HIV InfectionsSHAGNCT06230367
Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys
A study testing Sexual health advocacy for guys in people with HIV Infections, run by Center for Innovative Public Health Research at 2 sites in United States.
Trial summary
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Read more about this study
- Who is it for?
- Ages 13 to 22 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Sexual health advocacy for guys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 22 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- have been assigned male sex at birth and currently have a cisgender identity;
- be aged 13-22 years old;
- have had anal sex in the past 12 months;
- be English-speaking;
- exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
- have Internet access to complete online surveys;
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- provide informed assent for those under 18, and consent for those 18 years of age and older, including a capacity to consent and a positive self-safety assessment;
- Willing to take an OraQuick home test to confirm HIV negativity for youth who are 19-20 years of age or 18 years old and graduated high school. If they agree to do the test but do not upload a photo of their result, they will be eligible if they self-report a negative sero-status. Youth 18 years old who have not graduated high school, and 13-17 years of age will be asked to take a home test. If they determine that they cannot do so safely, they will be allowed to self-report their sero-status; and
- not currently enrolled in another HIV prevention program; or
- know anyone already enrolled in the RCT.
Who cannot join
- Being HIV positive
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Center for Innovative Public Health Research
San Clemente, California, 92672-6745
Michele L Ybarra, MPH PhD, 877-302-6858 ext. 801, Michele@InnovativePublicHealth.org
Michele L Ybarra, MPH PhD
- Recruiting
Center for Innovative Public Health Research
San Clemente, California, 92672
Michele Ybarra, MPH PhD, 8773026858 ext. 801, help@projectshag.com
About this study
Official title: Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.
Read the detailed description
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined.
- Conditions
- HIV Infections
- Being tested
- Sexual health advocacy for guys, Healthy lifestyle control
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual health advocacy for guysBehavioural
5 month HIV prevention program delivered via text messaging
Healthy lifestyle controlBehavioural
5 month control group program delivered via text messaging
| Study group | Role | What they receive |
|---|---|---|
| SHAG (Sexual Health Advocacy for Guys) | Experimental | Young people assigned to the intervention arm will receive ~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior. Receives: Behavioral: Sexual health advocacy for guys |
| Attention-matched control | Placebo comparator | Young people assigned to the control arm will receive ~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages. Receives: Behavioral: Healthy lifestyle control |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Incidence
HIV Incidence determined by home testing kit
Measured: 12-months post-intervention and immediately post-intervention
Secondary outcomes (3)
Self-reported HIV incidence
Self-reported HIV Status
Measured: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
Proportion of Participants Testing for an STI
This outcome will be measured as a cumulative indicator of whether the individual has tested for an STI
Measured: 12-month post intervention and immediately post-intervention
Proportion of Participants having used PrEP/PEP
This outcome will be measured as a cumulative indicator of whether the individual has used pre-exposure or post-exposure prophylaxis for HIV
Measured: 12-month post-Intervention and immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start15 Jan 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the intervention or control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Innovative Public Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230367
- Sponsor's protocol ID
- U01HD108738
- Acronym
- SHAG
- Status last verified
- Jul 2026
- First submitted
- 10 Jan 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level de-identified data will be made available through controlled access.
Publications
Ybarra ML, Feaster DJ, Garofalo R, Bull S. Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men. Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9.
PubMed 39762976
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing the Power of Text Messaging to Reduce HIV Incidence in Adolescent Males Across the United States
- ClinicalTrials.gov ID
- NCT06230367
- Acronym / sponsor ID
- SHAG / U01HD108738
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Center for Innovative Public Health ResearchUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 30 Jan 2024 (actual)
- 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.
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle.
Detailed description
SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the United States. Investigators will test it against a control group that receives messages about healthy lifestyle. Harnessing the power of technology, young people will be recruited online and largely enrolled digitally. The main outcome of interest is HIV incidence. The impact of the intervention on STI testing and pre-exposure prophylaxis (PrEP) will also be examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the intervention or control group
| Arm | Type | Receives |
|---|---|---|
| SHAG (Sexual Health Advocacy for Guys) | Experimental | Behavioral: Sexual health advocacy for guysYoung people assigned to the intervention arm will receive ~9 weeks of daily text messages that talk about healthy sexuality and ways to reduce HIV risk. After a 3 month 'quiet' period, they will receive a week of review messages. Messages are based upon the information-motivation-behavioral model of preventive behavior. |
| Attention-matched control | Placebo comparator | Behavioral: Healthy lifestyle controlYoung people assigned to the control arm will receive ~9 weeks of daily text messages that talk about healthy lifestyle, such as self-esteem and physical exercise. After a 3 month 'quiet' period, they will receive a week of review messages. |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- have been assigned male sex at birth and currently have a cisgender identity;
- be aged 13-22 years old;
- have had anal sex in the past 12 months;
- be English-speaking;
- exclusively own a cell phone with an unlimited text messaging plan and intend to have the same cell phone number for the next 6 months;
Key exclusion criteria (1 listed)
- Being HIV positive
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 |
|---|---|---|
| Sexual health advocacy for guys5 month HIV prevention program delivered via text messaging | Behavioural | SHAG (Sexual Health Advocacy for Guys) |
| Healthy lifestyle control5 month control group program delivered via text messaging | Behavioural | Attention-matched control |
Primary outcome
HIV Incidence
Time frame: 12-months post-intervention and immediately post-intervention
HIV Incidence determined by home testing kit
3 secondary outcomes
Self-reported HIV incidence
Time frame: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
Proportion of Participants Testing for an STI
Time frame: 12-month post intervention and immediately post-intervention
Proportion of Participants having used PrEP/PEP
Time frame: 12-month post-Intervention and immediately post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Derived from this study: PubMed 39762976Ybarra ML, Feaster DJ, Garofalo R, Bull S. Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among a national sample of sexual minority cisgender adolescent and young adult men. Trials. 2025 Jan 6;26(1):9. doi: 10.1186/s13063-024-08540-9.
- Individual participant dataSharing planned: Yes. Individual-level de-identified data will be made available through controlled access.
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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.
Center for Innovative Public Health Research
San Clemente, United States
Center for Innovative Public Health Research
San Clemente, United States
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual health advocacy for guys in people with HIV Infections, 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 10 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: looking for participants now, as of the sponsor's last update on 9 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Incidence (time frame: 12-months post-intervention and immediately post-intervention). 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 NCT06230367, 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 9 Jul 2026.