Sexual Health Advocacy for Guys

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

5000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized to either the intervention or control group

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Control group content is written to affect an experience as if one were in the intervention group.

Study Groups

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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.

Group Type EXPERIMENTAL

Intervention Type BEHAVIORAL

5 month HIV prevention program delivered via text messaging

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.

Group Type PLACEBO_COMPARATOR

Healthy lifestyle control

Intervention Type BEHAVIORAL

5 month control group program delivered via text messaging

Interventions

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Sexual health advocacy for guys

5 month HIV prevention program delivered via text messaging

Intervention Type BEHAVIORAL

Healthy lifestyle control

5 month control group program delivered via text messaging

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.