HIVH&HNCT00153504
Housing and Health Study
A study testing Housing and Health Study housing rental assistance and Standard local practice housing assistance in people with HIV and AIDS, run by Centers for Disease Control and Prevention.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Housing and Health Study housing rental assistance and Standard local practice housing assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 630 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Jan 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
About this study
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.
Read the detailed 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.
- Being tested
- Housing and Health Study housing rental assistance, Standard local practice housing assistance
- Keywords
- HIV, AIDS, Homeless, Homelessness, Housing, HIV seropositive, HIV risk behavior
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Seropositivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Housing and Health Study housing rental assistanceBehavioural
Standard local practice housing assistanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Housing and Health Study housing rental assistance | Experimental | Not described Receives: Behavioral: Housing and Health Study housing rental assistance |
| Standard local practice housing assistance | Active comparator | Not described Receives: Behavioral: Standard local practice housing assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV risk behaviors at 6, 12, and 18 months
Biological measures of HIV-related health status
Access to HIV/AIDS medical care
Adherence to HIV/AIDS medical care, including compliance with HIV medication therapies
Secondary outcomes (3)
Cost and cost effectiveness of the intervention
Proximal outcomes (e.g., increased condom use self-efficacy, social norms) associated with a reduction in HIV risk behaviors
Social contact, employment outcomes, quality of life, mental health
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- US Department of Housing and Urban Development, RTI International, Johns Hopkins University, University of Pittsburgh, Columbia University
- Investigators
- Daniel P Kidder, PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153504
- Sponsor's protocol ID
- CDC-NCHSTP-4015
- Acronym
- H&H
- Status last verified
- Apr 2012
- First submitted
- 8 Sep 2005
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Housing and Health Study
- ClinicalTrials.gov ID
- NCT00153504
- Acronym / sponsor ID
- H&H / CDC-NCHSTP-4015
- Keywords
- HIV, AIDS, Homeless, Homelessness, Housing, HIV seropositive, HIV risk behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- US Department of Housing and Urban Development, RTI International, Johns Hopkins University, University of Pittsburgh, Columbia University
- Study start
- Jul 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Housing and Health Study housing rental assistance | Experimental | Behavioral: Housing and Health Study housing rental assistance |
| Standard local practice housing assistance | Active comparator | Behavioral: Standard local practice housing assistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV seropositive
- At least 18 years of age
- English or Spanish speaking
- Able to provide informed consent
- Able to participate in data collection protocol
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Housing and Health Study housing rental assistance | Behavioural | Housing and Health Study housing rental assistance |
| Standard local practice housing assistance | Behavioural | Standard local practice housing assistance |
Primary outcome
HIV risk behaviors at 6, 12, and 18 months
Biological measures of HIV-related health status
Access to HIV/AIDS medical care
Adherence to HIV/AIDS medical care, including compliance with HIV medication therapies
3 secondary outcomes
Cost and cost effectiveness of the intervention
Proximal outcomes (e.g., increased condom use self-efficacy, social norms) associated with a reduction in HIV risk behaviors
Social contact, employment outcomes, quality of life, mental health
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2012.
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
Daniel P Kidder, PhD principal investigator
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A study testing Housing and Health Study housing rental assistance and Standard local practice housing assistance in people with HIV and AIDS, run by Centers for Disease Control and Prevention.
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 8 inclusion and 1 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 5 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HIV risk behaviors at 6, 12, and 18 months. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2012.