A community approach to protecting Hispanic youth at risk from HIV, substance use, and mental health challenges
| ISRCTN | ISRCTN91878894 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91878894 |
- Submission date
- 28/10/2025
- Registration date
- 04/11/2025
- Last edited
- 30/10/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
This study is working with local organizations in Miami-Dade County to get ready for a new program called Familias con Orgullo (“Families with Pride”). The program is designed to support Hispanic youth who may be at risk for HIV, substance use, and mental health challenges. The goal is to help families and communities prevent these issues before they start. Researchers are teaming up with community groups from the beginning to make sure the program is practical and easy to use in real life. They’re also creating a toolkit to help organizations adopt the program and testing how well it works. This effort supports national goals to end the HIV epidemic and reduce health problems in Hispanic communities.
Who can participate?
Community-based organizations in Miami-Dade County that work with Hispanic youth and families are invited to take part in the study.
What does the study involve?
Participating organizations will work with the research team to share their experiences, help design the toolkit, and test how useful and realistic it is. This may include meetings, interviews, and trying out parts of the program.
What are the possible benefits and risks of participating?
Benefits include helping shape a program that could make a real difference in the community and gaining tools to support youth and families. Risks are expected to be minimal, but may include time commitment and sharing organizational challenges.
Where is the study run from?
The study is based in Miami-Dade County, Florida, and is led by researchers at the University of Miami (USA)
When is the study starting and how long is it expected to run for?
January 2025 to August 2030
Who is funding the study?
National Institute of Mental Health (USA)
Who is the main contact?
Dr Alyssa Lozano, adl122@med.miami.edu
Contact information
Public, Scientific, Principal investigator
5030 Brunson Drive
Coral Gables
33146
United States of America
 ORCID ID |
0000-0003-2827-5463 |
|---|---|
| Phone | +1 3052849747 |
| adl122@miami.edu |
Study information
| Study design | Multicenter mixed method project grounded in implementation science |
|---|---|
| Primary study design | Observational |
| Secondary study design | Mixed methods |
| Study setting(s) | Community, Internet/virtual |
| Study type | Prevention |
| Scientific title | Planning for implementation of a family-based intervention for prevention of HIV, substance use, and mental health problems among Hispanic youth at risk: a community-engaged approach |
| Study objectives | This study is guided by the following research aims: AIM 1: Identify determinants affecting adoption and implementation of behavioral HIV prevention interventions, such as Familias con Orgullo, in community agencies. AIM 2: Iteratively co-design an implementation strategy package to support community agencies in adopting and implementing Familias con Orgullo. AIM 3: Evaluate the relative priority, acceptability, appropriateness, and feasibility of the implementation strategy package for promoting adoption and implementation of Familias con Orgullo. |
| Ethics approval(s) |
Approved 06/02/2025, University of Miami Institutional Review Board (1531 Brescia Avenue, Coral Gables, 33146, United States of America; +1 3052433195; vcarrasco@miami.edu), ref: 20250083 |
| Health condition(s) or problem(s) studied | A community approach to protecting Hispanic youth at risk from HIV, substance use, and mental health challenges |
| Intervention | This study will iteratively develop an implementation strategy package in collaboration with community agencies across Miami-Dade County using a systematic implementer-driven method to inform the future adoption and implementation of a family-based intervention for Hispanic youth at risk, Familias con Orgullo (“Families with Pride”). We will first identify determinants affecting adoption and implementation of behavioral HIV prevention interventions, such as Familias con Orgullo, in SMY-serving community agencies (Aim 1). Then, we will iteratively co-design an implementation strategy package to support community agencies in adopting and implementing Familias con Orgullo (Aim 2), and evaluate the relative priority, acceptability, appropriateness, and feasibility of the implementation strategy package for promoting adoption and implementation of Familias con Orgullo (Aim 3). Participants enrolled in this study may participate in the following activities. First, participants may complete a one-time one-on-one interview (approximately 60 minutes) to describe barriers and facilitators that have impacted the adoption and implementation of behavioural HIV preventive interventions in their respective community agencies and the anticipated barriers and facilitators to adopting and implementing Familias con Orgullo in their setting. Second, participants may take part in a workgroup that meets for two-hours three times over the course of two years to collaboratively develop implementation strategies. As part of the workgroup, participants will also complete a one-time survey to assess the relative priority, acceptability, appropriateness, and feasibility of the developed implementation strategy package. Participants who participated in the interviews have the option to also participate in the workgroup. There is no follow-up. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Acceptability of implementation strategies is measured using the Acceptability of Intervention Measure via electronic survey prior to Aim 3, following the second workgroup meeting 2. Appropriateness of implementation strategies is measured using the Appropriateness of Intervention Measure via electronic survey prior to Aim 3, following the second workgroup meeting 3. The Relative Priority of implementation strategies is measured using participant reported ratings via electronic survey during Aim 3. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 06/01/2025 |
| Completion date | 31/08/2030 |
Eligibility
| Participant type(s) | Employee |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target number of participants | Aim 1: 20-30 participants, Aim 2: 10-20 participants |
| Key inclusion criteria | Community agency staff ≥18 years working at community agencies that deliver standard community outreach which consists of distributing informational pamphlets about HIV testing, PrEP, and behavioral health (i.e., substance use and mental health). |
| Key exclusion criteria | 1. Unable to provide consent 2. Deemed that participating would be potentially harmful to the participant 3. Have a medical or psychiatric condition that would interfere with ability to participate in study procedures |
| Date of first enrolment | 01/02/2026 |
| Date of final enrolment | 01/12/2029 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Coral Gables
33146
United States of America
Sponsor information
Research organisation
6001 Executive Boulevard, MSC 9663
Bethesda
20892
United States of America
| Phone | +1 8666156464 |
|---|---|
| nimhinfo@nih.gov | |
| Website | https://www.nimh.nih.gov/index.shtml |
"ROR" |
https://ror.org/04xeg9z08 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Mental Health NIMH, NIH National Institute of Mental Health, Instituto Nacional de la Salud Mental, NIMH
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/08/2030 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publications in a peer-reviewed journal and presentations at national and international conferences. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to their qualitative nature and public repositories are typically used for quantitative data. |
Editorial Notes
29/10/2025: Trial's existence confirmed by National Institutes of Health.
