ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03167606
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : July 18, 2018
Sponsor:
Collaborators:
University of Washington
New York Blood Center
University of Alabama at Birmingham
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Rebecca Schnall, Columbia University

Brief Summary:

The proposed MyPEEPS Mobile intervention is a novel and evidence-driven intervention using mobile technology to deliver HIV prevention information specifically developed for at-risk young men who have sex with men (YMSM). This will be the one of the first studies to test the efficacy of a scaled-up, mobile version of an existing human immunodeficiency virus (HIV) prevention intervention originally developed for, designed by, and piloted for, a diverse group of YMSM.

MyPEEPS Mobile will be tested in an randomized controlled trial with racially and ethnically diverse HIV-negative or unknown status YMSM aged 13-18 at four geographically diverse sites: Birmingham, Chicago, New York City, and Seattle, allowing for increased generalizability of findings.


Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: MyPEEPS Mobile Not Applicable

Detailed Description:
Men who have sex with men (MSM) bear a greater burden of HIV/AIDS than any other population group in the US, comprising only 2% of the population but 56% of individuals living with HIV/AIDS. Although much of the increased incidence in HIV has been reported among YMSM, especially among racial and ethnic minority groups, and is linked to high-risk sexual behavior, there remains a dearth of evidence-based HIV prevention interventions for YMSM - and none that address racially/ethnically diverse YMSM. To address this need, this study leverages mobile technology and MyPEEPS, an existing theory-driven, multi-ethnic, group-level, evidence-based intervention for diverse YMSM. MyPEEPS is a manualized curriculum, comprised of 6 modules focusing on key intermediate social and personal factors, including knowledge (e.g., correct way to use a condom), self-efficacy for safer sex, interpersonal communication skills and behavioral skills. MyPEEPS is one of the only HIV prevention interventions in the literature that focuses on diverse adolescent MSM. Long-term sustainability of face-to face, group-level behavioral interventions, such as MyPEEPS, have been problematic for dissemination in at-risk populations, particularly among young racial and ethnic minority groups. In response to this challenge, the investigators propose to translate MyPEEPS from a face-to-face, group-based curriculum to a mobile, responsive-driven web-based platform, accessible by smartphone or other web-enabled devices, to increase accessibility and scalability for diverse YMSM. The ubiquitous nature of mobile phones in daily life, especially among 13-18 year olds, has created opportunities for health interventions in a portable format with enhanced privacy. Using a participatory approach, this study will incorporate user-centered design in the translation of the MyPEEPS intervention onto a mobile platform.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Pragmatic Clinical Trial of MyPEEPS Mobile to Improve HIV Prevention Behaviors in Diverse Adolescent MSM
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Immediate Intervention
Study participants randomized to the intervention arm will have access to the MyPEEPS Mobile for the next three months.
Behavioral: MyPEEPS Mobile
Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.

Experimental: Delayed Intervention
Participants randomized to the delayed intervention arm will not have access to MyPEEPS Mobile and will be asked to complete their surveys every 3 months and return to the study site in 9 months for a follow-up visit (at which time they will receive the MyPEEPS Mobile intervention).
Behavioral: MyPEEPS Mobile
Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.




Primary Outcome Measures :
  1. Decrease male-male sexual risk [ Time Frame: Baseline, 3 month follow up, 6 month follow up, 9 month follow up, 12 month follow up ]
    Change in Male-male sexual risk will be evaluated at all time points using the AIDS-Risk Behavior Assessment (ARBA) adapted for YMSM. Variables of interest include: total number of sex partners and condomless anal sex partners, frequencies of condomless sex acts (anal or oral), sex (anal or oral) with or without condoms under the influence of drugs/alcohol, unprotected anal intercourse under the influence of alcohol/drugs, nPEP and PrEP (if FDA approved for this age group) use and self-reported HIV/STI testing.


Secondary Outcome Measures :
  1. Change in Behavioral Intention [ Time Frame: Baseline, 3 month follow up, 6 month follow up, 9 month follow up, 12 month follow up ]
    The focus for a change in intent surrounding male-male sexual risk behaviors, specifically: intent to reduce the number of anal sex partners, the intent to reduce the number of anal sex partners with whom a condom was not used, the intent to use condoms during anal sex, the intent to get an HIV/STI test, and the intent to uptake nPEP/PrEP (if guidelines change for under 18 years old).


