HIV PreventionCHIPPERNCT05412433
Clinic-based HIV Identification and Prevention Project Using Electronic Resources
A study testing Patient Level and Multilevel in people with HIV Prevention and Primary Care, run by Johns Hopkins University at 1 site in United States.
Trial summary
Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention, Primary Care, PrEP
- What is being tested?
- Patient Level and Multilevel
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,170 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 31 Dec 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 15 to 65 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients of enrolled providers aged 15-65 years
- Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).
Who cannot join
- Pregnant and has established prenatal care, i.e., visit is for prenatal care
- Non-English or non-Spanish speaking
- Living with HIV
- Unable to complete the eHxForm
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Health System
Baltimore, Maryland, 21287
About this study
Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.
Read the detailed description
Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.
Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
- Conditions
- HIV Prevention, Primary Care, PrEP
- Being tested
- Patient Level, Multilevel, Control
- Keywords
- HIV prevention, PrEP, Cis-gender women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient LevelBehavioural
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations
MultilevelBehavioural
Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts
ControlBehavioural
Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Participants in this arm will receive standard of care Receives: Behavioral: Control |
| Patient Level + Multilevel | Experimental | Participants in the arm will receive the patient level and multi-level intervention Receives: Behavioral: Patient Level; Behavioral: Multilevel |
| Multilevel | Experimental | Participants in this arm will receive the multi-level intervention Receives: Behavioral: Multilevel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PrEP prescriptions written for each patient
Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.
Measured: 4 weeks
Secondary outcomes (4)
Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)
Incremental cost-effectiveness ratios
Measured: Approximately 5 years
Cost-Effectiveness Analysis (Return on Investment)
Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs)
Measured: Approximately 5 years
Cost-Effectiveness Analysis (Total Budget)
Total budget to finance each intervention strategy (intervention and implementation costs)
Measured: Approximately 5 years
Proportion of patients who complete the Electronic History Form (eHxForm)
Adoption of Electronic History Form as assessed by the proportion of consecutive eligible patients in each clinic who completed the eHxForm.
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 posted9 Jun 2022
- Study start3 Oct 2022
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 PreventionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Anna Powell, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412433
- Sponsor's protocol ID
- IRB00331706
- Other IDs
- 1R01MH132146
- Acronym
- CHIPPER
- Status last verified
- Jan 2026
- First submitted
- 2 Jun 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Izadi LH, Mmeje O, Drabo EF, Perin J, Martin S, Coleman JS. An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care. Front Reprod Health. 2023 Jun 8;5:1196392. doi: 10.3389/frph.2023.1196392. eCollection 2023.
PubMed 37361343
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinic-based HIV Identification and Prevention Project Using Electronic Resources
- ClinicalTrials.gov ID
- NCT05412433
- Acronym / sponsor ID
- CHIPPER / IRB00331706
- Conditions
- HIV Prevention, Primary Care, PrEP
- Keywords
- HIV prevention, PrEP, Cis-gender women
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,170 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute of Mental Health (NIMH)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Jun 2022 (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.
Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.
Detailed description
Forty-two Obgyn providers will be randomized into 1 of three arms. Patients of enrolled providers who attend an ObGyn clinic for any preventative visit will complete an electronic history form (eHxForm) before clinic through a message sent through the patient portal (MyChart), email, or secure text messaging. The sexual history questions will be scored and categorized into 3 categories. Patients with a low score (0-3) will receive an electronic message offering a laboratory HIV test per USPSTF guidelines. If she accepts, then an automated Epic order will be placed for the provider to sign during the office visit.
Patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a PrEP video, arm 3: procedures in arm 2 PLUS providers will receive an electronic health record alert that the patient may have HIV risk factors. This will occur automatically via programming integrated into the electronic health record. The primary outcome is PrEP uptake. The implementation strategy will be evaluated using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: ControlParticipants in this arm will receive standard of care |
| Patient Level + Multilevel | Experimental | Behavioral: Patient Level, Behavioral: MultilevelParticipants in the arm will receive the patient level and multi-level intervention |
| Multilevel | Experimental | Behavioral: MultilevelParticipants in this arm will receive the multi-level intervention |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of enrolled providers aged 15-65 years
- Presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control).
Key exclusion criteria (4 listed)
- Pregnant and has established prenatal care, i.e., visit is for prenatal care
- Non-English or non-Spanish speaking
- Living with HIV
- Unable to complete the eHxForm
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 |
|---|---|---|
| Patient LevelElectronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations | Behavioural | Patient Level + Multilevel |
| MultilevelElectronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts | Behavioural | Multilevel, Patient Level + Multilevel |
| ControlStandard of care | Behavioural | Standard of Care |
Primary outcome
Number of PrEP prescriptions written for each patient
Time frame: 4 weeks
Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.
4 secondary outcomes
Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)
Time frame: Approximately 5 years
Cost-Effectiveness Analysis (Return on Investment)
Time frame: Approximately 5 years
Cost-Effectiveness Analysis (Total Budget)
Time frame: Approximately 5 years
Proportion of patients who complete the Electronic History Form (eHxForm)
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 26 Jan 2026.
- Derived from this study: PubMed 37361343Izadi LH, Mmeje O, Drabo EF, Perin J, Martin S, Coleman JS. An effectiveness-implementation trial protocol to evaluate PrEP initiation among U.S. cisgender women using eHealth tools vs. standard care. Front Reprod Health. 2023 Jun 8;5:1196392. doi: 10.3389/frph.2023.1196392. eCollection 2023.
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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.
Anna Powell, MD principal investigator
Johns Hopkins 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 Patient Level and Multilevel in people with HIV Prevention and Primary Care, run by Johns Hopkins 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 2 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. 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?
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?
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?
Number of PrEP prescriptions written for each patient (time frame: 4 weeks). 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 NCT05412433, 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 26 Jan 2026.