NCT04846946

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

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"

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2021-04-15
• Last updated: 2022-05-02

Locations

1 site across 1 country: United States