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| ID | Type | Description | Link |
|---|---|---|---|
| DAHBR 9A-ASPG | Other Identifier | National Institute of Mental Health (NIMH-DAHBR) | |
| R01MH068746 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management in promoting safer sex practices in HIV-infected men.
In recent years, the spread of HIV and other STDs has increased, especially among men who have sex with men. This increase signifies continued sexual risk taking within this population. In order to curb the increase of HIV infections, prevention programs are needed. A standard prevention case management program has been developed; however, new programs that further improve outcomes are needed. This study will evaluate the effectiveness of a behavioral intervention program versus standard prevention case management (PCM) in promoting safer sex practices in HIV-infected men.
Participants in this 1-year open-label study will be randomly assigned to receive either PCM alone or a behavioral intervention called Project Enhance, in addition to PCM. The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. PCM will entail standard case management, as well as referrals to specific services that each individual may need. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Project Enhance | Experimental | Participants will receive the risk reduction program, Project Enhance |
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| Active Comparison Condition | Active Comparator | Participants will receive standard prevention case management |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Enhance | Behavioral | The behavioral intervention will be administered by a trained medical social worker on an individual basis. It will include an education component, as well as motivational and behavioral skills enhancement. Treatment will occur for only the first 3 months, after which follow-up sessions will be held every 3 months for the remainder of the year. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in rates of unprotected anal intercourse from baseline to 12-month follow-up | Measured at Months 3, 6, 9, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of sexually transmitted diseases | Measured at Months 3, 6, 9, and 12 | |
| Higher risk-reduction self-efficacy | Measured at Months 3, 6, 9, and 12 | |
| Increased behavioral intentions to engage in safer behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Mayer, MD | Fenway Community Health and Brown University | Principal Investigator |
| Steven Safren, PhD | Fenway Community Health and Harvard Medical School | Principal Investigator |
| Conall O'Cleirigh, PhD | Fenway Community Health and Massachusetts General Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Community Health | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| Standard prevention case management (PCM) | Behavioral | Participants will receive standard PCM for HIV prevention. |
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| Measured at Months 3, 6, 9, and 12 |
| Increased risk-reduction strategies (other than condom use) | Measured at Months 3, 6, 9, and 12 |
| 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 |