Text Messaging Program for HIV Prevention

(SHAG Trial)

Age: < 65

Sex: Male

Trial Phase: Academic

Sponsor: Center for Innovative Public Health Research

Disqualifiers: HIV positive

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

5000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a text messaging program aimed at preventing HIV in cisgender sexual minority boys and men aged 13-22 across the United States. Participants will receive daily text messages for about nine weeks, focusing on healthy sexuality and ways to reduce HIV risk. A control group will receive messages about general healthy living instead. This trial suits those who have had anal sex in the past year, are English-speaking, own a cellphone with unlimited texting, and are HIV-negative. As an unphased trial, this study provides a unique opportunity to contribute to innovative HIV prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that this text messaging program is safe for HIV prevention?

Research has shown that text messaging programs like SHAG, designed to prevent HIV, are safe and easy to use. These programs send daily messages with information and encouragement, which do not cause harm. Since SHAG is neither a medication nor a medical procedure, it has no known physical side effects. Instead, it promotes healthy habits and strategies to prevent HIV. Participants receive messages about healthy sexuality and ways to reduce HIV risk, with no negative effects linked to these messages. Overall, these programs are non-invasive and focus on education, making them a low-risk choice for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Text Messaging Program for HIV Prevention because it offers a unique approach to reducing HIV risk among young people by using daily text messages. Unlike traditional methods such as medication or in-person counseling, this program leverages technology to provide ongoing, accessible education about healthy sexuality and preventive behaviors based on the information-motivation-behavioral model. The use of text messages allows for a more continuous and personalized engagement, which could potentially lead to better adoption of preventive practices. This innovative delivery method is particularly appealing as it meets young people where they are—on their phones.

What evidence suggests that this text messaging program is effective for HIV prevention?

Research shows that the Sexual Health Advocacy for Guys (SHAG) program, which participants in this trial may receive, might help reduce the risk of HIV among boys and men aged 13-20 who identify as sexual minorities. Studies have found that similar text messaging programs can lead to more frequent testing for HIV and other sexually transmitted infections (STIs) and encourage the use of preventive medications like PrEP (pre-exposure prophylaxis) and PEP (post-exposure prophylaxis). The SHAG program aims to lower HIV rates by sending daily text messages about healthy sexuality and reducing risk. Early results suggest that these types of programs can effectively promote safer behaviors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for cisgender sexual minority boys and men aged 13-20 in the U.S. who are interested in participating in an HIV prevention program. The eligibility criteria details are not fully provided, so additional requirements may apply.

Inclusion Criteria

Had anal sex in the past 12 months

Not currently enrolled in another HIV prevention program

I am willing to take or have taken an at-home HIV test and can report a negative result.

Exclusion Criteria

Being HIV positive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive daily text messages for 9 weeks about healthy sexuality and ways to reduce HIV risk

9 weeks

Quiet Period

A 3-month period with no intervention messages

3 months

Review

Participants receive a week of review messages after the quiet period

1 week

Follow-up

Participants are monitored for HIV incidence and other outcomes post-intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Healthy lifestyle control
• Sexual Health Advocacy for Guys

Trial Overview The SHAG program, which uses text messaging to prevent HIV among young guys into guys, is being tested against a control group that receives texts about maintaining a healthy lifestyle.

How Is the Trial Designed?

Group I: SHAG (Sexual Health Advocacy for Guys) Experimental Treatment 1 Intervention

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 II: Attention-matched control Placebo Group 1 Intervention

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.

Sexual Health Advocacy for Guys is already approved in United States for the following indications:

Approved in United States as SHAG for:

• HIV prevention

Who Is Running the Clinical Trial?

Center for Innovative Public Health Research

Lead Sponsor

Trials

11

Recruited

8,100+

Published Research Related to This Trial

The Men's Safer Sex (MenSS) website is being tested in a pilot trial with 166 male participants aged 16 and over, aiming to assess its feasibility in increasing condom use and reducing sexually transmitted infections (STIs) among men who have had recent unprotected sex.

The primary outcome of the trial is to measure condom use at 3 months, while STI rates will be tracked through clinic records at 12 months, providing insights into the effectiveness of this digital intervention compared to usual sexual health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

A study involving 1,231 men who have sex with men (MSM) found that 83% accepted the inclusion of HIV/STI prevention messages in sexually explicit media (SEM), indicating a strong potential for using SEM as a platform for health messaging.

Younger men who endorsed all prevention strategies were more likely to prefer SEM that depicted condom use, while those who rejected all strategies were more inclined to prefer SEM without condom use and reported higher rates of unprotected anal sex, highlighting the need for targeted prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of HIV-prevention messages in sexually explicit media viewed by men who have sex with men. Wilkerson, JM., Iantaffi, A., Smolenski, DJ., et al.[2021]

The Guy2Guy (G2G) program effectively increased HIV testing rates among sexually active adolescents, with participants being 3.42 times more likely to get tested compared to those in the control group.

While G2G did not significantly reduce condomless sex acts (CSAs) at the 90-day mark, it did lead to a decrease in CSAs at the end of the intervention, suggesting that the program may help improve comfort around sexual activity without increasing HIV transmission risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot RCT Results of an mHealth HIV Prevention Program for Sexual Minority Male Adolescents. Ybarra, ML., Prescott, TL., Phillips, GL., et al.[2022]

The introduction of a text message result service in an inner London sexual health clinic significantly reduced the time to diagnosis for patients, with an average of 7.9 days compared to 11.2 days for standard recall methods.

This service also led to a quicker treatment initiation, with a median time of 8.5 days for the text message group versus 15.0 days for the standard group, while saving 46 hours of staff time per month.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Texting decreases the time to treatment for genital Chlamydia trachomatis infection. Menon-Johansson, AS., McNaught, F., Mandalia, S., et al.[2022]

A randomized controlled trial involving 631 HIV-negative men who have sex with men (MSM) demonstrated that a customized SMS intervention significantly reduced high-risk HIV behaviors, such as having multiple partners and engaging in condomless anal intercourse, compared to a control group.

The positive effects of the SMS intervention persisted for at least six months after the intervention ended, indicating its potential for long-term impact on reducing HIV-related risks among MSM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Customized Short Message Service on High-Risk Behaviors Among MSM in China, a Randomized Controlled Trial Study. Huang, H., Xu, Z., Ge, Q., et al.[2023]

The M-Cubed intervention, designed for gay, bisexual, and other men who have sex with men (GBMSM), utilizes mobile technology to deliver tailored HIV prevention messages and link users to healthcare resources, aiming to reduce new HIV infections.

Interviews with 26 GBMSM revealed key themes regarding video message acceptability and comprehension, leading to the selection of 12 effective videos for a randomized controlled trial, highlighting the need for diverse content in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video selection and assessment for an app-based HIV prevention messaging intervention: formative research. Downing, MJ., Wiatrek, SE., Zahn, RJ., et al.[2023]

This systematic review aims to be the first comprehensive examination of how text messaging (SMS) can improve the prevention and management of sexually transmitted infections (STIs), addressing a significant gap in existing research.

By analyzing both quantitative and qualitative studies published since 1995, the review will provide evidence to support the integration of SMS interventions into standard STI care practices, potentially enhancing patient communication and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short message service (SMS) interventions for the prevention and treatment of sexually transmitted infections: a systematic review protocol. Lunny, C., Taylor, D., Memetovic, J., et al.[2021]

From August 2007 to June 2010, the 'Tell them' service on the WhyTest website saw a significant increase in usage, with a total of 7923 partner notification messages sent, primarily via SMS (96%).

The 'Remind me' service also gained traction, with 1023 STI testing reminders sent during the same period, and 55% of surveyed participants recognized the health promotion campaign, indicating effective outreach and awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promotion and uptake of a new online partner notification and retesting reminder service for gay men. Bourne, C., Zablotska, I., Williamson, A., et al.[2015]

The Men's Safer Sex website was developed to improve condom use among men, and a feasibility randomized controlled trial (RCT) involving 159 participants showed that while the intervention did not significantly reduce condomless sex or STI diagnoses compared to usual care, it provided valuable insights for future research.

Challenges included technical issues and low response rates for online questionnaires, but the study indicated that integrating digital health interventions with clinical services could be feasible, highlighting the need for improved software and data collection methods in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Hunter, R., et al.[2022]

The study involved 159 men from UK sexual health clinics and aimed to assess the feasibility of an online intervention for promoting safer sex, but faced significant challenges such as poor online response rates and technical issues.

While there was no significant difference in condomless sex between the intervention and control groups, the intervention group had a lower rate of new acute STI diagnoses (8.8% vs. 13.0%), suggesting potential benefits that warrant further investigation in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Men's Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men. Bailey, JV., Webster, R., Griffin, M., et al.[2022]

Focus groups with 18-25-year-old African American and Latino young men who have sex with men revealed that they frequently use text messaging, highlighting its potential as a tool for sexual health promotion.

Participants identified both advantages and disadvantages of texting for health communication, suggesting that tailored texting interventions could effectively engage this demographic in sexual health discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The cellular generation and a new risk environment: implications for texting-based sexual health promotion interventions among minority young men who have sex with men. George, S., Phillips, R., McDavitt, B., et al.[2022]

A study of 141 male sex workers (MSWs) across 8 U.S. cities revealed that high client demand and financial incentives were the primary reasons for engaging in condomless anal sex (CAS), despite the associated risks of HIV and STIs.

Participants often felt their risk of acquiring HIV/STIs was low due to client characteristics and personal precautions, highlighting the potential for targeted HIV/STI prevention interventions through hookup and dating apps where these exchanges are arranged.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Condomless Anal Sex Between Male Sex Workers and Clients in the Age of Hookup Apps. Siegel, K., Cabán, M., Brown-Bradley, CJ., et al.[2023]

The Guy2Guy mHealth program for HIV prevention was found to be both feasible and acceptable among sexual minority boys aged 14-18, with 94% of participants completing the follow-up survey and 93% expressing positive feedback about the program.

Participants appreciated the program's content focused on HIV risk reduction and skills-building, although some requested more information on condom negotiation, indicating a strong engagement with the program's educational components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Process Indicators for Guy2Guy, an mHealth HIV Prevention Program for Sexual Minority Adolescent Boys. Ybarra, ML., Prescott, T., Mustanski, B., et al.[2020]

The Guy2Guy program, a text messaging-based HIV prevention initiative, was successfully implemented with 302 adolescent gay and bisexual males aged 14 to 18, demonstrating that ethical protocols can facilitate sensitive health interventions for this age group.

Key ethical considerations included obtaining telephone assent to respect participants' autonomy, waiving parental permission to enhance beneficence, and ensuring a diverse sample to promote justice in the program's development and testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethical Considerations in Recruiting Online and Implementing a Text Messaging-Based HIV Prevention Program With Gay, Bisexual, and Queer Adolescent Males. Ybarra, ML., Prescott, TL., Phillips, GL., et al.[2018]

Citations

1. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08540-9

Sexual Health Advocacy for Guys (SHAG): a randomized trial ... Outcomes include testing for HIV and other STIs, increasing PrEP and PEP use, and HIV incidence. Generalized linear models will be used to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39762976/

Sexual Health Advocacy for Guys (SHAG): a randomized trial ... Sexual Health Advocacy for Guys (SHAG): a randomized trial of the impact of a text-messaging program on HIV incidence and STI testing among ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06230367

Sexual Health Advocacy for Guys - a Text Messaging ... 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. Official ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7386844/

A Randomized Controlled Trial of a Peer-Led Safer Sex ... In this article, we report the results of an efficacy trial of the Treatment Advocacy Program (TAP), a peer-based counseling intervention for sexual safety and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06230367/sexual-health-advocacy-for-guys-a-text-messaging-based-hiv-prevention-program-for-guys-who-are-into-guys

a Text Messaging-based HIV Prevention Program for Guys ... 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 ...

6. researchgate.net researchgate.net/publication/387759984_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_y

(PDF) Sexual Health Advocacy for Guys (SHAG) 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 ...

7. ctv.veeva.com ctv.veeva.com/study/sexual-health-advocacy-for-guys-a-text-messaging-based-hiv-prevention-program-for-guys-who-are-int

Sexual Health Advocacy for Guys - a Text Messaging-based ... SHAG is a text messaging-based HIV prevention program designed for cisgender sexual minority boys and men 13-20 years of age across the ...