Get Connected Efficacy Trial

University of Pennsylvania

Status: Completed

Conditions: HIV Infections

Treatments: Behavioral: Get Connected; Behavioral: HIV Test Locator

Study type: Interventional

Funder types: Other

Identifiers

NCT03132415

1U19HD089881 (U.S. NIH Grant/Contract)

1U19HD089881 (SubProject 8780)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 285 patients

Sex: Male

Ages: 15 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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285 participants in 2 patient groups

Get Connected

Experimental group

Description:

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.

Treatment:

Behavioral: Get Connected

HIV Test Locator

Active Comparator group

Description:

Participants randomized to the control condition will receive the Get Connected testing site locator. Given the availability of search engines to locate HIV/STI testing sites, the test locator condition may be considered usual care.

Treatment:

Behavioral: HIV Test Locator