Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior

NCT02113956 | Completed Results

• 2 other identifiers: Pro000074811R01MH096660-01A1
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to examine whether Guy2Guy (G2G), a text messaging-based healthy sexuality and human immunodeficiency virus (HIV) prevention program intervention for 14-18 year gay, bisexual and queer men, is associated with HIV preventive behavior (e.g., condom use) compared to an attention-matched control group.

Conditions

HIV

Keywords

HIV Prevention; Adolescent Men who Have Sex with Men (AMSM); Text-Messaging; Information-Motivation-Behavioral Skills(IMB)Model

Outcome Measures

Primary Outcomes (2)

• The Number of Condomless Sex Acts at 3-months Post-intervention

  The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at 3-months post-intervention. The count was truncated at 10 or higher to correct for over-dispersion.

  3-months post-intervention

• Percent of Boys Reporting Abstinence at 3-months Post-intervention

  At 3 months post intervention participants were asked whether or not they had had vaginal and anal sex in the past 90 days. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined in the intervention versus control group.

  3-months post-intervention

Secondary Outcomes (12)

• Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention

  3-months post-intervention

• Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention

  3-months post-intervention

• Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention

  3-months post-intervention

• Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention

  3-months post-intervention

• Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention

  3-months post-intervention

Study Arms (2)

Guy2Guy (G2G)

EXPERIMENTAL

G2G is a 6-week HIV prevention program delivered daily via text messaging to 14-18 year old males who self-identify as gay, bisexual, and/or queer. In addition to program content, participants are paired with another participant (i.e., a Text Buddy) with whom they can text throughout the program to provide support; and an on-demand advice line, G2Genie, which shares information about condoms, sex, relationships, and the lesbian, gay, bisexual, transgender (LGBT) community.

Behavioral: Guy2Guy (G2G)

Healthy Lifestyle Control

NO INTERVENTION

The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD information, nutrition and sleep hygiene, self-esteem and body image, bullying, and drugs and alcohol. The control arm is 6-weeks in length (Week 6 is a review booster) and is delivered via text messaging. Messages are didactic and not tailored to user sexual experience. Additionally, the Text Buddy and G2Genie intervention program components are not available.

Interventions

Guy2Guy (G2G) BEHAVIORAL

G2G is a text messaging-based healthy sexuality and HIV prevention program specifically for 14-18 year old GBQ adolescent males. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 5 weeks long. A "booster" is delivered 6-weeks post-intervention end and reviews the topics covered in the intervention. G2G content is tailored based upon whether one is abstinent or sexually active.

Guy2Guy (G2G)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Self-identified as gay, bisexual, or queer
• Male biological sex
• Male gender
• Between the ages of 14-18
• English speaking
• Exclusive owners of a cell phone with an unlimited text messaging plan, have used text messaging for at least 6 months, and intend to have the same number for the next 6 months
• Able to provide informed assent, including an acceptable score on the "capacity to consent assessment"

You may not qualify if:

• Female or Transgender
• Participated in earlier study development activities

Sponsors & Collaborators

• Center for Innovative Public Health Research: lead
• Northwestern University: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Center for Innovative Public Health Research

San Clemente, California, 92672-6745, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (9)

• Prescott TL, Phillips Ii G, DuBois LZ, Bull SS, Mustanski B, Ybarra ML. Reaching Adolescent Gay, Bisexual, and Queer Men Online: Development and Refinement of a National Recruitment Strategy. J Med Internet Res. 2016 Aug 4;18(8):e200. doi: 10.2196/jmir.5602.

  PMID: 27492781 BACKGROUND

• Ybarra ML, Prescott TL, Phillips GL 2nd, Parsons JT, Bull SS, Mustanski B. Ethical Considerations in Recruiting Online and Implementing a Text Messaging-Based HIV Prevention Program With Gay, Bisexual, and Queer Adolescent Males. J Adolesc Health. 2016 Jul;59(1):44-9. doi: 10.1016/j.jadohealth.2016.03.020. Epub 2016 May 13.

  PMID: 27185621 BACKGROUND

• Phillips G 2nd, Ybarra ML, Prescott TL, Parsons JT, Mustanski B. Low Rates of Human Immunodeficiency Virus Testing Among Adolescent Gay, Bisexual, and Queer Men. J Adolesc Health. 2015 Oct;57(4):407-12. doi: 10.1016/j.jadohealth.2015.06.014. Epub 2015 Aug 26.

  PMID: 26318671 BACKGROUND

• Ybarra ML, Prescott TL, Philips GL 2nd, Bull SS, Parsons JT, Mustanski B. Iteratively Developing an mHealth HIV Prevention Program for Sexual Minority Adolescent Men. AIDS Behav. 2016 Jun;20(6):1157-72. doi: 10.1007/s10461-015-1146-3.

  PMID: 26238038 BACKGROUND

• DuBois LZ, Macapagal KR, Rivera Z, Prescott TL, Ybarra ML, Mustanski B. To have sex or not to have sex? An online focus group study of sexual decision making among sexually experienced and inexperienced gay and bisexual adolescent men. Arch Sex Behav. 2015 Oct;44(7):2027-40. doi: 10.1007/s10508-015-0521-5. Epub 2015 Apr 30.

  PMID: 25925896 BACKGROUND

• Ybarra ML, DuBois LZ, Parsons JT, Prescott TL, Mustanski B. Online focus groups as an HIV prevention program for gay, bisexual, and queer adolescent males. AIDS Educ Prev. 2014 Dec;26(6):554-64. doi: 10.1521/aeap.2014.26.6.554.

  PMID: 25490735 BACKGROUND

• Mustanski B, DuBois LZ, Prescott TL, Ybarra ML. A mixed-methods study of condom use and decision making among adolescent gay and bisexual males. AIDS Behav. 2014 Oct;18(10):1955-69. doi: 10.1007/s10461-014-0810-3.

  PMID: 24906532 BACKGROUND

• Ybarra ML, Liu W, Prescott TL, Phillips G 2nd, Mustanski B. The Effect of a Text Messaging Based HIV Prevention Program on Sexual Minority Male Youths: A National Evaluation of Information, Motivation and Behavioral Skills in a Randomized Controlled Trial of Guy2Guy. AIDS Behav. 2018 Oct;22(10):3335-3344. doi: 10.1007/s10461-018-2118-1.

  PMID: 29696403 RESULT

• Ybarra ML, Prescott TL, Phillips GL 2nd, Bull SS, Parsons JT, Mustanski B. Pilot RCT Results of an mHealth HIV Prevention Program for Sexual Minority Male Adolescents. Pediatrics. 2017 Jul;140(1):e20162999. doi: 10.1542/peds.2016-2999.

  PMID: 28659456 RESULT

Limitations and Caveats

All data were collected via self-report questionnaires, so may be affected by recall and social desirability bias. The sample may not be representative of gay and bisexual youth who use the Internet less frequently or are not 'out' on social media.

Results Point of Contact

• Title: Dr. Michele Ybarra
• Organization: Center for Innovative Public Health Research

michele@innovativepublichealth.org

877-302-5858

Study Officials

• Michele L Ybarra, PhD

  Center for Innovative Public Health Research

  PRINCIPAL INVESTIGATOR

• Brian S Mustanski, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 15, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 10, 2020
• Results First Posted: June 4, 2019

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)