HIV Prevention and PrEP Intervention for SGM Adolescents and Parents: Hey, Friend

Study Overview
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Brief Summary
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In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South.

Detailed Description
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In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South. To do so, in Aim 1, we will assess stakeholders' knowledge, sentiments, and beliefs related to HIV risk, HIV stigma, and HIV prevention including preferences related to modality of PrEP and PrEP acceptability. Then, in Aim 2, we will use Aim 1 data, applying the 4-step intervention mapping framework, to inform the development of intervention modules targeting 14-18 year old SGM adolescents (rationale for this age range presented later in this proposal). We will also, develop corollary modules for parents or guardians. After intervention modules have been finalized, in Aim 3, we will conduct a 4-arm randomization to assess each module's acceptability, feasibility, and clinical signal of effectiveness as compared to a time-attention control.

Official Title
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Conducting the Preparation Phase of a Multiphase Optimization Strategy (MOST) to Develop a Modular HIV Prevention and PrEP Intervention for Sexual and Gender Minority Adolescents and Parents: Hey, Friend

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Hey, Friend


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents aged 14-18 Parental or guardian consent SGM identity English speaking Exclusion Criteria: Does not fit the inclusion criteria

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In Aim 3 of our study, our goal is to complete the MOST preparation phase wherein we collect acceptability, feasibility, and some effectiveness data on each module prior to combining them to test the effects of the full intervention package.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Time attention control condition. | |
| Experimental: Intervention, Module 1 - Knowledge<br>20-minute module that aims to improve HIV prevention knowledge. | Behavioral: Hey, Friend<br>* Intervention in development. However, we will use intervention mapping and the designing for dissemination approach, informed by self-reported qualitative data, to develop the Hey, Friend modules. The mHealth intervention will include three modules that include multiple sub-topics (e.g., What is HIV?; How do I protect myself from HIV?; What is PrEP?, etc.), deliver culturally appropriate counseling content in community settings, juvenile court system, clinics, and schools; will include Motivational Interviewing components that are effective in evoking behavior change while being acceptable to adolescents and parents, and will include ongoing support through a text reminder to maximize the likelihood of initiating HIV prevention through testing and PrEP.<br>|
| Experimental: Intervention, Module 1 - Stigma<br>20-minute module that aims to reduce SGM- and HIV- related stigma. | Behavioral: Hey, Friend<br>* Intervention in development. However, we will use intervention mapping and the designing for dissemination approach, informed by self-reported qualitative data, to develop the Hey, Friend modules. The mHealth intervention will include three modules that include multiple sub-topics (e.g., What is HIV?; How do I protect myself from HIV?; What is PrEP?, etc.), deliver culturally appropriate counseling content in community settings, juvenile court system, clinics, and schools; will include Motivational Interviewing components that are effective in evoking behavior change while being acceptable to adolescents and parents, and will include ongoing support through a text reminder to maximize the likelihood of initiating HIV prevention through testing and PrEP.<br>|
| Experimental: Intervention, Module 1 - Prevention<br>20-minute module that aims to promote HIV prevention strategies including testing and PrEP. | Behavioral: Hey, Friend<br>* Intervention in development. However, we will use intervention mapping and the designing for dissemination approach, informed by self-reported qualitative data, to develop the Hey, Friend modules. The mHealth intervention will include three modules that include multiple sub-topics (e.g., What is HIV?; How do I protect myself from HIV?; What is PrEP?, etc.), deliver culturally appropriate counseling content in community settings, juvenile court system, clinics, and schools; will include Motivational Interviewing components that are effective in evoking behavior change while being acceptable to adolescents and parents, and will include ongoing support through a text reminder to maximize the likelihood of initiating HIV prevention through testing and PrEP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Knowledge | HIV Knowledge Questionnaire (HIV-K-Q), Scored 0-18 with 18 indicating thorough HIV knowledge and 0 indicating no HIV knowledge | Year 2 | 
| SGM Related Stigma | Perceived Racism Scale (PRS). Scores for the PRS frequency of exposure scale can range from 0 to 301; higher scores indicate more frequent perceptions of exposure to racism. | Year 2 | 
| HIV Testing Behaviors | Binary Yes or No to Accept an HIV Test after Module | Year 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, PrEP