HIV InfectionsPhase 1NCT03293290
Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
A Phase 1 study testing PrEP in people with HIV Infections, run by Yale University at 1 site in United States.
Trial summary
This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- PrEP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2017to 15 May 2020
- Phase
- Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Index participants reside in, or planning to reside in New Haven or Hartford, Connecticut,.
- Criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)).
- Self-reported HIV negative.
- Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.
- Risk network members must:
- have a unique and valid referral coupon (from Index participant).
Show all 9Show fewer
- Reside or planning to reside in New Haven or Hartford, Connecticut.
- Self-reported HIV negative
- 18 years of age or older
Who cannot join
- They are unable or unwilling to provide informed consent.
- Are threatening to staff.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Clinical and Community Research, 270 Congress Ave
New Haven, Connecticut, 06519
About this study
This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. The second component is designed to evaluate the acceptability and feasibility of strategically delivering PrEP to CJ involved women and their risk network members.
Read the detailed description
Risk networks can be leveraged to maximally disseminate effective interventions to women, including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV infections in the U.S. Few studies to date have capitalized on risk networks as a way to identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit from PrEP. This study advances the field by: 1) Using an innovative network-based framework (a non-traditional model of care delivery) to engage a high risk population in PrEP dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma; and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are difficult to reach by other means. In doing so, this proposal addresses key funding priorities of the Gilead Investigator Sponsored Research program, which includes research on PrEP implementation targeted to high risk populations and delivered in non-traditional clinical settings.
- Conditions
- HIV Infections
- Being tested
- PrEP
- Keywords
- HIV pre-exposure prophylaxis, criminal justice, women, risk networks
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrEPDrug
Also called TDF/FTC
Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.
| Study group | Role | What they receive |
|---|---|---|
| PrEP | Experimental | For participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments. Receives: Drug: PrEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
% PrEP uptake
# starting PrEP/ # enrolled subjects
Measured: Month 1
% eligible PrEP uptake
# starting PrEP/ # eligible subjects
Measured: Month 1
Secondary outcomes (3)
Mean % PrEP adherence
# PrEP pills taken/# PrEP pills prescribed per month
Measured: 12 months
Mean TDF level
TDF level by dried blood spot testing
Measured: 12 months
HIV incidence
New HIV+ by 4th generation HIV Ag/Ab testing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start11 Dec 2017
- Primary completion15 May 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Yale UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaimie Meyer, MD, MS, FACP, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293290
- Sponsor's protocol ID
- 1606017882
- Status last verified
- Jul 2021
- First submitted
- 20 Sep 2017
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Meyer JP, Price CR, Ye Y, Qin Y, Tracey D, Demidont AC, Melbourne K, Altice FL. A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks. AIDS Behav. 2022 Dec;26(12):3807-3817. doi: 10.1007/s10461-022-03709-2. Epub 2022 Jun 7.
PubMed 35672552
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
- ClinicalTrials.gov ID
- NCT03293290
- Acronym / sponsor ID
- 1606017882
- Conditions
- HIV Infections
- Keywords
- HIV pre-exposure prophylaxis, criminal justice, women, risk networks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 26 Sep 2017 (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 has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. The second component is designed to evaluate the acceptability and feasibility of strategically delivering PrEP to CJ involved women and their risk network members.
Detailed description
Risk networks can be leveraged to maximally disseminate effective interventions to women, including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV infections in the U.S. Few studies to date have capitalized on risk networks as a way to identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit from PrEP. This study advances the field by: 1) Using an innovative network-based framework (a non-traditional model of care delivery) to engage a high risk population in PrEP dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma; and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are difficult to reach by other means. In doing so, this proposal addresses key funding priorities of the Gilead Investigator Sponsored Research program, which includes research on PrEP implementation targeted to high risk populations and delivered in non-traditional clinical settings.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrEP | Experimental | Drug: PrEPFor participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Index participants reside in, or planning to reside in New Haven or Hartford, Connecticut,.
- Criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)).
- Self-reported HIV negative.
- Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.
- have a unique and valid referral coupon (from Index participant).
Key exclusion criteria (2 listed)
- They are unable or unwilling to provide informed consent.
- Are threatening to staff.
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 |
|---|---|---|
| PrEPAlso: TDF/FTCSubjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed. | Drug | PrEP |
Primary outcome
% PrEP uptake
Time frame: Month 1
# starting PrEP/ # enrolled subjects
% eligible PrEP uptake
Time frame: Month 1
# starting PrEP/ # eligible subjects
3 secondary outcomes
Mean % PrEP adherence
Time frame: 12 months
Mean TDF level
Time frame: 12 months
HIV incidence
Time frame: 12 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 Jul 2021.
- Derived from this study: PubMed 35672552Meyer JP, Price CR, Ye Y, Qin Y, Tracey D, Demidont AC, Melbourne K, Altice FL. A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks. AIDS Behav. 2022 Dec;26(12):3807-3817. doi: 10.1007/s10461-022-03709-2. Epub 2022 Jun 7.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Jaimie Meyer, MD, MS, FACP principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PrEP in people with HIV Infections, run by Yale University 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 9 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 Jul 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: Month 1). The study lists 2 primary outcomes in all. 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 NCT03293290, which also lists 1 linked publication.
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 Jul 2021.