PrEP UptakeNCT06335121
Implementation of PrEP Care Among Women in Family Planning Clinics
A study testing POWER Up strategies - in people with PrEP Uptake and HIV, run by Rush University Medical Center.
Trial summary
This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PrEP Uptake, HIV, Prevention
- What is being tested?
- POWER Up strategies -
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible participants include ciswomen presenting at a PPIL health center with a positive STI test (syphilis, gonorrhea, or chlamydia) and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling.
Who cannot join
- Participants will be excluded if they are not PrEP eligible, have a negative STI test, or are not identified in the EHR.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study will evaluate implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.
- Conditions
- PrEP Uptake, HIV, Prevention
- Being tested
- POWER Up strategies -
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POWER Up strategies -Behavioural
Clinics will implement adapted POWER Up intervention strategies when a patient is flagged as PrEP eligible.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Aim 2 | Experimental | During the intervention period, PPIL staff will capture PrEP eligible women through an updated electronic flag alert in the patient's electronic medical record. The flag will alert to offer the patient PrEP navigation services and implement adapted POWER Up intervention strategies according to training. Receives: Behavioral: POWER Up strategies - |
| Control - Aim 2 | No intervention | PPIL health centers will follow current PrEP navigation procedures using current monitoring system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP.
PrEP eligibility among Black women will be defined based on positive STI test and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling. Using de-identified patient-level EHR data for eligible women at each clinic within each time point, we will create a dichotomous variable for having received a prescription for PrEP during a given time period.
Measured: 1 month
Secondary outcomes (1)
Receipt of PrEP refills among Black women accessing FP services at 6 months.
Using de-identified patient-level EHR data for eligible patients at each clinic within each time point, we will create a dichotomous variable for receiving refills of prescriptions for PrEP of those with an initial PrEP prescription.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study startDec 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrEP UptakeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Illinois Chicago, Planned Parenthood of Illinois
- Responsible party
- Sponsor
- Investigators
- Sadia Haider, MD, MPH, Principal investigator, Rush University Medical CenterAmy Johnson, PhD, MSW, Principal investigator, Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335121
- Sponsor's protocol ID
- 21120602
- Other IDs
- 1R01MH134264
- Status last verified
- Jan 2026
- First submitted
- 21 Mar 2024
- Last updated
- 22 Jan 2026
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of PrEP Care Among Women in Family Planning Clinics
- ClinicalTrials.gov ID
- NCT06335121
- Acronym / sponsor ID
- 21120602
- Conditions
- PrEP Uptake, HIV, Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Illinois Chicago, Planned Parenthood of Illinois
- Study start
- Dec 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 Mar 2024 (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 implementation strategies to address barriers and increase uptake of PrEP among Black cisgender women in Planned Parenthood of Illinois (PPIL) health centers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Aim 2 | Experimental | Behavioral: POWER Up strategies -During the intervention period, PPIL staff will capture PrEP eligible women through an updated electronic flag alert in the patient's electronic medical record. The flag will alert to offer the patient PrEP navigation services and implement adapted POWER Up intervention strategies according to training. |
| Control - Aim 2 | No intervention | –PPIL health centers will follow current PrEP navigation procedures using current monitoring system. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligible participants include ciswomen presenting at a PPIL health center with a positive STI test (syphilis, gonorrhea, or chlamydia) and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling.
Key exclusion criteria (1 listed)
- Participants will be excluded if they are not PrEP eligible, have a negative STI test, or are not identified in the EHR.
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 |
|---|---|---|
| POWER Up strategies -Clinics will implement adapted POWER Up intervention strategies when a patient is flagged as PrEP eligible. | Behavioural | Intervention - Aim 2 |
Primary outcome
PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP.
Time frame: 1 month
PrEP eligibility among Black women will be defined based on positive STI test and identified in the EHR using STI testing records and new fields for optimizing support of provider PrEP counseling. Using de-identified patient-level EHR data for eligible women at each clinic within each time point, we will create a dichotomous variable for having received a prescription for PrEP during a given time period.
1 secondary outcome
Receipt of PrEP refills among Black women accessing FP services at 6 months.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- 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.
Sadia Haider, MD, MPH principal investigator
Rush University Medical Center
Amy Johnson, PhD, MSW principal investigator
Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing POWER Up strategies - in people with PrEP Uptake and HIV, run by Rush University Medical Center.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina MA Barkowski, MSW (312-942-6382, cristina_m_barkowski@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP prescriptions among Black women accessing PPIL services and eligible for PrEP. (time frame: 1 month). 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 22 Jan 2026.