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.
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|ClinicalTrials.gov Identifier: NCT03138135|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Prevention Sexually Transmitted Diseases Pre-Exposure Prophylaxis||Behavioral: HOME Study intervention Behavioral: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||January 9, 2017|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
The Intervention group will receive the HOME Study intervention.
Behavioral: HOME Study intervention
Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.
Active Comparator: Control
The Control group will receive standard of care.
Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.
- 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.
- Feasibility of the individual components of the study intervention. [ Time Frame: 9 months ]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.
- Acceptability of the HOME package to support linkage to HIV care or PrEP. [ Time Frame: 9 months ]Acceptability scores from online questionnaires and the distribution of repeated scores at follow-up timepoints.
- Who uses home HIV self-testing and home STI self-collection. [ Time Frame: 9 months ]Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.
- Who uses a buddy. [ Time Frame: 9 months ]Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.
- Use of HIV prevention services. [ Time Frame: 9 months ]Proportion of HIV uninfected participants who attend group or individual counseling services.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03138135
|Contact: Kenneth Coleman, MAfirstname.lastname@example.org|
|Contact: Rafael Gonzalezemail@example.com|
|United States, California|
|Bridge HIV, San Francisco Department of Public Health||Recruiting|
|San Francisco, California, United States, 94102|
|Principal Investigator: Susan Buchbinder, MD|
|Principal Investigator: Hyman Scott, MD, MPH|
|Principal Investigator:||Hyman Scott, MD, MPH||Public Health Foundation Enterprises; San Francisco Department of Public Health|
|Principal Investigator:||Susan Buchbinder, MD||Public Health Foundation Enterprises; San Francisco Department of Public Health|