HIV ChemoprophylaxisSHIPPNCT02074891
Sustainable Healthcenter Implementation PrEP Pilot Study
An observational study of HIV Chemoprophylaxis and HIV Preexposure Prophylaxis, run by Centers for Disease Control and Prevention at 5 sites in United States.
Trial summary
A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Chemoprophylaxis, HIV Preexposure Prophylaxis
- What is being tested?
- coformulated TDF/FTC
- Type of treatment
- Pill or oral medicine
- How many people
- 1,420 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2014to Nov 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1200 adult men who have sex with men, injection drug users, and heterosexually-active men and women who are at substantial risk of acquiring HIV infection and initiate the use of daily oral antiretroviral preexposure prophylaxis (PrEP) with TDF/FTC
Who may be able to join
- adult
- documented without HIV infection (acute or established)
- report sexual behaviors that indicate substantial risk of HIV acquisition
- report injection-related behaviors that indicate substantial risk of HIV acquisition
Who cannot join
- <18 years of age
- documented HIV infection (acute or established)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Access Community Health Network - Grand Boulevard Health and Specialty Center
Chicago, Illinois, 60609
Howard Brown Community Health Center
Chicago, Illinois, 60613
Open Arms Healthcare Center
Jackson, Mississippi, 39216
Strawberry Mansion Health Center
Philadelphia, Pennsylvania, 19132
Whitman Walker Health
Washington D.C., District of Columbia, 20009
About this study
A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.
- Conditions
- HIV Chemoprophylaxis, HIV Preexposure Prophylaxis
- Being tested
- coformulated TDF/FTC
- Keywords
- preexposure prophylaxis, PrEP, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coformulated TDF/FTCDrug
Also called Truvada, Tenofovir disoproxil fumarate (TDF), Emtracitabine (FTC)
Daily oral dose of coformulated TDF/FTC
| Study group | Role | What they receive |
|---|---|---|
| Persons prescribed PrEP | adults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition. Receives: Drug: coformulated TDF/FTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical safety
Side effects, rates of renal adverse events, rates of atraumatic bone fractures, HIV infections with/without virus with mutations associated with TDF or FTC resistance, documented at clinical visits while prescribed PrEP
Measured: Every 3 months up to 36 months
Medication adherence
Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP
Measured: Every 3 months up to 36 months
Behavioral Responses
Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP
Measured: Every 3 months up to 36 months
Secondary outcomes (2)
Costs
Source of payment, cost, and reimbusement for medication and clinical care associated with each clinical visit for PrEP
Measured: Up to 3 years
Clinical practice variation
Variation in clinical practices at each clinic visit for PrEP-related care relative to PHS PrEP guidelines, and the relationship of clinical practices to patient outcomes
Measured: Every 3 months up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV ChemoprophylaxisStudies 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
- 1,420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- CDC Foundation, Gilead Sciences
- Responsible party
- Principal investigator, Karen Hoover, Centers for Disease Control and Prevention
- Investigators
- Dawn K Smith, MD, MS, MPH, Study chair, Centers for Disease Control and PreventionRebecca Cook, MPH, Study director, CDC Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074891
- Sponsor's protocol ID
- CDC-NCHHSTP-6511
- Acronym
- SHIPP
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2014
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable Healthcenter Implementation PrEP Pilot Study
- ClinicalTrials.gov ID
- NCT02074891
- Acronym / sponsor ID
- SHIPP / CDC-NCHHSTP-6511
- Conditions
- HIV Chemoprophylaxis, HIV Preexposure Prophylaxis
- Keywords
- preexposure prophylaxis, PrEP, HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,420 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- CDC Foundation, Gilead Sciences
- Study start
- Oct 2014
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 28 Feb 2014 (estimated)
- 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.
A health services implementation pilot study, conducted with an observational cohort of HIV-uninfected persons including men who have sex with men, heterosexual women and men, and injection drug users receiving daily oral antiretroviral preexposure prophylaxis (PrEP) at four federally qualified health centers that provide sexual health and primary care services to communities with high HIV incidence/prevalence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persons prescribed PrEP | – | Drug: coformulated TDF/FTCadults prescribed daily oral antiretroviral preexposure prophylaxis (PrEP) with the coformulated TDF/FTC to reduce HIV acquisition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1200 adult men who have sex with men, injection drug users, and heterosexually-active men and women who are at substantial risk of acquiring HIV infection and initiate the use of daily oral antiretroviral preexposure prophylaxis (PrEP) with TDF/FTC
Key inclusion criteria (4 listed)
- adult
- documented without HIV infection (acute or established)
- report sexual behaviors that indicate substantial risk of HIV acquisition
- report injection-related behaviors that indicate substantial risk of HIV acquisition
Key exclusion criteria (2 listed)
- <18 years of age
- documented HIV infection (acute or established)
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 |
|---|---|---|
| coformulated TDF/FTCAlso: Truvada, Tenofovir disoproxil fumarate (TDF), Emtracitabine (FTC)Daily oral dose of coformulated TDF/FTC | Drug | Persons prescribed PrEP |
Primary outcome
Clinical safety
Time frame: Every 3 months up to 36 months
Side effects, rates of renal adverse events, rates of atraumatic bone fractures, HIV infections with/without virus with mutations associated with TDF or FTC resistance, documented at clinical visits while prescribed PrEP
Medication adherence
Time frame: Every 3 months up to 36 months
Self-reported medication adherence and detection of tenofovir in dried blood spots at each clinical visit while prescribed PrEP
Behavioral Responses
Time frame: Every 3 months up to 36 months
Trends in sexual and injection HIV acquisition risk behaviors among patients measured at each clinic visit while prescribed PrEP
2 secondary outcomes
Costs
Time frame: Up to 3 years
Clinical practice variation
Time frame: Every 3 months up to 36 months
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 28 May 2024.
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.
Dawn K Smith, MD, MS, MPH study chair
Centers for Disease Control and Prevention
Rebecca Cook, MPH study director
CDC Foundation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Chemoprophylaxis and HIV Preexposure Prophylaxis, run by Centers for Disease Control and Prevention at 5 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 4 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 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Clinical safety (time frame: Every 3 months up to 36 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 28 May 2024.