Study for IFE4PrEP Intervention on PrEP Uptake by Southern African American Women

NCT05087927 | Completed

• 1 other identifier: 21-1244
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study is partnering with communities to identify the best ways to provide HIV prevention communication and services for women living in public housing who have been disproportionately affected by HIV but underserved by current HIV prevention programs. The investigators want to work with community members to develop and design the delivery of a program to promote awareness of and access to pre-exposure prophylaxis (PrEP) for HIV prevention among women living in public housing. Participants: Up to 248 cisgender females who are 18 years of age or older and currently reside in Durham Housing Authority (DHA) housing will be enrolled in this study at UNC. Procedures (methods): Data collection for this formative study will consist of 4 focus groups of up to 12 women in each focus group living in DHA as well as a survey of 200 women living in DHA.

Conditions

HIV Prevention

Keywords

HIV; pre-exposure prophylaxis; PrEP; Prevention; Women's Health; Health Messaging

Outcome Measures

Primary Outcomes (1)

• Modified Jaspal, Lopes, and Maatouk Attitudes toward PrEP Scale (APS)

  A subset of the Attitudes toward PrEP Scale (APS) will be used to assess the association between message exposure and attitudes toward pre-exposure prophylaxis (PrEP). This sub-set scale will include nine items rated on a 5-point Likert scale (responses ranging from 1=Strongly Disagree to 5=Strongly Agree). The nine items are a sub-set of the original APS scale and will include four items comprising sub-scale 2, three items comprising sub-scale 3, and two items from sub-scale 1. A mean score will be calculated for each complete sub-scale (2 and 3) ranging from 1-5. Each of the two items from sub-scale 1 will be scored individually, ranging from 1-5. Higher scores indicate more positive attitudes toward PrEP.

  Baseline

Study Arms (2)

Focus Group

There will be 4 focus groups of up to 12 women in each focus group.

Behavioral: Gain framing plus demographically targeted photos; Behavioral: Loss framing plus demographically targeted photos; Behavioral: Gain framing plus not demographically targeted photos; Behavioral: Loss framing plus not demographically targeted photos

Survey Group

There will be up to 200 women who complete the survey for this study.

Behavioral: Gain framing plus demographically targeted photos; Behavioral: Loss framing plus demographically targeted photos; Behavioral: Gain framing plus not demographically targeted photos; Behavioral: Loss framing plus not demographically targeted photos

Interventions

Gain framing plus demographically targeted photos BEHAVIORAL

Gain framing: Participant feels PrEP puts her in control Participants (majority of whom will be African American) will be shown an image of women of multiple races.

Focus Group; Survey Group

Loss framing plus demographically targeted photos BEHAVIORAL

Loss framing: Without PrEP, participant feels less in control Participants (majority of whom will be African American) will be shown an image of women of multiple races.

Focus Group; Survey Group

Gain framing plus not demographically targeted photos BEHAVIORAL

Gain framing: Participant feels PrEP puts her in control Participants (majority of whom will be African American) will be shown an image of an African American woman.

Focus Group; Survey Group

Loss framing plus not demographically targeted photos BEHAVIORAL

Loss framing: Without PrEP, participant feels less in control Participants (majority of whom will be African American) will be shown an image of an African American woman.

Focus Group; Survey Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identify as cisgender female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is African American cisgender women at least 18 years old residing in DHA (Durham Housing Authority) community housing. The vast majority of DHA residents are African American, so the investigators anticipate recruiting participants who are majority African American without explicitly excluding prospective participants on the basis of race.

You may qualify if:

• Women will be eligible to participate if they meet the following criteria:
• years of age or older
• Identify as cisgender female (assigned female sex at birth and currently identify as female)
• Currently reside in Durham Housing Authority (DHA) housing

You may not qualify if:

• Women will not be eligible to participate if they meet the following criteria:
• Younger than 18 years of age
• Do not Identify as cisgender female (assigned female sex at birth and currently identify as female)
• Do not currently reside in Durham Housing Authority (DHA) housing

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Gilead Sciences: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Study Officials

• Carol Golin, MD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lauren Hill, PhD

  UNC-Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: April 18, 2023
• Primary Completion: November 28, 2023
• Study Completion: March 10, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)