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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH068171-06 | U.S. NIH Grant/Contract | View source | |
| PCC: DAHBR 9A-ASPQ |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| University of Rochester | OTHER |
| Brown University | OTHER |
| Syracuse University |
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This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.
Sexually transmitted infections (STIs) can produce long-term health problems. They are often linked to HIV, which can also be sexually transmitted, because both occur in the same populations and because STIs and HIV interact biologically. Having an STI other than HIV can increase the risk of HIV acquisition and transmission as well as negatively impact HIV progression. The population of people who go to clinics specializing in STIs are particularly at risk of engaging in risky sexual behaviors and having poor health outcomes-like infection with an STI. This study will test the effectiveness of using an educational DVD to reduce incidence of risky sexual behaviors and STI acquisition, including risk of HIV, and to improve overall health.
Participation in this study will involve two phases. In Phase 1, participants will complete both computerized and paper surveys and watch an educational DVD. The educational DVD may include information on diet, physical activity, sleep, smoking, STIs, and stress. Participants will be recruited from among people who are already going to the clinic, and participation will add approximately 1.5 hours to their visits. In Phase 2, participants will be asked to complete four follow-up visits occurring 3, 6, 9, and 12 months after Phase 1. During these follow-up visits, participants will complete a 45-minute computerized survey similar to that in Phase 1 and provide urine and throat samples for STI testing. All surveys will assess health-related thoughts, feelings, and behaviors, including sexual behaviors. Participants will be compensated for completing Phase 1 and each visit in Phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVD 1 plus assessment 1 | Experimental | Participants will view educational DVD 1 and complete the first version of the study assessment. |
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| DVD 1 plus assessment 2 | Experimental | Participants will view educational DVD 1 and complete the second version of the study assessment. |
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| DVD 2 plus assessment 1 | Experimental | Participants will view educational DVD 2 and complete the first version of the study assessment. |
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| DVD 2 plus assessment 2 | Experimental | Participants will view educational DVD 2 and complete the second version of the study assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVD 1 | Behavioral | The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Sexual Partners, 3 Months Post Intervention | number of sexual partners in the past 3 months, assessed 3 months post intervention | Measured after 3 months |
| Number of Sexual Partners, 6 Months Post Intervention | number of sexual partners reported in the past 3 months, assessed 6 months post intervention. | 6 months post intervention |
| Number of Sexual Partners, 9 Months Post Intervention | number of sexual partners in the past 3 months, assessed 9 months post intervention | 9 months post intervention |
| Number of Sexual Partners, 12 Months Post Intervention | number of sexual partners in the past 3 months, assessed 12 months post intervention | 12 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Sexually Transmitted Infection Incidence | number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up | Measured throughout the 12 months post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P. Carey, Ph.D. | The Miriam Hospital and Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Monroe County Health Department | Rochester | New York | 14611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23816489 | Background | Carey MP, Senn TE, Coury-Doniger P, Urban MA, Vanable PA, Carey KB. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial. Contemp Clin Trials. 2013 Sep;36(1):135-46. doi: 10.1016/j.cct.2013.06.019. Epub 2013 Jun 29. | |
| 26310596 | Derived | Carey KB, Senn TE, Walsh JL, Scott-Sheldon LA, Carey MP. Alcohol Use Predicts Number of Sexual Partners for Female but not Male STI Clinic Patients. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S52-9. doi: 10.1007/s10461-015-1177-9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | DVD 1 Plus Assessment 1 | Participants will view educational DVD 1 and complete the first version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
| FG001 | DVD 1 Plus Assessment 2 | Participants will view educational DVD 1 and complete the second version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
| FG002 | DVD 2 Plus Assessment 1 | Participants will view educational DVD 2 and complete the first version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
| FG003 | DVD 2 Plus Assessment 2 | Participants will view educational DVD 2 and complete the second version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Months Post Intervention |
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| 6 Months Post Intervention |
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| 9 Months Post Intervention |
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| 12 Months Post Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | DVD 1 Plus Assessment 1 | Participants will view educational DVD 1 and complete the first version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Sexual Partners, 3 Months Post Intervention | number of sexual partners in the past 3 months, assessed 3 months post intervention | Posted | Least Squares Mean | Standard Error | number of partners | Measured after 3 months |
|
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DVD 1 Plus Assessment 1 | Participants will view educational DVD 1 and complete the first version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Carey | The Miriam Hospital | 401-793-8218 | michael_carey@brown.edu |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| D015658 | HIV Infections |
| D012725 | Sexual Behavior |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| OTHER |
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| DVD 2 | Behavioral | The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
|
| 25433653 | Derived | Carey MP, Senn TE, Walsh JL, Coury-Doniger P, Urban MA, Fortune T, Vanable PA, Carey KB. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial. AIDS Behav. 2015 Jul;19(7):1228-46. doi: 10.1007/s10461-014-0960-3. |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| DVD 1 Plus Assessment 2 |
Participants will view educational DVD 1 and complete the second version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health |
| BG002 | DVD 2 Plus Assessment 1 | Participants will view educational DVD 2 and complete the first version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
| BG003 | DVD 2 Plus Assessment 2 | Participants will view educational DVD 2 and complete the second version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG002 | DVD 2 Plus Assessment 1 | Participants will view educational DVD 2 and complete the first version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
| OG003 | DVD 2 Plus Assessment 2 | Participants will view educational DVD 2 and complete the second version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health |
|
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| Secondary | Sexually Transmitted Infection Incidence | number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up | Participants who provided a urine sample for STI testing at any study follow up (3, 6, 9, or 12 months) OR who had STI testing performed at the STI clinic during the 12 months post intervention were included in these analyses | Posted | Number | participants diagnosed with any STI | Measured throughout the 12 months post intervention |
|
|
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| Primary | Number of Sexual Partners, 6 Months Post Intervention | number of sexual partners reported in the past 3 months, assessed 6 months post intervention. | Posted | Least Squares Mean | Standard Error | number of partners | 6 months post intervention |
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|
|
| Primary | Number of Sexual Partners, 9 Months Post Intervention | number of sexual partners in the past 3 months, assessed 9 months post intervention | Posted | Least Squares Mean | Standard Error | number of partners | 9 months post intervention |
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|
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| Primary | Number of Sexual Partners, 12 Months Post Intervention | number of sexual partners in the past 3 months, assessed 12 months post intervention | Posted | Least Squares Mean | Standard Error | number of partners | 12 months post intervention |
|
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|
| 0 |
| 254 |
| 0 |
| 254 |
| EG001 | DVD 1 Plus Assessment 2 | Participants will view educational DVD 1 and complete the second version of the study assessment. DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health | 0 | 252 | 0 | 252 |
| EG002 | DVD 2 Plus Assessment 1 | Participants will view educational DVD 2 and complete the first version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health | 0 | 254 | 0 | 254 |
| EG003 | DVD 2 Plus Assessment 2 | Participants will view educational DVD 2 and complete the second version of the study assessment. DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health | 0 | 250 | 0 | 250 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D001519 | Behavior |