Clinical trial NCT02113956: Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
Official title: Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV Prevention
Adolescent Men who Have Sex with Men (AMSM)
Text-Messaging
Information-Motivation-Behavioral Skills(IMB)Model
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: National Institute of Mental Health (NIMH)
First posted: 2014-04-15
Enrollment: 302
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: The Number of Condomless Sex Acts at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Percent of Boys Reporting Abstinence at 3-months Post-intervention
timeFrame: 3-months post-intervention
Secondary outcomes:
measure: Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention
timeFrame: 3-months post-intervention
measure: Number of Condomless Sex Acts at 5 Weeks Post-enrollment
timeFrame: Intervention end (5-weeks post enrollment)
measure: Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment
timeFrame: Intervention-end (5 weeks post-randomization)
measure: Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment
timeFrame: Intervention end (5-weeks post enrollment)
measure: Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment
timeFrame: Intervention end (5-weeks post enrollment)
measure: Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment
timeFrame: Intervention end (5-weeks post enrollment)
measure: Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment
timeFrame: Intervention end (5 weeks post enrollment)
measure: Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment
timeFrame: Intervention end (5 weeks post enrollment)
Other outcomes:
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Center for Innovative Public Health Research
name: Michele L Ybarra, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Brian S Mustanski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.