Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Center for Innovative Public Health Research

Collaborator
Northwestern University
National Institute of Mental Health (NIMH)

Information provided by (Responsible Party)
Center for Innovative Public Health Research
ClinicalTrials.gov Identifier
NCT02113956

First received: April 10, 2014
Last updated: April 9, 2020
Last Verified: April 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV

Behavioral : Guy2Guy (G2G)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior

Further study details as provided by Center for Innovative Public Health Research:

Primary Outcome Measures

  • The Number of Condomless Sex Acts at 3-months Post-intervention [ Time Frame: 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.
  • Percent of Boys Reporting Abstinence at 3-months Post-intervention [ Time Frame: 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.
Secondary Outcome Measures:
  • Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention [ Time Frame: 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
  • Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention [ Time Frame: 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
  • Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention [ Time Frame: 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.
  • Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention [ Time Frame: 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.
  • Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention [ Time Frame: 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
  • Number of Condomless Sex Acts at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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
  • Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment [ Time Frame: Intervention-end (5 weeks post-randomization) ]
    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).
  • Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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
  • Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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
  • Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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.
  • Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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.
  • Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment [ Time Frame: Intervention end (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

Enrollment: 302
Study Start Date: June 2014
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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.

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.

Eligibility

Eligibility

Ages Eligible for Study: 14 Years to 18 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

Criteria

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

contacts and locations

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02113956

Locations

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

Sponsors and Collaborators

Center for Innovative Public Health Research
Northwestern University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Michele L Ybarra, PhD Center for Innovative Public Health Research
Principal Investigator: Brian S Mustanski, PhD Northwestern University
More Information

More Information


Responsible Party: Center for Innovative Public Health Research  
ClinicalTrials.gov Identifier: NCT02113956   History of Changes  
Other Study ID Numbers: Pro00007481  
  1R01MH096660-01A1  
Study First Received: April 10, 2014  
Last Updated: April 9, 2020  
Individual Participant Data    
Plan to Share IPD: No  

Keywords provided by Center for Innovative Public Health Research:

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

ClinicalTrials.gov processed this data on May 24, 2020
This information is provided by ClinicalTrials.gov.