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Completed

NCT Number: NCT02113956

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

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.

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Key information

Conditions

HIV

Age range

14 year–18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Innovative Public Health Research, San Clemente, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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).

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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

Sponsors and collaborators

Lead sponsor

Center for Innovative Public Health Research

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Northwestern University

Registry information

Acronym: G2G

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 15, 2014
Registry last updated
Apr 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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