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This study explores whether offering follow-up counseling and referral over the phone after using a home-based HIV test increases rates of ever and repeat testing, compared with home-based testing with no follow-up (HBST alone) or mailing reminders for clinic-based testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Enhanced" home-based testing | Experimental | These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. |
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| Home-based testing alone | Active Comparator | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. |
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| Reminders for clinic-based testing | Sham Comparator | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Smart" home-based test for HIV | Behavioral | A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Received HIV Testing | Count of the number of participants who reported receiving HIV testing. | Up to 28 weeks |
| Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional. | Up to 28 weeks |
| Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional. | Up to 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University School of Public Health | Providence | Rhode Island | 02906 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | "Enhanced" Home-based Testing | These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. "Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring. |
| FG001 | Home-based Testing Alone | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. Home-based testing only: A standard home-based HIV test kit. |
| FG002 | Reminders for Clinic-based Testing | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | "Enhanced" Home-based Testing | These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. "Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Received HIV Testing | Count of the number of participants who reported receiving HIV testing. | Posted | Count of Participants | Participants | Up to 28 weeks |
|
Adverse event data was collected monthly over the course of the 7-month study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Enhanced" Home-based Testing | These participants will download a study-specific smartphone app ("eTEST"), and receive home-based HIV test kits in the mail every 3 months. These kits will have been fit with sensors that enable remote detection of when the kit was opened. Qualified HIV test counselors (QHTC) will then follow up with these participants within 24 hours of receiving notification that the test has been opened to conduct routine counseling, offer referrals for other services, and connect those with reactive results with follow-up care. "Smart" home-based test for HIV: A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tyler Wray | Brown University School of Public Health | 401-863-6659 | tyler_wray@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 15, 2018 | Jan 16, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 15, 2018 | Jan 16, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000069078 | Seroconversion |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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| Home-based testing only | Behavioral | A standard home-based HIV test kit. |
|
| Reminder letters for clinic-based testing | Behavioral | Letters reminding patients to get tested at a free clinic location |
|
| BG001 | Home-based Testing Alone | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. Home-based testing only: A standard home-based HIV test kit. |
| BG002 | Reminders for Clinic-based Testing | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | Home-based Testing Alone | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. Home-based testing only: A standard home-based HIV test kit. |
| OG002 | Reminders for Clinic-based Testing | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location |
|
|
| Primary | Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional. | Posted | Count of Participants | Participants | Up to 28 weeks |
|
|
|
| Primary | Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | Count of the number of participants who reported actually having received a prescription for pre-exposure prophylaxis after having been referred by a medical professional. | Posted | Count of Participants | Participants | Up to 28 weeks |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Home-based Testing Alone | These participants will receive a typical home-based test for HIV in the mail every 3 months, but no phone-based follow-up will be provided. Home-based testing only: A standard home-based HIV test kit. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG002 | Reminders for Clinic-based Testing | Participants in this condition will receive a letter in the mail every 3 months reminding them to be tested at a local clinic for free. Reminder letters for clinic-based testing: Letters reminding patients to get tested at a free clinic location | 0 | 22 | 0 | 22 | 0 | 22 |
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