HIV InfectionsNCT03132415
Get Connected Efficacy Trial
A study testing Get Connected and HIV Test Locator in people with HIV Infections, run by University of Pennsylvania at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Get Connected and HIV Test Locator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Nov 2017to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30322
Texas Children's Hospital
Houston, Texas, 77030
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Get Connected, HIV Test Locator
- Keywords
- Prevention & Control, Internet, Adolescents, Young adults
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Get ConnectedBehavioural
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 LocatorBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Get Connected | Experimental | 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. Receives: Behavioral: Get Connected |
| HIV Test Locator | Active comparator | 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. Receives: Behavioral: HIV Test Locator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 month
Secondary outcomes (2)
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.
Measured: 12 month
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.
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start1 Nov 2017
- Primary completion15 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, University of Michigan, University of Minnesota, Emory University, Children's Hospital of Philadelphia, Baylor College of Medicine
- Responsible party
- Sponsor
- Investigators
- Lisa Hightow-Weidman, MD, Study chair, University of North CarolinaJose A Bauermeister, PhD, Principal investigator, University of PennsylvaniaRob B Stephenson, PhD, Principal investigator, University of MichiganPatrick S Sullivan, PhD, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132415
- Sponsor's protocol ID
- 1U19HD089881 (SubProject 8780)
- Other IDs
- 1U19HD089881
- Status last verified
- Aug 2023
- First submitted
- 24 Apr 2017
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
Publications
Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Harper GW, Horvath K, Weiss G, Dittus P. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav. 2015 Oct;19(10):1860-74. doi: 10.1007/s10461-015-1009-y.
PubMed 25638038Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Meanley S, Alapati D, Moore M, Lowther M, Wade R, Harper GW. The use of mystery shopping for quality assurance evaluations of HIV/STI testing sites offering services to young gay and bisexual men. AIDS Behav. 2015 Oct;19(10):1919-27. doi: 10.1007/s10461-015-1174-z.
PubMed 26303197Horvath KJ, Bauermeister JA. eHealth Literacy and Intervention Tailoring Impacts the Acceptability of a HIV/STI Testing Intervention and Sexual Decision Making Among Young Gay and Bisexual Men. AIDS Educ Prev. 2017 Feb;29(1):14-23. doi: 10.1521/aeap.2017.29.1.14.
PubMed 28195779Bauermeister JA, Golinkoff JM, Horvath KJ, Hightow-Weidman LB, Sullivan PS, Stephenson R. A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 2;7(8):e10444. doi: 10.2196/10444.
PubMed 30072358Bauermeister JA, Golinkoff JM, Lin WY, Claude KF, Horvath KJ, Dowshen N, Schlupp A, Vickroy WJ, Desir K, Lopez AV, Castillo M, Tanney M, Wimbly TA, Leung K, Sullivan PS, Santiago DL, Hernandez R, Paul ME, Hightow-Weidman L, Lee S, Stephenson R. Testing the Testers: Are Young Men Who Have Sex With Men Receiving Adequate HIV Testing and Counseling Services? J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S133-S141. doi: 10.1097/QAI.0000000000002173.
PubMed 31658201Bauermeister JA, Horvath KJ, Lin WY, Golinkoff JM, Claude KF, Dowshen N, Castillo M, Sullivan PS, Paul M, Hightow-Weidman L, Stephenson R. Enhancing routine HIV and STI testing among young men who have sex with men: primary outcomes of the get connected clinical randomized trial (ATN 139). BMC Public Health. 2024 Apr 17;24(1):1072. doi: 10.1186/s12889-024-18522-w.
PubMed 38632603
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Get Connected: Linking YMSM to Adequate Care Through a Multilevel, Tailored WebApp Intervention
- ClinicalTrials.gov ID
- NCT03132415
- Acronym / sponsor ID
- 1U19HD089881 (SubProject 8780)
- Conditions
- HIV Infections
- Keywords
- Prevention & Control, Internet, Adolescents, Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- University of North Carolina, University of Michigan, University of Minnesota, Emory University, Children's Hospital of Philadelphia, Baylor College of Medicine
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 27 Apr 2017 (actual)
- Results
- Posted 18 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Get Connected | Experimental | Behavioral: Get ConnectedGet Connected is a brief intervention focused on resolving ambivalence about HIV prevention behaviors, increasing self-efficacy for change, and enhancing motivation moving toward action. |
| HIV Test Locator | Active comparator | Behavioral: HIV Test LocatorParticipants 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. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Get ConnectedThe 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. | Behavioural | Get Connected |
| HIV Test LocatorThe 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. | Behavioural | HIV Test Locator |
Primary outcome
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires
Time frame: 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.
2 secondary outcomes
Percent of Participants Reporting Changes in PrEP Uptake Using Self-report Questionnaires
Time frame: 12 month
Percent of Participants Reporting Changes in Their STI Testing Behavior Using Self-report Questionnaires
Time frame: 12 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25638038Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Harper GW, Horvath K, Weiss G, Dittus P. Acceptability and preliminary efficacy of a tailored online HIV/STI testing intervention for young men who have sex with men: the Get Connected! program. AIDS Behav. 2015 Oct;19(10):1860-74. doi: 10.1007/s10461-015-1009-y.
- Background: PubMed 26303197Bauermeister JA, Pingel ES, Jadwin-Cakmak L, Meanley S, Alapati D, Moore M, Lowther M, Wade R, Harper GW. The use of mystery shopping for quality assurance evaluations of HIV/STI testing sites offering services to young gay and bisexual men. AIDS Behav. 2015 Oct;19(10):1919-27. doi: 10.1007/s10461-015-1174-z.
- Background: PubMed 28195779Horvath KJ, Bauermeister JA. eHealth Literacy and Intervention Tailoring Impacts the Acceptability of a HIV/STI Testing Intervention and Sexual Decision Making Among Young Gay and Bisexual Men. AIDS Educ Prev. 2017 Feb;29(1):14-23. doi: 10.1521/aeap.2017.29.1.14.
- Background: PubMed 30072358Bauermeister JA, Golinkoff JM, Horvath KJ, Hightow-Weidman LB, Sullivan PS, Stephenson R. A Multilevel Tailored Web App-Based Intervention for Linking Young Men Who Have Sex With Men to Quality Care (Get Connected): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 2;7(8):e10444. doi: 10.2196/10444.
- Results publication: PubMed 31658201Bauermeister JA, Golinkoff JM, Lin WY, Claude KF, Horvath KJ, Dowshen N, Schlupp A, Vickroy WJ, Desir K, Lopez AV, Castillo M, Tanney M, Wimbly TA, Leung K, Sullivan PS, Santiago DL, Hernandez R, Paul ME, Hightow-Weidman L, Lee S, Stephenson R. Testing the Testers: Are Young Men Who Have Sex With Men Receiving Adequate HIV Testing and Counseling Services? J Acquir Immune Defic Syndr. 2019 Dec 1;82 Suppl 2(2):S133-S141. doi: 10.1097/QAI.0000000000002173.
- Derived from this study: PubMed 38632603Bauermeister JA, Horvath KJ, Lin WY, Golinkoff JM, Claude KF, Dowshen N, Castillo M, Sullivan PS, Paul M, Hightow-Weidman L, Stephenson R. Enhancing routine HIV and STI testing among young men who have sex with men: primary outcomes of the get connected clinical randomized trial (ATN 139). BMC Public Health. 2024 Apr 17;24(1):1072. doi: 10.1186/s12889-024-18522-w.
- Individual participant dataSharing planned: Yes. The investigators will assure the timely release and sharing of data two years after the publication of the main trial findings from the final dataset. Study variables will be available; however, the investigators will protect the rights and privacy of human subjects by redacting all identifiers from the dataset. The de-identified data from this project will be available through individual requests directed to the Principal Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hightow-Weidman, MD study chair
University of North Carolina
Jose A Bauermeister, PhD principal investigator
University of Pennsylvania
Rob B Stephenson, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Get Connected and HIV Test Locator in people with HIV Infections, run by University of Pennsylvania at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Participants Reporting Changes in Their HIV Testing Behavior Using Self-report Questionnaires (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132415, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.