HIVNCT02896699
Advanced HIV Prevention (PrEP Chicago)
A study testing PrEP Intervention Group in people with HIV, run by University of Chicago at 1 site in United States.
Trial summary
This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks. Read more about this study
- Who is it for?
- Ages 18 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- PrEP Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 424 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Aug 2019
- 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 18 to 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Lives on the South Side of Chicago, Illinois
- Born male
- Has had sex with men in the previous year
- Is an active Facebook user
- Does not have plans to leave Chicago
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks.
Read the detailed description
The specific aims of this study are:
- To recruit 450 participants in Chicago, Illinois, and to train them as peer change agents (randomized to cross-over groups) to disseminate PrEP information and motivate PrEP interest and knowledge of PrEP in their local networks.
- To evaluate feasibility of the program over 2 years of participant follow-up through: 1) peer change agent exit survey; 2) peer change agent booster sessions; 3) peer change agent communication with University of Chicago PrEP program social media; 4) referrals into the project and; 5) calls into the PrEP warmline.
- Conditions
- HIV
- Being tested
- PrEP Intervention Group, Control Group
- Keywords
- Pre-exposure prophylaxis (PrEP), diffusion of innovation, men who have sex with men, LGBT, African American, Black, HIV, network analysis, network intervention
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEP Intervention GroupBehavioural
Control GroupOther
| Study group | Role | What they receive |
|---|---|---|
| PrEP Intervention Group | Experimental | Group training session including HIV Education, PrEP Education, Following the training session Booster phone calls HIv and syphillis testing Receives: Behavioral: PrEP Intervention Group |
| Control Group | Active comparator | Group HIV risk vignettes Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Network member call into the PrEPline
Measured: 2 years
Secondary outcomes (4)
PrEP Attitudes questionnaire
Monitor the change in attitude towards PrEP (1) from baseline measure to 12-months; (2) 12-months to 24-months; and (3) baseline to 24-month.
Measured: 2 years
Peer change agent boosters sessions completed
Measured: 2 years
Number of Facebook posts with respect to PrEP and sexual health
Measured: 2 years
Number of referrals enrolled into the study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2019
- Study completionAug 2019
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 HIVStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02896699
- Sponsor's protocol ID
- IRB15-1250
- Status last verified
- Jan 2024
- First submitted
- 26 Jul 2016
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Young LE, Schumm P, Alon L, Bouris A, Ferreira M, Hill B, Khanna AS, Valente TW, Schneider JA. PrEP Chicago: A randomized controlled peer change agent intervention to promote the adoption of pre-exposure prophylaxis for HIV prevention among young Black men who have sex with men. Clin Trials. 2018 Feb;15(1):44-52. doi: 10.1177/1740774517730012. Epub 2017 Sep 1.
PubMed 28862483
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced HIV Prevention (PrEP Chicago)
- ClinicalTrials.gov ID
- NCT02896699
- Acronym / sponsor ID
- IRB15-1250
- Conditions
- HIV
- Keywords
- Pre-exposure prophylaxis (PrEP), diffusion of innovation, men who have sex with men, LGBT, African American, Black, HIV, network analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 424 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 12 Sep 2016 (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.
This study will evaluate the feasibility of a network intervention to train individuals to disseminate PrEP information and motivate initial PrEP interest and knowledge of PrEP in their social networks.
Detailed description
The specific aims of this study are:
- To recruit 450 participants in Chicago, Illinois, and to train them as peer change agents (randomized to cross-over groups) to disseminate PrEP information and motivate PrEP interest and knowledge of PrEP in their local networks.
- To evaluate feasibility of the program over 2 years of participant follow-up through: 1) peer change agent exit survey; 2) peer change agent booster sessions; 3) peer change agent communication with University of Chicago PrEP program social media; 4) referrals into the project and; 5) calls into the PrEP warmline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PrEP Intervention Group | Experimental | Behavioral: PrEP Intervention GroupGroup training session including HIV Education, PrEP Education, Following the training session Booster phone calls HIv and syphillis testing |
| Control Group | Active comparator | Other: Control GroupGroup HIV risk vignettes |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Lives on the South Side of Chicago, Illinois
- Born male
- Has had sex with men in the previous year
- Is an active Facebook user
- Does not have plans to leave Chicago
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| PrEP Intervention Group | Behavioural | PrEP Intervention Group |
| Control Group | Other | Control Group |
Primary outcome
Network member call into the PrEPline
Time frame: 2 years
4 secondary outcomes
PrEP Attitudes questionnaire
Time frame: 2 years
Peer change agent boosters sessions completed
Time frame: 2 years
Number of Facebook posts with respect to PrEP and sexual health
Time frame: 2 years
Number of referrals enrolled into the study
Time frame: 2 years
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 18 Jan 2024.
- Derived from this study: PubMed 28862483Young LE, Schumm P, Alon L, Bouris A, Ferreira M, Hill B, Khanna AS, Valente TW, Schneider JA. PrEP Chicago: A randomized controlled peer change agent intervention to promote the adoption of pre-exposure prophylaxis for HIV prevention among young Black men who have sex with men. Clin Trials. 2018 Feb;15(1):44-52. doi: 10.1177/1740774517730012. Epub 2017 Sep 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrEP Intervention Group in people with HIV, run by University of Chicago 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 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 18 Jan 2024. 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.
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?
Network member call into the PrEPline (time frame: 2 years). 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 NCT02896699, 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 18 Jan 2024; AzTrials last refreshed its copy on 28 Oct 2026.