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| ID | Type | Description | Link |
|---|---|---|---|
| R01AI104309 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| San Francisco Department of Public Health | OTHER_GOV |
| University of California, San Francisco | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The Intervention group will receive the HOME Study intervention. |
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| Control | Active Comparator | The Control group will receive standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HOME Study intervention | Behavioral | Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Who uses home HIV self-testing and home STI self-collection. | Testing and self-collection rates by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis. | 9 months |
| Who uses a buddy. |
Inclusion Criteria:
Exclusion Criteria:
Cisgender male
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bridge HIV, San Francisco Department of Public Health | San Francisco | California | 94102 | United States |
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| Label | URL |
|---|---|
| Bridge HIV Health Equity Studies homepage | View source |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D040242 | Risk Reduction Behavior |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Control | Behavioral | Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet. |
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| 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. | 9 months |
Differences in testing with a buddy by occasion, age, county, race/ethnicity, and prior testing history. Aggregate descriptive analysis.
| 9 months |
| Use of HIV prevention services. | Proportion of HIV uninfected participants who attend group or individual counseling services. | 9 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |