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

NCT04846946 | Withdrawn

• 1 other identifier: MISP #60819
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

HIV; PrEP

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Control

NO INTERVENTION

Time attention control condition.

Intervention, Module 1 - Knowledge

EXPERIMENTAL

20-minute module that aims to improve HIV prevention knowledge.

Behavioral: Hey, Friend

Intervention, Module 1 - Stigma

EXPERIMENTAL

20-minute module that aims to reduce SGM- and HIV- related stigma.

Behavioral: Hey, Friend

Intervention, Module 1 - Prevention

EXPERIMENTAL

20-minute module that aims to promote HIV prevention strategies including testing and PrEP.

Behavioral: Hey, Friend

Interventions

Hey, Friend BEHAVIORAL

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.

Intervention, Module 1 - Knowledge; Intervention, Module 1 - Prevention; Intervention, Module 1 - Stigma

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 15, 2021
• Study Start: January 1, 2022
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)