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| ID | Type | Description | Link |
|---|---|---|---|
| R01TW013191 | U.S. NIH Grant/Contract | View source |
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The Spanish language Healthy Choices intervention pilot study (N=45) holds direct relevance to the United States and federal priorities related to improving HIV outcomes to reduce transmission using implementation science models. If Healthy Choices is found to have a clinical signal of impact, our team is committed to testing the intervention in the United States and training Spanish speaking HIV care navigators on the intervention, specifically in the southern United States where Spanish speaking populations are concentrated, namely in Alabama, Texas, New Mexico, Arizona, Nevada, and Florida.
Three specific aims will guide this work. Aim 1: Elucidate barriers and implementation strategies for the Healthy Choices intervention. Aim 2: Adapt and contextually translate the Healthy Choices intervention for Spanish contexts. Aim 3: Pilot test Healthy Choices with implementation strategies for feasibility and acceptability (N=45). By testing Healthy Choices in the Dominican Republic, we can move quickly with recruitment, ultimately maximizing benefit to Americans. If this study is successful and Healthy Choices is feasible and acceptable, we will have the preliminary data necessary for a full-scale hybrid type 1 effectiveness-implementation randomized controlled clinical trial of the Spanish language Healthy Choices intervention that can be tested in Spanish speaking communities in the United States. This record is for the scientific work detailed in Aim 3, specifically the 2:1 allocation pilot randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Choices | Experimental | Healthy Choices |
|
| Control | Sham Comparator | Time Attention Control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Choices | Behavioral | Healthy Choices is a 4-session counseling intervention. Each session is ~30 minutes, and all Healthy Choices sessions are completed in 2 months. Sessions occur in a community setting selected by the YPWH and can be facilitated by a trained peer navigator. Sessions include specific strategies to overtly communicate acceptance and support autonomy to reduce stigma and increase motivational statements, known as change talk. Information or advice is given in Motivational Interviewing-consistent and developmentally appropriate ways. The peer navigator is trained to de-emphasize counter change talk in decisional balance and non-selective reflection |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention | Feasibility by the Feasibility of Intervention Measure (9 items) | Within 6 Month Post-Enrollment |
| Acceptability of the Intervention | Acceptability derived from the Acceptability of Intervention Measure (12 items) | Within 6 Month Post-Enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henna Budhwani, PhD, MPH | Contact | (850) 296-7509 | hbudhwani@fsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Henna Budhwani, PhD, MPH | Florida State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University | Tallahassee | Florida | 32310 | United States |
De-identified data will be deposited in the NICHD Data and Specimen Hub (DASH), a NIH-supported repository for HIV-related behavioral and intervention research or similar public access repository.
Files will be attached to this record and will be made available for as long as this record Is publicly available.
Upon upload, data will be publicly available upon request via controlled-access mechanism to ensure protection of sensitive information, given the stigmatized nature of HIV and potential re-identification risks in small populations. Access will be granted to qualified researchers under a data use agreement prohibiting attempts at re-identification.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2026 | Jun 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057545 | Social Stigma |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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Complete a 2:1 randomization of 45 young people with HIV (YPWH) with 30 to Healthy Choices and 15 to a non-HIV time attention control.
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| Time Attention Control | Other | Counseling on diet and nutrition in the same 4 session format. |
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