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| ID | Type | Description | Link |
|---|---|---|---|
| U10DA013720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of California, San Francisco | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIV rapid test & counseling | Experimental | Participants will be offered an oral fluid HIV rapid test (via oral swab) and brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach (Project RESPECT-2 counseling). Prior to receiving testing, study participants must first provide consent for HIV testing. Consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test. |
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| HIV rapid test and info | Experimental | Participants will be offered an oral fluid HIV rapid test (via oral swab). Prior to receiving testing, study participants must first provide consent for HIV testing. Again, consent for testing will be obtained through a second consent form required of all participants who wish to proceed with the HIV test. Participants will receive rapid HIV testing and test results after signing the consent to be tested. In both Groups 1 and 2, participants who test reactive (preliminary positive) will be counseled on the sexual risk behaviors associated with transmission of HIV and the acquisition of STDs, as is current clinical practice with those testing HIV positive. Confirmed positives will be linked to HIV primary care. |
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| HIV testing referral | Active Comparator | Participants randomized to group 3 will receive a referral list for HIV community-testing agencies. Each CTP site will have previously prepared an extensive referral list of testing sites in the surrounding geographic area. By virtue of their status as patients in the CTPs, they will receive whatever HIV testing and HIV education referrals the CTPs normally provide to their patients. This is the standard of care at CTPs that do not provide on-site testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| On-site HIV rapid test and brief, prevention counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month post-randomization |
| 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). | Six months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| Self-Report of Ever Having Been Tested |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Metsch, Ph.D. | Columbia University | Principal Investigator |
| Grant Colfax, M.D. | PATH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Frontera Center, Inc. | Tucson | Arizona | 85713 | United States | ||
| Midwestern Connecticut Council on Alcoholism |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22515871 | Result | Metsch LR, Feaster DJ, Gooden L, Matheson T, Mandler RN, Haynes L, Tross S, Kyle T, Gallup D, Kosinski AS, Douaihy A, Schackman BR, Das M, Lindblad R, Erickson S, Korthuis PT, Martino S, Sorensen JL, Szapocznik J, Walensky R, Branson B, Colfax GN. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health. 2012 Jun;102(6):1160-7. doi: 10.2105/AJPH.2011.300460. Epub 2012 Apr 19. | |
| 22971593 |
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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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | HIV Testing Referral | Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. |
| FG001 | HIV Rapid Test & Counseling |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 1 Month Follow-up |
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| On- site HIV rapid test & information | Behavioral | Participants will be offered an on-site oral fluid HIV rapid test with basic info. |
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| Referral for off-site HIV testing | Behavioral | Participants will be offered a referral list of HIV testing agencies in the community. |
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The HIV testing secondary outcomes are all binary (Yes/No). The below data represents self-reported completion of HIV test by 1 month. |
| 1 month post-randomization |
| Danbury |
| Connecticut |
| 06818 |
| United States |
| Wheeler Clinic | Plainville | Connecticut | 06062 | United States |
| Glenwood Life Counseling Center | Baltimore | Maryland | 21212 | United States |
| Gibson Recover Centers | Cape Girardeau | Missouri | 63703 | United States |
| The Life Link | Santa Fe | New Mexico | 87505 | United States |
| Daymark Recovery Services, Inc. | Salisbury | North Carolina | 28146 | United States |
| CODA | Portland | Oregon | 97214 | United States |
| Addiction Medicine Services (Western Psychiatric Institute) | Pittsburgh | Pennsylvania | 15213 | United States |
| Morris Village Alcohol and Drug Treatment Center | Columbia | South Carolina | 29203 | United States |
| Lexington / Richland Alcohol and Drug Abuse Council | Columbia | South Carolina | 29250 | United States |
| Chesterfield CSB Substance Abuse Service | Chesterfield | Virginia | 23832 | United States |
| Schackman BR, Metsch LR, Colfax GN, Leff JA, Wong A, Scott CA, Feaster DJ, Gooden L, Matheson T, Haynes LF, Paltiel AD, Walensky RP. The cost-effectiveness of rapid HIV testing in substance abuse treatment: results of a randomized trial. Drug Alcohol Depend. 2013 Feb 1;128(1-2):90-7. doi: 10.1016/j.drugalcdep.2012.08.009. Epub 2012 Sep 9. |
| 25291977 | Derived | Schackman BR, Leff JA, Barter DM, DiLorenzo MA, Feaster DJ, Metsch LR, Freedberg KA, Linas BP. Cost-effectiveness of rapid hepatitis C virus (HCV) testing and simultaneous rapid HCV and HIV testing in substance abuse treatment programs. Addiction. 2015 Jan;110(1):129-43. doi: 10.1111/add.12754. |
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.
| FG002 | 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. |
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| NOT COMPLETED |
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| 6 Month Follow-up |
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Participants were recruited from 12 community-based drug treatment programs. The Baseline Analysis Population represents the 1281 participants who completed baseline and were subsequently randomized.
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| ID | Title | Description |
|---|---|---|
| BG000 | HIV Testing Referral | Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | 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 | 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. | 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 | Posted | Number | participants | One month post-randomization |
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| 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). | 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. | Posted | Mean | Standard Deviation | number of unprotected sex acts | Six months post-randomization |
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| 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. | Posted | Number | n of people changing needle sharing | Six months |
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| 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. | 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 | Posted | Number | participants | 1 month post-randomization |
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AE will be reported within 7 days of the site becoming aware of the event. 24 hr expedited reporting is required for reportable serious adverse events. Lead investigators and the NIDA assigned Safety Monitor will be notified within 24 hours.
Research staff will use a standard checklist to document adverse events at each research visit following randomization. This information will be collected and documented in the study database via CRF.
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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) |
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| EG000 | HIV Testing Referral | Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community. | 2 | 429 | 0 | 429 | ||
| EG001 | 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. | 2 | 433 | 0 | 433 | ||
| EG002 | 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. | 2 | 419 | 0 | 419 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Myocardial infarction | Cardiac disorders | Systematic Assessment |
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| Overdose | General disorders | Systematic Assessment |
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| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Death | General disorders | Systematic Assessment | unknown cause; "general disorders" selected as default |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Metsch | Columbia University, Mailman School of Public Health | 212-305-3577 | lm2892@columbia.edu |
| ID | Term |
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| D019966 | Substance-Related Disorders |
| ID | Term |
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| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| Incarcerated |
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| Withdrew consent |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| White |
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| American Indian/Alaskan Native |
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| Mixed race |
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| Other |
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| Hispanic |
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