HIVKIU!NCT01836445
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
A study testing Keep It Up! in people with HIV and Gonorrhea, run by Northwestern University at 3 sites in United States.
Trial summary
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- What is being tested?
- Keep It Up!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 901 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to Mar 2017
- Phase
- Interventional
- 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 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Birth male who identifies as male and reports sexual contact with another male
- Received an HIV negative test result from a participating clinic/recruitment site
- Unprotected anal sex with another male in the last 6 months
- Ability to read English at 8th grade level
Who cannot join
- HIV positive
- Female or Transgender
- No email address for contact
- Currently in a monogamous relationship lasting longer than 6 months
- Participated in previous versions of KIU!
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
Northwestern University
Chicago, Illinois, 60611
Hunter College
New York, New York, 10065
About this study
Official title: Efficacy of Internet-based HIV Prevention
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.
The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.
Read more
Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.
The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.
In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.
- Being tested
- Keep It Up!, HIV Knowledge Control
- Medical subject headings
- Gonorrhea, Chlamydia Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keep It Up!Behavioural
Also called KIU!, KIU! 2.0, Keep It Up! 2.0
HIV Knowledge ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Keep It Up! Intervention | Experimental | The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. Receives: Behavioral: Keep It Up! |
| HIV Knowledge Control | Active comparator | The control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). Receives: Behavioral: HIV Knowledge Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Change in self-report of condomless anal sex acts at three months.
Measured: Baseline, 3 Months
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
Change in self-report of condomless anal sex acts at six months.
Measured: Baseline, 6 Months
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
Change in self-report of condomless anal sex acts at twelve months.
Measured: Baseline, 12 Months
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Measured: Baseline
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.
Measured: 12 months
Secondary outcomes (14)
Mean Score of Condom Errors at Baseline and 3 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at three months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Measured: Baseline, 3 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months
The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at three months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Measured: Baseline, 3 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months
At three months, the change in:
- Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
- Social Norms (for example, partners, friends, or family members opinions about condom use)
- Behavioral Skills (for example, negotiating condom use)
Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Measured: Baseline, 3 Months
Mean Score of Health Protective Communication Skills at Baseline and 3 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at three months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Measured: Baseline, 3 Months
Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
The change in number of participants who report using illegal drugs or drugs not prescribed by a doctor before sex.
Measured: Baseline, 12 Month
Mean Score of Condom Errors at Baseline and 6 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at six months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors
Measured: Baseline, 6 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months
The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at six months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Measured: Baseline, 6 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months
At six months, the change in:
- Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
- Social Norms (for example, partners, friends, or family members opinions about condom use)
- Behavioral Skills (for example, negotiating condom use)
Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Measured: Baseline, 6 Months
Mean Score of Health Protective Communication Skills at Baseline and 6 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at six months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Measured: Baseline, 6 Months
Mean Score of Condom Errors at Baseline and 12 Months
The change in frequency that a participant has not correctly used a condom (for example, starting sex without a condom or using the wrong lube with condoms) at twelve months. Must have reported anal sex and using a condom with a partner at both time points. Range of scores - 0-11; higher scores = more errors.
Measured: Baseline, 12 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months
The change in number of HIV statements (e.g. "Only the receptive/bottom partner is at risk of being infected with HIV during anal sex", "There is a vaccine that can stop people from getting HIV", and "A natural skin (lamb skin) condom works better against HIV than does a latex condom") correctly labeled as true or false at twelve months. All 26 statements were recoded such that correct responses = 1 and incorrect or 'don't know' responses = 0. Composite scores were calculated to reflect the percentage of correct responses. Higher scores reflect greater knowledge of HIV transmission/risk.
Measured: Baseline, 12 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months
At twelve months, the change in:
- Motivation (for example, intentions to use condoms, perceived threat of HIV or STI infection, desire to become safer)
- Social Norms (for example, partners, friends, or family members opinions about condom use)
- Behavioral Skills (for example, negotiating condom use)
Motivational Self-Rating - higher score = higher motivation; range 1-4 Social Norms - higher score = higher endorsement of social norms; range 1-5 Behavioral Skills - higher score = less perceived difficulty using condoms; range 1-4
Measured: Baseline, 12 Months
Mean Score of Health Protective Communication Skills at Baseline and 12 Months
The change in how frequently health protection (for example, condom use and regular HIV testing) is discussed with sex partners at twelve months. Higher score = less HPC skills; range 1-4 for each item on scale (relationship maintenance, condom use, and HIV testing).
Measured: Baseline, 12 Months
Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months
The change in effect that HIV testing has on health beliefs (for example, "I cannot get HIV") and sexual behaviors at twelve months. Range 1-5; higher scores = more feelings of invulnerability
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2017
- Study completionMar 2017
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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 901 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Emory University, Hunter College of City University of New York
- Responsible party
- Principal investigator, Brian Mustanski, Northwestern University
- Investigators
- Brian Mustanski, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836445
- Sponsor's protocol ID
- 1R01DA035145-01
- Other IDs
- 1R01DA035145-01
- Acronym
- KIU!
