Understanding and sharing strategies for linking community members to HIV and mental health/substance use services
| ISRCTN | ISRCTN63954463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63954463 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | National Institute of Mental Health |
| Funders | National Institute of Mental Health, National Institute of Allergy and Infectious Diseases |
- Submission date
- 22/10/2025
- Registration date
- 28/10/2025
- Last edited
- 27/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
HIV organizations use different approaches to help community members get HIV-prevention and mental health/substance use treatment services. This study is trying to learn from community organizations about how they help community members get these services, then develop a website that showcases those approaches. These are our study aims:
Aim 1: Learn from HIV organizations about their approaches for helping community members get HIV-prevention and mental health/substance use treatment services.
Aim 2: Create a website that explains all of the different approaches we learned about in Aim 1.
Aim 3: Share the website with HIV organizations across the United States to see if it helps them get community members in their area linked to HIV-prevention and mental health/substance use treatment services.
Who can participate?
Aim 1: HIV organizations that serve Latino men who have sex with men and are in the Miami FL area, Orlando FL area, or San Juan PR area can participate.
Aim 2: HIV implementers from the organizations in Aim 1 can participate. HIV implementers from other organizations across the US can also participate.
Aim 3: HIV organizations that are not already part of Aim 1 that are in “Ending the HIV Epidemic” priority jurisdictions in the United States can participate.
What does the study involve?
Aim 1: The study team will visit HIV organizations that are part of our network (Miami, Orlando, San Juan) and learn about their approaches for helping community members get linked to HIV-prevention and mental health/substance use treatment services. The team will create protocols and evaluate the approaches against the published literature (e.g., does the approach address things that we know from past research affects engagement in services; does the approach use methods that we know from past research can improve engagement in services).
Aim 2: The study team will create an initial version of a website that explains all the approaches/protocols from Aim 1. Implementers from HIV within and outside our existing network will give feedback on the website to make sure it’s helpful to HIV organizations. We will revise the website based on their feedback.
Aim 3: The study team will invite HIV organizations across the United States to join the project. Those HIV organizations will get access to the website we developed in Aim 2. We’ll invite those organizations to do surveys and interviews to learn about their experiences using the website to see if it is helpful in getting their communities linked to HIV-prevention and mental health/substance use treatment services.
What are the possible benefits and risks of participating?
The benefits of participating in Aim 1 include having the public learn about the organizations’ approaches for getting their communities linked to HIV-prevention and mental health services. It gives a potentially national platform for their expertise. Benefits of participating in Aim 2 include contributing to a public online tool that could be helpful to other HIV organizations. Benefits of participating in Aim 3 include getting access to an online resource that could help HIV organizations achieve their goals with respect to linking communities to HIV-prevention and mental health/substance use treatment services. Risks of participating in any of the aims are minimal; of note, this project was considered not human subjects research but the IRB because we aren’t collecting personal information about the organizations but moreso learning about and developing processes to help them get HIV-prevention and mental health/substance use treatment services to reach their communities more effectively.
Where is the study run from?
The study is run from University of Miami, with collaborators throughout the Miami FL area, Orlando FL area, and San Juan PR area.
When is the study starting and how long is it expected to run for?
January 2025 to May 2029
Who is funding the study?
1. National Institute of Mental Health (NIMH) (USA)
2. National Institute of Allergy and Infectious Diseases (NIAID) (USA)
Who is the main contact?
1. Dr Audrey Harkness, aharkness@miami.edu
2. Dr Maeleigh Tidd, mxt1526@miami.edu
Contact information
Principal investigator
5030 Brunson Drive
Coral Gables
33146
United States of America
 ORCID ID |
0000-0003-2290-9904 |
|---|---|
| Phone | +1 (0)3052841306 |
| aharkness@miami.edu |
Public, Scientific
5030 Brunson Drive
Coral Gables
33146
United States of America
| ORCID ID |
0009-0001-4769-3284 |
|---|---|
| Phone | +1 (0)3059219939 |
| mxt1526@miami.edu |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicenter sequential exploratory mixed method project grounded in implementation science |
| Secondary study design | Multicenter sequential exploratory mixed method project grounded in implementation science |
| Scientific title | Leveraging a strategic alliance to characterize, protocolize, and scale up local implementation strategies for improving pre-exposure prophylaxis and mental health/substance use treatment reach |
| Study acronym | SOMOS Alianza |
| Study objectives | This study is guided by the following research aims: Aim 1: To characterize, assess, and protocolize implementation strategies that are currently used in SOMOS Alianza organizations to improve pre-exposure prophylaxis (PrEP) and mental health/substance use treatment reach. Aim 2: Through user-centered design, to build a Dashboard of locally used implementation strategies identified in Aim 1 that improve the reach of PrEP and mental health/substance use treatment. Aim 3: To assess Dashboard usability and associated organizational outcomes. |
| Ethics approval(s) | Ethics approval not required |
| Health condition(s) or problem(s) studied | The reach of pre-exposure prophylaxis (PrEP), mental health, and substance use treatment services to Latino men who have sex with men |
| Intervention | This study uses reverse implementation mapping to assess unique implementation strategies and adjunctive interventions local organizations are using to improve the reach of PrEP and mental health/substance use treatment services to Latino MSM (Aim 1). Then, through user-centered design, we will build a Dashboard of the locally used implementation strategies and adjunctive interventions identified (Aim 2). We will assess the usability, acceptability, appropriateness of the Dashboard and associated organizational outcomes (e.g., adoption/implementation of Dashboard strategies/interventions, reach of Latino men who have sex with men in PrEP and mental health/substance use treatment services) (Aim 3). |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Implementation strategies and adjunctive interventions identified using reverse implementation mapping during Aim 1 |
| Key secondary outcome measure(s) |
1. Acceptability of implementation strategies and adjunctive interventions measured using Acceptability of Intervention Measure during Aim 3 (years 4 and 5) |
| Completion date | 31/05/2029 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 62 |
| Key inclusion criteria | HIV organizations providing PrEP and mental health/substance use treatment services to Latino MSM in Ending of the HIV Epidemic jurisdictions |
| Key exclusion criteria | Organizations that do not have any strategies or adjunctive interventions to improve the reach of PrEP or mental health/substance use treatment services to Latino MSM HIV organizations that are not in an Ending of the HIV Epidemic jurisdiction |
| Date of first enrolment | 30/09/2025 |
| Date of final enrolment | 31/05/2029 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Coral Gables
33146
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | Aim 1 data will be publicly available as it will be featured in the Aim 1 Implementation Strategy Dashboard which we plan to launch for public use as part of this study. Aim 2 data will be largely qualitative, therefore we will retain it but will not deposit in a public repository which are typically used for quantitative data. We plan to deposit de-identified Aim 3 data into the Inter-University Consortium for Political and Social Research (ICPSR) repository to facilitate replicability and secondary analysis. |
Editorial Notes
23/10/2025: Study's existence confirmed by the University of Miami.
