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HIV Prevention in the Primary Care Setting

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00381524
First received: September 26, 2006
Last updated: November 12, 2009
Last verified: November 2009

September 26, 2006
November 12, 2009
June 2004
June 2007   (final data collection date for primary outcome measure)
Proportion of participants reporting 100% condom use preintervention versus post intervention [ Time Frame: End of enrollment ] [ Designated as safety issue: No ]
  • Proportion of participants reporting 100% condom use preintervention versus post intervention
  • Proportion of participants reporting more than one sexual partner preintervention versus post intervention
  • Proportion of participants reporting disclosure of HIV status to partner preintervention versus post intervention
Complete list of historical versions of study NCT00381524 on ClinicalTrials.gov Archive Site
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HIV Prevention in the Primary Care Setting
Special Projects of National Significance

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.

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.

Interventional
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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Human Immunodeficiency Virus
Behavioral: Increase condom use
Voluntary increase in condom use
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
234
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00381524
F040223020, 6 H97HA01191-03-02 (HRSA)
Not Provided
Edward W. Hook, III, M.D., UAB
University of Alabama at Birmingham
Not Provided
Principal Investigator: Edward W Hook, MD University of Alabama at Birmingham
University of Alabama at Birmingham
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP