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

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: HIV Infections

Treatments: Behavioral: Hey, Friend

Study type: Interventional

Funder types: Other

Identifiers

NCT04846946

MISP #60819

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 14 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Does not fit the inclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Control

No Intervention group

Description:

Time attention control condition.

Intervention, Module 1 - Knowledge

Experimental group

Description:

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

Treatment:

Behavioral: Hey, Friend

Intervention, Module 1 - Stigma

Experimental group

Description:

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

Treatment:

Behavioral: Hey, Friend

Intervention, Module 1 - Prevention

Experimental group

Description:

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

Treatment:

Behavioral: Hey, Friend