Homosexuality, MaleNCT01771237
HIV Prevention Among Vulnerable Male Youth
A study testing MyPeeps Manualized Group Intervention and Standard Sexual Health Education in people with Homosexuality, Male and HIV, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
This exploratory study aims to design and test an HIV prevention intervention for young men who have sex with men (MSM) between the ages of 16-20 as this group comprises the US adolescent population most at-risk for HIV infection through sexual contact. Read more about this study
- Who is it for?
- Ages 16 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Homosexuality, Male, HIV, Substance-related Disorders
- What is being tested?
- MyPeeps Manualized Group Intervention and Standard Sexual Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2011
- 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 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- able to speak and read English
- age 16-20
- biological/cisgender male
- willing and able to provide assent/consent
- HIV-negative or of an unknown HIV serostatus
- sexually active with male partner in past 12 mos.
- willing to provide locator information
Who cannot join
- unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- active suicidal ideation at the time of baseline interview
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Feasibility and Acceptability Trial of Behavioral Group-based HIV Prevention Intervention for Young Men Who Have Sex With Men (YMSM).
This exploratory study aims to design and test an HIV prevention intervention for young men who have sex with men (MSM) between the ages of 16-20 as this group comprises the US adolescent population most at-risk for HIV infection through sexual contact. To help develop the content and format of our intervention we will first conduct in-depth interviews with twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact between ages 16-20 (i.e., the target age of our intended intervention). We will then design a group-based primary intervention for young MSM between ages 16-20, relying on the information we gathered from these interviews, as well as consultation from an advisory board of young MSM and HIV prevention experts. Last, we will use an experimental design to compare our intervention to a control condition. We hypothesize that, relative to a control condition of sexual health education and risk reduction, participants in our intervention will demonstrate lower rates of HIV risk behavior, find participation more feasible, and endorse greater acceptability of our intervention.
Read the detailed description
The purpose of this three year study is to develop and then test the feasibility and acceptability of a uniquely targeted HIV risk reduction intervention for young men who have sex with men (MSM), ages 16 to 20, at risk for HIV acquisition or transmission. In year one, the preliminary components of a primary prevention intervention for young MSM aged 16-20 will result from the findings of qualitative interviews conducted among a multiethnic sample of 21 young MSM (aged 18-24) who acquired HIV through male-to-male sexual contact between ages 16-20. In year two, a preliminary primary prevention intervention curriculum will be completed and subsequently refined through community advisory board review. In year three, the feasibility and acceptability of the intervention will be tested in a two-arm randomized controlled trial in a community-based agency with excellent access to and research experience with the population. We will enroll 100 at-risk young MSM ages 16-20; two-thirds of the sample (N=66)will be randomized to the intervention condition while one-third (N=34) will be randomized to the time-matched attention control condition and receive standard health promotion information in a group-based format. Sexual risk will be assessed at baseline, 6, and 12 weeks post-intervention. The specific aims of this exploratory study are: 1) to design an HIV and substance use primary prevention program for 16-20 year-old urban, ethnically-diverse YMSM; 2) to pilot test and refine study methods; 3) to test the revised multi-ethnic intervention with 100 young YMSM and examine preliminary effects on risky sexual behavior, alcohol/drug use, and psychosocial intermediate outcomes specified by our theoretical framework in preparation for a large-scale, efficacy study. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample.
- Being tested
- MyPeeps Manualized Group Intervention, Standard Sexual Health Education
- Keywords
- HIV infection
- Medical subject headings
- Homosexuality, Male, Substance-Related Disorders, Sexual Dysfunctions, Psychological, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyPeeps Manualized Group InterventionBehavioural
Also called MyPeeps Intervention
Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
Standard Sexual Health EducationBehavioural
Also called Sexual health education-as-usual
Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
| Study group | Role | What they receive |
|---|---|---|
| MyPeeps Manualized Group Intervention | Experimental | Highly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM. Receives: Behavioral: MyPeeps Manualized Group Intervention |
| Standard Sexual Health Education | Active comparator | Educational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM. Receives: Behavioral: Standard Sexual Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA)
The ARBA assesses changes in substance use (i.e, type of drugs, number of times, method), sexual behavior (e.g., frequency of condom use, frequency of sex with high-risk partners, frequency of sex while using drugs or alcohol, number of partners, frequency of vaginal, oral, and anal sex, and age of sexual debut) and lifetime needle use (e.g., any history of tattooing, sharing, and piercing) across three time periods (i.e., 2 weeks preintervention, 6 week postintervention, and 12 week postintervention).
Measured: Baseline, 6- and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionJan 2011
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 Homosexuality, MaleStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Howard Brown Health Center
- Responsible party
- Sponsor
- Investigators
- Robert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771237
- Sponsor's protocol ID
- R34MH079707
- Status last verified
- Jan 2021
- First submitted
- 18 Dec 2012
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hidalgo MA, Kuhns LM, Hotton AL, Johnson AK, Mustanski B, Garofalo R. The MyPEEPS randomized controlled trial: a pilot of preliminary efficacy, feasibility, and acceptability of a group-level, HIV risk reduction intervention for young men who have sex with men. Arch Sex Behav. 2015 Feb;44(2):475-85. doi: 10.1007/s10508-014-0347-6. Epub 2014 Aug 19.