Other Outcome Measures:
  1. Change (decrease) in sexual behavior risk [ Time Frame: Baseline ]
    The Sexual Behavior Risk Index is a 7-item scale is a hierarchical index of sexual behavior and demonstrates good psychometric properties. It includes lower risk behaviors such as deep kissing and genital touching. Focusing solely on a single dimension f sexual behavior such as "anal sex" or high risk events like "unprotected anal sex" in an adolescent population may be difficult when some or many of the individual behaviors are rare. This measure is more sensitive to low risk sexual behaviors and thus will be able to detect more subtle changes in risk behavior among participants.

  2. Change (Increase) in self-efficacy for safer sex and situational temptation for unsafe sex [ Time Frame: Baseline, 3 month follow up, 6 month follow up, 9 month follow up, 12 month follow up ]
    The self-efficacy for safer sex and situational temptation for unsafe sex is a 10-item scale is used to assess self-efficacy in in practicing condom use and safer sex communication with a partner. A sample item is "if I didn't want to have sex with my partner, I would be able to say no."

  3. Change (Decrease) in condom use errors [ Time Frame: Baseline, 3 month follow up, 6 month follow up, 9 month follow up, 12 month follow up ]
    The condom errors survey is a 12-item questionnaire was adapted to reflect a 6-week recall period. A sample question is "when you used condoms during the last six weeks, how often was the condom put on the wrong side up so that it had to be flipped over?"

  4. Change (Increase) in health-related partner verbal communication [ Time Frame: Baseline, 3 month follow up, 6 month follow up, 9 month follow up, 12 month follow up ]
    The health-related partner verbal communication scale is a 9-item scale assesses the quality of safer sex verbal communication between partners. A sample item is "how often in the past 6 weeks have you told a new sex partner that you won't have sex unless a condom is used?"



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Self-identify as male
  • Male sex assigned at birth
  • Understand and read English
  • Live within the metropolitan area of one of the 4 sites (Birmingham (AL), Chicago, NYC, Seattle)
  • Own a smartphone
  • Same-sex attraction and either kissed another guy or intending to engage in sexual activity with another guy in next year
  • Self-report HIV-negative or unknown status

Exclusion Criteria:

  • HIV+

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03167606


Contacts
Contact: Rebecca Schnall, PhD 212-342-6886 rb897@cumc.columbia.edu
Contact: Adrienne Pichon, MPH 212-342-5106 ab3886@cumc.columbia.edu

Locations
United States, Alabama
Birmingham Aids Outreach Recruiting
Birmingham, Alabama, United States, 35233
Contact: Joshua Bruce    205-322-4197 ext 105    josh@birminghamaidsoutreach.org   
Principal Investigator: Michael Mugavero, PhD         
United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Robert Garofalo, MD, MPH    773-303-6058    RGarofalo@luriechildrens.org   
Principal Investigator: Robert Garofalo, MD, MPH         
United States, New York
Columbia University School of Nursing Recruiting
New York, New York, United States, 10032
Contact: Rebecca Schnall, PhD    212-342-6886    rb897@cumc.columbia.edu   
Contact: Adrienne Pichon, MPH    212-342-5106    ab3886@cumc.columbia.edu   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Cynthia Pearson, PhD    206-543-9441    pearsonc@uw.edu   
Principal Investigator: Cynthia Pearson, PhD         
Sponsors and Collaborators
Columbia University
University of Washington
New York Blood Center
University of Alabama at Birmingham
Ann & Robert H Lurie Children's Hospital of Chicago
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Rebecca Schnall, PhD Columbia University School of Nursing

Responsible Party: Rebecca Schnall, Mary Dickey Lindsay Assistant Professor of Disease Prevention and Health Promotion in the Faculty of Nursing, Columbia University
ClinicalTrials.gov Identifier: NCT03167606     History of Changes
Other Study ID Numbers: AAAQ6500
U01MD011279 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rebecca Schnall, Columbia University:
myPEEPS
Mobile Intervention
Human Immunodeficiency Virus (HIV)
Men who have sex with men (MSM)

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases