Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Laura Bogart, RAND
ClinicalTrials.gov Identifier:
NCT01350544
First received: May 6, 2011
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: May 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Investigator;   Primary Purpose: Treatment
Condition: HIV
Intervention: Behavioral: Treatment Advocacy

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Wait-list Control   Treatment Advocacy
STARTED   108   108 
COMPLETED   85   86 
NOT COMPLETED   23   22 
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 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Wait-list Control   Treatment Advocacy   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   107   215 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 108   107   215 
   47.0  (10.2)   50.1  (10.0)   48.6  (10.2) 
Sex/Gender, Customized 
[Units: Participants]
Count of Participants
     
Male       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Male   79   78   157 
Female       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Female   24   27   51 
Transgender       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Transgender   5   2   7 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Hispanic or Latino   7   6   13 
Not Hispanic or Latino       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Not Hispanic or Latino   101   101   202 
Unknown or Not Reported       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Unknown or Not Reported   0   0   0 
Income 
[Units: Participants]
Count of Participants
     
None       
Participants Analyzed 
[Units: Participants]
 108   107   215 
None   11   10   21 
>$0 - <$10K       
Participants Analyzed 
[Units: Participants]
 108   107   215 
>$0 - <$10K   66   53   119 
$10K - $20K       
Participants Analyzed 
[Units: Participants]
 108   107   215 
$10K - $20K   18   35   53 
>$20K – $30K       
Participants Analyzed 
[Units: Participants]
 108   107   215 
>$20K – $30K   10   8   18 
>$30K - $40K       
Participants Analyzed 
[Units: Participants]
 108   107   215 
>$30K - $40K   2   0.0   2 
Unknown       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Unknown   1   1   2 
Education 
[Units: Participants]
Count of Participants
     
7th to 11th Grade       
Participants Analyzed 
[Units: Participants]
 108   107   215 
7th to 11th Grade   17   23   40 
High School diploma or GED       
Participants Analyzed 
[Units: Participants]
 108   107   215 
High School diploma or GED   37   33   70 
Some college       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Some college   41   40   81 
College degree       
Participants Analyzed 
[Units: Participants]
 108   107   215 
College degree   6   7   13 
Some graduate school       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Some graduate school   3   4   7 
Graduate degree       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Graduate degree   4   0.0   4 
Housing Status 
[Units: Participants]
Count of Participants
     
Rent/Own       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Rent/Own   65   69   134 
Treatment facility       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Treatment facility   9   2   11 
Subsidized / Sect. 8       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Subsidized / Sect. 8   8   8   16 
Friend / relative       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Friend / relative   11   8   19 
Temporary or transitional       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Temporary or transitional   9   13   22 
Homeless       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Homeless   5   6   11 
Other       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Other   1   1   2 
Employment Status 
[Units: Participants]
Count of Participants
     
Full time       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Full time   4   1   5 
Part time       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Part time   4   5   9 
Unemployed       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Unemployed   63   71   134 
Retired       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Retired   19   14   33 
Other       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Other   18   17   35 
Length of Time Diagnosed 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 108   107   215 
   15.3  (8.8)   15.5  (7.9)   15.5  (8.3) 
Viral Load [1] 
[Units: Participants]
Count of Participants
     
Detectable       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Detectable   41   30   71 
Undetectable (<200 copies)       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Undetectable (<200 copies)   41   54   95 
Unknown       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Unknown   26   23   49 
[1] Medical record value closest to baseline
CD4 Cell Count [1] 
[Units: Cells per microliter]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 83   84   167 
   534  (316)   650  (343)   593  (334) 
[1] 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 
[Units: Participants]
Count of Participants
     
received HIV care       
Participants Analyzed 
[Units: Participants]
 108   107   215 
received HIV care   103   102   205 
did not receive HIV care       
Participants Analyzed 
[Units: Participants]
 108   107   215 
did not receive HIV care   5   5   10 
Sexual Orientation 
[Units: Participants]
Count of Participants
     
Straight       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Straight   36   43   79 
Gay man       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Gay man   50   42   92 
Gay woman       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Gay woman   1   3   4 
Bisexual       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Bisexual   16   16   32 
Not Sure       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Not Sure   1   2   3 
Other       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Other   4   2   6 
Ever Incarcerated 
[Units: Participants]
Count of Participants
     
ever incarcerated       
Participants Analyzed 
[Units: Participants]
 108   107   215 
ever incarcerated   58   59   117 
never incarcerated       
Participants Analyzed 
[Units: Participants]
 108   107   215 
never incarcerated   49   48   97 
Unknow       
Participants Analyzed 
[Units: Participants]
 108   107   215 
Unknow   1   0   1 


  Outcome Measures

1.  Primary:   Medication Adherence   [ Time Frame: Baseline, 1.5 months, 3 months, 4.5 months, and 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

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
e-mail: lbogart@rand.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laura Bogart, RAND
ClinicalTrials.gov Identifier: NCT01350544     History of Changes
Other Study ID Numbers: R01MD006058 ( US NIH Grant/Contract Award Number )
Study First Received: May 6, 2011
Results First Received: May 19, 2016
Last Updated: April 7, 2017