- Status last verified
- Aug 2022
- First submitted
- 17 Apr 2013
- Last updated
- 15 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Centers for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
Centers for Disease Control and Prevention (CDC). Trends in HIV/AIDS diagnoses among men who have sex with men--33 states, 2001-2006. MMWR Morb Mortal Wkly Rep. 2008 Jun 27;57(25):681-6.
PubMed 18583954Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6(8):e17502. doi: 10.1371/journal.pone.0017502. Epub 2011 Aug 3.
PubMed 21826193Mustanski B, Lyons T, Garcia SC. Internet use and sexual health of young men who have sex with men: a mixed-methods study. Arch Sex Behav. 2011 Apr;40(2):289-300. doi: 10.1007/s10508-009-9596-1. Epub 2010 Feb 25.
PubMed 20182787Mustanski B, Parsons JT, Sullivan PS, Madkins K, Rosenberg E, Swann G. Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT. Am J Prev Med. 2018 Aug;55(2):151-158. doi: 10.1016/j.amepre.2018.04.026. Epub 2018 Jun 28.
PubMed 29937115Mustanski B, Madkins K, Greene GJ, Parsons JT, Johnson BA, Sullivan P, Bass M, Abel R. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0. JMIR Res Protoc. 2017 Jan 7;6(1):e1. doi: 10.2196/resprot.5740.
PubMed 28062389
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Internet-based HIV Prevention
- ClinicalTrials.gov ID
- NCT01836445
- Acronym / sponsor ID
- KIU! / 1R01DA035145-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 901 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Emory University, Hunter College of City University of New York
- Study start
- May 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Young men who have sex with men (YMSM) account for almost 70% of HIV diagnoses among all young people in the U.S. and are alone in facing an increasing rate of infections. Because YMSM are less likely to receive relevant sexual health education in traditional settings (e.g. schools, community), the Internet is a unique route of reaching and helping YMSM.
The purpose of this study is to compare two different versions of an online HIV prevention program for YMSM. The study is being conducted by researchers at Northwestern University in Chicago, Hunter College in New York City, and Emory University in Atlanta. A total of 900 YMSM will be enrolled into this study from the clinics of community partners in Chicago, New York, and Atlanta.
Participants will be randomly assigned to one of two versions of the program. Some topics in the program include HIV facts and myths, sexually transmitted infections (STIs), and condom use. All participants, regardless of the program version they receive, will also take at-home urine and rectal tests for the STIs chlamydia and gonorrhea. After completing the program, participants will be contacted three more times over the course of a year for follow-up sessions and surveys.
The research team hypothesizes that the YMSM-specific prevention program will lead to a significant reduction in the frequency of unprotected anal sex acts and new STI infections compared to the HIV knowledge program that is for a general audience. The YMSM-specific program will also lead to improvements in secondary knowledge, motivation, and skills outcomes.
In order for the research team to measure the effectiveness of the YMSM-specific prevention program and determine if the study hypothesis is correct, participants will be asked questions about themselves, including questions about their sexual orientation, sexual experiences, health practices, including drug use, health knowledge, and questions about their feelings and emotions. Based on this information, the research team hopes to later change, improve, or expand the program to better address the needs of YMSM.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keep It Up! Intervention | Experimental | Behavioral: Keep It Up!The KIU! intervention is a multi-media online HIV prevention program developed specifically for young (18-29 years old) men who have sex with men (MSM) who recently tested HIV negative. Intervention content includes discussions of community involvement, scenarios on hooking-up online, communication skills in relationships (including negotiating safer sex), condom use, HIV knowledge, and HIV/STI risks. Information is presented in various formats like games, animation, and videos to address gaps in HIV knowledge, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors. The intervention is completed across three sessions, done at least 24 hours apart (i.e. at least 3 days), and takes about 2 hours total to complete. |
| HIV Knowledge Control | Active comparator | Behavioral: HIV Knowledge ControlThe control condition reflects HIV information that is currently available on many websites so as to understand how the KIU! intervention improves upon what is currently available online. It is not tailored to YMSM, non-interactive, and focused on HIV/STI knowledge. The control is completed across three sessions done at least 24 hours apart (i.e. at least 3 days). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Birth male who identifies as male and reports sexual contact with another male
- Received an HIV negative test result from a participating clinic/recruitment site
- Unprotected anal sex with another male in the last 6 months
- Ability to read English at 8th grade level
Key exclusion criteria (5 listed)
- HIV positive
- Female or Transgender
- No email address for contact
- Currently in a monogamous relationship lasting longer than 6 months
- Participated in previous versions of KIU!
