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HIV Prevention in the Primary Care Setting

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ClinicalTrials.gov Identifier: NCT00381524
Recruitment Status : Completed
First Posted : September 28, 2006
Last Update Posted : June 12, 2017
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Human Immunodeficiency Virus Behavioral: Increase condom use

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Special Projects of National Significance
Study Start Date : June 2004
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Increase condom use
    Voluntary increase in condom use

Outcome Measures

Primary Outcome Measures :
  1. Proportion of participants reporting 100% condom use preintervention versus post intervention [ Time Frame: End of enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381524

United States, Alabama
UAB 1917 Clinic
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Edward W Hook, MD University of Alabama at Birmingham
More Information

Responsible Party: Edward Hook III, MD, Professor of Medicine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00381524     History of Changes
Other Study ID Numbers: F040223020
6 H97HA01191-03-02 (HRSA)
First Posted: September 28, 2006    Key Record Dates
Last Update Posted: June 12, 2017
Last Verified: November 2009
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edward Hook III, MD, University of Alabama at Birmingham:
human immunodeficiency virus
behavior change

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases