Trial Outcomes & Findings for Treatment Advocacy Intervention for HIV-Positive African Americans (NCT NCT01350544)
NCT ID: NCT01350544
Last Updated: 2017-04-11
Results Overview
We used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
Baseline, 1.5 months, 3 months, 4.5 months, and 6 months
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
Wait-list Control
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
|
Treatment Advocacy
Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
108
|
|
Overall Study
COMPLETED
|
85
|
86
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
Reasons for withdrawal
| Measure |
Wait-list Control
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
|
Treatment Advocacy
Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
|
|---|---|---|
|
Overall Study
Administrative Withdrawal
|
0
|
1
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Moved out of LA County
|
2
|
2
|
|
Overall Study
Medical Issues
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Incarceration
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
18
|
15
|
Baseline Characteristics
These values are based on medical records data. We could only obtain medical records data for a subset of participants.
Baseline characteristics by cohort
| Measure |
Wait-list Control
n=108 Participants
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
|
Treatment Advocacy
n=107 Participants
Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
|
Total
n=215 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.0 years
STANDARD_DEVIATION 10.2 • n=108 Participants
|
50.1 years
STANDARD_DEVIATION 10.0 • n=107 Participants
|
48.6 years
STANDARD_DEVIATION 10.2 • n=215 Participants
|
|
Sex/Gender, Customized
Male
|
79 Participants
n=108 Participants
|
78 Participants
n=107 Participants
|
157 Participants
n=215 Participants
|
|
Sex/Gender, Customized
Female
|
24 Participants
n=108 Participants
|
27 Participants
n=107 Participants
|
51 Participants
n=215 Participants
|
|
Sex/Gender, Customized
Transgender
|
5 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=215 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
7 Participants
n=108 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=215 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
101 Participants
n=108 Participants
|
101 Participants
n=107 Participants
|
202 Participants
n=215 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=215 Participants
|
|
Income
None
|
11 Participants
n=108 Participants
|
10 Participants
n=107 Participants
|
21 Participants
n=215 Participants
|
|
Income
>$0 - <$10K
|
66 Participants
n=108 Participants
|
53 Participants
n=107 Participants
|
119 Participants
n=215 Participants
|
|
Income
$10K - $20K
|
18 Participants
n=108 Participants
|
35 Participants
n=107 Participants
|
53 Participants
n=215 Participants
|
|
Income
>$20K - $30K
|
10 Participants
n=108 Participants
|
8 Participants
n=107 Participants
|
18 Participants
n=215 Participants
|
|
Income
>$30K - $40K
|
2 Participants
n=108 Participants
|
0.0 Participants
n=107 Participants
|
2 Participants
n=215 Participants
|
|
Income
Unknown
|
1 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=215 Participants
|
|
Education
7th to 11th Grade
|
17 Participants
n=108 Participants
|
23 Participants
n=107 Participants
|
40 Participants
n=215 Participants
|
|
Education
High School diploma or GED
|
37 Participants
n=108 Participants
|
33 Participants
n=107 Participants
|
70 Participants
n=215 Participants
|
|
Education
Some college
|
41 Participants
n=108 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=215 Participants
|
|
Education
College degree
|
6 Participants
n=108 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=215 Participants
|
|
Education
Some graduate school
|
3 Participants
n=108 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=215 Participants
|
|
Education
Graduate degree
|
4 Participants
n=108 Participants
|
0.0 Participants
n=107 Participants
|
4 Participants
n=215 Participants
|
|
Housing Status
Rent/Own
|
65 Participants
n=108 Participants
|
69 Participants
n=107 Participants
|
134 Participants
n=215 Participants
|
|
Housing Status
Treatment facility
|
9 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=215 Participants
|
|
Housing Status
Subsidized / Sect. 8
|
8 Participants
n=108 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=215 Participants
|
|
Housing Status
Friend / relative
|
11 Participants
n=108 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=215 Participants
|
|
Housing Status
Temporary or transitional
|
9 Participants
n=108 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=215 Participants
|
|
Housing Status
Homeless
|
5 Participants
n=108 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=215 Participants
|
|
Housing Status
Other
|
1 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=215 Participants
|
|
Employment Status
Full time
|
4 Participants
n=108 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=215 Participants
|
|
Employment Status
Part time
|
4 Participants
n=108 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=215 Participants
|
|
Employment Status
Unemployed
|
63 Participants
n=108 Participants
|
71 Participants
n=107 Participants
|
134 Participants
n=215 Participants
|
|
Employment Status
Retired
|
19 Participants
n=108 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=215 Participants
|
|
Employment Status
Other
|
18 Participants
n=108 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=215 Participants
|
|
Length of Time Diagnosed
|
15.3 years
STANDARD_DEVIATION 8.8 • n=108 Participants
|
15.5 years
STANDARD_DEVIATION 7.9 • n=107 Participants
|
15.5 years
STANDARD_DEVIATION 8.3 • n=215 Participants
|
|
Viral Load
Detectable
|
41 Participants
n=108 Participants
|
30 Participants
n=107 Participants
|
71 Participants
n=215 Participants
|
|
Viral Load
Undetectable (<200 copies)
|
41 Participants
n=108 Participants
|
54 Participants
n=107 Participants
|
95 Participants
n=215 Participants
|
|
Viral Load
Unknown
|
26 Participants
n=108 Participants
|
23 Participants
n=107 Participants
|
49 Participants
n=215 Participants
|
|
CD4 Cell Count
|
534 cells per microliter
STANDARD_DEVIATION 316 • n=83 Participants • These values are based on medical records data. We could only obtain medical records data for a subset of participants.
