NCT05412433

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,170

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Oct 2022Dec 2027

First Submitted

Initial submission to the registry

June 2, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 9, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

June 2, 2022

Last Update Submit

January 22, 2026

Conditions

Primary CarePrEPHIV Prevention

Keywords

HIV preventionPrEPCis-gender women

Outcome Measures

Primary Outcomes (1)

  • Number of PrEP prescriptions written for each patient

    Number of PrEP prescriptions written for each patient up to 4 weeks after office visit.

    4 weeks

Secondary Outcomes (4)

  • Cost-Effectiveness Analysis (Incremental cost-effectiveness ratios)

    Approximately 5 years

  • Cost-Effectiveness Analysis (Return on Investment)

    Approximately 5 years

  • Cost-Effectiveness Analysis (Total Budget)

    Approximately 5 years

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

    6 months

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

Participants in this arm will receive standard of care

Behavioral: Control

Patient Level + Multilevel

EXPERIMENTAL

Participants in the arm will receive the patient level and multi-level intervention

Behavioral: Patient LevelBehavioral: Multilevel

Multilevel

EXPERIMENTAL

Participants in this arm will receive the multi-level intervention

Behavioral: Multilevel

Interventions

Patient LevelBEHAVIORAL

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

Patient Level + Multilevel
MultilevelBEHAVIORAL

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

MultilevelPatient Level + Multilevel
ControlBEHAVIORAL

Standard of care

Standard of Care

Eligibility Criteria

Age15 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCisgender
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Health System

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 37361343DERIVED

MeSH Terms

Interventions

Multilevel Analysis

Intervention Hierarchy (Ancestors)

Statistics as TopicEpidemiologic MethodsPublic HealthEnvironment and Public Health

Study Officials

  • Anna Powell, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 9, 2022

Study Start

October 3, 2022

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

US(1)