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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed study is a three-armed randomized clinical trial. A total of 750 clients will be randomly assigned (using a random number table) to the interviewer-administered intervention, the self-administered intervention, and waitlist control conditions upon completion of screening, informed consent, HIV pretest counseling and test administration, and collection of baseline risk behavior data. Outcomes will be measured at 3, 6 and 12 months.
The specific aims of the 5-year study are to:
identify the covariates of baseline substance abuse and sexual risks (including demographics, social risk measures, peer norms, abuse history, and mental health status) among a sample of 750 heterosexually active, not-in-treatment, club and prescription drug users ages 18 to 39 in Miami, Florida.
evaluate, through random assignment, the relative effectiveness of two intervention conditions and a waitlist control in reducing sex risks and drug use, as measured at 3-, 6- and 12-month follow-ups:
conduct qualitative process evaluation research with 40 participants in each study arm to contextualize the study findings and intervention outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAPI Intervention | Experimental | an interviewer-administered comprehensive health and social risk assessment intervention |
|
| ACASI Intervention | Experimental | self-administered comprehensive health and social risk assessment intervention |
|
| Control | No Intervention | waitlist control condition |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-theoretical Process of Change Model-self | Behavioral | self-administered, computer-based intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| unprotected sexual intercourse events outside of primary relationships | 3 months | |
| unprotected sexual intercourse events outside of primary relationship | 6 months | |
| unprotected sexual intercourse events outside of primary relationship | 12 months | |
| Days drug use in the past 90 days | 3 months | |
| Days drug use in the past 90 days | 6 months | |
| Days drug use in the past 90 days | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NSU Research Center | Miami | Florida | 33137 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Trans-theoretical Process of Change Model - interviewer | Behavioral | interviewer-administered intervention |
|
| D012749 | Sexually Transmitted Diseases |
| 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 |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D012897 | Slow Virus Diseases |