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Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens

Primary Purpose

HIV

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Information, motivation, behavioral skills treatment arm
Information only control arm
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring Human immunodeficiency virus, Adolescents, Sexual and gender minority, Lesbian, gay, bisexual, and transgender, Sexually transmitted infections, Sexual health

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: male identified or male sex at birth Have penetrative (vaginal/anal) sex with partners assigned male at birth within the past 12 months SGM identity including people who are "questioning" "unsure" or "exploring". Cis-gender heterosexual men are eligible if they report having sex with a male/male-identified partner 13-18 years old reads in English at a 8th grade level HIV negative or unknown status own a cell phone with an unlimited MMS plan and plan to have the same number during the study can provide informed assent, as shown on a capacity to consent assessment live in the U.S. or territories. Exclusion Criteria: Previous lifetime testing for HIV or an STI HIV positive Currently on PrEP cisgender female

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Information only control

    Information, motivation, behavioral skills treatment arm

    Arm Description

    The attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-4 total participants with whom participants can discuss program content).

    The active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-4 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition.

    Outcomes

    Primary Outcome Measures

    HIV/STI testing
    Participants asked to self-report their history of HIV testing; scale item (No, I have never been tested for HIV/Yes, I have been tested HIV/ I do not know or not sure)
    Most recent HIV test
    Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I do not know)
    Objective proof of HIV testing
    Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image)

    Secondary Outcome Measures

    Lifetime STI testing
    Participants asked to self-report their history of STI testing; outcomes assessed via scale items (No, I have never been tested for any STI/Yes, I have been tested for at least one STI/ I do not know or not sure)
    Lifetime number of sexual partners someone has had condom-less sex with
    Incidence of Condomless Sex
    Ever taken PrEP
    Binary-scale item (yes/no)
    Currently taking PrEP
    Binary-scale item (yes/no)
    Sexual Health Communications Scale
    This is a 4-item Likert scale (1=Never - 5= Always) which asks participants about their communicative experiences as an LGBTQ person receiving services from medical healthcare providers, specifically around HIV testing, PrEP, STI and HIV prevention, and an individual's LGBTQ identity. Scale adapted from the Sexual Health Communications Scale (Fisher et al., 2018). Minimum value on the adapted version used in this study is a 4 (four) and the maximum value is a 20 (twenty). HIgher scores indicate better outcomes.

    Full Information

    First Posted
    May 18, 2023
    Last Updated
    October 18, 2023
    Sponsor
    Northwestern University
    Collaborators
    National Institute of Mental Health (NIMH)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06096519
    Brief Title
    Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens
    Official Title
    Effectiveness and Implementation of Text Messaging to Improve Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority Adolescents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2024 (Anticipated)
    Primary Completion Date
    December 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    National Institute of Mental Health (NIMH)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).
    Detailed Description
    Adolescent sexual minority males, transgender girls, and gender diverse teens (ASMM/TGD; ages 13-18) are disproportionately affected by HIV, accounting for 79% of new infections among this age group. Furthermore, in the U.S., 44% of 13-24-year-olds who are HIV-positive are unaware of their status - the highest percentage of undiagnosed infections of all age groups. Most of these infections occur among ASMM/TGD. Although the Center for Disease Control (CDC) recommends screening teens at risk for HIV at least annually, testing rates in this age group are extremely low. As such there is a need for interventions that aim to increase HIV testing in ASMM/TGD. This study builds upon the work of a previous text-based sexual health intervention program called G2G. The G2G pilot randomized controlled trial showed adolescents in the active treatment arm were >3x more likely to report being tested for HIV at follow-up compared to those in the control arm. Given the success of HIV testing behaviors in G2G this current study will aim to update G2G with the latest HIV prevention and testing science, tailor the intervention content so it is modern and inclusive of TGD teens, and test its effectiveness on the outcome of validated HIV testing (e.g., photo of HIV test result). We will test this in a nationwide randomized controlled trial with 360 ASMM/TGD aged 13-18. The primary efficacy outcome measure is HIV/STI testing via self report and objective evidence (e.g., photo of their test results) at 3 month and 6 month follow up surveys. Our study hypothesizes that participants assigned to the treatment arm of the intervention will have higher odds of having received an HIV test at 3 and 6 month follow up compared to those in the control arm. Ultimately, increased HIV testing in this group will mitigate transmission rates and improve the HIV prevention and care continua in this population.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV
    Keywords
    Human immunodeficiency virus, Adolescents, Sexual and gender minority, Lesbian, gay, bisexual, and transgender, Sexually transmitted infections, Sexual health

