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"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- HIV Knowledge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 14 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adolescents aged 14-18
- •Parental or guardian consent
- •SGM identity
- •English speaking
Exclusion Criteria
- •Does not fit the inclusion criteria
Arms & Interventions
Control
Time attention control condition.
Intervention, Module 1 - Knowledge
20-minute module that aims to improve HIV prevention knowledge.
Intervention: Hey, Friend (Behavioral)
Intervention, Module 1 - Stigma
20-minute module that aims to reduce SGM- and HIV- related stigma.
Intervention: Hey, Friend (Behavioral)
Intervention, Module 1 - Prevention
20-minute module that aims to promote HIV prevention strategies including testing and PrEP.
Intervention: Hey, Friend (Behavioral)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Henna Budhwani
Assistant Professor
University of Alabama at Birmingham
