Clinical trial NCT03132415: Get Connected Efficacy Trial
Official title: Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Prevention & Control
Internet
Adolescents
Young adults
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of Michigan
name: University of Minnesota
name: Emory University
name: Children's Hospital of Philadelphia
name: Baylor College of Medicine
First posted: 2017-04-27
Enrollment: 285
Sex: MALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
timeFrame: 12 month
Secondary outcomes:
measure: Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires
timeFrame: 12 month
measure: Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires
timeFrame: 12 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: University of North Carolina
name: Lisa Hightow-Weidman, MD
role: STUDY_CHAIR
affiliation: University of Pennsylvania
name: Jose A Bauermeister, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Rob B Stephenson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Patrick S Sullivan, PhD
role: STUDY_CHAIR
References:
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.
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.
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.
citation: 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.
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 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.