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 |
|---|---|---|
| Keep It Up!Also: KIU!, KIU! 2.0, Keep It Up! 2.0 | Behavioural | Keep It Up! Intervention |
| HIV Knowledge Control | Behavioural | HIV Knowledge Control |
Primary outcome
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months
Time frame: Baseline, 3 Months
Change in self-report of condomless anal sex acts at three months.
Participants Self-Reporting Condomless Anal Sex at Baseline and 6 Months
Time frame: Baseline, 6 Months
Change in self-report of condomless anal sex acts at six months.
Participants Self-Reporting Condomless Anal Sex at Baseline and 12 Months
Time frame: Baseline, 12 Months
Change in self-report of condomless anal sex acts at twelve months.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at Baseline
Time frame: Baseline
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at baseline.
Number of Participants With Occurrence of Sexually Transmitted Infections (STIs) at 12 Months
Time frame: 12 months
The incidence (number of new cases or diagnoses) of chlamydia and gonorrhea at twelve months.
14 secondary outcomes
Mean Score of Condom Errors at Baseline and 3 Months
Time frame: Baseline, 3 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 3 Months
Time frame: Baseline, 3 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 3 Months
Time frame: Baseline, 3 Months
Mean Score of Health Protective Communication Skills at Baseline and 3 Months
Time frame: Baseline, 3 Months
Number of Participants Reporting Drug Use Before Sex at Baseline and 12 Months
Time frame: Baseline, 12 Month
Mean Score of Condom Errors at Baseline and 6 Months
Time frame: Baseline, 6 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 6 Months
Time frame: Baseline, 6 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 6 Months
Time frame: Baseline, 6 Months
Mean Score of Health Protective Communication Skills at Baseline and 6 Months
Time frame: Baseline, 6 Months
Mean Score of Condom Errors at Baseline and 12 Months
Time frame: Baseline, 12 Months
Percentage of Correct Responses on HIV Knowledge Assessment at Baseline and 12 Months
Time frame: Baseline, 12 Months
Mean Score of Motivation and Behavioral Skills at Baseline and 12 Months
Time frame: Baseline, 12 Months
Mean Score of Health Protective Communication Skills at Baseline and 12 Months
Time frame: Baseline, 12 Months
Mean Score of Feelings of HIV Invulnerability at Baseline and 12 Months
Time frame: Baseline, 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCenters for Disease Control and Prevention (CDC). HIV Surveillance in Adolescents and Young Adults. 2010.
- Background: PubMed 18583954Centers for Disease Control and Prevention (CDC). Trends in HIV/AIDS diagnoses among men who have sex with men--33 states, 2001-2006. MMWR Morb Mortal Wkly Rep. 2008 Jun 27;57(25):681-6.
- Background: PubMed 21826193Prejean J, Song R, Hernandez A, Ziebell R, Green T, Walker F, Lin LS, An Q, Mermin J, Lansky A, Hall HI; HIV Incidence Surveillance Group. Estimated HIV incidence in the United States, 2006-2009. PLoS One. 2011;6(8):e17502. doi: 10.1371/journal.pone.0017502. Epub 2011 Aug 3.
- Background: PubMed 20182787Mustanski B, Lyons T, Garcia SC. Internet use and sexual health of young men who have sex with men: a mixed-methods study. Arch Sex Behav. 2011 Apr;40(2):289-300. doi: 10.1007/s10508-009-9596-1. Epub 2010 Feb 25.
- Derived from this study: PubMed 29937115Mustanski B, Parsons JT, Sullivan PS, Madkins K, Rosenberg E, Swann G. Biomedical and Behavioral Outcomes of Keep It Up!: An eHealth HIV Prevention Program RCT. Am J Prev Med. 2018 Aug;55(2):151-158. doi: 10.1016/j.amepre.2018.04.026. Epub 2018 Jun 28.
- Derived from this study: PubMed 28062389Mustanski B, Madkins K, Greene GJ, Parsons JT, Johnson BA, Sullivan P, Bass M, Abel R. Internet-Based HIV Prevention With At-Home Sexually Transmitted Infection Testing for Young Men Having Sex With Men: Study Protocol of a Randomized Controlled Trial of Keep It Up! 2.0. JMIR Res Protoc. 2017 Jan 7;6(1):e1. doi: 10.2196/resprot.5740.
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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.
Brian Mustanski, PhD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keep It Up! in people with HIV and Gonorrhea, run by Northwestern University at 3 sites 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 4 inclusion and 5 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 15 Aug 2022. 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 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?
Yes. Results are posted in the registry (first posted 11 Jul 2018). 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?
Participants Self-Reporting Condomless Anal Sex at Baseline and 3 Months (time frame: Baseline, 3 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 NCT01836445, which also lists 6 linked publications.
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 15 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.