Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:57 PM
Ignite Modification Date: 2025-12-24 @ 11:57 PM
NCT ID: NCT04373551
Brief Summary: The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama. The investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the Centers for Disease Control and Prevention (CDC) PrEP toolkit that focuses on the first three steps of the PrEP cascade (e.g., recognizing HIV risk, identifying as a PrEP candidate, and interested in PrEP) to increase PrEP uptake via referrals to local PrEP clinics.
Detailed Description: Investigators completed formative qualitative research to explore the HIV risk perceptions of African American or Black (AA) women with recent PrEP use, AA women who are candidates for PrEP, and providers and to identify preferences around patient-provider communication about HIV risk and PrEP services (Aim 1). The investigators then systematically adapted a patient-provider communication tool to increase PrEP uptake at federally qualified health centers in Alabama, using an iterative implementation process (Aim 2A), and assessed the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among women in a pilot pre-/post-intervention design (Aim 2B). Provider training completion rates and satisfaction with the communication tool were assessed to evaluate implementation feasibility and intervention delivery. The study systematically documented and evaluated reasons for declining PrEP referrals, incomplete referrals, failure to initiate PrEP after successful referral, and ongoing PrEP use at 3 and 12 months post-intervention.
Study: NCT04373551
Study Brief:
Protocol Section: NCT04373551