HIV InfectionsPhase 2NCT00183456

A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs

A Phase 2 study testing Peer-oriented intervention and Group cognitive behavioral therapy (CBT) in people with HIV Infections and Sexually Transmitted Diseases, 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

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs). Read more about this study

Who is it for?: Ages 18 to 74 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections, Sexually Transmitted Diseases
What is being tested?: Peer-oriented intervention and Group cognitive behavioral therapy (CBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 746 participants
Where: 1 siteUnited States
Study dates: Sep 2005to Dec 2009
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 74 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years old or older
One of the following:
Injected drugs
Sex partner of index
Social network member that the index felt comfortable talking to about HIV/STIs

Who cannot join

Currently 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: Network HIV Prevention Intervention for Drug Users

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

Read the detailed description

The persistence of HIV and STD epidemics indicates that more effective, sustainable preventive interventions are needed, particularly for low-income, inner-city populations. This study will determine the effectiveness of a theoretically based peer outreach program in preventing HIV and STD transmission among adults in the Baltimore, Maryland area.

Participants will be randomly assigned to receive either a network-oriented peer program emphasizing one's social identity and the goals of protecting one's family and community or group cognitive behavioral therapy (CBT). The peer program will also train participants to provide HIV/STD education to their peers. Participants will be assessed at study entry and during several subsequent follow-up visits. At these study visits, participants will complete questionnaires about their sexual health knowledge and sexual behaviors. Participants and members of their peer network will have follow-up visits at Months 6, 12, and 18.

Conditions: HIV Infections, Sexually Transmitted Diseases
Being tested: Peer-oriented intervention, Group cognitive behavioral therapy (CBT)
Keywords: Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education
Medical subject headings: HIV Infections, Sexually Transmitted Diseases

What participants receive

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

Peer-oriented interventionBehavioural
The peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.
Group cognitive behavioral therapy (CBT)Behavioural
Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.

Study groups in NCT00183456
Study group	Role	What they receive
Intervention Condition: CHAT	Experimental	Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options. Receives: Behavioral: Peer-oriented intervention
Comparison Condition: Standard of Care	Active comparator	The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information. Receives: Behavioral: Group cognitive behavioral therapy (CBT)
Network Participants	No intervention	Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Non-randomized Baseline index participants	No intervention	This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

What is being measured

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

Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Number of participants that had 2 or more sex partners in the past 90 days.
Measured: 6 months
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Measured: 12 months
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Measured: 18 month
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Measured: 18 months
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Measured: 18 months
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Measured: 18 months
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Measured: 18 months

Secondary outcomes (3)

HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Measured: 6 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Measured: 12 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Measured: 18 months

Timeline

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

Sep 2005Dec 2009

First posted16 Sep 2005 (estimated)
Study startSep 2005
Primary completionJul 2007
Study completionDec 2009

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 HIV InfectionsStudies of the same condition, open and under way.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 746 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00183456
Sponsor's protocol ID: R01MH066810
Other IDs: R01MH066810, DAHBR 9A-ASI
Status last verified: Jun 2013
First submitted: 13 Sep 2005
Last updated: 28 Jun 2013
Results posted: Yes, on ClinicalTrials.gov

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?

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Network HIV Prevention Intervention for Drug Users
ClinicalTrials.gov ID: NCT00183456
Acronym / sponsor ID: R01MH066810
Conditions: HIV Infections, Sexually Transmitted Diseases
Keywords: Sex Education, Peer Group, Social Identity Theory, HIV Seronegativity, Intervention, women, Social Networks, Peer Education
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 746 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Sep 2005
Primary completion: Jul 2007 (actual)
Study completion: Dec 2009 (actual)
First posted: 16 Sep 2005 (estimated)
Results: Posted 18 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will determine the effectiveness of a peer outreach intervention in preventing HIV infection in adults at high risk for contracting HIV and other sexually transmitted diseases (STDs).

