Housing and Health Study

HIV Clinical Trial

— H&H  

Official title:

Housing and Health Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00153504
• Other study ID #: CDC-NCHSTP-4015
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: April 4, 2012
• Start date: July 2004
• Est. completion date: January 2007

Study information

• Verified date: April 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their HIV disease progression, risks of transmitting HIV, and medical care access and utilization.

Description:

Evidence is accumulating that homelessness and housing may be important factors that influence human immunodeficiency virus (HIV) sex and drug risk behaviors. Despite this apparent connection, few studies have investigated whether homelessness or unstable housing, compared with stable and adequate housing, is linked with HIV risk behaviors, and whether change in housing status is associated with change in risk behaviors.

The Housing and Health Study is a multi-site, multi-agency research collaboration. This project is a unique collaboration between federal agencies (the Department of Housing and Urban Development and the Centers for Disease Control and Prevention), local government agencies, universities, and private not-for-profit organizations.

The goal of the project is to examine the impact of providing housing for people living with HIV who are homeless or at imminent risk of homelessness on their disease progression, their risks of transmitting HIV, and medical care access and utilization. A total of 630 people living with HIV from three study sites complete the baseline study sessions. Half the participants (n=315) are randomly assigned to each of the two study groups. Treatment group participants receive Housing and Health Study housing rental assistance, and comparison group participants receive assistance finding housing according to local standard practice.

At baseline, 6, 12, and 18 months after baseline, participants complete study questionnaires and provide blood specimens to test for CD4 and viral load. In addition, the cost effectiveness of the study will be investigated by examining the HIV-related costs averted by providing housing to persons at high risk for transmitting HIV.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: January 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV seropositive

• At least 18 years of age

• English or Spanish speaking

• Able to provide informed consent

• Able to participate in data collection protocol

• Categorized as low income (less than 80% of the Area Median Income)

• Homeless or at imminent risk of homelessness

• Able to provide information about identity

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS
• HIV

Intervention

Behavioral:
• Housing and Health Study housing rental assistance

• Standard local practice housing assistance

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Columbia University, Johns Hopkins University, RTI International, University of Pittsburgh, US Department of Housing and Urban Development

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV risk behaviors at 6, 12, and 18 months
Primary	Biological measures of HIV-related health status
Primary	Access to HIV/AIDS medical care
Primary	Adherence to HIV/AIDS medical care, including compliance with HIV medication therapies
Secondary	Cost and cost effectiveness of the intervention
Secondary	Proximal outcomes (e.g., increased condom use self-efficacy, social norms) associated with a reduction in HIV risk behaviors
Secondary	Social contact, employment outcomes, quality of life, mental health