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Clinical Trials/NCT04846946
NCT04846946WithdrawnNot Applicable

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"

University of Alabama at Birmingham1 site in 1 countryStarted: January 1, 2022Last updated:
Conditions
Interventions

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Withdrawn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

No Intervention

Time attention control condition.

Intervention, Module 1 - Knowledge

Experimental

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

Intervention: Hey, Friend (Behavioral)

Intervention, Module 1 - Stigma

Experimental

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

Intervention: Hey, Friend (Behavioral)

Intervention, Module 1 - Prevention

Experimental

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Henna Budhwani

Assistant Professor

University of Alabama at Birmingham

Study Sites (1)

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