HIV, HIV Infections, Sexually Transmitted Diseases
Conditions
Keywords
STD, STI, Sexual Behavior, Prevention, HIV seronegativity
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDVD 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
BEHAVIORALDVD 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
Sponsors
National Institute of Mental Health (NIMH)
University of Rochester
Brown University
Syracuse University
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD
Exclusion criteria
* Impaired mental status that would prevent participant from providing informed consent or participating meaningfully * Inability to understand English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Sexual Partners, 3 Months Post Intervention | Measured after 3 months | number of sexual partners in the past 3 months, assessed 3 months post intervention |
| Number of Sexual Partners, 6 Months Post Intervention | 6 months post intervention | number of sexual partners reported in the past 3 months, assessed 6 months post intervention. |
| Number of Sexual Partners, 9 Months Post Intervention | 9 months post intervention | number of sexual partners in the past 3 months, assessed 9 months post intervention |
| Number of Sexual Partners, 12 Months Post Intervention | 12 months post intervention | number of sexual partners in the past 3 months, assessed 12 months post intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexually Transmitted Infection Incidence | Measured throughout the 12 months post intervention | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 254 |
| 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 | 252 |
| 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 | 254 |
| 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 | 250 |
| Total | 1,010 |
Baseline characteristics
| Characteristic | Total | DVD 1 Plus Assessment 1 | DVD 1 Plus Assessment 2 | DVD 2 Plus Assessment 1 | DVD 2 Plus Assessment 2 |
|---|---|---|---|---|---|
| Age, Continuous | 28.5 years STANDARD_DEVIATION 9.5 | 27.9 years STANDARD_DEVIATION 8.9 | 29.3 years STANDARD_DEVIATION 9.7 | 28.0 years STANDARD_DEVIATION 9.2 | 28.9 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 82 Participants | 25 Participants | 16 Participants | 17 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 927 Participants | 229 Participants | 236 Participants | 237 Participants | 225 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 3 Participants | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 691 Participants | 168 Participants | 180 Participants | 177 Participants | 166 Participants |
| Race (NIH/OMB) More than one race | 72 Participants | 18 Participants | 14 Participants | 23 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 4 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 42 Participants | 16 Participants | 11 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) White | 189 Participants | 49 Participants | 43 Participants | 43 Participants | 54 Participants |
| Region of Enrollment United States | 1010 participants | 254 participants | 252 participants | 254 participants | 250 participants |
| Sex: Female, Male Female | 443 Participants | 107 Participants | 100 Participants | 129 Participants | 107 Participants |
| Sex: Female, Male Male | 567 Participants | 147 Participants | 152 Participants | 125 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 254 | 0 / 252 | 0 / 254 | 0 / 250 |
| serious Total, serious adverse events | 0 / 254 | 0 / 252 | 0 / 254 | 0 / 250 |
Outcome results
Primary
Number of Sexual Partners, 12 Months Post Intervention
number of sexual partners in the past 3 months, assessed 12 months post intervention
Time frame: 12 months post intervention
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DVD 1 Plus Assessment 1 | Number of Sexual Partners, 12 Months Post Intervention | 1.84 number of partners | Standard Error 0.1 |
| DVD 1 Plus Assessment 2 | Number of Sexual Partners, 12 Months Post Intervention | 1.78 number of partners | Standard Error 0.09 |
| DVD 2 Plus Assessment 1 | Number of Sexual Partners, 12 Months Post Intervention | 1.79 number of partners | Standard Error 0.09 |
| DVD 2 Plus Assessment 2 | Number of Sexual Partners, 12 Months Post Intervention | 1.90 number of partners | Standard Error 0.1 |
Primary
Number of Sexual Partners, 3 Months Post Intervention
number of sexual partners in the past 3 months, assessed 3 months post intervention
Time frame: Measured after 3 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DVD 1 Plus Assessment 1 | Number of Sexual Partners, 3 Months Post Intervention | 2.19 number of partners | Standard Error 0.13 |
| DVD 1 Plus Assessment 2 | Number of Sexual Partners, 3 Months Post Intervention | 2.04 number of partners | Standard Error 0.11 |
| DVD 2 Plus Assessment 1 | Number of Sexual Partners, 3 Months Post Intervention | 2.14 number of partners | Standard Error 0.1 |
| DVD 2 Plus Assessment 2 | Number of Sexual Partners, 3 Months Post Intervention | 2.13 number of partners | Standard Error 0.1 |
Primary
Number of Sexual Partners, 6 Months Post Intervention
number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Time frame: 6 months post intervention
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DVD 1 Plus Assessment 1 | Number of Sexual Partners, 6 Months Post Intervention | 1.92 number of partners | Standard Error 0.13 |
| DVD 1 Plus Assessment 2 | Number of Sexual Partners, 6 Months Post Intervention | 2.18 number of partners | Standard Error 0.13 |
| DVD 2 Plus Assessment 1 | Number of Sexual Partners, 6 Months Post Intervention | 2.18 number of partners | Standard Error 0.11 |
| DVD 2 Plus Assessment 2 | Number of Sexual Partners, 6 Months Post Intervention | 2.09 number of partners | Standard Error 0.13 |
Primary
Number of Sexual Partners, 9 Months Post Intervention
number of sexual partners in the past 3 months, assessed 9 months post intervention
Time frame: 9 months post intervention
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DVD 1 Plus Assessment 1 | Number of Sexual Partners, 9 Months Post Intervention | 1.98 number of partners | Standard Error 0.13 |
| DVD 1 Plus Assessment 2 | Number of Sexual Partners, 9 Months Post Intervention | 1.83 number of partners | Standard Error 0.1 |
| DVD 2 Plus Assessment 1 | Number of Sexual Partners, 9 Months Post Intervention | 2.11 number of partners | Standard Error 0.12 |
| DVD 2 Plus Assessment 2 | Number of Sexual Partners, 9 Months Post Intervention | 2.04 number of partners | Standard Error 0.13 |
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
Time frame: Measured throughout the 12 months post intervention
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DVD 1 Plus Assessment 1 | Sexually Transmitted Infection Incidence | 33 participants diagnosed with any STI |
| DVD 1 Plus Assessment 2 | Sexually Transmitted Infection Incidence | 36 participants diagnosed with any STI |
| DVD 2 Plus Assessment 1 | Sexually Transmitted Infection Incidence | 46 participants diagnosed with any STI |
| DVD 2 Plus Assessment 2 | Sexually Transmitted Infection Incidence | 36 participants diagnosed with any STI |