Intervention to Retain HIV-positive Patients in Medical Care (Phase II)

This study has been completed.
Sponsor:
Collaborator:
Health Resources and Services Administration (HRSA)
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01537367
First received: February 10, 2012
Last updated: August 22, 2013
Last verified: August 2013
Results First Received: August 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Caregiver);   Primary Purpose: Health Services Research
Condition: Primary Care Appointment Keeping
Interventions: Behavioral: Enhanced contact plus behavioral skills
Behavioral: Enhanced contact only
Behavioral: Standard of Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from June 15, 2010 through February 11, 2011. Recruitment time varied from 6 months to 8 months, by clinic site. Recruitment always occurred during regularly scheduled primary care appointments, either in a private corner of the waiting room, or in an adjacent room of the clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No exclusions from the trial if participant was deemed eligible and agreed to participate. Once participants were deemed eligible, and agreed, they were escorted to a private room to do the audio-CASI questionnaire. After the audio-CASI was completed they were immediately randomized to one of the three arms.

Reporting Groups
  Description
Enhanced Contact-only The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
Enhanced Contact-plus Behavioral Skills This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.
Standard of Care Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.

Participant Flow:   Overall Study
    Enhanced Contact-only     Enhanced Contact-plus Behavioral Skills     Standard of Care  
STARTED     615     610     613  
COMPLETED     615 [1]   610 [1]   613 [1]
NOT COMPLETED     0     0     0  
[1] All participants who were enrolled were followed for routine HIV clinic attendance via clinic EMR.



  Baseline Characteristics
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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.
The transgendered particpants were all males at birth, so we added the transgendered to the male count in the gender field.

Reporting Groups
  Description
Enhanced Contact-only The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
Enhanced Contact-plus Behavioral Skills This arm was described in the summary/Detailed Description as the "longer comprehensive intervention arm". Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments.
Standard of Care Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
Total Total of all reporting groups

Baseline Measures
    Enhanced Contact-only     Enhanced Contact-plus Behavioral Skills     Standard of Care     Total  
Number of Participants  
[units: participants]
  615     610     613     1838  
Age, Customized [1]
[units: participants]
       
18-29 years     59     67     73     199  
30-39 years     118     121     122     361  
40-49 years     210     202     212     624  
50-59 years     187     176     167     530  
60-plus years     41     44     39     124  
Gender  
[units: participants]
       
Female     203     234     228     665  
Male     412     376     385     1173  
Race/Ethnicity, Customized [2]
[units: participants]
       
Black     431     422     409     1262  
White     87     72     76     235  
Other race     18     15     20     53  
Hispanic     79     101     108     288  
[1] Five-category Age Age groups: 18-29 30-39 40-49 50-59 60-plus
[2] Mutually exclusive categories where Hispanic is treated as a distinct race category, over-riding any other selection from the OMB race variable.



  Outcome Measures
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1.  Primary:   The Percentage of Patients Attending a Primary Care Visit in Each of 3 Four-month Periods (First Measure)   [ Time Frame: 12 months after enrollment ]

2.  Primary:   The Percentage of Kept Divided by Scheduled Primary Care Visits, Excluding Cancelled (Second Measure).   [ Time Frame: 12 months after enrollment ]

3.  Secondary:   Mean Counts Per Person (Rates) of Kept Visits.   [ Time Frame: 12 months after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Lytt I. Gardner, Ph.D., CDC Project Officer
Organization: Division of HIV/AIDS (Epidemiology Branch), National Center for HIV/Hepatitis/STD/Tuberculosis Prevention, Centers for Disease Control and Prevention
phone: (404) 639-6163
e-mail: lig0@cdc.gov


No publications provided


Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01537367     History of Changes
Other Study ID Numbers: CDCHRSA9272007
Study First Received: February 10, 2012
Results First Received: August 7, 2013
Last Updated: August 22, 2013
Health Authority: United States: Federal Government