HIV InfectionsPhase 3NCT00218673
RCT of Russian IDU Peer Network HIV Prevention Intervention - 1
A Phase 3 study testing Peer mentor intervention in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Russia.
Trial summary
The purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Peer mentor intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- Oct 2003to Jun 2009
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Of legal age to independently provide written informed consent for research
- Report having injected drugs at least 12 times in the last three months
- HIV seronegative (ELISA confirmed)
- Willing and able to recruit at least three HIV risk network members who are eligible for study participation
Who cannot join
- Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study
- Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff
- Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention
The purpose of this study is to conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. We expect that participants who receive the intervention will demonstrate a reduction in the rate of HIV infection and HIV risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group.
Read the detailed description
Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1 infections have occurred within communities of IDUs. In St. Petersburg (population 5 million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years.
The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators' social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks.
Comparison condition: Informed by the Centers for Disease Control model of best practice" standard of care of HIV testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors.
- Conditions
- HIV Infections
- Being tested
- Peer mentor intervention
- Keywords
- HIV, injection drug use, social networks
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer mentor interventionBehavioural
groups sessions, 8
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | social network Receives: Behavioral: Peer mentor intervention |
| control | No intervention | testing and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident number of HIV Infections in social networks
Measured: 1 year
Secondary outcomes (2)
Self reported risk behaviors: entry into drug treatment, cessation of drug use
Measured: 1 year
Self reported risk behaviors: number of sex partners, freq of condom use
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionJun 2009
- Study completionJun 2009
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 Johns Hopkins Bloomberg School of Public HealthThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Johns Hopkins University
- Responsible party
- Principal investigator, Carl Latkin, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Carl Latkin, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218673
- Sponsor's protocol ID
- DESPR DA016142
- Other IDs
- 5R01DA016142, R01-16142-1, NIDA-16142-1
- Status last verified
- May 2016
- First submitted
- 16 Sep 2005
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Hoffman IF, Latkin CA, Kukhareva PV, Malov SV, Batluk JV, Shaboltas AV, Skochilov RV, Sokolov NV, Verevochkin SV, Hudgens MG, Kozlov AP. A peer-educator network HIV prevention intervention among injection drug users: results of a randomized controlled trial in St. Petersburg, Russia. AIDS Behav. 2013 Sep;17(7):2510-20. doi: 10.1007/s10461-013-0563-4.
PubMed 23881187
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Russian IDU Peer Network HIV Prevention Intervention
- ClinicalTrials.gov ID
- NCT00218673
- Acronym / sponsor ID
- DESPR DA016142
- Conditions
- HIV Infections
- Keywords
- HIV, injection drug use, social networks
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Johns Hopkins University
- Study start
- Oct 2003
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Sep 2005 (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 conduct a randomized controlled trial to assess the efficacy of a peer-educator intervention focused on injection drug users and their drug and sexual networks. We expect that participants who receive the intervention will demonstrate a reduction in the rate of HIV infection and HIV risk behaviors and members of their risk network will also demonstrate reductions in risk behaviors compared to those in the control group.
Detailed description
Intravenous drug use (IDU) is driving the HIV epidemic in Russia; over 90% of all HIV-1 infections have occurred within communities of IDUs. In St. Petersburg (population 5 million), the prevalence of HIV infection in IDUs (estimated population 100,000) leapt from 4% in 1999 to 12% in 2000. At present there are an estimated 5-7 million IDUs, a four-fold increase since the end of the Soviet Union. In St. Petersburg, there has been a three-fold increase in regular IDUs and a nine-fold increase in teenage IDUs during the past five years.
The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Providing peer educator training to IDUs may efficiently cultivate sustainable protective behavioral norms related to injection and sexual risk among the IDU educators' social networks. Prior studies have demonstrated that peer educator programs can realize such normative changes, and it is hypothesized in this study that these normative changes will be reflected in significant reductions in the rates of HIV transmission among the peer educators and the members of their social networks.
Comparison condition: Informed by the Centers for Disease Control model of best practice" standard of care of HIV testing and counseling, participants in the comparison condition will receive risk reduction education and motivational counseling to reduce their risk behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Behavioral: Peer mentor interventionsocial network |
| control | No intervention | –testing and counseling |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Of legal age to independently provide written informed consent for research
- Report having injected drugs at least 12 times in the last three months
- HIV seronegative (ELISA confirmed)
- Willing and able to recruit at least three HIV risk network members who are eligible for study participation
Key exclusion criteria (3 listed)
- Prior or concurrent enrollment in the last 6 months in another HIV behavioral or biomedical prevention study
- Psychological disturbance or cognitive impairment that appears to limit the ability to understand study procedures, as determined by clinic staff
- Any other condition that, in the opinion of the investigator, would make participation in the study unsafe, or otherwise interfere with the study objectives
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 |
|---|---|---|
| Peer mentor interventiongroups sessions, 8 | Behavioural | experimental |
Primary outcome
Incident number of HIV Infections in social networks
Time frame: 1 year
2 secondary outcomes
Self reported risk behaviors: entry into drug treatment, cessation of drug use
Time frame: 1 year
Self reported risk behaviors: number of sex partners, freq of condom use
Time frame: 3 months
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 13 May 2016.
- Derived from this study: PubMed 23881187Hoffman IF, Latkin CA, Kukhareva PV, Malov SV, Batluk JV, Shaboltas AV, Skochilov RV, Sokolov NV, Verevochkin SV, Hudgens MG, Kozlov AP. A peer-educator network HIV prevention intervention among injection drug users: results of a randomized controlled trial in St. Petersburg, Russia. AIDS Behav. 2013 Sep;17(7):2510-20. doi: 10.1007/s10461-013-0563-4.
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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.
Carl Latkin, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peer mentor intervention in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Russia.
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 4 inclusion and 3 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 13 May 2016. 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 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 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.
What does the primary outcome measure?
Incident number of HIV Infections in social networks (time frame: 1 year). 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 NCT00218673, 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 13 May 2016.