ClinicalTrials.gov
ClinicalTrials.gov Menu

Treatment Advocacy Intervention for HIV-Positive African Americans (TA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01350544
Recruitment Status : Completed
First Posted : May 9, 2011
Results First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Laura Bogart, RAND

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition HIV
Intervention Behavioral: Treatment Advocacy
Enrollment 216
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Wait-list Control Treatment Advocacy
Hide Arm/Group Description Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment. 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.
Period Title: Overall Study
Started 108 108
Completed 85 86
Not Completed 23 22
Reason Not Completed
Administrative Withdrawal             0             1
Death             1             2
Moved out of LA County             2             2
Medical Issues             1             1
Withdrawal by Subject             0             1
Incarceration             1             0
Lost to Follow-up             18             15
Arm/Group Title Wait-list Control Treatment Advocacy Total
Hide Arm/Group Description Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment. 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 of all reporting groups
Overall Number of Baseline Participants 108 107 215
Hide Baseline Analysis Population Description
One participant was administratively withdrawn from the intervention condition because it was found that she was ineligible (not on medications) after being randomized to the intervention.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 107 participants 215 participants
47.0  (10.2) 50.1  (10.0) 48.6  (10.2)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 108 participants 107 participants 215 participants
79
  73.1%
78
  72.9%
157
  73.0%
Female Number Analyzed 108 participants 107 participants 215 participants
24
  22.2%
27
  25.2%
51
  23.7%
Transgender Number Analyzed 108 participants 107 participants 215 participants
5
   4.6%
2
   1.9%
7
   3.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 108 participants 107 participants 215 participants
7
   6.5%
6
   5.6%
13
   6.0%
Not Hispanic or Latino Number Analyzed 108 participants 107 participants 215 participants
101
  93.5%
101
  94.4%
202
  94.0%
Unknown or Not Reported Number Analyzed 108 participants 107 participants 215 participants
0
   0.0%
0
   0.0%
0
   0.0%
Income  
Measure Type: Count of Participants
Unit of measure:  Participants
None Number Analyzed 108 participants 107 participants 215 participants
11
  10.2%
10
   9.3%
21
   9.8%
>$0 - <$10K Number Analyzed 108 participants 107 participants 215 participants
66
  61.1%
53
  49.5%
119
  55.3%
$10K - $20K Number Analyzed 108 participants 107 participants 215 participants
18
  16.7%
35
  32.7%
53
  24.7%
>$20K – $30K Number Analyzed 108 participants 107 participants 215 participants
10
   9.3%
8
   7.5%
18
   8.4%
>$30K - $40K Number Analyzed 108 participants 107 participants 215 participants
2
   1.9%
0.0
2
   0.9%
Unknown Number Analyzed 108 participants 107 participants 215 participants
1
   0.9%
1
   0.9%
2
   0.9%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
7th to 11th Grade Number Analyzed 108 participants 107 participants 215 participants
17
  15.7%
23
  21.5%
40
  18.6%
High School diploma or GED Number Analyzed 108 participants 107 participants 215 participants
37
  34.3%
33
  30.8%
70
  32.6%
Some college Number Analyzed 108 participants 107 participants 215 participants
41
  38.0%
40
  37.4%
81
  37.7%
College degree Number Analyzed 108 participants 107 participants 215 participants
6
   5.6%
7
   6.5%
13
   6.0%
Some graduate school Number Analyzed 108 participants 107 participants 215 participants
3
   2.8%
4
   3.7%
7
   3.3%
Graduate degree Number Analyzed 108 participants 107 participants 215 participants
4
   3.7%
0.0
4
   1.9%
Housing Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Rent/Own Number Analyzed 108 participants 107 participants 215 participants
65
  60.2%
69
  64.5%
134
  62.3%
Treatment facility Number Analyzed 108 participants 107 participants 215 participants
9
   8.3%
2
   1.9%
11
   5.1%
Subsidized / Sect. 8 Number Analyzed 108 participants 107 participants 215 participants
8
   7.4%
8
   7.5%
16
   7.4%
Friend / relative Number Analyzed 108 participants 107 participants 215 participants
11
  10.2%
8
   7.5%
19
   8.8%
Temporary or transitional Number Analyzed 108 participants 107 participants 215 participants
9
   8.3%
13
  12.1%
22
  10.2%
Homeless Number Analyzed 108 participants 107 participants 215 participants
5
   4.6%
6
   5.6%
11
   5.1%
Other Number Analyzed 108 participants 107 participants 215 participants
1
   0.9%
1
   0.9%
2
   0.9%
Employment Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Full time Number Analyzed 108 participants 107 participants 215 participants
4
   3.7%
1
   0.9%
5
   2.3%
Part time Number Analyzed 108 participants 107 participants 215 participants
4
   3.7%
5
   4.7%
9
   4.2%
Unemployed Number Analyzed 108 participants 107 participants 215 participants
63
  58.3%
71
  66.4%
134
  62.3%
Retired Number Analyzed 108 participants 107 participants 215 participants
