Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior (G2G)
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|ClinicalTrials.gov Identifier: NCT02113956|
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Behavioral: Guy2Guy (G2G)||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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.
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.
- Unprotected sex acts [ 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
- Abstinence [ Time Frame: 3-months post-intervention ]The relative difference of abstinence (neither engaging in anal nor vaginal sex) in the intervention versus control group at 3-months post-intervention
- Unprotected sex acts by sexual experience group [ 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; and among youth who have never had sex at baseline
- Abstinence by sexual experience group [ 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; and among youth who have never had sex at baseline
- Intervention end outcomes [ Time Frame: 5-weeks post enrollment ]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 ]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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113956
|United States, California|
|Center for Innovative Public Health Research|
|San Clemente, California, United States, 92672-6745|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Michele L Ybarra, PhD||Center for Innovative Public Health Research|
|Principal Investigator:||Brian S Mustanski, PhD||Northwestern University|