Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhanced Housing Placement Assistance (EHPA)

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: NCT03334825
Recruitment Status : Completed
First Posted : November 7, 2017
Results First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ellen Wiewel, New York City Department of Health and Mental Hygiene

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Conditions HIV/AIDS
Housing Problems
Interventions Other: Enhanced housing placement assistance
Other: Standard housing placement assistance
Enrollment 236
Recruitment Details The study team recruited participants onsite at 22 HIV emergency single adult shelters across NYC between April 2012 and April 2013
Pre-assignment Details  
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Hide Arm/Group Description Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
Period Title: Overall Study
Started 119 117
Completed 112 113
Not Completed 7 4
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance Total
Hide Arm/Group Description Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White Total of all reporting groups
Overall Number of Baseline Participants 119 117 236
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 119 participants 117 participants 236 participants
48
(42 to 54)
48
(40 to 54)
48
(41.5 to 54)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 119 participants 117 participants 236 participants
84
  70.6%
90
  76.9%
174
  73.7%
Female Number Analyzed 119 participants 117 participants 236 participants
30
  25.2%
21
  17.9%
51
  21.6%
Transgender Number Analyzed 119 participants 117 participants 236 participants
5
   4.2%
6
   5.1%
11
   4.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Non-Hispanic Black Number Analyzed 119 participants 117 participants 236 participants
72
  60.5%
70
  59.8%
142
  60.2%
Hispanic Number Analyzed 119 participants 117 participants 236 participants
41
  34.5%
37
  31.6%
78
  33.1%
Non-Hispanic White Number Analyzed 119 participants 117 participants 236 participants
5
   4.2%
10
   8.5%
15
   6.4%
Unknown Number Analyzed 119 participants 117 participants 236 participants
1
   0.8%
0
   0.0%
1
   0.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 119 participants 117 participants 236 participants
119
 100.0%
117
 100.0%
236
 100.0%
Placement in Permanent Housing   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 119 participants 117 participants 236 participants
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Persons were sampled for this study from emergency housing. Therefore, by design, none were placed in permanent housing at baseline.
Engagement in HIV Care   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 117 participants 235 participants
116
  98.3%
117
 100.0%
233
  99.1%
[1]
Measure Description: any reported HIV viral load (VL) or CD4 test within 12 months pre-enrollment
[2]
Measure Analysis Population Description: One person enrolled in the EHPA arm had baseline interview data but could not be matched with the HIV surveillance registry, which provided laboratory test results indicative of HIV care and viral suppression, so care and suppression characteristics could not be obtained for this one person
HIV Viral Suppression   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 118 participants 117 participants 235 participants
33
  28.0%
61
  52.1%
94
  40.0%
[1]
Measure Description: Last viral load is under 200 copies/mL in the 12 months pre-enrollment
[2]
Measure Analysis Population Description: One person enrolled in the EHPA arm had baseline interview data but could not be matched with the HIV surveillance registry, which provided laboratory test results indicative of HIV care and viral suppression, so care and suppression characteristics could not be obtained for this one person
1.Primary Outcome
Title Number of Participants With Placement in Permanent Housing
Hide Description supportive housing, rental assistance, other non-emergency housing, etc.
Time Frame 12 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
persons who survived 12 months post-enrollment
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Hide Arm/Group Description:
Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
53
  47.3%
37
  32.7%
2.Secondary Outcome
Title Number of Participants With Engagement in HIV Care
Hide Description any reported HIV viral load (VL) or CD4 test
Time Frame 12 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
persons who survived 12 months post-enrollment
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Hide Arm/Group Description:
Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
109
  97.3%
110
  97.3%
3.Secondary Outcome
Title Number of Participants With HIV Viral Suppression
Hide Description Last viral load is under 200 copies/mL
Time Frame 12 months post-enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
persons who survived 12 months post-enrollment
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Hide Arm/Group Description:
Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
Overall Number of Participants Analyzed 112 113
Measure Type: Count of Participants
Unit of Measure: Participants
53
  47.3%
64
  56.6%
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Hide Arm/Group Description

assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients’ capacity to live independently and maintain housing stability

Enhanced housing placement assistance: assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability

standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White

Standard housing placement assistance: standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White

All-Cause Mortality
Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Affected / at Risk (%) Affected / at Risk (%)
Total   6/119 (5.04%)   4/117 (3.42%) 
Show Serious Adverse Events Hide Serious Adverse Events
Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/117 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Enhanced Housing Placement Assistance Standard Housing Placement Assistance
Affected / at Risk (%) Affected / at Risk (%)
Total   0/119 (0.00%)   0/117 (0.00%) 

Rates of viral suppression at baseline were unequal between the two study arms, in spite of randomization.

Electronically reported laboratory test data does not distinguish routine vs. acute medical care.

Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
All PIs have been employed by the New York City Department of Health and Mental Hygiene. Dr. Towe is no longer at the New York City Department of Health and Mental Hygiene and is currently at RAND Corporation. Any results communications must be cleared by the New York City Department of Health and Mental Hygiene prior to public release.
Results Point of Contact
Name/Title: Dr. Ellen Wiewel
Organization: New York City Department of Health and Mental Hygiene
Phone: 347-396-7653
Responsible Party: Ellen Wiewel, New York City Department of Health and Mental Hygiene
ClinicalTrials.gov Identifier: NCT03334825     History of Changes
Other Study ID Numbers: 17-049
First Submitted: November 3, 2017
First Posted: November 7, 2017
Results First Submitted: November 15, 2017
Results First Posted: February 8, 2019
Last Update Posted: February 8, 2019