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

Overview

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.

Full Title of Study: “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””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 25, 2022

Detailed Description

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.

Interventions

  • Behavioral: Hey, Friend
    • 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.

Arms, Groups and Cohorts

  • No Intervention: Control
    • Time attention control condition.
  • Experimental: Intervention, Module 1 – Knowledge
    • 20-minute module that aims to improve HIV prevention knowledge.
  • Experimental: Intervention, Module 1 – Stigma
    • 20-minute module that aims to reduce SGM- and HIV- related stigma.
  • Experimental: Intervention, Module 1 – Prevention
    • 20-minute module that aims to promote HIV prevention strategies including testing and PrEP.

Clinical Trial Outcome Measures

Primary Measures

  • HIV Knowledge
    • Time Frame: Year 2
    • HIV Knowledge Questionnaire (HIV-K-Q), Scored 0-18 with 18 indicating thorough HIV knowledge and 0 indicating no HIV knowledge
  • SGM Related Stigma
    • Time Frame: Year 2
    • 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.
  • HIV Testing Behaviors
    • Time Frame: Year 2
    • Binary Yes or No to Accept an HIV Test after Module

Participating in This Clinical Trial

Inclusion Criteria

  • Adolescents aged 14-18 – Parental or guardian consent – SGM identity – English speaking Exclusion Criteria:

  • Does not fit the inclusion criteria

Gender Eligibility: All

Minimum Age: 14 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Provider of Information About this Clinical Study
    • Principal Investigator: Henna Budhwani, Assistant Professor – University of Alabama at Birmingham

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