Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior (G2G)

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.

Study Overview

• Status: Completed
• Conditions: HIV
• Intervention / Treatment: Behavioral: Guy2Guy (G2G)

Detailed Description

Adolescent men who have sex with men (AMSM) are disproportionately affected by HIV. They account for almost 70% of HIV diagnoses among all young people and are the only risk group with an increasing number of HIV/AIDS diagnoses. Despite this disproportionate burden, current HIV prevention programs focus primarily on adults and heterosexual youth. As such, there is an urgent need for evidence-based HIV prevention programs targeting AMSM. Because issues affecting sexual health decisions among AMSM are unique, intervention programs cannot be translated from heterosexually focused interventions. Instead, they need to be designed from the ground up to ensure appropriately tailored content that resonates with the target population. Evidence-based HIV prevention programs targeting AMSM are urgently needed.

The Guy2Guy (G2G) intervention is a text messaging-based HIV prevention program designed for the specific needs of adolescent males who self-identify as gay, bisexual, or queer (GBQ) and are between the ages of 14-18 years. The intervention will be tested in a randomized controlled trial against an attention-matched control group which receives text messages about healthy lifestyle (e.g., exercise, nutrition). A total of 300 GBQ adolescent males will be into the study using an online recruitment strategy. The study is being conducted by researchers at the Center for Innovative Public Health Research and Northwestern University.

The primary efficacy outcome measures are unprotected sex acts and abstinence at 3-months follow-up. The investigators hypothesize that those in the G2G intervention will be significantly more likely to be engage in HIV preventive behavior (e.g., use condoms when having vaginal/anal sex) at 3-months follow-up compared to the attention-matched control group. Secondary efficacy outcomes include unprotected sex acts and abstinence at 3-month follow-up by sexual experience groups (i.e., ever had sex versus never had sex at baseline), HIV testing rates, and unprotected sex acts and abstinence at intervention end (5 weeks post enrollment) for those in the intervention versus control groups; and for participants who were sexually experienced and inexperienced at baseline, separately.

If effective, G2G has promise to be quickly and cost-effectively implemented to scale to help to curb the spread of HIV infection among AMSM long into adulthood.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Clemente, California, United States, 92672-6745
      • Center for Innovative Public Health Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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"

Exclusion Criteria:

• Female or Transgender
• Participated in earlier study development activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guy2Guy (G2G); 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); 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.
No Intervention: Healthy Lifestyle Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Unprotected Sex Acts Among Sexually Experienced 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 among youth who have ever had sex at baseline	3-months post-intervention
Number of Unprotected Sex Acts Among Sexually Inexperienced 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 among youth who have never had sex at baseline	3-months post-intervention
Percent of Boys Reporting Abstinence Among Sexually Experienced 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 among youth who have ever had sex at baseline in the intervention versus control groups.	3-months post-intervention
Percent of Boys Reporting Abstinence Among Sexually Inexperienced 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 among youth who have never had sex at baseline in the intervention versus control groups.	3-months post-intervention
Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention	The relative difference of HIV testing over the past 3 months in the intervention versus control group at 3-months post-intervention among those who had ever vaginal or anal sex with a penis at baseline	3-months post-intervention
Number of Condomless Sex Acts at 5 Weeks Post-enrollment	Relative difference of unprotected sex acts at intervention end (5 weeks post enrollment) for those in the intervention versus control groups	Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment	The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at intervention end (5 weeks post enrollment).	Intervention-end (5 weeks post-randomization)
Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment	The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group intervention end (5 weeks post enrollment) among youth who have ever had sex at baseline	Intervention end (5-weeks post enrollment)
Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment	The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at at intervention end (5 weeks post enrollment) among youth who have never had sex at baseline	Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment	At 5 weeks post-enrollment, participants were asked whether or not they had had vaginal and anal sex since the beginning of the program. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have ever had sex at baseline in the intervention versus control groups.	Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment	At 5 weeks post-enrollment, participants were asked whether or not they had had vaginal and anal sex since the beginning of the program. Those who said no to both were coded as abstinent. The relative difference of abstinence (neither engaging in anal nor vaginal sex) was examined among youth who have never had sex at baseline in the intervention versus control groups.	Intervention end (5 weeks post enrollment)
Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment	The relative difference of HIV testing since the beginning of the program in the intervention versus control group at intervention end (5 weeks post enrollment) among those who ever had vaginal or anal sex with a penis at baseline	Intervention end (5 weeks post enrollment)

Collaborators and Investigators

• Sponsor: Center for Innovative Public Health Research
• Collaborators: National Institute of Mental Health (NIMH); Northwestern University
• Investigators: Principal Investigator: Brian S Mustanski, PhD, Northwestern University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Actual): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: HIV Prevention; Text-Messaging; Information-Motivation-Behavioral Skills(IMB)Model; Adolescent Men who Have Sex with Men (AMSM)
• Other Study ID Numbers: Pro00007481; 1R01MH096660-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO