Get Connected Efficacy Trial

• ClinicalTrials.gov Identifier: NCT03132415
• Recruitment Status: Active, not recruiting
• First Posted: April 27, 2017
• Last Update Posted: January 20, 2022
• Sponsor: University of Pennsylvania
• Collaborators: University of North Carolina; University of Michigan; University of Minnesota; Emory University; Children's Hospital of Philadelphia; Baylor College of Medicine
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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 480 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Behavioral: Get Connected; Behavioral: HIV Test Locator	Not Applicable

Detailed Description:

The number of HIV infections among men who have sex with men aged 15-24 (YMSM) has grown significantly in the past decade. For YMSM to successfully engage in HIV prevention and care services requires that they navigate a series of multilevel barriers operating at the individual (e.g., risk awareness, self-efficacy to get tested), systems (e.g., costs, medical mistrust, lack of culturally competent care), and structural (e.g., homelessness, costs, stigma) levels.

The investigators developed Get Connected (GC) as an online brief intervention that employs individual and systems-level tailoring technology to reduce barriers to linkage to competent prevention care (e.g., HIV/STI testing, PrEP) for YMSM (ages 15-24). After a formative phase comprised of assessing HIV testing sites' performance via a mystery shopping procedure, the investigators will test the efficacy of GC for increasing YMSM's successful engagement in locally appropriate HIV prevention and care using a two-arm randomized controlled trial.

The trial will compare GC (N=240) to an existing online HIV test locator (N=240). Participants will be recruited from three cities (Houston, Philadelphia and Atlanta) characterized by high HIV incidence, and followed over 12 months. Assessments will be collected at 30 days and at 3, 6, 9 and 12 month follow-up.

Specific Aims include:

Aim 1: Examine the quality of HIV test counseling and PrEP-related referrals to YMSM within local HIV/STI testing sites in 3 cities (Houston, Philadelphia & Atlanta).

Aim 2: Test the efficacy of GC for increasing HIV-negative or HIV-unknown YMSM's successful uptake of HIV prevention services (e.g., routine HIV/STI testing) and PrEP awareness and willingness, as compared to the attention-control condition over a 12-month period.

Aim 3: Qualitatively assess sites' satisfaction with performance assessments and their improvements in service delivery when working with YMSM across the three regions.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 285 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
• Actual Study Start Date: November 1, 2017
• Actual Primary Completion Date: December 15, 2021
• Estimated Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Get Connected; 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; 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.
Active Comparator: Non-tailored HIV Test Locator; Participants randomized to the control condition will be directed to a 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Percent of Participants reporting changes in their HIV Testing Behavior using self-report questionnaires [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
   The investigators will estimate the proportion of participants who test for HIV by intervention group and by time on study.

Secondary Outcome Measures :

1. Percent of participants reporting changes in PrEP uptake using self-report questionnaires [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
   The investigators will test the proportion of the sample that begins PrEP during the 12-month follow-ups.
2. Mean Change in motivations to engage in HIV prevention behaviors using self-report questionnaires [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
   The investigators will measure the change in HIV prevention attitudes, norms, and self-efficacy using the NIH Adolescent Trials Network's Harmonized Questionnaire by intervention group and by time on study.
3. Mean Change in PrEP motivations using self-report questionnaires [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
   The investigators will measure the change in PrEP awareness and willingness over time using the NIH Adolescent Trials Network's Harmonized Questionnaire.
4. Percent of Participants reporting changes in their STI Testing Behavior using self-report questionnaires [ Time Frame: 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments ]
   The investigators will estimate the proportion of participants who test for STIs at least once over the trial period.

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 24 Years (Child, Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Pennsylvania

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Texas Children's Hospital

Houston, Texas, United States, 77030

Sponsors and Collaborators

University of Pennsylvania

University of North Carolina

University of Michigan

University of Minnesota

Emory University

Children's Hospital of Philadelphia

Baylor College of Medicine

Investigators

• Study Chair: Lisa Hightow-Weidman, MD; University of North Carolina
• Principal Investigator: Jose A Bauermeister, PhD; University of Pennsylvania
• Principal Investigator: Rob B Stephenson, PhD; University of Michigan
• Study Chair: Patrick S Sullivan, PhD; Emory University

  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:

Study Protocol and Statistical Analysis Plan  [PDF] February 1, 2019

More Information

Publications of Results:

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.

Other Publications:

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03132415
• Other Study ID Numbers: 1U19HD089881 (SubProject 8780); 1U19HD089881 ( U.S. NIH Grant/Contract )
• First Posted: April 27, 2017
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:

Prevention & Control; Internet; Adolescents; Young adults

Additional relevant MeSH terms:

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases