HIV/AIDSEHPANCT03334825

Enhanced Housing Placement Assistance

A study testing Enhanced housing placement assistance and Standard housing placement assistance in people with HIV/AIDS and Housing Problems, run by New York City Department of Health and Mental Hygiene.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized controlled trial of housing placement assistance for homeless persons with HIV Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV/AIDS, Housing Problems
What is being tested?: Enhanced housing placement assistance and Standard housing placement assistance
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 236 participants
Where: No sites listed yet
Study dates: 1 Apr 2012to 31 Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Inability to provide informed consent
Inability to complete survey in English or Spanish

About this study

Official title: An Enhanced Housing Placement Assistance (EHPA) Program for Homeless Persons Living With HIV/AIDS in New York City

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.

Conditions: HIV/AIDS, Housing Problems
Being tested: Enhanced housing placement assistance, Standard housing placement assistance
Keywords: HIV, housing, homelessness
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03334825
Study group	Role	What they receive
Enhanced housing placement assistance	Experimental	Not described Receives: Other: Enhanced housing placement assistance
Standard housing placement assistance	Active comparator	Not described Receives: Other: Standard housing placement assistance

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Placement in Permanent Housing
supportive housing, rental assistance, other non-emergency housing, etc.
Measured: 12 months post-enrollment

Secondary outcomes (2)

Number of Participants With Engagement in HIV Care
any reported HIV viral load (VL) or CD4 test
Measured: 12 months post-enrollment
Number of Participants With HIV Viral Suppression
Last viral load is under 200 copies/mL
Measured: 12 months post-enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201231 Jul 2017

First posted7 Nov 2017
Study start1 Apr 2012
Primary completion31 Jul 2017
Study completion31 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV/AIDSStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: randomized controlled trial
Masking: None (open label)
Enrolment: 236 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03334825
Sponsor's protocol ID: 17-049
Acronym: EHPA
Status last verified: Sep 2018
First submitted: 3 Nov 2017
Last updated: 8 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV/AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Enhanced Housing Placement Assistance (EHPA) Program for Homeless Persons Living With HIV/AIDS in New York City
ClinicalTrials.gov ID: NCT03334825
Acronym / sponsor ID: EHPA / 17-049
Conditions: HIV/AIDS, Housing Problems
Keywords: HIV, housing, homelessness
Study type: Interventional
Recruitment status: Completed
Enrolment: 236 participants (actual)
Lead sponsor: New York City Department of Health and Mental HygieneOther government
Study start: 1 Apr 2012 (actual)
Primary completion: 31 Jul 2017 (actual)
Study completion: 31 Jul 2017 (actual)
First posted: 7 Nov 2017 (actual)
Results: Posted 8 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: randomized controlled trial

Arm	Type	Receives
Enhanced housing placement assistance	Experimental	Other: Enhanced housing placement assistance
Standard housing placement assistance	Active comparator	Other: Standard housing placement assistance

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

Inability to provide informed consent
Inability to complete survey in English or Spanish

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Enhanced housing placement assistanceassistance 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	Other	Enhanced housing placement assistance
Standard housing placement assistancestandard connections to services and housing programs offered by HASA, HOPWA, or Ryan White	Other	Standard housing placement assistance

Primary outcome

Number of Participants With Placement in Permanent Housing
Time frame: 12 months post-enrollment
supportive housing, rental assistance, other non-emergency housing, etc.

2 secondary outcomes

Number of Participants With Engagement in HIV Care
Time frame: 12 months post-enrollment
Number of Participants With HIV Viral Suppression
Time frame: 12 months post-enrollment

Results and safety

Results posted to the registry on 8 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Housing Placement Assistance	119	112
Standard Housing Placement Assistance	117	113

Primary outcome: Number of Participants With Placement in Permanent Housing

Time frame: 12 months post-enrollment. Count of participants. Unit: Participants

Measure	Enhanced Housing Placement Assistance n = 112	Standard Housing Placement Assistance n = 113
Value	53	37

Population analysed: persons who survived 12 months post-enrollment

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Housing Placement Assistance	0 of 119 (0%)	0 of 119 (0%)	6 of 119
Standard Housing Placement Assistance	0 of 117 (0%)	0 of 117 (0%)	4 of 117

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ellen W Wiewel, DrPH principal investigator

New York City Department of Health and Mental Hygiene

Vivian L Towe, PhD principal investigator

RAND

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Placement in Permanent Housing (time frame: 12 months post-enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03334825.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.