Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women

NCT05139069 | Completed

• 1 other identifier: IRB00012361
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-exposure prophylaxis may be a viable option for African American women at-risk for HIV infection, but few studies have identified optimal strategies to reach African American women in need of Pre-Exposure Prophylaxis nor examined effective strategies to scale-up Pre-Exposure Prophylaxis among African American women in the South. African American women in the South experience high rates of intimate partner violence which could force women to choose between HIV prevention or intimate partner violence prevention. The proposed research study seeks to develop, pilot-test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit within two community healthcare clinics located in Jackson, Mississippi to increase Pre-Exposure Prophylaxis uptake among African American, address intimate partner violence as a barrier to Pre-Exposure Prophylaxis uptake, and ultimately combat racial disparities in women's HIV diagnoses.

Conditions

HIV Infections; Domestic Violence

Outcome Measures

Primary Outcomes (1)

• Clinic's proportion of women with Pre-Exposure Prophylaxis uptake

  Pre-Exposure Prophylaxis uptake will be classified as a woman receiving a Pre-Exposure Prophylaxis prescription from a pharmacy. Pre-Exposure Prophylaxis uptake will be coded as a binary variable (0=did not receive Pre-Exposure Prophylaxis prescription; 1=received Pre-Exposure Prophylaxis prescription) and will be obtained from clinic aggregated data.

  Baseline to 8-months after Toolkit implementation in each clinic

Secondary Outcomes (3)

• Clinic's proportion of women with Pre-Exposure Prophylaxis retention

  Baseline to 8-months after Toolkit implementation in each clinic

• Clinic's %Pre-Exposure Prophylaxis Uptake

  Baseline to 8-months after Toolkit implementation in each clinic

• Clinic's Pre-Exposure Prophylaxis Coverage

  Baseline to 8-months after Toolkit implementation in each clinic

Study Arms (1)

Trauma-Informed Pre-Exposure Prophylaxis Implementation Toolkit

EXPERIMENTAL

The Toolkit to be developed in the proposed study includes components from the women-specific Pre-Exposure Prophylaxis care continuum theoretical model and implementation challenges, and is adapted to identify and provide care to women experiencing intimate partner violence. Overall, the Toolkit is designed to create culturally-congruent, intimate partner violence-informed clinical settings; and equip clinical staff with the knowledge and skills they need to address HIV prevention for African American women; and integrate intimate partner violence into Pre-Exposure Prophylaxis care services.

Behavioral: Trauma-Informed Toolkit

Interventions

Trauma-Informed Toolkit BEHAVIORAL

Staff in this intervention will be trained to conducting intimate partner violence screening, and providing support to women through referrals to local community resources; to help African American women identify and understand HIV risk factors (e.g., unprotected condom less sex with a male partner who is HIV-positive or unknown HIV status); and to communicate with their African American women patients in a respectful way in order to build trust and facilitate shared decision making.

Trauma-Informed Pre-Exposure Prophylaxis Implementation Toolkit

Eligibility Criteria

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

You may qualify if:

• \- currently providing care at a community healthcare clinic in Mississippi

You may not qualify if:

• non-English speaking
• inability to read and comprehend questions

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, 21220, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Tiara C. Willie, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: October 31, 2021
• Primary Completion: June 28, 2025
• Study Completion: September 22, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)