Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
HIV Prevention for STD Clinic Patients
2 other identifiers
interventional
1,010
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hiv
Started Oct 2009
Longer than P75 for phase_3 hiv
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
September 17, 2014
CompletedSeptember 17, 2014
September 1, 2014
4.7 years
July 27, 2009
August 25, 2014
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Secondary Outcomes (1)
Sexually Transmitted Infection Incidence
Measured throughout the 12 months post intervention
Study Arms (4)
DVD 1 plus assessment 1
EXPERIMENTALParticipants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1 plus assessment 2
EXPERIMENTALParticipants will view educational DVD 1 and complete the second version of the study assessment.
DVD 2 plus assessment 1
EXPERIMENTALParticipants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2 plus assessment 2
EXPERIMENTALParticipants will view educational DVD 2 and complete the second version of the study assessment.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Impaired mental status that would prevent participant from providing informed consent or participating meaningfully
- Inability to understand English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Miriam Hospitallead
- National Institute of Mental Health (NIMH)collaborator
- University of Rochestercollaborator
- Brown Universitycollaborator
- Syracuse Universitycollaborator
Study Sites (1)
Monroe County Health Department
Rochester, New York, 14611, United States
Related Publications (3)
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.
PMID: 23816489BACKGROUNDCarey 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.
PMID: 26310596DERIVEDCarey 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.
PMID: 25433653DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael Carey
- Organization
- The Miriam Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Michael P. Carey, Ph.D.
The Miriam Hospital and Brown University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Centers for Behavioral and Preventive Medicine
Study Record Dates
First Submitted
July 27, 2009
First Posted
July 28, 2009
Study Start
October 1, 2009
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
September 17, 2014
Results First Posted
September 17, 2014
Record last verified: 2014-09