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Active, Not Recruiting

NCT Number: NCT05412433

Clinic-based HIV Identification and Prevention Project Using Electronic Resources

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Prevention PreP Primary Care

Age range

15 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Health System

Baltimore, Maryland, 21287, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

Patient Level

Behavioral

Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations

Multilevel

Behavioral

Electronic data collection with scoring, patient awareness of HIV risk score, patient viewing of PrEP animations, provider electronic health records (EHR) alerts

Control

Behavioral

Standard of care

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)

    Time frame: Approximately 5 years

    Incremental cost-effectiveness ratios

  2. Cost-Effectiveness Analysis (Return on Investment)

    Time frame: Approximately 5 years

    Return on investment (intervention benefits, avoided direct medical costs, and incremental implementation costs)

  3. Cost-Effectiveness Analysis (Total Budget)

    Time frame: Approximately 5 years

    Total budget to finance each intervention strategy (intervention and implementation costs)

  4. Proportion of patients who complete the Electronic History Form (eHxForm)

    Time frame: 6 months

    Adoption of Electronic History Form as assessed by the proportion of consecutive eligible patients in each clinic who completed the eHxForm.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Michigan

Registry information

Acronym: CHIPPER

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 9, 2022
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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