|
650 cells per microliter
STANDARD_DEVIATION 343 • n=84 Participants • These values are based on medical records data. We could only obtain medical records data for a subset of participants.
|
593 cells per microliter
STANDARD_DEVIATION 334 • n=167 Participants • These values are based on medical records data. We could only obtain medical records data for a subset of participants.
|
|
Received HIV care in last 6 months
received HIV care
|
103 Participants
n=108 Participants
|
102 Participants
n=107 Participants
|
205 Participants
n=215 Participants
|
|
Received HIV care in last 6 months
did not receive HIV care
|
5 Participants
n=108 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=215 Participants
|
|
Sexual Orientation
Straight
|
36 Participants
n=108 Participants
|
43 Participants
n=107 Participants
|
79 Participants
n=215 Participants
|
|
Sexual Orientation
Gay man
|
50 Participants
n=108 Participants
|
42 Participants
n=107 Participants
|
92 Participants
n=215 Participants
|
|
Sexual Orientation
Gay woman
|
1 Participants
n=108 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=215 Participants
|
|
Sexual Orientation
Bisexual
|
16 Participants
n=108 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=215 Participants
|
|
Sexual Orientation
Not Sure
|
1 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=215 Participants
|
|
Sexual Orientation
Other
|
4 Participants
n=108 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=215 Participants
|
|
Ever Incarcerated
ever incarcerated
|
58 Participants
n=108 Participants
|
59 Participants
n=107 Participants
|
117 Participants
n=215 Participants
|
|
Ever Incarcerated
never incarcerated
|
49 Participants
n=108 Participants
|
48 Participants
n=107 Participants
|
97 Participants
n=215 Participants
|
|
Ever Incarcerated
Unknow
|
1 Participants
n=108 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=215 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1.5 months, 3 months, 4.5 months, and 6 monthsWe used a repeated measures linear regression modeling continuous adherence with intervention, linear time, and their interaction, and demographic covariates. Continuous adherence is measured as average percentages of doses taken.
Outcome measures
| Measure |
Wait-list Control
n=85 Participants
Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
|
Treatment Advocacy
n=86 Participants
Treatment Advocacy: Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
|
|---|---|---|
|
Medication Adherence
Baseline
|
77.96 Percentage of doses taken
Standard Deviation 23.15
|
80.13 Percentage of doses taken
Standard Deviation 21.74
|
|
Medication Adherence
1.5 month follow-up
|
64.87 Percentage of doses taken
Standard Deviation 33.88
|
76.13 Percentage of doses taken
Standard Deviation 25.55
|
|
Medication Adherence
3 month follow-up
|
63.44 Percentage of doses taken
Standard Deviation 33.01
|
76.76 Percentage of doses taken
Standard Deviation 24.60
|
|
Medication Adherence
4.5 month follow-up
|
63.69 Percentage of doses taken
Standard Deviation 32.08
|
79.17 Percentage of doses taken
Standard Deviation 25.31
|
|
Medication Adherence
6 month follow-up
|
56.50 Percentage of doses taken
Standard Deviation 33.97
|
78.76 Percentage of doses taken
Standard Deviation 22.46
|
Adverse Events
Wait-list Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment Advocacy
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