HIV Infections
Conditions
Keywords
Prevention & Control, Internet, Adolescents, Young adults
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.
Interventions
BEHAVIORALGet 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.
BEHAVIORALHIV 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.
Sponsors
University of North Carolina
University of Michigan
University of Minnesota
Emory University
Children's Hospital of Philadelphia
Baylor College of Medicine
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
15 Years to 24 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 12 month | The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires | 12 month | The investigators will test the proportion of the sample that begins PrEP during the 12-month follow-ups. |
| Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires | 12 month | The investigators will estimate the proportion of participants who test for STIs at least once over the trial period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 143 |
| HIV Test Locator 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.
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. | 142 |
| Total | 285 |
Baseline characteristics
| Characteristic | HIV Test Locator | Total | Get Connected |
|---|---|---|---|
| Age, Continuous | 21.11 years STANDARD_DEVIATION 2.189 | 21.14 years STANDARD_DEVIATION 2.086 | 21.17 years STANDARD_DEVIATION 1.986 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 27 Participants | 57 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 228 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 33 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 31 Participants | 52 Participants | 21 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 29 Participants | 10 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 74 Participants | 163 Participants | 89 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 142 Participants | 285 Participants | 143 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 143 | 0 / 142 |
| other Total, other adverse events | 0 / 143 | 0 / 142 |
| serious Total, serious adverse events | 0 / 143 | 0 / 142 |
Outcome results
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.
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Get Connected | Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 53 Participants |
| HIV Test Locator | Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires | 54 Participants |
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.
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Get Connected | Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires | 38 Participants |
| HIV Test Locator | Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires | 36 Participants |
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.
Time frame: 12 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Get Connected | Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires | 73 Participants |
| HIV Test Locator | Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires | 75 Participants |