HIV InfectionsPhase 3NCT00000931
HIV Prevention Counseling for Men Who Have Sex With Men
A Phase 3 study testing Behavioral intervention and Risk-reduction counseling in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Behavioral intervention and Risk-reduction counseling
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,350 participants
- Where
- 6 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants may be eligible for this study if they:
- Are an HIV-negative man who has had anal sex with another man in the 12 months prior to study entry.
- Are able to attend all scheduled study visits.
- Are able to provide information for locator purposes (address, phone number, etc.).
- Are at least 18 years old.
Who cannot join
- Participants will not be eligible for this study if they:
- Have been in a monogamous relationship for 2 years or more with an HIV-negative man. (Monogamous is defined as a relationship in which the members of the couple engage in sexual activities with only each other.)
- Have an obvious mental disorder or any another condition that would prevent them from completing the study.
- Are currently enrolled in any Phase III HIV vaccine trial, including the AIDSVAX Phase III trial sponsored by VaxGen, Inc.
- Are currently enrolled in HIVNET Protocol 014.
- Were enrolled in the HIVNET 015 Pilot Study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Fenway Community Health Ctr
Boston, Massachusetts, 02115
Howard Brown Health Ctr
Chicago, Illinois, 60613
Denver Dept of Public Health / HIVNET
Denver, Colorado, 80204
San Francisco Dept of Hlth / AIDS Office
San Francisco, California, 94102
Univ of Washington
Seattle, Washington, 98104
New York Blood Ctr
The Bronx, New York, 10456
About this study
Official title: A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men
The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test.
In standard pre- and post-test counseling, everyone is told the same things about how to prevent HIV. The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs.
Read the detailed description
The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM. These reviews recommend an intervention that, unlike the current standard HIV pre-test and post-test risk-reduction counseling, is tailored to an individual's unique problems and needs, lifestyle, and situations that contribute to high-risk behavior. Furthermore, there is a need for HIV-prevention intervention trials using biological endpoints (e.g., HIV seroconversion) in addition to behavioral change indices.
Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling. The same counseling staff provides the two types of treatment. The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up. The intervention is conducted on a one-to-one basis and targets condom use, change in sexual practices associated with HIV risk, and change in sexual practices in the context of alcohol and drug use. Participants in the control group receive pre- and post-test counseling at enrollment, then semiannually through Month 36. Beginning at Month 6, all participants complete routine semiannual visits. At each visit, Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered. As is routine in most public counseling and testing venues, participants in the control condition do not see the same counselor consistently.
- Conditions
- HIV Infections
- Being tested
- Behavioral intervention, Risk-reduction counseling
- Keywords
- Homosexuality, Male, Risk-Taking, Behavior Therapy, HIV Seronegativity
- Medical subject headings
- HIV Infections, Homosexuality, Male, Risk-Taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral interventionBehavioural
Risk-reduction counselingBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 3
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Enrolment
- 4,350 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Chesney M, Coates T, Study chairKoblin B, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000931
- Sponsor's protocol ID
- HIVNET 015
- Status last verified
- Nov 2006
- First submitted
- 2 Nov 1999
- Last updated
- 9 Sep 2008
- Results posted
- No
Publications
Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004 Jul 3-9;364(9428):41-50. doi: 10.1016/S0140-6736(04)16588-4.
PubMed 15234855
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Efficacy of a Behavioral Intervention to Prevent Acquisition of HIV Among Men Who Have Sex With Men
- ClinicalTrials.gov ID
- NCT00000931
- Acronym / sponsor ID
- HIVNET 015
- Conditions
- HIV Infections
- Keywords
- Homosexuality, Male, Risk-Taking, Behavior Therapy, HIV Seronegativity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,350 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- First posted
- 31 Aug 2001 (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.
The purpose of this study is to see if a behavioral intervention, a special kind of counseling, can reduce the risk of HIV infection in men who have sex with men. The behavioral intervention will be compared to the standard risk reduction counseling that is given before and after getting an HIV test.
In standard pre- and post-test counseling, everyone is told the same things about how to prevent HIV. The behavioral intervention used in this study is designed to help each individual prevent HIV according to his specific problems and needs.
Detailed description
The intervention being evaluated in this trial is based on the extensive literature on behavioral approaches to risk reduction in MSM. These reviews recommend an intervention that, unlike the current standard HIV pre-test and post-test risk-reduction counseling, is tailored to an individual's unique problems and needs, lifestyle, and situations that contribute to high-risk behavior. Furthermore, there is a need for HIV-prevention intervention trials using biological endpoints (e.g., HIV seroconversion) in addition to behavioral change indices.
Participants are randomly assigned to receive either the behavioral intervention or the control risk-reduction counseling. The same counseling staff provides the two types of treatment. The behavioral intervention consists of 10 counseling sessions within a 4-month period followed by quarterly maintenance sessions for the remainder of the 3-year follow-up. The intervention is conducted on a one-to-one basis and targets condom use, change in sexual practices associated with HIV risk, and change in sexual practices in the context of alcohol and drug use. Participants in the control group receive pre- and post-test counseling at enrollment, then semiannually through Month 36. Beginning at Month 6, all participants complete routine semiannual visits. At each visit, Risk Assessment and phlebotomy for specimen collection for HIV antibody tests are administered. As is routine in most public counseling and testing venues, participants in the control condition do not see the same counselor consistently.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are an HIV-negative man who has had anal sex with another man in the 12 months prior to study entry.
- Are able to attend all scheduled study visits.
- Are able to provide information for locator purposes (address, phone number, etc.).
- Are at least 18 years old.
Key exclusion criteria (6 listed)
- Have been in a monogamous relationship for 2 years or more with an HIV-negative man. (Monogamous is defined as a relationship in which the members of the couple engage in sexual activities with only each other.)
- Have an obvious mental disorder or any another condition that would prevent them from completing the study.
- Are currently enrolled in any Phase III HIV vaccine trial, including the AIDSVAX Phase III trial sponsored by VaxGen, Inc.
- Are currently enrolled in HIVNET Protocol 014.
- Were enrolled in the HIVNET 015 Pilot Study.
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 |
|---|---|---|
| Behavioral intervention | Behavioural | – |
| Risk-reduction counseling | Behavioural | – |
Primary outcome
Not reported in the source record.
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 9 Sep 2008.
- Results publication: PubMed 15234855Koblin B, Chesney M, Coates T; EXPLORE Study Team. Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study. Lancet. 2004 Jul 3-9;364(9428):41-50. doi: 10.1016/S0140-6736(04)16588-4.
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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.
Chesney M, Coates T study chair
Koblin B study chair
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral intervention and Risk-reduction counseling in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites 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 5 inclusion and 6 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 9 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000931, which also lists 1 linked publication.
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 9 Sep 2008.