HIV PreventionNCT03138135
HOME Study: a Combination Support Package to Increase Uptake of PrEP and HIV/STI Testing
A study testing HOME Study intervention in people with HIV Prevention and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
Trial summary
Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Sexually Transmitted Diseases, Pre-Exposure Prophylaxis
- What is being tested?
- HOME Study intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2017to 30 Nov 2018
- 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 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-identify as Black or Latino.
- Report anal sex with at least one male sex partner in the prior 12 months.
- HIV negative by self-report.
- Currently own a cell phone.
- Willing and able to provide written informed consent.
Who cannot join
- Inadequate contact information for follow-up.
- In a mutually monogamous sexual relationship for the past 12 months.
- Currently taking PrEP.
- Does not have reliable access to the Internet.
- Does not live, work, or play in the San Francisco Bay Area.
- Planning to move out of the Bay Area during the 9 month study period.
- Previously participated in the HOME Pilot study.
- Any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bridge HIV, San Francisco Department of Public Health
San Francisco, California, 94102
About this study
Official title: HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.
Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").
We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.
Read the detailed description
Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).
- Being tested
- HOME Study intervention, Control
- Keywords
- PrEP, HIV prevention, Risk reduction, STI prevention, Home HIV testing, HIV testing, STI testing
- Medical subject headings
- Sexually Transmitted Diseases, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOME Study interventionBehavioural
Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.
ControlBehavioural
Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Intervention group will receive the HOME Study intervention. Receives: Behavioral: HOME Study intervention |
| Control | Active comparator | The Control group will receive standard of care. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the HOME package to support linkage to PrEP or HIV care
Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.
Measured: 9 months
Efficacy of the HOME package to increase HIV and STI testing frequency.
The proportion of participants reporting HIV and STI testing rates between visits.
Measured: 9 months
Secondary outcomes (2)
Feasibility of the individual components of the study intervention.
Combined analysis of overall use of study intervention: Usage of home HIV self-testing, with and without buddies, as well as STI-self collection; Proportion of participants who log-in to the HOME Study site at least once, distribution of numbers of log-ins, and use of HOME Study pages, as measured by numbers of clicks and views for each page.
Measured: 9 months
Acceptability of the HOME package to support linkage to HIV care or PrEP.
Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start9 Jan 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PreventionStudies 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
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation Enterprises, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, University of California, San Francisco
- Responsible party
- Principal investigator, Susan Buchbinder, Public Health Foundation Enterprises, Inc.
- Investigators
- Hyman Scott, MD, MPH, Principal investigator, Public Health Foundation Enterprises; San Francisco Department of Public HealthSusan Buchbinder, MD, Principal investigator, Public Health Foundation Enterprises; San Francisco Department of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138135
- Sponsor's protocol ID
- 16-20492
- Other IDs
- R01AI104309
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2017
- Last updated
- 9 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOME Study: Evaluation of a Combination Support Package to Increase Uptake of Pre-exposure Prophylaxis and HIV/STI Testing Among Young Black and Latino MSM in the San Francisco Bay Area.
- ClinicalTrials.gov ID
- NCT03138135
- Acronym / sponsor ID
- 16-20492
- Keywords
- PrEP, HIV prevention, Risk reduction, STI prevention, Home HIV testing, HIV testing, STI testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Public Health Foundation Enterprises, Inc.University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), San Francisco Department of Public Health, University of California, San Francisco
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 3 May 2017 (actual)
- 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.
Home HIV self-testing has been FDA approved and allows users to read their own HIV test results at home, while home sexually transmitted infection (STI) test self-collection allows men to use a swab at home and mail it in for testing. The purpose of this study is to learn how Men who have Sex with Men (MSM) use these new testing options, a set of online support tools, and the option to test with someone to support them (a testing "buddy").
We will also evaluate whether the online tools help these men to connect with HIV prevention services such as Pre-Exposure Prophylaxis (PrEP) if they test HIV negative, and to HIV care services if they test HIV positive.
Detailed description
Participants will be randomized 2:1 after enrollment to the intervention and control condition. Data obtained from this study will be used to inform the further tailoring and distribution of an intervention for young Black and Latino MSM to increase utilization of home HIV self-testing and linkage to HIV treatment and Pre-Exposure Prophylaxis (PrEP).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: HOME Study interventionThe Intervention group will receive the HOME Study intervention. |
| Control | Active comparator | Behavioral: ControlThe Control group will receive standard of care. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Self-identify as Black or Latino.
- Report anal sex with at least one male sex partner in the prior 12 months.
- HIV negative by self-report.
- Currently own a cell phone.
- Willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Inadequate contact information for follow-up.
- In a mutually monogamous sexual relationship for the past 12 months.
- Currently taking PrEP.
- Does not have reliable access to the Internet.
- Does not live, work, or play in the San Francisco Bay Area.
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 |
|---|---|---|
| HOME Study interventionAccess to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool. | Behavioural | Intervention |
| ControlCounseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet. | Behavioural | Control |
Primary outcome
Efficacy of the HOME package to support linkage to PrEP or HIV care
Time frame: 9 months
Between-arm differences in initiation of PrEP; qualitative evaluation of linkage to HIV care.
Efficacy of the HOME package to increase HIV and STI testing frequency.
Time frame: 9 months
The proportion of participants reporting HIV and STI testing rates between visits.
2 secondary outcomes
Feasibility of the individual components of the study intervention.
Time frame: 9 months
Acceptability of the HOME package to support linkage to HIV care or PrEP.
Time frame: 9 months
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 9 Apr 2021.
- Bridge HIV Health Equity Studies homepageLink provided by the sponsor.
- 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.
Hyman Scott, MD, MPH principal investigator
Public Health Foundation Enterprises; San Francisco Department of Public Health
Susan Buchbinder, MD principal investigator
Public Health Foundation Enterprises; San Francisco Department of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOME Study intervention in people with HIV Prevention and Sexually Transmitted Diseases, run by Public Health Foundation Enterprises, Inc. at 1 site in United States.
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 5 inclusion and 8 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 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Efficacy of the HOME package to support linkage to PrEP or HIV care (time frame: 9 months). The study lists 2 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 9 Apr 2021.