Get Connected Efficacy Trial
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|ClinicalTrials.gov Identifier: NCT03132415|
Recruitment Status : Recruiting
First Posted : April 27, 2017
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Get Connected Behavioral: AIDSVu||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||480 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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 website that includes information on the AIDSVU.org testing site locator. Given the availability of search engines to locate HIV/STI testing sites, the test locator condition may be considered usual care.
The investigators will use AIDSVu's available HIV/STI testing locator as the attention-control condition. The AIDSVu test locator provides a list of HIV testing sites in a city or zipcode.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132415
|Contact: Jose A Bauermeister, PhDfirstname.lastname@example.org|
|Contact: Rob B Stephenson, PhDemail@example.com|
|United States, Georgia|
|Emory University||Active, not recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Active, not recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Dalisa Santiago 832-824-1143 firstname.lastname@example.org|
|Principal Investigator: Mary E Paul, MD|
|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|