NCT03334825

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

February 8, 2019

Status Verified

September 1, 2018

Enrollment Period

5.3 years

First QC Date

November 3, 2017

Results QC Date

November 15, 2017

Last Update Submit

September 6, 2018

Conditions

Keywords

HIVhousinghomelessness

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Placement in Permanent Housing

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

    12 months post-enrollment

Secondary Outcomes (2)

  • Number of Participants With Engagement in HIV Care

    12 months post-enrollment

  • Number of Participants With HIV Viral Suppression

    12 months post-enrollment

Study Arms (2)

Enhanced housing placement assistance

EXPERIMENTAL
Other: Enhanced housing placement assistance

Standard housing placement assistance

ACTIVE COMPARATOR
Other: Standard housing placement assistance

Interventions

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

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

Standard housing placement assistance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

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.

Results Point of Contact

Title
Dr. Ellen Wiewel
Organization
New York City Department of Health and Mental Hygiene

Study Officials

  • Ellen W Wiewel, DrPH

    New York City Department of Health and Mental Hygiene

    PRINCIPAL INVESTIGATOR
  • Vivian L Towe, PhD

    RAND

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research and Evaluation

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

April 1, 2012

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

February 8, 2019

Results First Posted

February 8, 2019

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share