Substance-Related Disorders
Conditions
Brief summary
This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.
Detailed description
This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.
Interventions
BEHAVIORALOn-site HIV rapid test and brief, prevention counseling
Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
BEHAVIORALOn- site HIV rapid test & information
Participants will be offered an on-site oral fluid HIV rapid test with basic info.
BEHAVIORALReferral for off-site HIV testing
Participants will be offered a referral list of HIV testing agencies in the community.
Sponsors
National Institute on Drug Abuse (NIDA)
University of California, San Francisco
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * HIV-negative or HIV status unknown * No receipt of results from HIV test initiated within last 12 months * Be able to communicate in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-Report Receipt of HIV Test Results | One month post-randomization | The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test. |
| Number of Risky Sexual Behaviors | Six months post-randomization | The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sharing of Needles Used in Drug Use | Six months | Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed. |
| Self-Report of Ever Having Been Tested | 1 month post-randomization | The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month. |
Countries
United States
Participant flow
Recruitment details
Adults receiving drug abuse treatment in drug treatment clinics were recruited, screened for eligibility, and randomized from Jan - May 2009 into 1 of 3 arms: 1) on-site HIV rapid testing with counseling; 2) on-site HIV rapid testing with information only; and 3) referral for off-site HIV testing. Participants were then followed at 1 and 6 months.
Pre-assignment details
2473 patients were assessed for eligibility. Of these, 1313 were eligible and 1281 were randomized; 32 screened eligible, but were not randomized due to: failure to return to the study (n=30), lying about HIV status (n=1) and completing the baseline after the enrollment period closed (n=1).
Participants by arm
| Arm | Count |
|---|---|
| HIV Testing Referral Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. | 429 |
| HIV Rapid Test & Counseling On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach. | 433 |
| HIV Rapid Test and Info On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info. | 419 |
| Total | 1,281 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1 Month Follow-up | Death | 0 | 1 | 1 |
| 1 Month Follow-up | Incarcerated | 0 | 0 | 1 |
| 1 Month Follow-up | Lost contact | 1 | 2 | 1 |
| 1 Month Follow-up | Withdrew consent | 1 | 1 | 1 |
| 6 Month Follow-up | Death | 2 | 1 | 1 |
| 6 Month Follow-up | Incarcerated | 6 | 8 | 8 |
| 6 Month Follow-up | Lost contact | 16 | 14 | 14 |
| 6 Month Follow-up | Withdrew consent | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | HIV Rapid Test & Counseling | HIV Rapid Test and Info | Total | HIV Testing Referral |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 10 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 429 Participants | 415 Participants | 1269 Participants | 425 Participants |
| Age, Continuous | 39.62 years STANDARD_DEVIATION 11.19 | 39.56 years STANDARD_DEVIATION 11.77 | 40.00 years STANDARD_DEVIATION 11.35 | 40.81 years STANDARD_DEVIATION 10.76 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 13 participants | 11 participants | 33 participants | 9 participants |
| Race/Ethnicity, Customized Black or African American | 88 participants | 86 participants | 263 participants | 89 participants |
| Race/Ethnicity, Customized Hispanic | 49 participants | 47 participants | 147 participants | 51 participants |
| Race/Ethnicity, Customized Mixed race | 34 participants | 30 participants | 98 participants | 34 participants |
| Race/Ethnicity, Customized Other | 21 participants | 21 participants | 61 participants | 19 participants |
| Race/Ethnicity, Customized White | 277 participants | 271 participants | 826 participants | 278 participants |
| Region of Enrollment United States | 433 participants | 419 participants | 1281 participants | 429 participants |
| Sex: Female, Male Female | 170 Participants | 160 Participants | 503 Participants | 173 Participants |
| Sex: Female, Male Male | 263 Participants | 259 Participants | 778 Participants | 256 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 429 | 0 / 433 | 0 / 419 |
| serious Total, serious adverse events | 2 / 429 | 2 / 433 | 2 / 419 |
Outcome results
Primary
Number of Risky Sexual Behaviors
The sexual risk behavior primary outcome is self-reported sexual risk behavior, which will be measured at baseline and six months post-randomization as the self-reported number of unprotected sex acts (vaginal or anal sex without a condom).
