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

HIV Clinical Trial

— G2G  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113956
• Other study ID #: Pro00007481
• Secondary ID: 1R01MH096660-01A
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2020
• Source: Center for Innovative Public Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 14 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	Center for Innovative Public Health Research	San Clemente	California

Sponsors (3)

Lead Sponsor	Collaborator
Center for Innovative Public Health Research	National Institute of Mental Health (NIMH), Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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 — View 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. — View 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). pii: e20162999. doi: 10.1542/peds.2016-2999. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Condomless Sex Acts at 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.	3-months post-intervention
Primary	Percent of Boys Reporting Abstinence at 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.	3-months post-intervention
Secondary	Number of Unprotected Sex Acts Among Sexually Experienced at 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	3-months post-intervention
Secondary	Number of Unprotected Sex Acts Among Sexually Inexperienced at 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-months post-intervention
Secondary	Percent of Boys Reporting Abstinence Among Sexually Experienced at 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.	3-months post-intervention
Secondary	Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 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.	3-months post-intervention
Secondary	Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 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	3-months post-intervention
Secondary	Number of Condomless Sex Acts at 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	Intervention end (5-weeks post enrollment)
Secondary	Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment	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).	Intervention-end (5 weeks post-randomization)
Secondary	Number of Unprotected Sex Acts Among Sexually Experienced Boys at 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	Intervention end (5-weeks post enrollment)
Secondary	Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 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	Intervention end (5-weeks post enrollment)
Secondary	Percent of Boys Reporting Abstinence Among Sexually Experienced at 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.	Intervention end (5-weeks post enrollment)
Secondary	Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 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.	Intervention end (5 weeks post enrollment)
Secondary	Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 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	Intervention end (5 weeks post enrollment)