HIV
Conditions
Keywords
HIV, Home testing, Self-testing, HIV Infections/diagnosis, HIV Infections/prevention and control, AIDS Serodiagnosis, Oral fluids, Homosexuality, Male, Sexually transmitted diseases, Sexual behavior
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHome 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.
Sponsors
Public Health - Seattle and King County
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male * Age ≥18 * Has sex with men * HIV-negative * Meets PHSKC HIV/STD Program definition of high risk * Plans to live in Seattle for the next 15 months
Exclusion criteria
* Unable to safely and confidentially receive or store a home testing kit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HIV Testing Frequency | 15 months | Number of HIV tests during follow-up reported by participants at end-of-study visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed at 15 months | Includes syphilis, gonorrhea, and chlamydial infection |
| Number of Male Condomless Anal Intercourse Partners in Last 3 Months | From 6 to 9 and 12 to 15 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 116 |
| Standard Testing HIV testing as usual. | 114 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 18 | 14 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | Home Testing | Standard Testing |
|---|---|---|---|
| Age, Continuous | 36 years | 35.5 years | 37.5 years |
| Any condomless anal intercourse with an HIV-discordant partner in last 3 months No | 144 Participants | 70 Participants | 74 Participants |
| Any condomless anal intercourse with an HIV-discordant partner in last 3 months Unknown or not reported | 15 Participants | 9 Participants | 6 Participants |
| Any condomless anal intercourse with an HIV-discordant partner in last 3 months Yes | 71 Participants | 37 Participants | 34 Participants |
| Currently tests for HIV on regular basis No | 89 Participants | 50 Participants | 39 Participants |
| Currently tests for HIV on regular basis Unknown or not reported | 2 Participants | 0 Participants | 2 Participants |
| Currently tests for HIV on regular basis Yes | 139 Participants | 66 Participants | 73 Participants |
| Diagnosis of bacterial sexually transmitted infection at enrollment visit No | 202 Participants | 107 Participants | 95 Participants |
| Diagnosis of bacterial sexually transmitted infection at enrollment visit Yes | 28 Participants | 9 Participants | 19 Participants |
| Education Bachelor's degree or more | 122 Participants | 57 Participants | 65 Participants |
| Education High school or less | 28 Participants | 14 Participants | 14 Participants |
| Education Some college, Associate's, or technical training | 76 Participants | 44 Participants | 32 Participants |
| Education Unknown or not reported | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 21 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 192 Participants | 93 Participants | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 2 Participants | 2 Participants |
| Ever used a home HIV test No | 217 Participants | 113 Participants | 104 Participants |
| Ever used a home HIV test Unknown or not reported | 1 Participants | 1 Participants | 0 Participants |
| Ever used a home HIV test Yes | 12 Participants | 2 Participants | 10 Participants |
| Gender of sex partners in last 3 months Both men and women | 14 Participants | 8 Participants | 6 Participants |
| Gender of sex partners in last 3 months Men | 214 Participants | 107 Participants | 107 Participants |
| Gender of sex partners in last 3 months Unknown or not reported | 1 Participants | 0 Participants | 1 Participants |
| Gender of sex partners in last 3 months Women | 1 Participants | 1 Participants | 0 Participants |
| Inhaled nitrite use in last 3 months No | 156 Participants | 77 Participants | 79 Participants |
| Inhaled nitrite use in last 3 months Yes | 74 Participants | 39 Participants | 35 Participants |
| Living Situation Alone in a house or apartment | 87 Participants | 40 Participants | 47 Participants |
| Living Situation In school or university dormitories | 1 Participants | 1 Participants | 0 Participants |
| Living Situation No regular place to stay, couch surfing, homeless | 13 Participants | 8 Participants | 5 Participants |
| Living Situation Unknown or not reported | 2 Participants | 1 Participants | 1 Participants |
| Living Situation With a sex partner, lover, or spouse | 34 Participants | 16 Participants | 18 Participants |
| Living Situation With friends or roommates | 77 Participants | 46 Participants | 31 Participants |
| Living Situation With parents, guardians, or other relatives | 16 Participants | 4 Participants | 12 Participants |
| Methamphetamine use in last 3 months No | 206 Participants | 103 Participants | 103 Participants |
| Methamphetamine use in last 3 months Unknown or not reported | 2 Participants | 1 Participants | 1 Participants |
| Methamphetamine use in last 3 months Yes | 22 Participants | 12 Participants | 10 Participants |
| Number of HIV tests in last year | 2 HIV tests | 2 HIV tests | 2.5 HIV tests |
| Number of male condomless anal intercourse partners in last 3 months | 1 partners | 1 partners | 1 partners |
| Number of male sex partners in last 3 months | 5 partners | 5 partners | 5.5 partners |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 11 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 18 Participants | 7 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) White | 169 Participants | 90 Participants | 79 Participants |
| Region of Enrollment United States | 230 participants | 116 participants | 114 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 230 Participants | 116 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 116 | 0 / 114 |
| serious Total, serious adverse events | 0 / 116 | 0 / 114 |
Outcome results
Primary
HIV Testing Frequency
Number of HIV tests during follow-up reported by participants at end-of-study visit
Time frame: 15 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Home Testing | HIV Testing Frequency | 5.3 HIV tests |
| Standard Testing | HIV Testing Frequency | 3.6 HIV tests |
p-value: <0.0001t-test, 2 sided
Secondary
Bacterial Sexually Transmitted Infections
Includes syphilis, gonorrhea, and chlamydial infection
Time frame: Assessed at 15 months
Population: Includes only participants who received screening for sexually transmitted infections at the end-of-study visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Home Testing | Bacterial Sexually Transmitted Infections | 5 Participants |
| Standard Testing | Bacterial Sexually Transmitted Infections | 11 Participants |
95% CI: [-0.16, 0.016]
Secondary
Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months
Time frame: From 6 to 9 months and 12 to 15 months of follow-up
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Home Testing | Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | Measured at 9 months | 16 Participants |
| Home Testing | Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | Measured at end of study (15 months) | 26 Participants |
| Standard Testing | Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | Measured at 9 months | 17 Participants |
| Standard Testing | Condomless Anal Intercourse With HIV-positive or Unknown Status Partner in Last 3 Months | Measured at end of study (15 months) | 23 Participants |
95% CI: [0.61, 1.9]Regression, Logistic
Secondary
Number of Male Condomless Anal Intercourse Partners in Last 3 Months
Time frame: From 6 to 9 and 12 to 15 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Home Testing | Number of Male Condomless Anal Intercourse Partners in Last 3 Months | Measured at 9 months | 1.375 number of partners | Standard Error 0.207 |
| Home Testing | Number of Male Condomless Anal Intercourse Partners in Last 3 Months | Measured at end of study (15 months) | 2.337 number of partners | Standard Error 0.355 |
| Standard Testing | Number of Male Condomless Anal Intercourse Partners in Last 3 Months | Measured at 9 months | 2.050 number of partners | Standard Error 0.313 |
| Standard Testing | Number of Male Condomless Anal Intercourse Partners in Last 3 Months | Measured at end of study (15 months) | 2.141 number of partners | Standard Error 0.314 |
95% CI: [0.64, 1.33]Poisson regression