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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113956
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : June 4, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
Northwestern University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Tracking Information
First Submitted Date  ICMJE April 10, 2014
First Posted Date  ICMJE April 15, 2014
Results First Submitted Date  ICMJE March 6, 2019
Results First Posted Date  ICMJE June 4, 2019
Last Update Posted Date April 10, 2020
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
Unprotected anal sex acts [ Time Frame: 3-months post-intervention ]
A comparison of ever engaging in unprotected anal sex (yes/no) in the intervention versus control group at 3-months post-intervention
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2014)
  • Sexual abstinence [ Time Frame: 3-months post-intervention ]
    A comparison of not having anal or vaginal sex with a penis (yes/no) in the intervention versus control group at 3-months post-intervention
  • Increase in HIV testing rates [ Time Frame: 3-months post-intervention ]
    A comparison of being tested for HIV (yes/no) in the intervention versus control group at 3-months post-intervention among those who have ever had vaginal or anal sex with a penis
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 11, 2014)
  • Participant rating of intervention acceptability and tolerability [ Time Frame: 3-months post-intervention ]
    Measured by Tarnowski and Simonian's measure of Intervention acceptability and tolerability which includes a combination of open-ended questions (e.g. "What aspect of the program did you like the least?") and closed-ended Likert-style questions
  • Intervention feasibility: Online protocol [ Time Frame: Up to 5 months prior to final participant being enrolled in study ]
    Measured by the amount of time needed to recruit all study participants. Online protocol feasibility will be defined as achieving a recruitment rate of at least 40 participants per month.
  • Intervention feasibility: Retention [ Time Frame: 3-months post-intervention ]
    Measured by achieving an 80% 3-month retention rate
 
Descriptive Information
Brief Title  ICMJE Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
Official Title  ICMJE Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE HIV
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Guy2Guy (G2G)
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 24, 2014)
302
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2014)
184
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113956
Other Study ID Numbers  ICMJE Pro00007481
1R01MH096660-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Center for Innovative Public Health Research
Study Sponsor  ICMJE Center for Innovative Public Health Research
Collaborators  ICMJE
  • Northwestern University
  • National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Michele L Ybarra, PhD Center for Innovative Public Health Research
Principal Investigator: Brian S Mustanski, PhD Northwestern University
PRS Account Center for Innovative Public Health Research
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP