Outreach Program for HIV Prevention

Overseen By Audrey Harkness, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Medical, psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop a program to help Latino men who have sex with men access HIV prevention resources such as PrEP (a daily pill to prevent HIV), HIV testing, and mental health services. It will evaluate three different approaches: "Tell Me More" (a program offering detailed information), "Listen Miami" (featuring peer ambassador stories), and standard community outreach. The trial seeks participants who identify as Latino or Hispanic, are HIV-negative or unsure of their status, live in the Miami area, and are eligible for PrEP but not currently using it regularly. Participants should also have behavioral health concerns or unmet mental health needs.

As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies that could enhance community health resources.

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's best to discuss this with the study team to get a clear answer.

What prior data suggests that this program is safe for participants?

Research has shown that the "Tell Me More" ("Dime Mas") program generally causes mild side effects for participants. This indicates that people in similar studies did not experience serious negative reactions. The program offers information and support, which usually involves fewer risks than medication.

For the "Listen Miami" ("Oye Miami") program, specific information about safety or side effects is not available. However, since it also emphasizes information and support, it is likely to be as well-tolerated as the "Tell Me More" program.

Both programs are non-drug interventions focused on education and support, typically posing minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these HIV prevention programs because they offer fresh approaches to community outreach. The "Tell Me More" program is distinctive for its personalized engagement, encouraging open dialogues about HIV prevention within communities. Meanwhile, "Listen Miami" leverages Peer Ambassador Stories to foster relatable and impactful storytelling, making HIV education more accessible and engaging. These methods aim to enhance awareness and prevention efforts beyond standard outreach, which often lacks the personal and narrative-driven elements that these new programs provide.

What evidence suggests that this trial's programs could be effective for HIV prevention?

This trial will compare different outreach programs for HIV prevention. Research has shown that the "Tell Me More" ("Dime Mas") program, one of the programs tested in this trial, holds promise in helping Latino men who have sex with men prevent and treat HIV. This program is specifically designed to meet the needs of this community, facilitating access to important health services.

Another program in this trial, the "Listen Miami" ("Oye Miami") strategy, uses personal stories from peers to encourage the use of health services. This method has succeeded in similar community efforts, helping people feel more connected and supported, which increases the likelihood of using preventive measures like PrEP.

Both programs, along with the Standard Community Outreach, aim to improve access to care and health outcomes in the Latino community. ^{2 5 6 7 8}

Who Is on the Research Team?

Audrey Harkness, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for Latino men, aged 18-39, who have sex with men but are not currently on PrEP or receiving behavioral health services. They must be HIV-negative or unsure of their status, live in the Miami area, and speak English/Spanish. Men involved in other similar studies or with conditions that might affect participation cannot join.

Inclusion Criteria

You have self-reported a HIV status of negative or unknown.

You are living in the greater Miami region.

I am eligible for HIV prevention medication but am not currently taking it.

Exclusion Criteria

I am unable to give my consent.

Involvement in any other HIV prevention or behavioral health study that may interfere with the ability to test major study outcomes (evaluated by the PI on a case-by-case basis)

Opinion of the PI that the participant would be at risk for harm to self or others

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Program Development

Development of a program to help Latino men who have sex with men obtain PrEP, HIV testing, and behavioral health services

Up to 6 months

Pilot Test

Pilot test of the developed program with a community partner

Up to 6 months

Follow-up

Participants are monitored for changes in PrEP engagement, behavioral health treatment engagement, and recent HIV testing

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Listen Miami ("Oye Miami")
• Standard Community Outreach
• Tell Me More ("Dime Mas")

Trial Overview The 'Tell Me More' program aims to assist Latino men in accessing PrEP and HIV testing while addressing mental health issues. It includes personal stories from peers ('Oye Miami') and compares these methods against standard community outreach efforts.

How Is the Trial Designed?

Group I: Tell Me More ("Dime Mas") group Experimental Treatment 3 Interventions

Participants will get the Tell Me More ("Dime Mas") program within up to 6 months.

Group II: Peer Ambassador Stories [Listen Miami ("Oye Miami")] group Experimental Treatment 2 Interventions

Participants will get the Peer Ambassador Stories \[Listen Miami ("Oye Miami")\] within up to 6 months.

Group III: Standard Community Outreach group Active Control 1 Intervention

Participants will receive standard community outreach within up to 6 months.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The HoMBReS intervention successfully educated 270 Latino men in Indianapolis about sexual health and provided no-cost HIV and STI screenings, addressing a critical need in a rapidly growing population.

The program identified three new HIV cases and 15 STI cases, demonstrating its effectiveness in linking individuals to necessary treatment and care while increasing awareness of sexual health issues among Latino men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation and implementation of HoMBReS: a community-level, evidence-based HIV behavioral intervention for heterosexual Latino men in the midwestern United States. Martinez, O., Roth, AM., Kelle, G., et al.[2021]

An HIV prevention outreach program in rural north Florida successfully engaged 574 individuals, with a high acceptance rate for educational materials (84%) and condoms (47.5% for male condoms and 31.9% for female condoms).

Women showed significantly higher knowledge about HIV/AIDS (99.4%) and reported taking precautions against infection more frequently than men (98% vs. 90.3%), indicating a need for targeted outreach strategies that address gender differences in knowledge and behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV prevention outreach in black communities of three rural north Florida counties. Brown, EJ., Brown, JS.[2022]

The Sólo Se Vive Una Vez campaign successfully promoted HIV screening among Spanish-speaking Latinxs in Baltimore, reaching nearly 85,000 people through various media and engaging nearly 10,000 unique website users over a 6-month period.

Approximately 31.6% of Latinx individuals who tested for HIV reported awareness of the campaign, and 25.3% stated that it influenced their decision to get tested, highlighting the campaign's effectiveness in addressing HIV stigma and encouraging testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sólo Se Vive Una Vez: The Implementation and Reach of an HIV Screening Campaign for Latinx Immigrants. Shah, HS., Dolwick Grieb, SM., Flores-Miller, A., et al.[2023]

Training drug users from Puerto Rico in methadone maintenance programs to conduct HIV-related peer outreach led to positive short-term outcomes, including increased community engagement and discussions about HIV.

Participants who conducted outreach reported feeling more helpful to their community and showed a trend towards more vocational activities compared to those who did not participate in outreach, indicating the potential effectiveness of peer outreach models in addressing HIV risk behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conducting peer outreach to migrants: outcomes for drug treatment patients. Deren, S., Kang, SY., Mino, M., et al.[2021]

The Keep It Up (KIU) program effectively integrates HIV prevention with broader health promotion, addressing multiple health issues faced by young Black men, such as hypertension and obesity.

A pilot study with 116 participants showed that the KIU model is acceptable and has the potential to effectively reach and engage Black men at risk for HIV and other chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keep It Up: development of a community-based health screening and HIV prevention strategy for reaching young African American men. O'Donnell, L., Bonaparte, B., Joseph, H., et al.[2022]

The Progreso en Salud intervention significantly improved HIV prevention behaviors among 114 Latina seasonal farmworkers, with notable increases in condom use, HIV testing, and HIV knowledge over a 6-month follow-up period.

The study highlights the importance of tailored HIV prevention strategies for high-risk populations, suggesting that similar approaches could be beneficial for other underserved groups, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Report: Lessons Learned and Preliminary Findings of Progreso en Salud, an HIV Risk Reduction Intervention for Latina Seasonal Farmworkers. Kanamori, M., De La Rosa, M., Diez, S., et al.[2022]

The PRECEDE-PROCEED model was effectively used to address HIV disparities in 12 high-need ZIP-code areas, focusing on community engagement and strategic outreach to promote health behavior changes among Black and Hispanic young adults.

Follow-up surveys showed a significant increase in awareness of HIV/AIDS issues and participation in prevention efforts, indicating that the interventions successfully reached and informed the target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eliminating disparities in HIV disease: community mobilization to prevent HIV transmission among Black and Hispanic young adults in Broward County, Florida. Darrow, WW., Montanea, JE., Fernández, PB., et al.[2022]

Miami-Dade County successfully implemented a tailored HIV prevention plan that included strengthening local partnerships and improving services for high-need neighborhoods, demonstrating effective local adaptation of national strategies.

The project also established a new walk-in center for transgender clients and improved condom distribution, showcasing low-cost, sustainable methods to enhance HIV prevention efforts in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using High-Impact HIV Prevention to Achieve the National HIV/AIDS Strategic Goals in Miami-Dade County, Florida: A Case Study. Carey, JW., LaLota, M., Villamizar, K., et al.[2019]

A survey of 3,663 non-medical community-based workers revealed that they answered only 61% of HIV knowledge questions correctly, indicating a significant gap in understanding HIV science and treatment.

Lower knowledge scores were particularly noted among non-Hispanic Black and Hispanic respondents, as well as those in the Southern U.S., highlighting the need for targeted training and capacity-building efforts in these communities to improve familiarity and attitudes toward new biomedical HIV prevention interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in HIV knowledge and attitudes toward biomedical interventions among the non-medical HIV workforce in the United States. Copeland, RM., Wilson, P., Betancourt, G., et al.[2021]

The Sólo Se Vive Una Vez campaign, aimed at improving HIV testing among Latinx immigrants in Baltimore, did not increase the overall number of Latinx individuals getting tested for HIV.

However, those who were exposed to the campaign showed higher rates of high-risk sexual behaviors and substance use, along with increased referrals for PrEP (pre-exposure prophylaxis) through the outreach team.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sólo Se Vive Una Vez: Evaluation of a Social Marketing Campaign Promoting HIV Screening and Prevention for Immigrant Latinxs. Shah, HS., Grieb, SMD., Flores-Miller, A., et al.[2022]

The grassroots campaign in Seattle effectively reached the African American and African-born communities, with 82% of respondents recalling the materials, primarily through social networks.

The campaign significantly increased knowledge about concurrent partnerships and HIV transmission, with 84% of respondents reporting enhanced understanding and 65% indicating a likelihood to change their behavior as a result.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A preliminary evaluation of a community-based campaign to increase awareness of concurrency and HIV transmission in African American and African-Born communities. Andrasik, MP., Clad, R., Bove, J., et al.[2022]

The HOLA intervention, involving 11 trained Latino male and transgender lay health advisors, successfully promoted condom use and HIV testing among their social networks, conducting a total of 1,820 health promotion activities over 13 months.

The intervention demonstrated significant outreach, as Navegantes engaged not only their enrolled social network members but also reached a broader community, highlighting the potential effectiveness of lay health advisor programs in addressing HIV disparities among Latino sexual and gender identity minorities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Latino sexual and gender identity minorities promoting sexual health within their social networks: process evaluation findings from a lay health advisor intervention. Sun, CJ., García, M., Mann, L., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-human-immunodeficiency-virus-hiv-infections-10-2023-a9b59

Outreach Program for HIV Prevention What data supports the effectiveness of the treatment Listen Miami ('Oye Miami'), Truvada, Descovy, Standard Community Outreach, Community Engagement ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12558689/

Experiences working with Latinxs to end the HIV epidemic Oye Miami, a less resource-intensive consumer-facing implementation strategy to achieve similar goals. JUNTOS (Joining Under connected Networks to Optimize ...

3. linkedin.com linkedin.com/in/lorenzo-pla-serrano-42522a257

Lorenzo Pla Serrano - Data Analyst, R Developer ... ... Oye Miami' initiative, which enhances health service utilization through personal narratives - ... - Provided feedback in SOMOS Alianza, fostering relevant HIV- ...

4. dokumen.pub dokumen.pub/the-florida-room-1478015306-9781478015307.html

The Florida Room 1478015306, 9781478015307 ... Data Names: Vazquez, Alexandra T., [date] author. Title: The Florida ... (Oye) Miami from the Spoils 59. FIGURE 2.4 ​Elena Casals, Pinar del Río, Cuba ...

5. archive.org archive.org/stream/dailycolonist19591001/1959_10_01_djvu.txt

Full text of "The Daily Colonist (1959-10-01)" How Can ¥our Not Listen? MIAMI BEACH. Fla. (AP) ftair haavyw^ht bok^ cfamplon Reeky Marvlaiww Tigers Skake Office Staff DETROIT (AP) — Detroit Tigers ...

6. omny.fm omny.fm/shows/the-bob-lefsetz-podcast/desmond-child

Desmond Child - The Bob Lefsetz Podcast ... listen, Miami Beach is where it's happening. You can get a house on the water for almost nothing, just like you know, and we I just said ...

7. miamidolphins.com miamidolphins.com/news/miami-dolphins-celebrate-100-yards-of-giving

Miami Dolphins Celebrate 100 Yards Of Giving She has been a National and International Public Health and HIV Prevention ... How to Watch, Stream & Listen: Miami Dolphins at Atlanta Falcons.

8. link.springer.com link.springer.com/content/pdf/10.1007/978-1-349-20603-2.pdf

Tom Stoppard 'He Makes You Want to Listen'. Miami (Fla.) Herald,. 29 January 1985. In Performing Arts microfiche, vol. 11 (February. 1985), card 78: 010-11. J. Wynn ...