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    360 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Information only control
    Arm Type
    Placebo Comparator
    Arm Description
    The attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-4 total participants with whom participants can discuss program content).
    Arm Title
    Information, motivation, behavioral skills treatment arm
    Arm Type
    Experimental
    Arm Description
    The active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-4 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Information, motivation, behavioral skills treatment arm
    Other Intervention Name(s)
    Guy2Guy (G2G)
    Intervention Description
    Our intervention will be an updated version of (Guy2Guy) G2G, a 2014 text messaging-based healthy sexuality and HIV prevention program specifically for 14-18 year old gay, bisexual, and queer (GBQ) adolescent males. The treatment arm of G2G was guided by the Information-Motivation-Behavioral Skills (IMB) model and proved to be efficacious at increasing HIV testing in 13-18 year old GBQ adolescent males. In this updated version we will continue to utilize the IMB model, but modernize the content to include updated HIV prevention information (e.g., novel methods of HIV testing, PrEP, PEP) and tailor the text-message content to meet the needs of adolescent sexual minority men and transgender and gender diverse adolescents.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Information only control arm
    Intervention Description
    This information only control arm will consist of content and text messages focused on health behavior information, including mood, sexual health, substance use, and other health behaviors. It will be identical in length to the intervention arm.
    Primary Outcome Measure Information:
    Title
    HIV/STI testing
    Description
    Participants asked to self-report their history of HIV testing; scale item (No, I have never been tested for HIV/Yes, I have been tested HIV/ I do not know or not sure)
    Time Frame
    Baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Most recent HIV test
    Description
    Participants asked to provide date (open-ended) and outcome of most recent HIV test (scale item: negative/positive/I do not know)
    Time Frame
    Baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Objective proof of HIV testing
    Description
    Participants are asked to upload image of proof of most recent HIV test; open-ended (upload image)
    Time Frame
    through study completion, an average of 9 months, 3-months post-intervention, 6-months post-intervention
    Secondary Outcome Measure Information:
    Title
    Lifetime STI testing
    Description
    Participants asked to self-report their history of STI testing; outcomes assessed via scale items (No, I have never been tested for any STI/Yes, I have been tested for at least one STI/ I do not know or not sure)
    Time Frame
    Baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Lifetime number of sexual partners someone has had condom-less sex with
    Description
    Incidence of Condomless Sex
    Time Frame
    baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Ever taken PrEP
    Description
    Binary-scale item (yes/no)
    Time Frame
    baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Currently taking PrEP
    Description
    Binary-scale item (yes/no)
    Time Frame
    baseline, 3-months post-intervention, 6-months post-intervention
    Title
    Sexual Health Communications Scale
    Description
    This is a 4-item Likert scale (1=Never - 5= Always) which asks participants about their communicative experiences as an LGBTQ person receiving services from medical healthcare providers, specifically around HIV testing, PrEP, STI and HIV prevention, and an individual's LGBTQ identity. Scale adapted from the Sexual Health Communications Scale (Fisher et al., 2018). Minimum value on the adapted version used in this study is a 4 (four) and the maximum value is a 20 (twenty). HIgher scores indicate better outcomes.
    Time Frame
    baseline, 3-months post-intervention, 6-months post-intervention

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    male identified or male sex at birth
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: male identified or male sex at birth Have penetrative (vaginal/anal) sex with partners assigned male at birth within the past 12 months SGM identity including people who are "questioning" "unsure" or "exploring". Cis-gender heterosexual men are eligible if they report having sex with a male/male-identified partner 13-18 years old reads in English at a 8th grade level HIV negative or unknown status own a cell phone with an unlimited MMS plan and plan to have the same number during the study can provide informed assent, as shown on a capacity to consent assessment live in the U.S. or territories. Exclusion Criteria: Previous lifetime testing for HIV or an STI HIV positive Currently on PrEP cisgender female
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kathryn Macapagal, PhD
    Phone
    3125033605
    Email
    kathryn.macapagal@northwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andrés Alvarado Avila, B.A
    Phone
    3125035446
    Email
    andres.avila@northwestern.edu

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31277991
    Citation
    Ybarra ML, Prescott T, Mustanski B, Parsons J, Bull SS. Feasibility, Acceptability, and Process Indicators for Guy2Guy, an mHealth HIV Prevention Program for Sexual Minority Adolescent Boys. J Adolesc Health. 2019 Sep;65(3):417-422. doi: 10.1016/j.jadohealth.2019.04.025. Epub 2019 Jul 2.
    Results Reference
    background
    PubMed Identifier
    28659456
    Citation
    Ybarra ML, Prescott TL, Phillips GL 2nd, Bull SS, Parsons JT, Mustanski B. Pilot RCT Results of an mHealth HIV Prevention Program for Sexual Minority Male Adolescents. Pediatrics. 2017 Jul;140(1):e20162999. doi: 10.1542/peds.2016-2999.
    Results Reference
    background
    PubMed Identifier
    29546468
    Citation
    Fisher CB, Fried AL, Macapagal K, Mustanski B. Patient-Provider Communication Barriers and Facilitators to HIV and STI Preventive Services for Adolescent MSM. AIDS Behav. 2018 Oct;22(10):3417-3428. doi: 10.1007/s10461-018-2081-x.
    Results Reference
    background

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    Text Messaging for Human Immunodeficiency Virus (HIV) Testing in Sexual and Gender Minority (SGM) Teens

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