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Intervention Condition: CHAT	Experimental	Behavioral: Peer-oriented interventionParticipants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
Comparison Condition: Standard of Care	Active comparator	Behavioral: Group cognitive behavioral therapy (CBT)The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
Network Participants	No intervention	–Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
Non-randomized Baseline index participants	No intervention	–This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

18 years old or older
One of the following:

Key exclusion criteria (1 listed)

Currently 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
Peer-oriented interventionThe peer-oriented intervention program emphasized social identity and the goals of protecting family and community. The peer program also trained participants to provide HIV/STD education to their peers.	Behavioural	Intervention Condition: CHAT
Group cognitive behavioral therapy (CBT)Group CBT will focus on teaching ways to modify thoughts and behaviors associated with risky sexual behaviors.	Behavioural	Comparison Condition: Standard of Care

Primary outcome

Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)
Time frame: 6 months
Number of participants that had 2 or more sex partners in the past 90 days.
Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)
Time frame: 12 months
Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)
Time frame: 18 month
Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)
Time frame: 18 months
Sex Risk Behaviors: Unprotected Sex With Main Partner (Past 90 Days)
Time frame: 18 months
Sex Risk Behaviors: Unprotected Sex With a Non-main Partner (Past 90 Days)
Time frame: 18 months
Sex Risk Behaviors: Any High Risk Sexual Behavior (Past 90 Days)
Time frame: 18 months

3 secondary outcomes

HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 6 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 12 months
HIV Communication: Talk to Family About HIV or STIs (Past 6 Months)
Time frame: 18 months

Results and safety

Results posted to the registry on 18 Oct 2012, 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: CHAT	85	82
Comparison Condition: Standard of Care	84	83
Network Participants	329	313
Non-randomized Baseline Index Participants	248	220

Primary outcome: Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners)

Time frame: 6 months. Number. Unit: participants

Measure	Intervention Condition: CHAT n = 73	Comparison Condition: Standard of Care n = 75	Network Participants n = 277	Non-randomized Baseline Index Participants n = 174
Value	17	29	50	53

Intervention Condition: CHAT vs Comparison Condition: Standard of Care: Odds Ratio (OR): 0.28 (95% CI 0.13 to 0.63), p <0.01, Generalized Estimating Equations

Primary outcome: Sex Risk Behaviors: Unprotected Sex With Non-main Partner (Past 90 Days)

Time frame: 12 months. Number. Unit: participants

Measure	Intervention Condition: CHAT n = 76	Comparison Condition: Standard of Care n = 74	Network Participants n = 264	Non-randomized Baseline Index Participants n = 185
Value	10	22	47	58

Intervention Condition: CHAT vs Comparison Condition: Standard of Care: Odds Ratio (OR): 0.36 (95% CI 0.16 to 0.84), p = 0.05, Generalized Estimating Equations

Primary outcome: Sex Risk Behaviors: Unprotected Anal Sex (Past 90 Days)

Time frame: 18 month. Number. Unit: participants

Measure	Intervention Condition: CHAT n = 80	Comparison Condition: Standard of Care n = 81	Network Participants n = 299	Non-randomized Baseline Index Participants n = 205
Value	5	18	43	35

Intervention Condition: CHAT vs Comparison Condition: Standard of Care: Odds Ratio (OR): 0.24 (95% CI 0.09 to 0.68), p = 0.01, Generalized Estimating Equations

Primary outcome: Sex Risk Behaviors: Unprotected Vaginal Sex (Past 90 Days)

Time frame: 18 months. Number. Unit: participants

Measure	Intervention Condition: CHAT n = 80	Comparison Condition: Standard of Care n = 81	Network Participants n = 299	Non-randomized Baseline Index Participants n = 205
Value	32	49	123	119

Intervention Condition: CHAT vs Comparison Condition: Standard of Care: Odds Ratio (OR): 0.47 (95% CI 0.25 to 0.87), p = 0.05, Generalized Estimating Equations

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Condition: CHAT	0 of 85 (0%)	0 of 85 (0%)	Not reported
Comparison Condition: Standard of Care	0 of 84 (0%)	0 of 84 (0%)	Not reported
Network Participants	0 of 329 (0%)	0 of 329 (0%)	Not reported
Non-randomized Baseline Index Participants	0 of 248 (0%)	0 of 248 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 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 A. Latkin, PhD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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 28 Jun 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 Oct 2012). 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?

Sex Risk Behaviors: Number of Sex Partners (>=2 Sex Partners) (time frame: 6 months). The study lists 7 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 NCT00183456.

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 28 Jun 2013.