HIV InfectionNCT01159704
Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
A study testing Peer Education Model and HIV Counseling and Education Model in people with HIV Infection and HIV Risk Behaviors, run by University of Colorado, Denver at 3 sites in Ukraine.
Trial summary
Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug users (IDUs) in three Ukraine oblasts (regions). Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV Risk Behaviors
- What is being tested?
- Peer Education Model and HIV Counseling and Education Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,304 participants
- Where
- 3 sitesUkraine
- Study dates
- Jul 2010to Mar 2017
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- active drug injector
- 16 years of age or older
- not too intoxicated to give informed consent
- not planning to leave the area in the next 6 months and no pending court date that might result in incarceration
- agree to HIV testing and counseling
- not involved in prior project research activities in teh previous 24 months
- Indexes: must be able to recruit two eligible network members into the study
- Network: agree to participate in five peer educator training sessions
Who cannot join
- being too intoxicated at the time of the interview
- impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
- have a known reason why they will not be available for the intervention or the follow-up interview
- have been involved in prior project research activities in the previous 24 months
Trial locations and contacts
3 sites in 1 country.
About this study
Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the effectiveness of a revised and updated manually-driven HIV testing and counseling intervention, the Counseling and Education (C \& E) model developed by NIDA, with the C \& E plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250 "index members" and 500 of their network members will be recruited through street outreach over a 32-month period and randomly assigned to C \& E alone or C \& E plus the network intervention. Participants will be tested for drug metabolites, interviewed using ACASI (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6 and 12-months. At six-months, network members will be asked to recruit two others they inject with but who are not in the study. Primary outcomes include knowledge, self-efficacy, injection and sex-related risk behavior reduction and partner disclosure among indexes and primary and secondary network members and intervention diffusion to secondary network members. The investigators hypothesize more positive and significant change, including injection and sex risk reduction, intervention diffusion, and partner disclosure, among indexes as well as first and second network members in the network plus C \& E arm compared to C \& E alone. Specific aims include:
- To compare the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in increasing knowledge about HIV and increasing self-efficacy to practice safer injection and sex-related behaviors among indexes, primary and secondary network members.
- To assess the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in reducing drug and sex risk behaviors among indexes, primary and secondary network members.
- To compare the extent of intervention diffusion to second wave network members in the two arms.
- To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms
- Conditions
- HIV Infection, HIV Risk Behaviors
- Being tested
- Peer Education Model, HIV Counseling and Education Model
- Keywords
- HIV infection, Intervention, Risk-reduction, Injection drug users
- 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.
Peer Education ModelBehavioural
The peer education intervention will be delivered by trained outreach workers in a group format with 8-10 indexes over five sessions spanning three weeks. The sessions will focus on knowledge of HIV transmission, self-efficacy and skills-building regarding HIV risk reduction, with an emphasis on the dissemination of such information and skills to network members.
HIV Counseling and Education ModelBehavioural
The C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening."
| Study group | Role | What they receive |
|---|---|---|
| Network plus HIV Counseling&Education | Experimental | Social network peer education model plus HIV testing and counseling; the C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." Receives: Behavioral: Peer Education Model; Behavioral: HIV Counseling and Education Model |
| HIV Counseling and Education (C&E) only | Active comparator | HIV testing and counseling C\&E; the C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." Receives: Behavioral: HIV Counseling and Education Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Knowledge
Measured: Follow-up interviews at 6 and 12 months
Self-efficacy regarding HIV risk reduction
Measured: Follow-up interviews at 6 and 12 months
Injection risk behavior reduction
Measured: Follow-up interviews at 6 and 12 months
Sex-related risk behavior reduction
Measured: Follow-up interviews at 6 and 12 months
Intervention diffusion to secondary network members
Measured: Follow-up interviews at 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2015
- Study completionMar 2017
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 InfectionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2,304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Robert Booth, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159704
- Sponsor's protocol ID
- 09-0823
- Other IDs
- R01DA026739-01A1
- Status last verified
- Jun 2019
- First submitted
- 8 Jul 2010
- Last updated
- 19 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Booth RE, Davis JM, Dvoryak S, Brewster JT, Lisovska O, Strathdee SA, Latkin CA. HIV incidence among people who inject drugs (PWIDs) in Ukraine: results from a clustered randomised trial. Lancet HIV. 2016 Oct;3(10):e482-9. doi: 10.1016/S2352-3018(16)30040-6. Epub 2016 Jul 29.
PubMed 27658879
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Leaders as HIV Risk Reduction Change Agents Among Injection Drug Users (IDUs) in Ukraine
- ClinicalTrials.gov ID
- NCT01159704
- Acronym / sponsor ID
- 09-0823
- Conditions
- HIV Infection, HIV Risk Behaviors
- Keywords
- HIV infection, Intervention, Risk-reduction, Injection drug users
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,304 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 9 Jul 2010 (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.
