Trial Outcomes & Findings for Get Connected Efficacy Trial (NCT NCT03132415)
NCT ID: NCT03132415
Last Updated: 2024-03-18
Results Overview
The investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
285 participants
Primary outcome timeframe
12 month
Results posted on
2024-03-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
142
|
|
Overall Study
COMPLETED
|
143
|
142
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Get Connected Efficacy Trial
Baseline characteristics by cohort
| Measure |
Get Connected
n=143 Participants
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.
|
HIV Test Locator
n=142 Participants
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.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.17 years
STANDARD_DEVIATION 1.986 • n=99 Participants
|
21.11 years
STANDARD_DEVIATION 2.189 • n=107 Participants
|
21.14 years
STANDARD_DEVIATION 2.086 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
143 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthThe investigators will estimate the proportion of participants who test at least twice for HIV over a 12-month period by intervention group.
Outcome measures
| Measure |
Get Connected
n=143 Participants
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.
|
HIV Test Locator
n=142 Participants
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.
|
|---|---|---|
|
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
|
53 Participants
|
54 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe investigators will test the proportion of the sample that begins PrEP during the 12-month follow-ups.
Outcome measures
| Measure |
Get Connected
n=143 Participants
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.
|
HIV Test Locator
n=142 Participants
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.
|
|---|---|---|
|
Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires
|
38 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: 12 monthThe investigators will estimate the proportion of participants who test for STIs at least once over the trial period.
Outcome measures
| Measure |
Get Connected
n=143 Participants
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.
|
HIV Test Locator
n=142 Participants
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.
|
|---|---|---|
|
Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires
|
73 Participants
|
75 Participants
|
Adverse Events
Get Connected
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Test Locator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place