is not an upper limit.
Outcome measures
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
n=44 Participants
A multilevel implementation strategy
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
n=43 Participants
An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
|---|---|---|
|
Staff-level Implementation Quality
|
4.61 score on a scale
Standard Deviation 9.87
|
12.39 score on a scale
Standard Deviation 20.57
|
SECONDARY outcome
Timeframe: Assessed at 4-weeks from the baseline assessmentA staff-level measure representing the average level of client participant change (follow-up minus baseline) in the number of days clients used their primary substance (i.e., the substance the client identified a willingness to talk about during the MIBI) during the past 28 day
Outcome measures
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
n=44 Participants
A multilevel implementation strategy
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
n=43 Participants
An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
|---|---|---|
|
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance
|
-1.11 days of reduced use
Standard Deviation 4.93
|
-5.95 days of reduced use
Standard Deviation 17.25
|
SECONDARY outcome
Timeframe: Assessed at 4-weeks from the baseline assessmentA staff-level measure of the average change (follow-up minus baseline) in their client participant's Generalized Anxiety Disorder 7-item (GAD-7) scale score. The GAD-7 ranges from 0 to 21, with higher scores indicating greater generalized anxiety. For change in the GAD-7 between baseline and follow-up (follow-up minus baseline), scores range from -20 to 20 and negative numbers are better as they indicate decreasing generalized anxiety. For this study, we examined the average GAD-7 change score that the HSO staff had with their client participants.
Outcome measures
| Measure |
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
n=44 Participants
A multilevel implementation strategy
The facilitation, training, feedback, and consultation (FTFC) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
|
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
n=43 Participants
An enhanced version of the multilevel implementation strategy
The facilitation, training, feedback, consultation, and incentivization (FTFCI) Strategy: A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and incentivization.
|
|---|---|---|
|
Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score
|
-0.14 change in scale score
Standard Deviation 3.63
|
-2.63 change in scale score
Standard Deviation 8.67
|
Adverse Events
Facilitation, Training, Feedback, and Consultation (FTFC) Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Facilitation, Training, Feedback, and Consultation (FTFC) Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Staff
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Facilitation, Training, Feedback, Consultation, and Incentivization (FTFCI) Clients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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