HIVPhase 2NCT00218335

A Network & Dyad HIV Prevention Intervention for IDU's - 1

A Phase 2 study testing Intervention Condition in people with HIV and Hepatitis, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners. Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: HIV, Hepatitis
What is being tested?: Intervention Condition
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,024 participants
Where: 1 siteUnited States
Study dates: Jun 2003to May 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

(i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

Who cannot join

Not concurrently enrolled in another HIV prevention intervention

Trial locations and contacts

1 site in 1 country.

United States1 site

The Lighthouse
Baltimore, Maryland, 21231

Other trials in United States

About this study

Official title: A Network & Dyad HIV Prevention Intervention for IDU's

The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

Read the detailed description

HIV seroincidence among injection drug users remains high, with unprotected sexual contact substantially contributing to new HIV infections among injection drug users (IDUs). Interventions that are culturally competent and target drug users' main sex and drug partners may be especially effective for HIV/STI and HCV control and prevention.

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. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Conditions: HIV, Hepatitis
Being tested: Intervention Condition, Control Condition
Keywords: HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network
Medical subject headings: Hepatitis

What participants receive

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

Intervention ConditionBehavioural
Also called STEP into action
In the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control ConditionBehavioural
The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Study groups in NCT00218335
Study group	Role	What they receive
Intervention Condition	Experimental	Participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member. Receives: Behavioral: Intervention Condition
Control Condition	Active comparator	The control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions. Receives: Behavioral: Control Condition

What is being measured

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

Any Sex Risk
Measured: 6 months
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Measured: 6 months
Showed a Needleless Syringe to Drug Buddies
Measured: 6 months
Talked About Responding to Overdose to Drug Buddies
Measured: 6 months
Any Injection Risk (Monthly Versus Never)
Measured: 12 months
Number of Needle or Cooker Sharers (2 or More Versus None)
Measured: 12 months
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Measured: 12 months
Showed a Needleless Syringe to Drug Buddies
Measured: 12 months
Any Injection Risk (Monthly Versus Never)
Measured: 18 months
Shared Cooker When Preparing Drugs
Measured: 18 months
Number of Needle or Cooker Sharers (2 or More Versus None)
Measured: 18 months
Injecting Drugs
Measured: 18 months
Talked About HIV-related Topics With Drug Buddies (in Past Month)
Measured: 18 months
Showed a Needleless Syringe to Drug Buddies
Measured: 18 months
Talked About Hepatitis to Drug Buddies
Measured: 18 months

Timeline

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

Jun 2003May 2008

First posted22 Sep 2005 (estimated)
Study startJun 2003
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIVStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 1,024 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00218335
Sponsor's protocol ID: DESPR DA016555-1
Other IDs: 5R01DA016555-05, 5R01DA016555-04, 5R01DA016555-03, 3R01DA016555-03S1, 3R01DA016555-02S1, 5R01DA016555-02, 3R01DA016555-01S1, 1R01DA016555-01
Status last verified: Mar 2013
First submitted: 16 Sep 2005
Last updated: 18 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Network & Dyad HIV Prevention Intervention for IDU's
ClinicalTrials.gov ID: NCT00218335
Acronym / sponsor ID: DESPR DA016555-1
Conditions: HIV, Hepatitis
Keywords: HIV prevention Intervention, injection drug user,peer-oriented, randomized controlled trial, social network
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,024 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: Jun 2003
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 22 Sep 2005 (estimated)
Results: Posted 18 Apr 2013

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 evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Intervention Condition	Experimental	Behavioral: Intervention ConditionParticipants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
Control Condition	Active comparator	Behavioral: Control ConditionThe control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

(i)Self reported injection drug use within the prior 6 months; (ii)Willingness to invite a risk network member into the study and to talk about HIV prevention; (iii)Age 18 or older

Key exclusion criteria (1 listed)

Not concurrently enrolled in another HIV prevention intervention

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
Intervention ConditionAlso: STEP into actionIn the intervention Condition participants were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.	Behavioural	Intervention Condition
Control ConditionThe control condition focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.	Behavioural	Control Condition

Primary outcome

Any Sex Risk
Time frame: 6 months
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time frame: 6 months
Showed a Needleless Syringe to Drug Buddies
Time frame: 6 months
Talked About Responding to Overdose to Drug Buddies
Time frame: 6 months
Any Injection Risk (Monthly Versus Never)
Time frame: 12 months
Number of Needle or Cooker Sharers (2 or More Versus None)
Time frame: 12 months
Talked About HIV-related Topics With Drug Buddies (in the Past Month)
Time frame: 12 months
Showed a Needleless Syringe to Drug Buddies
Time frame: 12 months
Any Injection Risk (Monthly Versus Never)
Time frame: 18 months
Shared Cooker When Preparing Drugs
Time frame: 18 months
Number of Needle or Cooker Sharers (2 or More Versus None)
Time frame: 18 months
Injecting Drugs
Time frame: 18 months
Talked About HIV-related Topics With Drug Buddies (in Past Month)
Time frame: 18 months
Showed a Needleless Syringe to Drug Buddies
Time frame: 18 months
Talked About Hepatitis to Drug Buddies
Time frame: 18 months

Results and safety

Results posted to the registry on 18 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Condition	114	108
Control Condition	113	110
Non-Randomized Baseline Index Participants	373	319
Risk Network Members	424	388

Primary outcome: Any Sex Risk

Time frame: 6 months. Number. Unit: participants

Measure	Intervention Condition n = 101	Control Condition n = 98	Non-Randomized Baseline Index Participants n = 217	Risk Network Members n = 298
Value	48	62	119	179

Population analysed: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Primary outcome: Talked About HIV-related Topics With Drug Buddies (in the Past Month)

Time frame: 6 months. Number. Unit: participants

Measure	Intervention Condition n = 95	Control Condition n = 87	Non-Randomized Baseline Index Participants n = 206	Risk Network Members n = 252
Value	80	54	108	104

Population analysed: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Primary outcome: Showed a Needleless Syringe to Drug Buddies

Time frame: 6 months. Number. Unit: participants

Measure	Intervention Condition n = 103	Control Condition n = 99	Non-Randomized Baseline Index Participants n = 219	Risk Network Members n = 300
Value	85	18	32	49

Population analysed: The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Primary outcome: Talked About Responding to Overdose to Drug Buddies

Time frame: 6 months. Number. Unit: participants

Measure	Intervention Participants n = 101	Control Participants n = 95
Value	2	21

Population analysed: Data for this outcome was only measured among randomized participants (intervention and control participants), not among non-randomized and network participants. The discrepancy between participant flow and number of participants analyzed is due to missing data and skip patterns employed during data collection.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Condition	0 of 114 (0%)	0 of 114 (0%)	Not reported
Control Condition	0 of 113 (0%)	0 of 113 (0%)	Not reported
Non-Randomized Baseline Index Participants	0 of 373 (0%)	0 of 373 (0%)	Not reported
Risk Network Members	0 of 424 (0%)	0 of 424 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 2 study testing Intervention Condition in people with HIV and Hepatitis, run by Johns Hopkins Bloomberg School of Public Health 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 1 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 18 Apr 2013. 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.

What does this 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Any Sex Risk (time frame: 6 months). The study lists 15 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 NCT00218335.

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 18 Apr 2013.