Using a randomized clinical trial (RCT), this study is designed to assess the effectiveness of HIV (human immunodeficiency virus) risk-reduction interventions targeting injection drug users (IDUs) in three Ukraine oblasts (regions). The investigators propose to compare the effectiveness of a revised and updated manually-driven HIV testing and counseling intervention, the Counseling and Education (C \& E) model developed by NIDA, with the C \& E plus a manualized network intervention. At each site, Odessa, Donetsk and Nikolayev, 250 "index members" and 500 of their network members will be recruited through street outreach over a 32-month period and randomly assigned to C \& E alone or C \& E plus the network intervention. Participants will be tested for drug metabolites, interviewed using ACASI (Audio Computer-Assisted Self-Interviewing), and given a rapid test for HIV at baseline, 6 and 12-months. At six-months, network members will be asked to recruit two others they inject with but who are not in the study. Primary outcomes include knowledge, self-efficacy, injection and sex-related risk behavior reduction and partner disclosure among indexes and primary and secondary network members and intervention diffusion to secondary network members. The investigators hypothesize more positive and significant change, including injection and sex risk reduction, intervention diffusion, and partner disclosure, among indexes as well as first and second network members in the network plus C \& E arm compared to C \& E alone. Specific aims include:
- To compare the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in increasing knowledge about HIV and increasing self-efficacy to practice safer injection and sex-related behaviors among indexes, primary and secondary network members.
- To assess the effectiveness of the C \& E alone with the additive effect of a network intervention plus C \& E in reducing drug and sex risk behaviors among indexes, primary and secondary network members.
- To compare the extent of intervention diffusion to second wave network members in the two arms.
- To evaluate the extent of disclosure by HIV positive indexes and network members in the two arms
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Network plus HIV Counseling&Education | Experimental | Behavioral: Peer Education Model, Behavioral: HIV Counseling and Education ModelSocial network peer education model plus HIV testing and counseling; the C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." |
| HIV Counseling and Education (C&E) only | Active comparator | Behavioral: HIV Counseling and Education ModelHIV testing and counseling C\&E; the C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- active drug injector
- 16 years of age or older
- not too intoxicated to give informed consent
- not planning to leave the area in the next 6 months and no pending court date that might result in incarceration
- agree to HIV testing and counseling
Key exclusion criteria (4 listed)
- being too intoxicated at the time of the interview
- impaired mentally due to physical or psychological problems to the point that they cannot voluntarily consent to participate in the study and/or respond to the interview
- have a known reason why they will not be available for the intervention or the follow-up interview
- have been involved in prior project research activities in the previous 24 months
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 Education ModelThe peer education intervention will be delivered by trained outreach workers in a group format with 8-10 indexes over five sessions spanning three weeks. The sessions will focus on knowledge of HIV transmission, self-efficacy and skills-building regarding HIV risk reduction, with an emphasis on the dissemination of such information and skills to network members. | Behavioural | Network plus HIV Counseling&Education |
| HIV Counseling and Education ModelThe C \& E intervention is a manualized individual-level model consisting of two education and counseling sessions that "structurally bracket confidential HIV antibody screening." | Behavioural | HIV Counseling and Education (C&E) only, Network plus HIV Counseling&Education |
Primary outcome
HIV Knowledge
Time frame: Follow-up interviews at 6 and 12 months
Self-efficacy regarding HIV risk reduction
Time frame: Follow-up interviews at 6 and 12 months
Injection risk behavior reduction
Time frame: Follow-up interviews at 6 and 12 months
Sex-related risk behavior reduction
Time frame: Follow-up interviews at 6 and 12 months
Intervention diffusion to secondary network members
Time frame: Follow-up interviews at 6 and 12 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 19 Jun 2019.
- Derived from this study: PubMed 27658879Booth RE, Davis JM, Dvoryak S, Brewster JT, Lisovska O, Strathdee SA, Latkin CA. HIV incidence among people who inject drugs (PWIDs) in Ukraine: results from a clustered randomised trial. Lancet HIV. 2016 Oct;3(10):e482-9. doi: 10.1016/S2352-3018(16)30040-6. Epub 2016 Jul 29.
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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.
Robert Booth, PhD principal investigator
University of Colorado, Denver
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Education Model and HIV Counseling and Education Model in people with HIV Infection and HIV Risk Behaviors, run by University of Colorado, Denver at 3 sites in Ukraine.
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 8 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 19 Jun 2019. 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 Ukraine. 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?
HIV Knowledge (time frame: Follow-up interviews at 6 and 12 months). The study lists 5 primary outcomes in all. 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 NCT01159704, 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 19 Jun 2019.