19
  17.6%
14
  13.1%
33
  15.3%
Other Number Analyzed 108 participants 107 participants 215 participants
18
  16.7%
17
  15.9%
35
  16.3%
Length of Time Diagnosed  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 107 participants 215 participants
15.3  (8.8) 15.5  (7.9) 15.5  (8.3)
Viral Load   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Detectable Number Analyzed 108 participants 107 participants 215 participants
41
  38.0%
30
  28.0%
71
  33.0%
Undetectable (<200 copies) Number Analyzed 108 participants 107 participants 215 participants
41
  38.0%
54
  50.5%
95
  44.2%
Unknown Number Analyzed 108 participants 107 participants 215 participants
26
  24.1%
23
  21.5%
49
  22.8%
[1]
Measure Description: Medical record value closest to baseline
CD4 Cell Count   [1] 
Mean (Standard Deviation)
Unit of measure:  Cells per microliter
Number Analyzed 83 participants 84 participants 167 participants
534  (316) 650  (343) 593  (334)
[1]
Measure Analysis Population Description: 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  
Measure Type: Count of Participants
Unit of measure:  Participants
received HIV care Number Analyzed 108 participants 107 participants 215 participants
103
  95.4%
102
  95.3%
205
  95.3%
did not receive HIV care Number Analyzed 108 participants 107 participants 215 participants
5
   4.6%
5
   4.7%
10
   4.7%
Sexual Orientation  
Measure Type: Count of Participants
Unit of measure:  Participants
Straight Number Analyzed 108 participants 107 participants 215 participants
36
  33.3%
43
  40.2%
79
  36.7%
Gay man Number Analyzed 108 participants 107 participants 215 participants
50
  46.3%
42
  39.3%
92
  42.8%
Gay woman Number Analyzed 108 participants 107 participants 215 participants
1
   0.9%
3
   2.8%
4
   1.9%
Bisexual Number Analyzed 108 participants 107 participants 215 participants
16
  14.8%
16
  15.0%
32
  14.9%
Not Sure Number Analyzed 108 participants 107 participants 215 participants
1
   0.9%
2
   1.9%
3
   1.4%
Other Number Analyzed 108 participants 107 participants 215 participants
4
   3.7%
2
   1.9%
6
   2.8%
Ever Incarcerated  
Measure Type: Count of Participants
Unit of measure:  Participants
ever incarcerated Number Analyzed 108 participants 107 participants 215 participants
58
  53.7%
59
  55.1%
117
  54.4%
never incarcerated Number Analyzed 108 participants 107 participants 215 participants
49
  45.4%
48
  44.9%
97
  45.1%
Unknow Number Analyzed 108 participants 107 participants 215 participants
1
   0.9%
0
   0.0%
1
   0.5%
1.Primary Outcome
Title Medication Adherence
Hide Description 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.
Time Frame Baseline, 1.5 months, 3 months, 4.5 months, and 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Wait-list Control Treatment Advocacy
Hide Arm/Group Description:
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, 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.
Overall Number of Participants Analyzed 85 86
Mean (Standard Deviation)
Unit of Measure: Percentage of doses taken
Baseline 77.96  (23.15) 80.13  (21.74)
1.5 month follow-up 64.87  (33.88) 76.13  (25.55)
3 month follow-up 63.44  (33.01) 76.76  (24.60)
4.5 month follow-up 63.69  (32.08) 79.17  (25.31)
6 month follow-up 56.50  (33.97) 78.76  (22.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Wait-list Control, Treatment Advocacy
Comments We used generalized linear mixed models predicting adherence at baseline and 1.5-, 3-, 4.5-, and 6-months post-baseline, with intervention , time, interaction between intervention and time, medical and socio-demographic covariates, and baseline viral load. Sample size was determined with a power analysis assuming .80 power and an alpha level of .05 that would allow for detection of a small-to-medium effect size in adherence between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .005
Comments a priori threshold for significance for p < .05
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.69 to 0.91
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Wait-list Control Treatment Advocacy
Hide Arm/Group Description Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment. 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.
All-Cause Mortality
Wait-list Control Treatment Advocacy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Wait-list Control Treatment Advocacy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Wait-list Control Treatment Advocacy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/108 (0.00%)   0/107 (0.00%) 
We did not assess long-term effects, as the 6-month follow-up assessment occurred immediately after the last booster session. In addition, we did not assess the effects of the intervention on viral suppression.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Laura M. Bogart, PhD
Organization: RAND Corporation
Phone: (310) 393-0411 ext 7281
Responsible Party: Laura Bogart, RAND
ClinicalTrials.gov Identifier: NCT01350544     History of Changes
Other Study ID Numbers: R01MD006058 ( U.S. NIH Grant/Contract )
R01MD006058 ( U.S. NIH Grant/Contract )
First Submitted: May 6, 2011
First Posted: May 9, 2011
Results First Submitted: May 19, 2016
Results First Posted: April 11, 2017
Last Update Posted: April 11, 2017