HIV Prevention in the Primary Care Setting
Primary Purpose
Human Immunodeficiency Virus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increase condom use
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus focused on measuring human immunodeficiency virus, behavior change
Eligibility Criteria
Inclusion Criteria:
- Active male patients over the age of 16 receiving routine primary care at the 1917 Clinic, reporting sexual contact with another man in the previous 6 months. Active patients will be defined as new patients (patients' first visit) with plans to continue follow-up at 1917 Clinic or an established patient seen at least once during the past year
- Willingness to follow-up for at least 18 months
- Ability to sign informed consent.
Exclusion Criteria:
- Female patient
- Male patient who is unwilling to follow-up for at least 18 months
- Male patient who is not a primary care patient at the clinic
- Unwillingness or inability to sign informed consent.
Sites / Locations
- UAB 1917 Clinic
Outcomes
Primary Outcome Measures
Proportion of participants reporting 100% condom use preintervention versus post intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT00381524
First Posted
September 26, 2006
Last Updated
June 8, 2017
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00381524
Brief Title
HIV Prevention in the Primary Care Setting
Official Title
Special Projects of National Significance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
5. Study Description
Brief Summary
In the third decade of the HIV pandemic, what was once a uniformly and rapidly fatal disease has been transformed into a chronic illness by advances in the understanding of HIV pathogenesis and therapeutics. As a result, HIV-infected individuals are living longer and better lives. This phenomenon, coupled with a continued steady rate of new HIV infections in this country, has led to the highest U.S. HIV prevalence rates since the beginning of the epidemic. In the past, HIV prevention efforts were separate from routine primary care delivery due to multiple factors including stigma and time constraints. Recent events, including increases in sexually transmitted disease (STD) rates among HIV-infected persons and evidence that infected individuals can be super-infected by HIV strains resistant to antiretroviral therapy, have inspired the SPNS program initiative to develop demonstration projects for interventions to reduce risky sexual exposures among HIV-infected patients receiving primary care.
Detailed Description
Goals of the Demonstration Project. The goals of this project are as follows:
Goal 1: To utilize recent technological advances and refine a theory-based, computerized intervention system currently being evaluated in a Birmingham STD clinic. Our proposed interventions will target men-who-have-sex-with-men (MSM) and will be designed to: increase condom use for specific sexual activities with both main and casual (other) partners; decrease numbers of sexual partners among those reporting multiple partners; and increase the frequency of HIV serostatus disclosure to sexual partners.
Goal 2: To evaluate a computer-guided, theory-based, provider-delivered intervention in the context of standard care in an HIV primary care facility in collaboration with the Center for AIDS Prevention Studies (CAPS). We will test the following hypotheses after 18 months of follow-up:
Hypothesis 1: That the proportion of HIV-positive MSM reporting 100% condom use with main partners will be significantly increased in the intervention group compared to the usual care group.
Hypothesis 2: That the proportion of patients reporting 100% condom use with casual partners will be significantly increased among patients in the intervention group compared to the usual care group.
Hypothesis 3: That the proportion of patients with multiple sexual partners will be significantly reduced among intervention group participants compared with the usual care group.
Hypothesis 4: That the proportion of HIV-positive MSM who disclose their HIV status to sex partners who are HIV-negative or are of unknown HIV status will be significantly increased among the patients receiving the intervention compared to the patients in the usual care group.
Goal 3: In collaboration with the Center and SPNS program, to conduct a holistic evaluation of the intervention program.
Goal 4: To compare the cumulative incidence of symptomatic and asymptomatic treatable STDs (gonococcal and chlamydial infections) between patients in the intervention and usual care groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus
Keywords
human immunodeficiency virus, behavior change
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Increase condom use
Intervention Description
Voluntary increase in condom use
Primary Outcome Measure Information:
Title
Proportion of participants reporting 100% condom use preintervention versus post intervention
Time Frame
End of enrollment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Active male patients over the age of 16 receiving routine primary care at the 1917 Clinic, reporting sexual contact with another man in the previous 6 months. Active patients will be defined as new patients (patients' first visit) with plans to continue follow-up at 1917 Clinic or an established patient seen at least once during the past year
Willingness to follow-up for at least 18 months
Ability to sign informed consent.
Exclusion Criteria:
Female patient
Male patient who is unwilling to follow-up for at least 18 months
Male patient who is not a primary care patient at the clinic
Unwillingness or inability to sign informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward W Hook, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB 1917 Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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HIV Prevention in the Primary Care Setting
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