PrEP Optimization Among Women to Enhance Retention and Uptake

NCT05626452 | Recruiting DMC

• 1 other identifier: IRB21-0971
• Study Type: interventional
• Target: 680
• Locations: 1 country
• Sites: 1

Brief Summary

Black women experience one of the highest incidences of HIV among all subpopulations in the United States, but pre-exposure prophylaxis (PrEP) use among Black cisgender women is very limited. The investigators will implement four strategies (provider training, patient education, EMR optimization, and PrEP navigation) at 12 community health clinics in the Midwest and South. The investigators predict that PrEP use and other related outcomes will improve for participants after the intervention period.

Conditions

PrEP Uptake

Keywords

Pre-exposure prophylaxis; Stepped-wedge randomized trial

Outcome Measures

Primary Outcomes (1)

• PrEP uptake

  Number of participants initiating PrEP

  Baseline through 36 months

Secondary Outcomes (21)

• PrEP persistence consecutive months

  Baseline through 36 months

• PrEP persistence amount of coverage

  Baseline through 36 months

• HIV risk assessment PrEP ineligibility

  Baseline through 36 months

• PrEP eligibility

  Baseline through 36 months

• PrEP ineligibility

  Baseline through 36 months

Study Arms (2)

Usual Care

NO INTERVENTION

The current mechanisms used at each healthcare site to assess HIV risk/ take a sexual history, assess PrEP eligibility, identify PrEP ineligibility for otherwise PrEP eligible patients, provide PrEP education, offer PrEP, provide PrEP navigation, measure PrEP uptake, and measure PrEP persistence/retention.

Intervention

EXPERIMENTAL

Implementation of 1) Patient Education, 2) Provider PrEP training, 3) EMR optimization, and 4) PrEP navigation, and the effect of these intervention components on the ability of each site to assess HIV risk/take a sexual history, assess PrEP eligibility, identify PrEP ineligibility for otherwise PrEP-eligible patients, provide PrEP education, offer PrEP, provide PrEP navigation, measure PrEP uptake, and measure PrEP persistence/retention.

Behavioral: PrEP Education; Behavioral: Provider training; Other: EMR Optimization; Other: PrEP Navigation; Other: Provider Audit and Feedback

Interventions

PrEP Navigation OTHER

Use of CHC staff members to assist participants with obtaining PrEP and attending PrEP care appointments

Intervention

Provider Audit and Feedback OTHER

Audit of provider rates of PrEP prescription and persistence among participants and regular provision of feedback to providers with their performance on these PrEP measures

Intervention

PrEP Education BEHAVIORAL

Education for participants regarding PrEP

Intervention

Provider training BEHAVIORAL

Training for medical providers at CHCs about how to identify participants eligible for PrEP, how to perform behavioral risk assessment and discussion of PrEP, and how to prescribe PrEP and monitor PrEP

Intervention

EMR Optimization OTHER

EMR modifications to enhance PrEP care continuum outcomes including HIV risk assessment, identification of participants eligible for PrEP, provision of PrEP education, clinical decision support tools for prescription of PrEP, and tracking of PrEP care continuum outcomes using an electronic population health management tool

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• HIV-negative

You may not qualify if:

• Younger than age 18 years
• HIV-positive

Sponsors & Collaborators

• University of Chicago: lead
• AllianceChicago: collaborator
• Howard Brown Health Center: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Northwestern University: collaborator
• Rush University: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Related Publications (1)

• Devlin SA, Ridgway JP, Dawdani A, Enaholo OE, Liegeon G, Kasal N, Pyra M, Hirschhorn LR, Simon J, Haider S, Ducheny K, Johnson AK. Adapting Provider Training and Pre-Exposure Prophylaxis Advertising to Increase Pre-Exposure Prophylaxis Awareness and Uptake Among Black Cisgender Women. AIDS Patient Care STDS. 2023 Dec;37(12):574-582. doi: 10.1089/apc.2023.0188. Epub 2023 Nov 21.

  PMID: 38011350 DERIVED

Study Officials

• Jessica Ridgway, MD, MS

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Ridgway, MD, MS

CONTACT

773-702-9185; jridgway@medicine.bsd.uchigao.edu

Samantha Devlin Devlin, MS

CONTACT

sdevlin1@medicine.bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will use a cluster randomized, cross-sectional stepped wedge study with 12 clusters (8 CHCs from the South and 4 CHCs from the Midwest) to evaluate the effect of the intervention package as compared to the control condition (usual care) on the proportion of PrEP prescriptions among eligible participants. Cross-sectional data from participants who are eligible for PrEP will be collected at 6 different calendar intervals of 6 months ("steps"). Although all clusters will begin the study in the control condition (usual care), beginning in step 3 at each six-month interval three randomly chosen CHCs (containing a mix of Southern and Midwestern CHCs) will switch from the control condition to the intervention condition. Beginning at step 2, the step prior to 3 CHCs switching from control to intervention condition will be spent in a six-month transition period. This design will allow for data collection at all CHCs to contain observations from both intervention and control periods.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: August 10, 2023
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)