Get Connected Efficacy Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Behavioral: Get Connected
* Behavioral: HIV Test Locator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Get Connected<br>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<br>* 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.<br>|
| Active Comparator: Non-tailored HIV Test Locator<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments | 
| Mean Change in motivations to engage in HIV prevention behaviors using self-report questionnaires | 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. | 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments | 
| Mean Change in PrEP motivations using self-report questionnaires | The investigators will measure the change in PrEP awareness and willingness over time using the NIH Adolescent Trials Network's Harmonized Questionnaire. | 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments | 
| 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. | 30-day, 3-month, 6-month, 9-month, and 12-month follow-up assessments | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention & Control, Internet, Adolescents, Young adults