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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113956
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : June 4, 2019
Last Update Posted : April 10, 2020
Sponsor:
Collaborators:
Northwestern University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Center for Innovative Public Health Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition HIV
Intervention Behavioral: Guy2Guy (G2G)
Enrollment 302
Recruitment Details All participants were recruited through national advertisements on Facebook. Multiple ad images and text were used. To ensure a demographically representative sample, targeted ads were also used to enroll individuals from particular subgroups who are typically more difficult to engage in research
Pre-assignment Details  
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description

Guy2Guy (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 were 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 LGBT (lesbian, gay, bisexual, transgender) community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored by sexual experience.

The attention-matched control arm message content consists of information publicly available online related to living a healthy lifestyle. Content discussed includes: STD (sexual transmitted diseases) 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.
Period Title: Intervention End (5 Weeks Post Baseline)
Started 150 152
Completed 141 148
Not Completed 9 4
Reason Not Completed
Withdrawal by Subject             5             1
Lost to Follow-up             4             3
Period Title: 3 Month Post-intervention
Started 141 148
Completed 137 146
Not Completed 4 2
Reason Not Completed
Lost to Follow-up             4             2
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control Total
Hide Arm/Group Description

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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. Total of all reporting groups
Overall Number of Baseline Participants 150 152 302
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age (y) Number Analyzed 150 participants 152 participants 302 participants
14
23
  15.3%
21
  13.8%
44
  14.6%
15
37
  24.7%
33
  21.7%
70
  23.2%
16
33
  22.0%
30
  19.7%
63
  20.9%
17
36
  24.0%
23
  15.1%
59
  19.5%
18
21
  14.0%
45
  29.6%
66
  21.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
150
 100.0%
152
 100.0%
302
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
Hispanic or Latino
31
  20.7%
36
  23.7%
67
  22.2%
Not Hispanic or Latino
119
  79.3%
116
  76.3%
235
  77.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 150 participants 152 participants 302 participants
White
104
  69.3%
100
  65.8%
204
  67.5%
African American
24
  16.0%
19
  12.5%
43
  14.2%
All other races
22
  14.7%
33
  21.7%
55
  18.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 150 participants 152 participants 302 participants
150 152 302
Gay Identity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
114
  76.0%
105
  69.1%
219
  72.5%
[1]
Measure Description: Youth reported their sexual identity
Rural Setting  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
35
  23.3%
35
  23.0%
70
  23.2%
U.S. Region  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
Northeast
20
  13.3%
26
  17.1%
46
  15.2%
South
47
  31.3%
53
  34.9%
100
  33.1%
Midwest
39
  26.0%
34
  22.4%
73
  24.2%
West
44
  29.3%
39
  25.7%
83
  27.5%
Family Income  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
Low Income
33
  22.0%
42
  27.6%
75
  24.8%
Middle Income
88
  58.7%
73
  48.0%
161
  53.3%
High Income
29
  19.3%
37
  24.3%
66
  21.9%
Ever HIV Test  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
12
   8.0%
14
   9.2%
26
   8.6%
Sexually Inexperienced  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
73
  48.7%
76
  50.0%
149
  49.3%
Number of condomless sex acts  
Mean (Standard Deviation)
Unit of measure:  Number of condomless sex acts
Number Analyzed 150 participants 152 participants 302 participants
1.3  (7.0) 2.7  (9.9) 2.02  (8.6)
Self-appraised greater than average or greater chances of getting HIV  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants 152 participants 302 participants
47
  31.3%
47
  30.9%
94
  31.1%
Social Support   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 150 participants 152 participants 302 participants
27.8  (9.4) 27.9  (9.2) 27.9  (9.3)
[1]
Measure Description: Multidimensional Scale of Perceived Social Support Total range: 0-36 Subscales for family, friends, and 'special person' are combined by summing Higher score is more positive social support
Self-esteem   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 150 participants 152 participants 302 participants
19.3  (4.9) 19.8  (4.7) 19.6  (4.8)
[1]
Measure Description: Rosenberg Self-Esteem Scale Range: 0-30 Higher scores reflect higher self-esteem
Internalized stigma   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 150 participants 152 participants 302 participants
5.9  (5.0) 5.8  (5.2) 5.9  (5.1)
[1]
Measure Description: Internalized Stigma Scale Range: 0-24 Higher scores reflect higher internalized stigma
1.Primary Outcome
Title The Number of Condomless Sex Acts at 3-months Post-intervention
Hide Description 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.
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 137 146
Mean (Standard Deviation)
Unit of Measure: number of unprotected sex acts
2.85  (12.25) 2.73  (15.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio (IRR)
Estimated Value 1.42
Confidence Interval (2-Sided) 95%
0.79 to 2.57
Estimation Comments Adjusted for age and baseline number of condomless sex acts
2.Primary Outcome
Title Percent of Boys Reporting Abstinence at 3-months Post-intervention
Hide Description 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.
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 137 146
Measure Type: Count of Participants
Unit of Measure: Participants
80
  58.4%
94
  64.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.63
Confidence Interval (2-Sided) 95%
0.36 to 1.12
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
3.Secondary Outcome
Title Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention
Hide Description 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
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Youth who had ever had sex at baseline
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 69 71
Mean (Standard Deviation)
Unit of Measure: unprotected sex acts
5.48  (16.90) 5.28  (22.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio
Estimated Value .95
Confidence Interval (2-Sided) 95%
0.45 to 2.02
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline number of condomless sex acts
4.Secondary Outcome
Title Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention
Hide Description 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
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Youth who had never had sex at baseline
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 68 75
Mean (Standard Deviation)
Unit of Measure: unprotected sex acts
.19  (.70) .31  (1.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio (IRR)
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.12 to 3.18
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline number of condomless sex acts
5.Secondary Outcome
Title Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention
Hide Description 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.
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Youth who had ever had sex at baseline
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 69 71
Measure Type: Count of Participants
Unit of Measure: Participants
23
  33.3%
33
  46.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.23 to 0.997
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
6.Secondary Outcome
Title Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention
Hide Description 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.
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Youth who had never had sex at baseline
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 68 75
Measure Type: Count of Participants
Unit of Measure: Participants
57
  83.8%
61
  81.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.38 to 2.53
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
7.Secondary Outcome
Title Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention
Hide Description 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
Time Frame 3-months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Youth who have ever had vaginal or anal sex with a penis at baseline
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 69 71
Measure Type: Count of Participants
Unit of Measure: Participants
38
  55.1%
20
  28.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.42
Confidence Interval (2-Sided) 95%
1.65 to 7.09
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of HIV testing
8.Secondary Outcome
Title Number of Condomless Sex Acts at 5 Weeks Post-enrollment
Hide Description Relative difference of unprotected sex acts at intervention end (5 weeks post enrollment) for those in the intervention versus control groups
Time Frame Intervention end (5-weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 141 148
Mean (Standard Deviation)
Unit of Measure: unprotected sex acts
1.81  (8.94) .89  (4.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Risk Ratio (IRR)
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.22 to 1.5
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline number of condomless sex acts
9.Secondary Outcome
Title Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment
Hide Description 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).
Time Frame Intervention-end (5 weeks post-randomization)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 141 148
Measure Type: Count of Participants
Unit of Measure: Participants
104
  73.8%
105
  70.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.6 to 2.09
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
10.Secondary Outcome
Title Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment
Hide Description 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
Time Frame Intervention end (5-weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 72 72
Mean (Standard Deviation)
Unit of Measure: unprotected sex acts
3.49  (12.31) 1.76  (6.57)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio (IRR)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.22 to 1.68
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline number of condomless sex acts
11.Secondary Outcome
Title Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment
Hide Description 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
Time Frame Intervention end (5-weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 145 youth who had never had sex at baseline and completed the 5 week intervention end survey.
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 69 76
Mean (Standard Deviation)
Unit of Measure: unprotected sex acts
0.6  (.48) .05  (.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Method of Estimation Estimation Parameter Incident Rate Ratio (IRR)
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
0.01 to 92.03
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline number of condomless sex acts
12.Secondary Outcome
Title Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment
Hide Description 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.
Time Frame Intervention end (5-weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
37
  51.4%
36
  50.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.93
Confidence Interval (2-Sided) 95%
0.46 to 1.88
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
13.Secondary Outcome
Title Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment
Hide Description 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.
Time Frame Intervention end (5 weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 145 youth who had never had sex at baseline and completed the 5 week intervention end survey.
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 69 76
Measure Type: Count of Participants
Unit of Measure: Participants
67
  97.1%
69
  90.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.4
Confidence Interval (2-Sided) 95%
0.88 to 16.95
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of abstinence
14.Secondary Outcome
Title Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment
Hide Description 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
Time Frame Intervention end (5 weeks post enrollment)
Hide Outcome Measure Data
Hide Analysis Population Description
Among the 144 youth who had ever had sex at baseline and completed the 5 week intervention end survey.
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description:

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
Overall Number of Participants Analyzed 72 72
Measure Type: Count of Participants
Unit of Measure: Participants
28
  38.9%
13
  18.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Guy2Guy (G2G), Healthy Lifestyle Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 3.39
Confidence Interval (2-Sided) 95%
1.52 to 7.58
Estimation Comments [Not Specified]
Other Statistical Analysis Adjusted for age and baseline rate of HIV testing
Time Frame Adverse event data were collected through the study period (i.e., from baseline to 3-month follow-up)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Guy2Guy (G2G) Healthy Lifestyle Control
Hide Arm/Group Description

Guy2Guy (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 were 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 LGBT community.

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 was reinforced using brief online videos. The intervention is 5 weeks long. A “booster” is delivered 6-weeks post-intervention end and reviews the topics. Content is tailored based upon whether one is abstinent or sexually active.

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.
All-Cause Mortality
Guy2Guy (G2G) Healthy Lifestyle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/152 (0.00%) 
Hide Serious Adverse Events
Guy2Guy (G2G) Healthy Lifestyle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/152 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Guy2Guy (G2G) Healthy Lifestyle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/150 (0.00%)   0/152 (0.00%) 
All data were collected via self-report questionnaires, so may be affected by recall and social desirability bias. The sample may not be representative of gay and bisexual youth who use the Internet less frequently or are not ‘out’ on social media.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michele Ybarra
Organization: Center for Innovative Public Health Research
Phone: 877-302-5858 ext 801
EMail: michele@innovativepublichealth.org
Other Publications:
Layout table for additonal information
Responsible Party: Center for Innovative Public Health Research
ClinicalTrials.gov Identifier: NCT02113956    
Other Study ID Numbers: Pro00007481
1R01MH096660-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 10, 2014
First Posted: April 15, 2014
Results First Submitted: March 6, 2019
Results First Posted: June 4, 2019
Last Update Posted: April 10, 2020