Human Immunodeficiency VirusNCT00381524
HIV Prevention in the Primary Care Setting
A study testing Increase condom use in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Increase condom use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 234 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Increase condom use
- Keywords
- human immunodeficiency virus, behavior change
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase condom useBehavioural
Voluntary increase in condom use
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants reporting 100% condom use preintervention versus post intervention
Measured: End of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2006 (estimated)
- Study startJun 2004
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Hook III, MD, University of Alabama at Birmingham
- Investigators
- Edward W Hook, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381524
- Sponsor's protocol ID
- F040223020
- Other IDs
- 6 H97HA01191-03-02 (HRSA)
- Status last verified
- Nov 2009
- First submitted
- 26 Sep 2006
- Last updated
- 12 Jun 2017
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Projects of National Significance
- ClinicalTrials.gov ID
- NCT00381524
- Acronym / sponsor ID
- F040223020
- Conditions
- Human Immunodeficiency Virus
- Keywords
- human immunodeficiency virus, behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 28 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Increase condom useVoluntary increase in condom use | Behavioural | – |
Primary outcome
Proportion of participants reporting 100% condom use preintervention versus post intervention
Time frame: End of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward W Hook, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Increase condom use in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants reporting 100% condom use preintervention versus post intervention (time frame: End of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.