HIV
Conditions
Keywords
HIV testing, Self-testing, Counseling, Referral
Brief summary
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.
Interventions
BEHAVIORALSmart home-based test for HIV
A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
BEHAVIORALHome-based testing only
A standard home-based HIV test kit.
BEHAVIORALReminder letters for clinic-based testing
Letters reminding patients to get tested at a free clinic location
Sponsors
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sex with a partner met online in the past year * Anal sex (either insertive or receptive) with a casual male partner in the past 6 months without using condoms or pre-exposure prophylaxis * Own a smartphone (iOS or Android) with a service contract and data plan * Have a stable address where mail can be received * Speak English fluently
Exclusion criteria
* Having tested for HIV in the last year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Received HIV Testing | Up to 28 weeks | Count of the number of participants who reported receiving HIV testing. |
| Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | Up to 28 weeks | Count of the number of participants who reported receiving a referral for pre-exposure prophylaxis from a counselor or medical professional. |
| Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | Up to 28 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 22 |
| 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 | 22 |
| Total | 65 |
Baseline characteristics
| Characteristic | Home-based Testing Alone | Reminders for Clinic-based Testing | Total | Enhanced Home-based Testing |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 22 Participants | 65 Participants | 21 Participants |
| Age, Continuous | 35.8 years STANDARD_DEVIATION 16.3 | 35.5 years STANDARD_DEVIATION 15.2 | 35.2 years STANDARD_DEVIATION 14.9 | 34.1 years STANDARD_DEVIATION 13.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 14 Participants | 50 Participants | 16 Participants |
| Region of Enrollment United States | 22 Participants | 22 Participants | 65 Participants | 21 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 65 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Number of Participants Who Received HIV Testing
Count of the number of participants who reported receiving HIV testing.
Time frame: Up to 28 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Home-based Testing | Number of Participants Who Received HIV Testing | 21 Participants |
| Home-based Testing Alone | Number of Participants Who Received HIV Testing | 22 Participants |
| Reminders for Clinic-based Testing | Number of Participants Who Received HIV Testing | 16 Participants |
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.
Time frame: Up to 28 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Home-based Testing | Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | 1 Participants |
| Home-based Testing Alone | Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | 1 Participants |
| Reminders for Clinic-based Testing | Number of Participants Who Reported Having Actually Received a Prescription for Pre-exposure Prophylaxis | 2 Participants |
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.
Time frame: Up to 28 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Enhanced Home-based Testing | Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | 8 Participants |
| Home-based Testing Alone | Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | 2 Participants |
| Reminders for Clinic-based Testing | Number of Participants Who Reported Having Been Referred for Pre-exposure Prophylaxis | 3 Participants |