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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH086360 | U.S. NIH Grant/Contract | View source | |
| NIMH86360-1 |
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| Name | Class |
|---|---|
| Public Health - Seattle and King County | OTHER_GOV |
| National Institute of Mental Health (NIMH) | NIH |
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The purpose of this study is to determine whether the availability of home self-testing for HIV will increase HIV testing frequency among men who have sex with men without negatively impacting their risk for HIV acquisition.
HIV counseling and testing remains one of the most effective HIV prevention interventions because many individuals newly diagnosed with HIV infection will alter their behaviors to reduce the risk of HIV transmission to others. In the U.S., men who have sex with men (MSM) represent the group with the greatest risk for HIV acquisition despite a high penetrance of testing, in part because their frequent exposures and infrequent testing can result in long intervals between HIV acquisition and diagnosis. Efforts to prevent HIV transmission among MSM must therefore increase the frequency of HIV testing and thereby decrease the time interval that infected individuals are unaware of their status and their potential for transmission. Home self-testing for HIV may increase the frequency of HIV testing, but there are concerns that it may also have negative consequences, including decreased access to risk reduction counseling.
We will randomize 246 MSM at high risk of HIV acquisition either to have access to home self-testing for HIV using the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test or to standard, clinic-based HIV testing for 15 months to determine the effects of home self-testing availability on HIV testing frequency and markers of risk for HIV acquisition and to assess the acceptability and ease of use of home self-testing. After screening to determine eligibility, study visits will occur at baseline and at 15 months. Both visits will include HIV/STD screening and surveys regarding HIV testing and risk behaviors. During follow-up, participants will be asked to complete brief online surveys after testing for HIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Testing | Experimental |
| |
| Standard Testing | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test | Behavioral | Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Testing Frequency | Number of HIV tests during follow-up reported by participants at end-of-study visit | 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | From 6 to 9 months and 12 to 15 months of follow-up | |
| Bacterial Sexually Transmitted Infections | Includes syphilis, gonorrhea, and chlamydial infection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne D Stekler, MD, MPH | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Public Health - Seattle & King County STD Clinic, located at Harborview Medical Center | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29697595 | Derived | Katz DA, Golden MR, Hughes JP, Farquhar C, Stekler JD. HIV Self-Testing Increases HIV Testing Frequency in High-Risk Men Who Have Sex With Men: A Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):505-512. doi: 10.1097/QAI.0000000000001709. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Home Testing | Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test | Device | The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV. |
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| Assessed at 15 months |
| Number of Male Condomless Anal Intercourse Partners in Last 3 Months | From 6 to 9 and 12 to 15 months |
| FG001 | Standard Testing | HIV testing as usual. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Home Testing | Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. |
| BG001 | Standard Testing | HIV testing as usual. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Sex at birth | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Living Situation | Count of Participants | Participants |
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| Number of HIV tests in last year | Median | Inter-Quartile Range | HIV tests |
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| Currently tests for HIV on regular basis | Count of Participants | Participants |
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| Ever used a home HIV test | Count of Participants | Participants |
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| Gender of sex partners in last 3 months | Count of Participants | Participants |
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| Number of male sex partners in last 3 months | Median | Inter-Quartile Range | partners |
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| Number of male condomless anal intercourse partners in last 3 months | Median | Inter-Quartile Range | partners |
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| Any condomless anal intercourse with an HIV-discordant partner in last 3 months | Count of Participants | Participants |
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| Methamphetamine use in last 3 months | Count of Participants | Participants |
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| Inhaled nitrite use in last 3 months | Count of Participants | Participants |
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| Diagnosis of bacterial sexually transmitted infection at enrollment visit | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | HIV Testing Frequency | Number of HIV tests during follow-up reported by participants at end-of-study visit | Posted | Mean | 95% Confidence Interval | HIV tests | 15 months |
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| Secondary | Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding non-concordant condomless anal intercourse in the last 3 months were included in this analysis for each time point. | Posted | Count of Participants | Participants | From 6 to 9 months and 12 to 15 months of follow-up |
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| Secondary | Bacterial Sexually Transmitted Infections | Includes syphilis, gonorrhea, and chlamydial infection | Includes only participants who received screening for sexually transmitted infections at the end-of-study visit. | Posted | Count of Participants | Participants | Assessed at 15 months |
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| Secondary | Number of Male Condomless Anal Intercourse Partners in Last 3 Months | Included "Overall Number of Participants Analyzed" as number who completed follow-up. However, only participants who responded to the question regarding condomless anal intercourse partners in the last 3 months were included in this analysis for each time point. | Posted | Mean | Standard Error | number of partners | From 6 to 9 and 12 to 15 months |
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During study follow up (approximately 15 months)
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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 | Home Testing | Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up. Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV. | 0 | 116 | 0 | 116 | ||
| EG001 | Standard Testing | HIV testing as usual. | 0 | 114 | 0 | 114 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Katz | University of Washington | 206-744-5877 | dkatz7@u.washington.edu |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D004194 | Disease |
| D018451 | Homosexuality, Male |
| D012749 | Sexually Transmitted Diseases |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006716 | Homosexuality |
| D019529 | Sexuality |
| D001519 | Behavior |
| D020969 | Disease Attributes |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Some college, Associate's, or technical training |
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| Bachelor's degree or more |
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| Unknown or not reported |
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| With a sex partner, lover, or spouse |
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| With friends or roommates |
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| With parents, guardians, or other relatives |
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| In school or university dormitories |
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| No regular place to stay, couch surfing, homeless |
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| Unknown or not reported |
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| No |
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| Unknown or not reported |
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| No |
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| Unknown or not reported |
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| Women |
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| Both men and women |
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| Unknown or not reported |
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| No |
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| Unknown or not reported |
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| No |
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| Unknown or not reported |
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| No |
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| No |
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