AzTrials
AzTrials

HIV InfectionsPhase 2/3NCT00310973

HIV Prevention Within High-Risk Bulgarian and Hungarian Social Networks

A Phase 2/3 study testing Social Network Intervention in people with HIV Infections, run by Medical College of Wisconsin at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease (STD)risk reduction educational counseling in reducing HIV risk behavior among the social networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
Social Network Intervention
How many people
320 participants
Where
3 sitesin 3 countries
Study dates
Feb 2003to Nov 2005
Phase
Phase 2/3
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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • At least 50% of social network members complete baseline assessments
  • At least 50% of assessed members of a social network report unprotected vaginal or anal intercourse outside of a mutually monogamous relationship in the 6 months prior to study entry

Who cannot join

  • Does not meet inclusion criteria

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Bulgaria1 site

  • Health and Social Development Foundation

    Sofia

Other trials in Bulgaria

Hungary1 site

  • Institute of Sociology, Hungarian Academy of Sciences

    Budapest

Other trials in Hungary

Russia1 site

  • Botkin Hospital for Infectious Diseases

    Saint Petersburg

Other trials in Russia

About this study

Official title: HIV Prevention Within High-Risk Social Networks

This study will evaluate the effectiveness of peer-led HIV/sexually transmitted disease (STD)risk reduction educational counseling in reducing HIV risk behavior among the social networks of young men who have sex with men and Roma men and women in Bulgaria and Hungary.

Read the detailed description

HIV is spreading more rapidly in Eastern Europe than anywhere else in the world. Bulgaria and Hungary are still in the early stages of the crisis. However, without efforts to prevent the spread of HIV and AIDS, both countries are likely to fall victim to the HIV/AIDS growth curve that has already affected the rest of Eastern Europe. Bulgarian and Hungarian young men who have sex with men (YMSM) and Roma men and women are at the greatest risk for HIV infection. In both countries, HIV is spread primarily through sexual transmission. Prevention efforts that are undertaken now could help these countries avoid an explosive HIV/AIDS epidemic. YMSM and Roma men in Bulgaria and Hungary are more likely to trust HIV/AIDS information received from someone they know than from an official statement. Therefore, entire social networks will be recruited for this study and the leader of each network will be responsible for delivering the prevention information to his or her peers. This study will evaluate the effectiveness of peer-led HIV/STD risk reduction educational counseling in reducing HIV risk behavior among the social networks of YMSM and Roma men and women in Bulgaria and Hungary.

This study will recruit 40 YMSM and 40 Roma high-risk social networks. Each network will be randomly assigned to receive either standard HIV/AIDS risk reduction or the intervention. Networks assigned to receive the intervention will be assessed sociometrically to determine the 'social influence' leaders of each group. The leaders will then attend a 9-session program over the course of 3 months that will train them to deliver theory-based risk-reduction messages and peer-counseling to their respective social networks. The messages will focus on promoting safer sex knowledge, attitudes, intentions, perceived norms, and self-efficacy. All participants will be offered STD testing and their HIV-risk behavior will be assessed at Months 3 and 12. Participants assigned to receive the standard HIV/AIDS risk reduction will then receive the network intervention for an additional 12 months.

Conditions
HIV Infections
Being tested
Social Network Intervention
Keywords
HIV, Prevention, Risk Behavior Reduction, Roma, Bulgaria, HIV seronegativity
Medical subject headings
HIV Infections, Risk Reduction Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social Network InterventionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse

    Measured: Months 3 and 12 post intervention

Secondary outcomes (2)

  1. Lower incidence of sexually transmitted diseases

    Measured: Months 3 and 12 post intervention

  2. Change in AIDS-related scales

    Measured: Months 3 and 12 post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2006 (estimated)
  2. Study startFeb 2003
  3. Primary completionNov 2005
  4. Study completionNov 2005

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Enrolment
320 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00310973
Sponsor's protocol ID
R01MH064410
Other IDs
R01MH064410, DAHBR 9A-ASPG
Status last verified
Apr 2015
First submitted
3 Apr 2006
Last updated
22 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Kabakchieva E, Vassileva S, Kelly JA, Amirkhanian YA, DiFranceisco WJ, McAuliffe TL, Antonova R, Mihaylova M, Vassilev B, Khoursine R, Petrova E. HIV risk behavior patterns, predictors, and sexually transmitted disease prevalence in the social networks of young Roma (Gypsy) men in Sofia, Bulgaria. Sex Transm Dis. 2006 Aug;33(8):485-90. doi: 10.1097/01.olq.0000204533.20324.56.

