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"

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Hey, Friend

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham (UAB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Does not fit the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): April 25, 2022
• Study Completion (Actual): April 25, 2022

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: HIV; PrEP
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: MISP #60819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not intend to share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No