ClinicalTrials.gg
CompletedNCT03334825EHPAUpdated Feb 8, 2019Results posted

Enhanced Housing Placement Assistance

An interventional study of Enhanced housing placement assistance and Standard housing placement assistance in HIV/AIDS and Housing Problems, sponsored by New York City Department of Health and Mental Hygiene. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by New York City Department of Health and Mental Hygiene · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Apr 2012, registered Nov 2017).

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Phase
Not applicable
Study type
Interventional
Enrollment
236
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Randomized controlled trial of housing placement assistance for homeless persons with HIV

Read the detailed description

Approximately 800 persons living with HIV/AIDS (PLWHA) reside in HIV emergency single-room-occupancy (SRO) hotels in New York City and do not have the ability to secure permanent housing on their own. The study evaluated a pilot program which fast-tracked PLWHA from HIV emergency SRO hotels into permanent housing. The Enhanced Housing Placement Assistance (EHPA) program had three components: 1) active recruitment of emergency SRO hotel residents with high need for housing; 2) assistance in the rapid (fast-track) acquisition of permanent housing; and 3) 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. Participants were randomly assigned to either 1) EHPA or 2) usual care, which included standard connections to services and housing programs offered by the New York City HIV/AIDS Services Administration (HASA), Housing Opportunities for Persons With AIDS (HOPWA), or Ryan White services, and were followed over twelve months using a questionnaire developed with significant input from the target population of PLWHA residing in emergency SRO hotels.

02

Conditions studied

  • HIV/AIDS
  • Housing Problems

Keywords

  • HIV
  • housing
  • homelessness
03

In context

Acquired Immunodeficiency Syndrome

3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.

This study's enrollment of 236 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

New York City Department of Health and Mental Hygiene is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Person living with in New York City
  • Residing in an New York City HASA single-adult single-room-occupancy (SRO) hotel

Exclusion criteria

Exclusion Criteria:

  • Inability to provide
  • Inability to complete survey in English or Spanish
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
236 participants (actual)

Study arms

  • Experimental
    Enhanced housing placement assistance

    Other: Enhanced housing placement assistance

  • Active comparator
    Standard housing placement assistance

    Other: Standard housing placement assistance

Interventions

  • OtherEnhanced 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

  • OtherStandard housing placement assistance

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

06

What researchers measure

Primary outcomes

  1. Number of Participants With Placement in Permanent Housing

    supportive housing, rental assistance, other non-emergency housing, etc.

    Time frame: 12 months post-enrollment

Secondary outcomes

  1. Number of Participants With Engagement in HIV Care

    any reported HIV viral load (VL) or CD4 test

    Time frame: 12 months post-enrollment

  2. Number of Participants With HIV Viral Suppression

    Last viral load is under 200 copies/mL

    Time frame: 12 months post-enrollment

07

Results

Posted Feb 8, 2019
Limitations and caveats
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.

Participant flow

The study team recruited participants onsite at 22 HIV emergency single adult shelters across NYC between April 2012 and April 2013

Participant flow — Overall Study
MilestoneEnhanced Housing Placement AssistanceStandard Housing Placement Assistance
Started119117
Completed112113
Not completed74

Outcome measures

PrimaryNumber of Participants With Placement in Permanent Housing

supportive housing, rental assistance, other non-emergency housing, etc.

Time frame:
12 months post-enrollment
Reported as:
Count of participants · Participants
Number of Participants With Placement in Permanent Housing
ParticipantsEnhanced Housing Placement AssistanceStandard Housing Placement Assistance
Number of Participants With Placement in Permanent Housing5337
SecondaryNumber of Participants With Engagement in HIV Care

any reported HIV viral load (VL) or CD4 test

Time frame:
12 months post-enrollment
Reported as:
Count of participants · Participants
Number of Participants With Engagement in HIV Care
ParticipantsEnhanced Housing Placement AssistanceStandard Housing Placement Assistance
Number of Participants With Engagement in HIV Care109110
SecondaryNumber of Participants With HIV Viral Suppression

Last viral load is under 200 copies/mL

Time frame:
12 months post-enrollment
Reported as:
Count of participants · Participants
Number of Participants With HIV Viral Suppression
ParticipantsEnhanced Housing Placement AssistanceStandard Housing Placement Assistance
Number of Participants With HIV Viral Suppression5364

Adverse events

Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Enhanced Housing Placement Assistance6/119 (5%)0/119 (0%)0/119 (0%)
Standard Housing Placement Assistance4/117 (3.4%)0/117 (0%)0/117 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Median48 (42 to 54)48 (40 to 54)48 (41.5 to 54)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Male8490174
Female302151
Transgender5611
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Non-Hispanic Black7270142
Hispanic413778
Non-Hispanic White51015
Unknown101
Region of Enrollment
Region of Enrollment(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
United States119117236
Placement in Permanent Housing
Placement in Permanent Housing(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Count of participants000
Engagement in HIV Care
Engagement in HIV Care(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Count of participants116117233
HIV Viral Suppression
HIV Viral Suppression(Participants)Enhanced Housing Placement AssistanceStandard Housing Placement AssistanceTotal
Count of participants336194
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2012 to primary completion in Jul 2017, 63 months.

Results were first posted in Feb 2019, 1 year 6 months after primary completion.

Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 63 months is above that.

Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 3, 2017
First posted
Nov 7, 2017
StartActual
Apr 1, 2012
Primary completionActual
Jul 31, 2017
CompletionActual
Jul 31, 2017
Results first posted
Feb 8, 2019
Last update
Feb 8, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03334825
Lead sponsor
New York City Department of Health and Mental Hygiene
Responsible party
Ellen Wiewel (Director of Research and Evaluation, New York City Department of Health and Mental Hygiene) — Principal investigator
First posted
Nov 7, 2017
Start date
Apr 1, 2012
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Results posted
Feb 8, 2019
Last update
Feb 8, 2019

Study contacts

Ellen W Wiewel, DrPH
principal investigator · New York City Department of Health and Mental Hygiene
Vivian L Towe, PhD
principal investigator · RAND

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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