    PubMed 16641823

  • Amirkhanian YA, Kelly JA, Kabakchieva E, Kirsanova AV, Vassileva S, Takacs J, DiFranceisco WJ, McAuliffe TL, Khoursine RA, Mocsonaki L. A randomized social network HIV prevention trial with young men who have sex with men in Russia and Bulgaria. AIDS. 2005 Nov 4;19(16):1897-905. doi: 10.1097/01.aids.0000189867.74806.fb.

    PubMed 16227798

  • Takacs J, Amirkhanian YA, Kelly JA, Kirsanova AV, Khoursine RA, Mocsonaki L. "Condoms are reliable but I am not": A qualitative analysis of AIDS-related beliefs and attitudes of young heterosexual adults in Budapest, Hungary, and St. Petersburg, Russia. Cent Eur J Public Health. 2006 Jun;14(2):59-66. doi: 10.21101/cejph.a3373.

    PubMed 16830606

  • Amirkhanian YA, Kelly JA, Kirsanova AV, DiFranceisco W, Khoursine RA, Semenov AV, Rozmanova VN. HIV risk behaviour patterns, predictors, and sexually transmitted disease prevalence in the social networks of young men who have sex with men in St Petersburg, Russia. Int J STD AIDS. 2006 Jan;17(1):50-6. doi: 10.1258/095646206775220504.

    PubMed 16409680

  • Amirkhanian YA, Kelly JA, Kabakchieva E, McAuliffe TL, Vassileva S. Evaluation of a social network HIV prevention intervention program for young men who have sex with men in Russia and Bulgaria. AIDS Educ Prev. 2003 Jun;15(3):205-20. doi: 10.1521/aeap.15.4.205.23832.

    PubMed 12866833

  • Kelly JA, Amirkhanian YA, Kabakchieva E, Csepe P, Seal DW, Antonova R, Mihaylov A, Gyukits G. Gender roles and HIV sexual risk vulnerability of Roma (Gypsies) men and women in Bulgaria and Hungary: an ethnographic study. AIDS Care. 2004 Feb;16(2):231-45. doi: 10.1080/09540120410001641075.

    PubMed 14676028

  • Amirkhanian YA, Kelly JA, McAuliffe TL. Identifying, recruiting, and assessing social networks at high risk for HIV/AIDS: methodology, practice, and a case study in St Petersburg, Russia. AIDS Care. 2005 Jan;17(1):58-75. doi: 10.1080/09540120412331305133.

    PubMed 15832834

  • Kelly JA, Amirkhanian YA, Kabakchieva E, Vassileva S, Vassilev B, McAuliffe TL, DiFranceisco WJ, Antonova R, Petrova E, Khoursine RA, Dimitrov B. Prevention of HIV and sexually transmitted diseases in high risk social networks of young Roma (Gypsy) men in Bulgaria: randomised controlled trial. BMJ. 2006 Nov 25;333(7578):1098. doi: 10.1136/bmj.38992.478299.55. Epub 2006 Oct 13.

    PubMed 17040924

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Social Network Intervention in people with HIV Infections, run by Medical College of Wisconsin at 3 sites in 3 countries.

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 2 inclusion and 1 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Bulgaria, Hungary, Russia. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

Reductions in the prevalence and frequency of unprotected vaginal or anal intercourse (time frame: Months 3 and 12 post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00310973, which also lists 8 linked publications.

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 22 Apr 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in