Clinical trial NCT05139069: Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women
Official title: Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: HIV Infections
Domestic Violence
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Detailed description: HIV and intimate partner violence are intersecting, mutually-reinforcing epidemics that significantly affect African American women, particularly women in the U.S. South. African American women face some of the highest rates of both HIV and intimate partner violence among U.S. women, and these burdens are most pronounced in the South. African American surviving intimate partner violence may experience forced, condom less sex, which increases the risk of HIV acquisition. Pre-exposure prophylaxis has the potential to be the most innovative HIV prevention strategy, however it remains underutilized by African American women and residents of the South. In order to reduce African American women's HIV acquisition risk in the South, effective HIV prevention interventions need to concurrently address relationship safety and HIV acquisition risks. Developing effective interventions to tackle this HIV-related disparity among African American women is essential to reach national HIV goals.Therefore, the proposed research aims to develop, test, and evaluate a Pre-Exposure Prophylaxis Implementation Toolkit for clinical staff in community healthcare settings in the South. The Toolkit will be evaluated using the Reach, Effectiveness-Adoption, Implementation, Maintenance (RE-AIM). The Toolkit will serve the dual purpose of increasing Pre-Exposure Prophylaxis uptake among African American women in the South while addressing intimate partner violence as a potential Pre-Exposure Prophylaxis barrier. This research project will include a formative evaluation (i.e., reach stage), including key informant interviews with clinical staff at the partnering community healthcare clinics (N=10), and six focus groups with African American women at risk for HIV acquisition (i.e., Pre-Exposure Prophylaxis-eligible; %50 intimate partner violence-exposed). The qualitative data from the formal evaluation will inform the development of the Pre-Exposure Prophylaxis Implementation Toolkit, including detailed curriculum and supporting materials. The Toolkit will be pilot tested in two community healthcare clinics using a nonrandomized waitlist control design employed at the clinic-level. Clinic 1 will receive the Toolkit; and after the 8-month data is collected, Clinic 2 will receive the Toolkit. Changes in Pre-Exposure Prophylaxis uptake and retention in care will be assessed at the clinic level from 8-months before and after the Toolkit is implemented (i.e., effectiveness stage). To examine these effects at the clinic-level, a series of interrupted time series analyses will be conducted. This approach allows us to analyze population changes as opposed to individual change. To yield a moderate effect size with a power=.80 and alpha =.05, a sample size of at least 8 timepoints are needed. Following the Toolkit's implementation, four focus groups with clinical staff will be conducted to assess barriers and facilitators (i.e., adoption stage). Lastly, key informant interviews with clinical staff (N=20) will be conducted to assess fidelity of the Toolkit's components.

Eligibility criteria: Inclusion Criteria:

- currently providing care at a community healthcare clinic in Mississippi

Exclusion Criteria:

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

Primary outcomes:
measure: Clinic's proportion of women with Pre-Exposure Prophylaxis uptake
timeFrame: Baseline to 8-months after Toolkit implementation in each clinic
Secondary outcomes:
measure: Clinic's proportion of women with Pre-Exposure Prophylaxis retention
timeFrame: Baseline to 8-months after Toolkit implementation in each clinic
measure: Clinic's %Pre-Exposure Prophylaxis Uptake
timeFrame: Baseline to 8-months after Toolkit implementation in each clinic
measure: Clinic's Pre-Exposure Prophylaxis Coverage
timeFrame: Baseline to 8-months after Toolkit implementation in each clinic
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Tiara C. Willie, PhD
role: PRINCIPAL_INVESTIGATOR
References: