HIVG2GNCT02113956
Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
A study testing Guy2Guy (G2G) in people with HIV, run by Center for Innovative Public Health Research at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Guy2Guy (G2G)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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"
Who cannot join
- Female or Transgender
- Participated in earlier study development activities
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
Center for Innovative Public Health Research
San Clemente, California, 92672-6745
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Guy2Guy (G2G)
- Keywords
- HIV Prevention, Adolescent Men who Have Sex with Men (AMSM), Text-Messaging, Information-Motivation-Behavioral Skills(IMB)Model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guy2Guy (G2G)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Guy2Guy (G2G) | Experimental | 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. Receives: Behavioral: Guy2Guy (G2G) |
| Healthy Lifestyle Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-months post-intervention
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.
Measured: 3-months post-intervention
Secondary outcomes (12)
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
Measured: 3-months post-intervention
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
Measured: 3-months post-intervention
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.
Measured: 3-months post-intervention
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.
Measured: 3-months post-intervention
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
Measured: 3-months post-intervention
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
Measured: Intervention end (5-weeks post enrollment)
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).
Measured: Intervention-end (5 weeks post-randomization)
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
Measured: Intervention end (5-weeks post enrollment)
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
Measured: Intervention end (5-weeks post enrollment)
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.
Measured: Intervention end (5-weeks post enrollment)
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.
Measured: Intervention end (5 weeks post enrollment)
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
Measured: Intervention end (5 weeks post enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michele L Ybarra, PhD, Principal investigator, Center for Innovative Public Health ResearchBrian S Mustanski, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113956
- Sponsor's protocol ID
- Pro00007481
- Other IDs
- 1R01MH096660-01A1
- Acronym
- G2G
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2014
- Last updated
- 10 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27492781Ybarra 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.
PubMed 27185621Phillips 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.
PubMed 26318671Ybarra 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.
PubMed 26238038DuBois 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.
PubMed 25925896Ybarra 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.
PubMed 25490735Mustanski 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.
PubMed 24906532Ybarra 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.
PubMed 29696403Ybarra 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.
PubMed 28659456
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Text Messaging to Invigorate AMSM HIV Preventive Behavior
- ClinicalTrials.gov ID
- NCT02113956
- Acronym / sponsor ID
- G2G / Pro00007481
- Conditions
- HIV
- Keywords
- HIV Prevention, Adolescent Men who Have Sex with Men (AMSM), Text-Messaging, Information-Motivation-Behavioral Skills(IMB)Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Collaborators
- Northwestern University, National Institute of Mental Health (NIMH)
- Study start
- Jun 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guy2Guy (G2G) | Experimental | Behavioral: 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. |
| Healthy Lifestyle Control | No intervention | –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. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Self-identified as gay, bisexual, or queer
- Male biological sex
- Male gender
- Between the ages of 14-18
- English speaking
Key exclusion criteria (2 listed)
- Female or Transgender
- Participated in earlier study development activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Guy2Guy (G2G) |
Primary outcome
The Number of Condomless Sex Acts at 3-months Post-intervention
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. The count was truncated at 10 or higher to correct for over-dispersion.
Percent of Boys Reporting Abstinence at 3-months Post-intervention
Time frame: 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.
12 secondary outcomes
Number of Unprotected Sex Acts Among Sexually Experienced at 3-months Post-intervention
Time frame: 3-months post-intervention
Number of Unprotected Sex Acts Among Sexually Inexperienced at 3-months Post-intervention
Time frame: 3-months post-intervention
Percent of Boys Reporting Abstinence Among Sexually Experienced at 3-months Post-intervention
Time frame: 3-months post-intervention
Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 3-months Post-intervention
Time frame: 3-months post-intervention
Percent of Sexually Active Boys Reporting an HIV Test in the Past 3 Months at 3-months Post-intervention
Time frame: 3-months post-intervention
Number of Condomless Sex Acts at 5 Weeks Post-enrollment
Time frame: Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence at 5 Weeks Post-enrollment
Time frame: Intervention-end (5 weeks post-randomization)
Number of Unprotected Sex Acts Among Sexually Experienced Boys at 5 Weeks Post-enrollment
Time frame: Intervention end (5-weeks post enrollment)
Number of Unprotected Sex Acts Among Sexually Inexperienced Boys at 5 Weeks Post-enrollment
Time frame: Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence Among Sexually Experienced at 5 Weeks Post-enrollment
Time frame: Intervention end (5-weeks post enrollment)
Percent of Boys Reporting Abstinence Among Sexually Inexperienced at 5 Weeks Post-enrollment
Time frame: Intervention end (5 weeks post enrollment)
Percent of Sexually Experienced Boys Reporting Being Tested for HIV Since Program Start at 5 Weeks Post-enrollment
Time frame: Intervention end (5 weeks post enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27492781Prescott 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.
- Background: PubMed 27185621Ybarra 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.
- Background: PubMed 26318671Phillips 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.
- Background: PubMed 26238038Ybarra 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.
- Background: PubMed 25925896DuBois 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.
- Background: PubMed 25490735Ybarra 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.
- Background: PubMed 24906532Mustanski 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.
- Results publication: PubMed 29696403Ybarra 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.
- Results publication: PubMed 28659456Ybarra 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele L Ybarra, PhD principal investigator
Center for Innovative Public Health Research
Brian S Mustanski, PhD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guy2Guy (G2G) in people with HIV, run by Center for Innovative Public Health Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Condomless Sex Acts at 3-months Post-intervention (time frame: 3-months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02113956, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2020.