Time frame: Six months post-randomization
Population: All randomized participants who provided self-report of number of unprotected sex acts (vaginal or anal sex without a condom) at six-month follow-up are included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HIV Testing Referral | Number of Risky Sexual Behaviors | 20.5 number of unprotected sex acts | Standard Deviation 49.8 |
| HIV Rapid Test & Counseling | Number of Risky Sexual Behaviors | 21.3 number of unprotected sex acts | Standard Deviation 47.6 |
| HIV Rapid Test and Info | Number of Risky Sexual Behaviors | 21.3 number of unprotected sex acts | Standard Deviation 44.8 |
Comparison: Hypothesis: The HIV rapid testing arms would have a lower rate of unprotected sexual episodes than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.p-value: 0.3997.5% CI: [0.95, 1.14]generalized estimating equations (GEE)
Comparison: The data analysis information presented is for the comparison of the 2 on-site testing groups.~Hypothesis: HIV rapid test and counseling group will have fewer unprotected sexual acts than will HIV rapid test and info groupp-value: 0.8197.5% CI: [0.84, 1.26]Generalized estimating equations (GEE)
Primary
Self-Report Receipt of HIV Test Results
The HIV testing primary outcome is self-reported receipt of HIV test results. This will be measured at one month post-randomization for all participants. We recognize that there are three potential HIV testing behaviors that could be evaluated in this study: acceptance of HIV testing, completion of HIV testing, and receipt of HIV testing results. Acceptance of testing refers to whether or not a participant would accept the offer of an HIV test. Completion of testing refers to whether or not a participant completes the HIV test. Receipt of HIV test results refers to whether or not a participant self-reports having received the results of the HIV test.
Time frame: One month post-randomization
Population: All randomized participants who provided self-report of either receipt or non-receipt of testing results at one month follow-up are included. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Testing Referral | Self-Report Receipt of HIV Test Results | 78 participants |
| HIV Rapid Test & Counseling | Self-Report Receipt of HIV Test Results | 338 participants |
| HIV Rapid Test and Info | Self-Report Receipt of HIV Test Results | 347 participants |
Comparison: Hypothesis: The HIV rapid testing arms would have a higher rate of HIV testing than the HIV testing referral arm. Thus there is one comparison: HIV rapid test \& counseling+HIV rapid test and info versus HIV testing referral.p-value: <0.00197.5% CI: [3.57, 5.72]Cochran-Mantel-Haenszel
Secondary
Self-Report of Ever Having Been Tested
The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month.
Time frame: 1 month post-randomization
Population: Number reporting having taken an HIV test, whether they received results or not, at one month follow-up. Note that 3, 5, and 6 participants who completed a one-month follow-up did not provide this self-report in HIV testing referral, HIV rapid test and counseling, and HIV rapid test and info, respectively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HIV Testing Referral | Self-Report of Ever Having Been Tested | 103 participants |
| HIV Rapid Test & Counseling | Self-Report of Ever Having Been Tested | 344 participants |
| HIV Rapid Test and Info | Self-Report of Ever Having Been Tested | 352 participants |
p-value: <0.0001Chi-squared
Secondary
Sharing of Needles Used in Drug Use
Change in sharing of needles. The number of individuals reporting needle sharing at baseline and 6-month follow-up were measured and the change in sharing of needles assessed.
Time frame: Six months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HIV Testing Referral | Sharing of Needles Used in Drug Use | Number initiating sharing | 2 n of people changing needle sharing |
| HIV Testing Referral | Sharing of Needles Used in Drug Use | Number discontinuing sharing | 17 n of people changing needle sharing |
| HIV Rapid Test & Counseling | Sharing of Needles Used in Drug Use | Number initiating sharing | 1 n of people changing needle sharing |
| HIV Rapid Test & Counseling | Sharing of Needles Used in Drug Use | Number discontinuing sharing | 32 n of people changing needle sharing |
| HIV Rapid Test and Info | Sharing of Needles Used in Drug Use | Number discontinuing sharing | 24 n of people changing needle sharing |
| HIV Rapid Test and Info | Sharing of Needles Used in Drug Use | Number initiating sharing | 6 n of people changing needle sharing |
p-value: 0.044Chi-squared