PubMed 25135064
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Trial of Behavioral Group-based HIV Prevention Intervention for Young Men Who Have Sex With Men (YMSM).
- ClinicalTrials.gov ID
- NCT01771237
- Acronym / sponsor ID
- R34MH079707
- Keywords
- HIV infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Howard Brown Health Center
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Jan 2013 (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 exploratory study aims to design and test an HIV prevention intervention for young men who have sex with men (MSM) between the ages of 16-20 as this group comprises the US adolescent population most at-risk for HIV infection through sexual contact. To help develop the content and format of our intervention we will first conduct in-depth interviews with twenty-one 18 to 24 year-old young MSM who acquired HIV through male-to-male sexual contact between ages 16-20 (i.e., the target age of our intended intervention). We will then design a group-based primary intervention for young MSM between ages 16-20, relying on the information we gathered from these interviews, as well as consultation from an advisory board of young MSM and HIV prevention experts. Last, we will use an experimental design to compare our intervention to a control condition. We hypothesize that, relative to a control condition of sexual health education and risk reduction, participants in our intervention will demonstrate lower rates of HIV risk behavior, find participation more feasible, and endorse greater acceptability of our intervention.
Detailed description
The purpose of this three year study is to develop and then test the feasibility and acceptability of a uniquely targeted HIV risk reduction intervention for young men who have sex with men (MSM), ages 16 to 20, at risk for HIV acquisition or transmission. In year one, the preliminary components of a primary prevention intervention for young MSM aged 16-20 will result from the findings of qualitative interviews conducted among a multiethnic sample of 21 young MSM (aged 18-24) who acquired HIV through male-to-male sexual contact between ages 16-20. In year two, a preliminary primary prevention intervention curriculum will be completed and subsequently refined through community advisory board review. In year three, the feasibility and acceptability of the intervention will be tested in a two-arm randomized controlled trial in a community-based agency with excellent access to and research experience with the population. We will enroll 100 at-risk young MSM ages 16-20; two-thirds of the sample (N=66)will be randomized to the intervention condition while one-third (N=34) will be randomized to the time-matched attention control condition and receive standard health promotion information in a group-based format. Sexual risk will be assessed at baseline, 6, and 12 weeks post-intervention. The specific aims of this exploratory study are: 1) to design an HIV and substance use primary prevention program for 16-20 year-old urban, ethnically-diverse YMSM; 2) to pilot test and refine study methods; 3) to test the revised multi-ethnic intervention with 100 young YMSM and examine preliminary effects on risky sexual behavior, alcohol/drug use, and psychosocial intermediate outcomes specified by our theoretical framework in preparation for a large-scale, efficacy study. An additional exploratory aim is to describe the prevalence of HIV and STIs in the community recruited sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyPeeps Manualized Group Intervention | Experimental | Behavioral: MyPeeps Manualized Group InterventionHighly interactive, HIV prevention skills-based group intervention in 6 sessions. Tailored to YMSM. |
| Standard Sexual Health Education | Active comparator | Behavioral: Standard Sexual Health EducationEducational group intervention focused on HIV and STI knowledge using a lecture-based format in 6 sessions. Non-tailored to YMSM. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- able to speak and read English
- age 16-20
- biological/cisgender male
- willing and able to provide assent/consent
- HIV-negative or of an unknown HIV serostatus
Key exclusion criteria (2 listed)
- unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- active suicidal ideation at the time of baseline interview
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 |
|---|---|---|
| MyPeeps Manualized Group InterventionAlso: MyPeeps InterventionTopics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction | Behavioural | MyPeeps Manualized Group Intervention |
| Standard Sexual Health EducationAlso: Sexual health education-as-usualTopics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use | Behavioural | Standard Sexual Health Education |
Primary outcome
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA)
Time frame: Baseline, 6- and 12-week
The ARBA assesses changes in substance use (i.e, type of drugs, number of times, method), sexual behavior (e.g., frequency of condom use, frequency of sex with high-risk partners, frequency of sex while using drugs or alcohol, number of partners, frequency of vaginal, oral, and anal sex, and age of sexual debut) and lifetime needle use (e.g., any history of tattooing, sharing, and piercing) across three time periods (i.e., 2 weeks preintervention, 6 week postintervention, and 12 week postintervention).
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 27 Jan 2021.
- Results publication: PubMed 25135064Hidalgo MA, Kuhns LM, Hotton AL, Johnson AK, Mustanski B, Garofalo R. The MyPEEPS randomized controlled trial: a pilot of preliminary efficacy, feasibility, and acceptability of a group-level, HIV risk reduction intervention for young men who have sex with men. Arch Sex Behav. 2015 Feb;44(2):475-85. doi: 10.1007/s10508-014-0347-6. Epub 2014 Aug 19.
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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 Garofalo, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyPeeps Manualized Group Intervention and Standard Sexual Health Education in people with Homosexuality, Male and HIV, run by Ann & Robert H Lurie Children's Hospital 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 7 inclusion and 2 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 27 Jan 2021. 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?
Change in AIDS-risk behavior (AIDS-Risk Behavior Assessment - ARBA) (time frame: Baseline, 6- and 12-week). 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 NCT01771237, 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 27 Jan 2021.