Get Connected Efficacy Trial

HIV Infections Clinical Trial

Official title:

Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132415
• Other study ID #: 1U19HD089881 (SubProject 8780)
• Secondary ID: 1U19HD089881
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 the full GC intervention to the GC HIV test locator. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: June 30, 2022
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
University of Pennsylvania	Baylor College of Medicine, Children's Hospital of Philadelphia, Emory University, University of Michigan, University of Minnesota, University of North Carolina

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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 th — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires	The investigators will test the proportion of the sample that begins PrEP during the 12-month follow-ups.	12 month
Secondary	Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires	The investigators will estimate the proportion of participants who test for STIs at least once over the trial period.	12 month