Clinical trial NCT00947271: Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
Official title: HIV Prevention for STD Clinic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV
Sexually Transmitted Diseases
HIV Infections
Keywords: STD
STI
Sexual Behavior
Prevention
HIV seronegativity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Rochester
name: Brown University
name: Syracuse University
First posted: 2009-07-28
Enrollment: 1010
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Sexual Partners, 3 Months Post Intervention
timeFrame: Measured after 3 months
measure: Number of Sexual Partners, 6 Months Post Intervention
timeFrame: 6 months post intervention
measure: Number of Sexual Partners, 9 Months Post Intervention
timeFrame: 9 months post intervention
measure: Number of Sexual Partners, 12 Months Post Intervention
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Sexually Transmitted Infection Incidence
timeFrame: Measured throughout the 12 months post intervention
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Monroe County Health Department
state: New York
Study officials:
affiliation: The Miriam Hospital and Brown University
name: Michael P. Carey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.