Get Connected Efficacy Trial

NCT03132415 | Completed Results DMC

• 2 other identifiers: 1U19HD089881 (SubProject 8780)1U19HD089881
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 3

Brief Summary

Get Connected (GC) is an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to HIV prevention care (e.g., HIV/STI testing, PrEP) for YMSM. The deployment of GC through a mobile-friendly WebApp seeks to optimize online interventions' acceptability, accessibility, availability, long-term affordability among youth. The investigators will enroll self-reported HIV-negative or sero-status unaware, sexually active YMSM (ages 15-24) across three cities and randomize them into the GC intervention condition or to an attention-control condition. Assessments will be collected at 30 days and at 3, 6, 9 and 12 month follow-up.

Conditions

HIV Infections

Keywords

Prevention & Control; Internet; Adolescents; Young adults

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires

  The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.

  12 month

Secondary Outcomes (2)

• Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires

  12 month

• Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires

  12 month

Study Arms (2)

Get Connected

EXPERIMENTAL

Get Connected is a brief intervention focused on resolving ambivalence about HIV prevention behaviors, increasing self-efficacy for change, and enhancing motivation moving toward action.

Behavioral: Get Connected

HIV Test Locator

ACTIVE COMPARATOR

Participants randomized to the control condition will receive the Get Connected testing site locator. Given the availability of search engines to locate HIV/STI testing sites, the test locator condition may be considered usual care.

Behavioral: HIV Test Locator

Interventions

Get Connected BEHAVIORAL

The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics, HIV/STI testing history and testing motivations, and recent sexual behaviors.

Get Connected

HIV Test Locator BEHAVIORAL

The investigators will use a HIV/STI testing locator as the attention-control condition. The test locator provides a list of HIV testing sites in a city or zipcode.

HIV Test Locator

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Assigned male sex at birth and currently identifies as male
• Aged 15 to 24 years (inclusive) at time of screening
• Self-report as HIV-negative or sero-status unaware
• Speak and read English
• Not be on PrEP at time of enrollment
• Report having consensual anal sex with a male partner in the prior 6 months
• Reside in Philadelphia, Houston, or Atlanta
• Access to internet

You may not qualify if:

• Assigned female sex at birth
• Assigned male sex at birth but identifies as transgender or gender non-conforming
• Aged 14 years or younger or 25 years or older at time of screening
• HIV-positive
• Does not speak or read English
• Currently taking PrEP
• Did not have consensual anal sex with a male partner in the prior 6 months
• Does not reside in Philadelphia, Houston, or Atlanta
• Currently incarcerated
• Planning to move out of the region in next 12 months

Sponsors & Collaborators

• University of Pennsylvania: lead
• University of North Carolina: collaborator
• University of Michigan: collaborator
• University of Minnesota: collaborator
• Emory University: collaborator
• Children's Hospital of Philadelphia: collaborator
• Baylor College of Medicine: collaborator

Study Sites (3)

Emory University

Atlanta, Georgia, 30322, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (6)

• Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Harper GW, Horvath K, Weiss G, Dittus P. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav. 2015 Oct;19(10):1860-74. doi: 10.1007/s10461-015-1009-y.

  PMID: 25638038 BACKGROUND

• Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Meanley S, Alapati D, Moore M, Lowther M, Wade R, Harper GW. The use of mystery shopping for quality assurance evaluations of HIV/STI testing sites offering services to young gay and bisexual men. AIDS Behav. 2015 Oct;19(10):1919-27. doi: 10.1007/s10461-015-1174-z.

  PMID: 26303197 BACKGROUND

• Horvath KJ, Bauermeister JA. eHealth Literacy and Intervention Tailoring Impacts the Acceptability of a HIV/STI Testing Intervention and Sexual Decision Making Among Young Gay and Bisexual Men. AIDS Educ Prev. 2017 Feb;29(1):14-23. doi: 10.1521/aeap.2017.29.1.14.

  PMID: 28195779 BACKGROUND

• Bauermeister JA, Golinkoff JM, Horvath KJ, Hightow-Weidman LB, Sullivan PS, Stephenson R. A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 2;7(8):e10444. doi: 10.2196/10444.

  PMID: 30072358 BACKGROUND

• Bauermeister JA, Golinkoff JM, Lin WY, Claude KF, Horvath KJ, Dowshen N, Schlupp A, Vickroy WJ, Desir K, Lopez AV, Castillo M, Tanney M, Wimbly TA, Leung K, Sullivan PS, Santiago DL, Hernandez R, Paul ME, Hightow-Weidman L, Lee S, Stephenson R. Testing the Testers: Are Young Men Who Have Sex With Men Receiving Adequate HIV Testing and Counseling Services? J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S133-S141. doi: 10.1097/QAI.0000000000002173.

  PMID: 31658201 RESULT

• Bauermeister JA, Horvath KJ, Lin WY, Golinkoff JM, Claude KF, Dowshen N, Castillo M, Sullivan PS, Paul M, Hightow-Weidman L, Stephenson R. Enhancing routine HIV and STI testing among young men who have sex with men: primary outcomes of the get connected clinical randomized trial (ATN 139). BMC Public Health. 2024 Apr 17;24(1):1072. doi: 10.1186/s12889-024-18522-w.

  PMID: 38632603 DERIVED

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

Results Point of Contact

• Title: Jose Bauermeiser
• Organization: University of Pennsylvania

bjose@upenn.edu

215-898-9993

Study Officials

• Lisa Hightow-Weidman, MD

  University of North Carolina

  STUDY CHAIR

• Jose A Bauermeister, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Rob B Stephenson, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Patrick S Sullivan, PhD

  Emory University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 27, 2017
• Study Start: November 1, 2017
• Primary Completion: December 15, 2021
• Study Completion: June 30, 2022
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (3)