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

Not Applicable

Withdrawn

• Conditions: HIV Infections
• Interventions: Behavioral: Hey, Friend

• Registration Number: NCT04846946
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-04-12
• Study First Submitted QC: 2021-04-12
• Study First Posted: 2021-04-15
• Study Start: 2022-01-01
• Status Verified: 2022-04
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adolescents aged 14-18
• Parental or guardian consent
• SGM identity
• English speaking

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Exclusion Criteria

• Does not fit the inclusion criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention, Module 1 - Stigma	Hey, Friend	20-minute module that aims to reduce SGM- and HIV- related stigma.
Intervention, Module 1 - Knowledge	Hey, Friend	20-minute module that aims to improve HIV prevention knowledge.
Intervention, Module 1 - Prevention	Hey, Friend	20-minute module that aims to promote HIV prevention strategies including testing and PrEP.

Primary Outcome Measures

Name	Time	Method
HIV Knowledge	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	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	Year 2	Binary Yes or No to Accept an HIV Test after Module

Trial Locations

Locations (1)

University of Alabama at Birmingham (UAB); 🇺🇸 Birmingham, Alabama, United States