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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northwestern University
Information provided by (Responsible Party):
Michele Ybarra, Center for Innovative Public Health Research
ClinicalTrials.gov Identifier:
NCT02113956
First received: April 10, 2014
Last updated: November 24, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to compare two different versions of a text-messaging based healthy sexuality and human immunodeficiency virus (HIV) prevention program to determine whether the Guy2Guy (G2G) intervention is effective at promoting HIV prevention behavior (e.g., frequency of unprotected anal sex acts) compared to the attention-matched control group.


Condition Intervention
HIV
Behavioral: Guy2Guy (G2G)
Behavioral: Healthy Lifestyle Control

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Unprotected sex acts [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    The relative difference of unprotected anal and/or vaginal sex acts in the intervention versus control group at 3-months post-intervention

  • Abstinence [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at 3-months post-intervention


Secondary Outcome Measures:
  • Unprotected sex acts by sexual experience group [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    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; and among youth who have never had sex at baseline

  • Abstinence by sexual experience group [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    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; and among youth who have never had sex at baseline

  • Intervention end outcomes [ Time Frame: 5-weeks post enrollment ] [ Designated as safety issue: No ]
    Relative difference of: 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

  • Increased HIV testing rates [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    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 have ever had vaginal or anal sex with a penis


Other Outcome Measures:
  • Participant rating of intervention acceptability and tolerability [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measured by achieving an 80% 3-month retention rate


Enrollment: 302
Study Start Date: June 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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. Participants are matched with another participant (i.e., a "Text Buddy") with whom they can text for support throughout the program. Intervention participants will have access to "G2Genie", an automated service which provides tips and information on topics on demand.
Active Comparator: 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.
Behavioral: Healthy Lifestyle Control

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 by sexual experience groups (i.e., ever had sex versus never had sex at baseline), increased 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

Ages Eligible for Study:   14 Years to 18 Years
Genders 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
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
Investigators
Principal Investigator: Michele L Ybarra, PhD Center for Innovative Public Health Research
Principal Investigator: Brian S Mustanski, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Michele Ybarra, President and Research Director, 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: November 24, 2014
Health Authority: United States: Institutional Review Board

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 record on November 27, 2014