HIV InfectionsNCT02946164
Advancing HIV Prevention and Linkage to Care Among MSM With Gamification
A study testing Stick To It in people with HIV Infections and Sexually Transmitted Diseases, run by University of California, Berkeley at 2 sites in United States.
Trial summary
This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the concept of gamification. The objective of the program is to encourage young men who have sex with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs) and to adopt safer sexual behaviors, with the… Read more about this study
- Who is it for?
- Ages 18 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Stick To It
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-26 years of age
- male
- self-identify as gay / bisexual / queer
- willing and able to provide informed consent to join the Stick To It program
- resident in one of several zip code areas surrounding the clinic
Who cannot join
- Not a resident of one of included zip code areas
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AHF Hollywood Wellness Center
Los Angeles, California, 90027
AHF Wellness Center Oakland
Oakland, California, 94606
About this study
This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the concept of gamification. The objective of the program is to encourage young men who have sex with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs) and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI incidence. Gamification is the application of game elements, like points, badges, and rewards, to non-game settings.
Read the detailed description
The investigators will conduct a quasi-experimental pilot study of 'Stick To It', a prevention intervention that uses gamification principles and mechanics. The intervention includes an online timer that reminds men to get tested, online quizzes, and peer recruitment; these activities are awarded with points redeemable for chances at prizes at participating clinics. The intervention was designed based on findings from interviews with health staff and focus groups with young MSM, and with input from a gamification consultant. The primary hypothesis is that the intervention will increase repeat HIV/STI testing among young MSM. The intervention will be implemented at two STI clinics in Oakland and Los Angeles, California in 2-week intervals for six months. The investigators will review medical records of exposed and unexposed young MSM attending the same STI clinics to compare uptake of quarterly HIV testing and self-reported behavior after six months.
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Stick To It
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stick To ItBehavioural
The intervention is a prize system linked to points earned through online and real-world activities designed to incentivize young MSM to test for HIV and STIs every three months. Participants receive points for pre-determined activities, such as: answering online quizzes, inviting friends to participate, and getting tested for HIV/STIs. Points are redeemable in person at two AIDS Healthcare Foundation Men's Wellness Centers, where participants will be able to exchange their points for gumballs from a gumball machine; different color combinations of gumballs correspond to prizes of different values. Participants are reminded to get tested regularly via SMS messages; in addition, they can check when their next test is due by checking their testing timer on the stick2it.org website.
| Study group | Role | What they receive |
|---|---|---|
| Comparison: Standard of Care | No intervention | Standard services available to all men at AHF Wellness Centers. |
| Intervention: 'Stick To It' Intervention | Active comparator | Behavioral intervention. Receives: Behavioral: Stick To It |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat HIV Testing
The number of men in the intervention who receive ≥1 additional HIV tests over 6 months of follow-up
Measured: 6 months
Secondary outcomes (1)
HIV-related risk behavior
We will determine the number of reported sex partners, the prevalence and frequency of unprotected anal intercourse with a partner of opposite or unknown status in the past 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- AIDS Healthcare Foundation, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Sandra I McCoy, PhD, Principal investigator, Assistant Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946164
- Sponsor's protocol ID
- R34MH106359
- Status last verified
- Feb 2018
- First submitted
- 25 Oct 2016
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Mejia CM, Acland D, Buzdugan R, Grimball R, Natoli L, McGrath MR, Klausner JD, McCoy SI. An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually Transmitted Infection Screening Among Young Men Who Have Sex With Men in California: Rationale and Design of Stick To It. JMIR Res Protoc. 2017 Jul 17;6(7):e140. doi: 10.2196/resprot.8064.
PubMed 28716771
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing HIV Prevention and Linkage to Care Among MSM With Gamification
- ClinicalTrials.gov ID
- NCT02946164
- Acronym / sponsor ID
- R34MH106359
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- AIDS Healthcare Foundation, University of California, Los Angeles
- Study start
- Oct 2016
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot evaluation of 'Stick To It', a behavioral intervention based on the concept of gamification. The objective of the program is to encourage young men who have sex with men (MSM) to be regularly screened for HIV and sexually transmitted infections (STIs) and to adopt safer sexual behaviors, with the ultimate goal to decrease HIV and STI incidence. Gamification is the application of game elements, like points, badges, and rewards, to non-game settings.
Detailed description
The investigators will conduct a quasi-experimental pilot study of 'Stick To It', a prevention intervention that uses gamification principles and mechanics. The intervention includes an online timer that reminds men to get tested, online quizzes, and peer recruitment; these activities are awarded with points redeemable for chances at prizes at participating clinics. The intervention was designed based on findings from interviews with health staff and focus groups with young MSM, and with input from a gamification consultant. The primary hypothesis is that the intervention will increase repeat HIV/STI testing among young MSM. The intervention will be implemented at two STI clinics in Oakland and Los Angeles, California in 2-week intervals for six months. The investigators will review medical records of exposed and unexposed young MSM attending the same STI clinics to compare uptake of quarterly HIV testing and self-reported behavior after six months.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparison: Standard of Care | No intervention | –Standard services available to all men at AHF Wellness Centers. |
| Intervention: 'Stick To It' Intervention | Active comparator | Behavioral: Stick To ItBehavioral intervention. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-26 years of age
- male
- self-identify as gay / bisexual / queer
- willing and able to provide informed consent to join the Stick To It program
- resident in one of several zip code areas surrounding the clinic
Key exclusion criteria (1 listed)
- Not a resident of one of included zip code areas
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 |
|---|---|---|
| Stick To ItThe intervention is a prize system linked to points earned through online and real-world activities designed to incentivize young MSM to test for HIV and STIs every three months. Participants receive points for pre-determined activities, such as: answering online quizzes, inviting friends to participate, and getting tested for HIV/STIs. Points are redeemable in person at two AIDS Healthcare Foundation Men's Wellness Centers, where participants will be able to exchange their points for gumballs from a gumball machine; different color combinations of gumballs correspond to prizes of different values. Participants are reminded to get tested regularly via SMS messages; in addition, they can check when their next test is due by checking their testing timer on the stick2it.org website. | Behavioural | Intervention: 'Stick To It' Intervention |
Primary outcome
Repeat HIV Testing
Time frame: 6 months
The number of men in the intervention who receive ≥1 additional HIV tests over 6 months of follow-up
1 secondary outcome
HIV-related risk behavior
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Derived from this study: PubMed 28716771Mejia CM, Acland D, Buzdugan R, Grimball R, Natoli L, McGrath MR, Klausner JD, McCoy SI. An Intervention Using Gamification to Increase Human Immunodeficiency Virus and Sexually Transmitted Infection Screening Among Young Men Who Have Sex With Men in California: Rationale and Design of Stick To It. JMIR Res Protoc. 2017 Jul 17;6(7):e140. doi: 10.2196/resprot.8064.
- 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.
Sandra I McCoy, PhD principal investigator
Assistant Adjunct Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stick To It in people with HIV Infections and Sexually Transmitted Diseases, run by University of California, Berkeley 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 5 inclusion and 1 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 22 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Repeat HIV Testing (time frame: 6 months). 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 NCT02946164, which also lists 1 linked publication.
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 22 Feb 2018.