Sexual Health Advocacy for Guys - a Text Messaging-based HIV Prevention Program for Guys Who Are Into Guys (SHAG)

December 1, 2025 updated by: Center for Innovative Public Health Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Clemente, California, United States, 92672-6745
        • Recruiting
        • Center for Innovative Public Health Research
        • Contact:
        • Principal Investigator:
          • Michele L Ybarra, MPH PhD
      • San Clemente, California, United States, 92672
        • Recruiting
        • Center for Innovative Public Health Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. have been assigned male sex at birth and currently have a cisgender identity;
  2. be aged 13-22 years old;
  3. have had anal sex in the past 12 months;
  4. be English-speaking;
  5. 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;
  6. have Internet access to complete online surveys;
  7. 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;
  8. 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
  9. not currently enrolled in another HIV prevention program; or
  10. know anyone already enrolled in the RCT.

Exclusion Criteria:

  • Being HIV positive

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHAG (Sexual Health Advocacy for Guys)
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.
Behavioral: Sexual health advocacy for guys
5 month HIV prevention program delivered via text messaging
Placebo Comparator: Attention-matched control
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.
Behavioral: Healthy lifestyle control
5 month control group program delivered via text messaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV Incidence
Time Frame: 12-months post-intervention and immediately post-intervention
HIV Incidence determined by home testing kit
12-months post-intervention and immediately post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported HIV incidence
Time Frame: Post-Intervention, 3-months post, 6-months post, 9-months post, 12-month post
Self-reported HIV Status
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
This outcome will be measured as a cumulative indicator of whether the individual has tested for an STI
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
This outcome will be measured as a cumulative indicator of whether the individual has used pre-exposure or post-exposure prophylaxis for HIV
12-month post-Intervention and immediately post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center for Innovative Public Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 19, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U01HD108738 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual-level de-identified data will be made available through controlled access.

IPD Sharing Time Frame

Data will be available starting 12 months after the grant ends.

IPD Sharing Access Criteria

  • Data access requires sponsorship by an Institution on behalf of the prospective recipient.
  • Requester must provide documentation of local IRB approval
  • Requester agrees to make results of studies using the data available to the larger scientific community
  • Requester must provide a letter of collaboration with the primary study investigator
  • Use of the data is limited to not-for-profit organizations
  • Use of the data is limited to health purposes

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Sexual health advocacy for guys

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe