Unsafe SexNCT03637322
Evaluation of Implementation of the Phoenix PrEP (Pre-Exposure Prophylaxis) Access Project for Youth Aged 13-24
An observational study of Unsafe Sex and IV Drug Usage, run by Phoenix Children's Hospital at 1 site in United States.
Trial summary
This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Unsafe Sex, IV Drug Usage
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2022
- Phase
- Observational
- 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 13 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Youth aged 13 through 24 in the Phoenix area who are high risk for HIV infections because of unsafe sex practices and or IV drug use and have been offered PrEP as part of their standard medical care.
Who may be able to join
- sexually active youth aged 13 through 24,
- at risk for contracting HIV,
- Negative for HIV as indicated by Negative Elisa and Western Blot (WB) or Negative 4th Generation test,
- weight greater than 35kg,
- offered PrEP to reduce the risk of contracting HIV.
Who cannot join
- Unknown or Positive HIV status,
- Renal Impairment as indicated by elevated BUN or Creatinine, abnormal urinalysis,
- Active infection with Hepatitis B Virus,
- Taking other medications containing Emtricitabine, Tenofovir or tenofovir alafenamide(TAF) such as Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, and Viread taking drugs containing lamivudine,
- taking Hepsera,
- clinical symptoms consistent with acute viral infection within the past month.
Trial locations and contacts
1 site in 1 country.
United States1 site
Phoenix Children's Hospital, Bill Holt Clinic
Phoenix, Arizona, 85044
About this study
Official title: Evaluation of Implementation of the Phoenix PrEP Access Project for Youth Aged 13-24
This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined.
Read the detailed description
This observational study will describe the barriers encountered and the benefits found as youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in PrEP provided through standard medical care. This study does not investigate the safety, efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are trying to access PrEP.
- Conditions
- Unsafe Sex, IV Drug Usage
- Medical subject headings
- Unsafe Sex
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Uptake
Uptake of PrEP offered to youth presenting for PrEP ages 13-24
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start1 Jun 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unsafe SexStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice Piatt, MD, Principal investigator, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03637322
- Sponsor's protocol ID
- 17-196
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2018
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Implementation of the Phoenix PrEP Access Project for Youth Aged 13-24
- ClinicalTrials.gov ID
- NCT03637322
- Acronym / sponsor ID
- 17-196
- Conditions
- Unsafe Sex, IV Drug Usage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Phoenix Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Aug 2018 (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.
This study will evaluate the implementation of a PrEP program for youth aged 13-24 in Phoenix, AZ. Numbers of youth who initiate PrEP, how long they continue with PrEP, and the barriers for youth who are trying to initiate and continue taking PrEP will be examined.
Detailed description
This observational study will describe the barriers encountered and the benefits found as youth engage in a PrEP program, the Phoenix PrEP Access Project and as they participate in PrEP provided through standard medical care. This study does not investigate the safety, efficacy or other medical benefits of PrEP, but looks at the issues surrounding youth who are trying to access PrEP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth aged 13 through 24 in the Phoenix area who are high risk for HIV infections because of unsafe sex practices and or IV drug use and have been offered PrEP as part of their standard medical care.
Key inclusion criteria (5 listed)
- sexually active youth aged 13 through 24,
- at risk for contracting HIV,
- Negative for HIV as indicated by Negative Elisa and Western Blot (WB) or Negative 4th Generation test,
- weight greater than 35kg,
- offered PrEP to reduce the risk of contracting HIV.
Key exclusion criteria (6 listed)
- Unknown or Positive HIV status,
- Renal Impairment as indicated by elevated BUN or Creatinine, abnormal urinalysis,
- Active infection with Hepatitis B Virus,
- Taking other medications containing Emtricitabine, Tenofovir or tenofovir alafenamide(TAF) such as Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, and Viread taking drugs containing lamivudine,
- taking Hepsera,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PrEP Uptake
Time frame: 3 years
Uptake of PrEP offered to youth presenting for PrEP ages 13-24
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 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Janice Piatt, MD principal investigator
Phoenix Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unsafe Sex and IV Drug Usage, run by Phoenix Children's Hospital 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 5 inclusion and 6 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 31 Mar 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?
PrEP Uptake (time frame: 3 years). 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 31 Mar 2023.