HivNCT04207151
Expanding PrEP By Embedding Unannounced SNAPS Navigators in High STI Testing Clinical Sites
A study testing SNAPS intervention in people with Hiv and Sexually Transmitted Infection, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv, Sexually Transmitted Infection
- What is being tested?
- SNAPS intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 9 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Historical comparison group:
- all adults ≥18 years of age prescribed PrEP at H+H/Bellevue one year prior to SNAPS intervention initiation.
- Prospective group:
- all patients will be considered for study participation who are accessing care at H+H/Bellevue ≥ 18 years of age,
- have unknown HIV status,
- requesting STI testing/treatment or inquiring about PrEP or PEP in the ED or urgent care, OB/GYN, and Dermatology clinics.
Who cannot join
- patients who are HIV positive
- refuse consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Expanding PrEP By Embedding Unannounced SNAPS Navigators in High Sexually Transmitted Infection (STI) Testing Clinical Sites
The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.
Read the detailed description
The objective of the investigator's proposal is to evaluate the effectiveness of an intervention to (1) increase PrEP initiation overall, (2) increase uptake among groups disproportionately impacted by the HIV pandemic, and (3) to preserve high PrEP retention while expanding use. In addition, the proposal includes innovative secondary outcomes of (4) identifying barriers and facilitators of PrEP use that may be unique to urban safety-net populations, and (5) estimating the HIV infections averted due to greater PrEP uptake from the intervention.
The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS).
- Conditions
- Hiv, Sexually Transmitted Infection
- Being tested
- SNAPS intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNAPS interventionBehavioural
The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS). SNAPS will selectively target those care settings where PrEP prescribing is particularly rare or absent (eg, OB/GYN). Study team will utilize a quasi- experimental design to compare rates of PrEP uptake overall, PrEP initiation in disproportionately-impacted groups, and PrEP retention pre-versus post-initiation of SNAPS, controlling for secular trends.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will receive HIV and STI testing, clinical monitoring, client centered counseling and PrEP prescriptions as standard of care, this includes scheduled visits every three months. |
| Pre- and Post- SNAPS intervention | Experimental | In addition to the standard of care treatment, approximately twenty subjects will be selected for interview pre- and post-SNAPS intervention to assess PrEP facilitators and barriers for uptake. Participants of interest include cis- and trans-women, for which there is limited data regarding PrEP and HIV prevention. Receives: Behavioral: SNAPS intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PrEP prescriptions
Change in rate of PrEP prescriptions at H+H/Bellevue among those in care for 1-year before study period and during 1-year study period by gender, race/ethnicity, age, insurance type, and preferred language.
Measured: Visits 3 months, 6 months, and 12 months
Change in the knowledge of HIV
Through pre and post qualitative interviews, the perceived HIV risk, knowledge and attitudes regarding PrEP, and facilitators and barriers regarding PrEP use will be analyzed.
Measured: Visit baseline, Visit 12 months
Change in the number of HIV cases
The number of HIV cases averted and distribution of these cases among disproportionately-impacted groups will be assessed to determine if intervention is effective
Measured: Visit 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start22 Jul 2019
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Pitts, MD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207151
- Sponsor's protocol ID
- 19-00060
- Status last verified
- Feb 2023
- First submitted
- 16 Dec 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only by NYU/Bellevue researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding PrEP By Embedding Unannounced SNAPS Navigators in High Sexually Transmitted Infection (STI) Testing Clinical Sites
- ClinicalTrials.gov ID
- NCT04207151
- Acronym / sponsor ID
- 19-00060
- Conditions
- Hiv, Sexually Transmitted Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to assess the impact of an intervention, known as SNAPS, to expand Preexposure Prophylaxis (PrEP) prescriptions at Health + Hospitals (H+H)/Bellevue. In addition, evaluating whether this intervention, ie SNAPS, helps patients get on PrEP and stay on PrEP to prevent STIs like HIV. PrEP is a medication that needs to be taken on a regular basis in order to be effective to prevent HIV transmission.
Detailed description
The objective of the investigator's proposal is to evaluate the effectiveness of an intervention to (1) increase PrEP initiation overall, (2) increase uptake among groups disproportionately impacted by the HIV pandemic, and (3) to preserve high PrEP retention while expanding use. In addition, the proposal includes innovative secondary outcomes of (4) identifying barriers and facilitators of PrEP use that may be unique to urban safety-net populations, and (5) estimating the HIV infections averted due to greater PrEP uptake from the intervention.
The intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will receive HIV and STI testing, clinical monitoring, client centered counseling and PrEP prescriptions as standard of care, this includes scheduled visits every three months. |
| Pre- and Post- SNAPS intervention | Experimental | Behavioral: SNAPS interventionIn addition to the standard of care treatment, approximately twenty subjects will be selected for interview pre- and post-SNAPS intervention to assess PrEP facilitators and barriers for uptake. Participants of interest include cis- and trans-women, for which there is limited data regarding PrEP and HIV prevention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- all adults ≥18 years of age prescribed PrEP at H+H/Bellevue one year prior to SNAPS intervention initiation.
- all patients will be considered for study participation who are accessing care at H+H/Bellevue ≥ 18 years of age,
- have unknown HIV status,
- requesting STI testing/treatment or inquiring about PrEP or PEP in the ED or urgent care, OB/GYN, and Dermatology clinics.
Key exclusion criteria (2 listed)
- patients who are HIV positive
- refuse consent
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 |
|---|---|---|
| SNAPS interventionThe intervention is multi-level yet, targets the "weakest chains in the link" of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS). SNAPS will selectively target those care settings where PrEP prescribing is particularly rare or absent (eg, OB/GYN). Study team will utilize a quasi- experimental design to compare rates of PrEP uptake overall, PrEP initiation in disproportionately-impacted groups, and PrEP retention pre-versus post-initiation of SNAPS, controlling for secular trends. | Behavioural | Pre- and Post- SNAPS intervention |
Primary outcome
Change in PrEP prescriptions
Time frame: Visits 3 months, 6 months, and 12 months
Change in rate of PrEP prescriptions at H+H/Bellevue among those in care for 1-year before study period and during 1-year study period by gender, race/ethnicity, age, insurance type, and preferred language.
Change in the knowledge of HIV
Time frame: Visit baseline, Visit 12 months
Through pre and post qualitative interviews, the perceived HIV risk, knowledge and attitudes regarding PrEP, and facilitators and barriers regarding PrEP use will be analyzed.
Change in the number of HIV cases
Time frame: Visit 12 months
The number of HIV cases averted and distribution of these cases among disproportionately-impacted groups will be assessed to determine if intervention is effective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Individual participant dataSharing planned: No. Only by NYU/Bellevue researchers
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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.
Robert Pitts, MD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SNAPS intervention in people with Hiv and Sexually Transmitted Infection, run by NYU Langone Health at 1 site 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 6 inclusion and 2 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in PrEP prescriptions (time frame: Visits 3 months, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2023.