Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women

NCT07181616 | Not Yet Recruiting

• 2 other identifiers: 78084K01AG092253-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a group-based HIV prevention program can improve HIV knowledge, prevention behaviors, and testing in older Black women aged 50 and older who live in subsidized housing. The study focuses on improving how HIV prevention programs address the unique needs and life experiences of older Black women. The main questions it aims to answer are: Can a revised HIV prevention intervention tailored to reproductive health histories improve HIV knowledge, condom use, and testing in older Black women? Is the intervention feasible, acceptable, and engaging for participants? The PI will compare a group of participants receiving the Woman-2-Woman (W2W) intervention to a wait-listed control group to see if the intervention leads to better HIV prevention outcomes. Participants will: Join a group-based HIV prevention program designed for older Black women Be randomly assigned to either: Start the intervention right away, or Join a waitlist and start the program 4 weeks later Take part in four weekly sessions that include group discussions, education, and skill-building activities Share information about their reproductive health histories and sexual health decisions during focus groups or surveys Complete questionnaires at the start, after the program ends, and 4 weeks later to assess HIV knowledge, condom use, and testing behavior This research aims to create a culturally tailored, evidence-based HIV intervention that fits the lives and needs of older Black women and can be used in future, larger studies.

Conditions

Health Risk Behaviors

Keywords

HIV; Health Education; Health Equity

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Feasibility will be measured by recruitment rate (number of participants who sign the informed consent divided by those participants who meet the eligibility criteria)

  Baseline

• Acceptability

  Acceptability will be measured by program satisfaction evaluations. Participants rate statements (1-5) with higher scores equating to greater satisfaction.

  Assessed at weeks 1,2,3,4, 8 and 12

• Retention Rate

  Feasibility will also be measured by retention rate (number of participants who complete all 4 sessions divided by those participants who signed the informed consent)

  Baseline (week 1) and Post-Intervention (Week 8)

• Change in HIV Knowledge

  HIV knowledge will be measured by the HIV-KQ-18. Scores range from 0-18 with higher scores equating to greater HIV knowledge.

  Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

• Change in Condom-use self-efficacy (CUSES)

  CUSES is a 28 item scale that will assess behavioral intentions and past behavior related to feelings about purchasing, using, and negotiating use of condoms with a new partner. Each item has a 5-point response format ranging from 0 (strongly disagree) to 4 (strongly agree). After reversing negatively worded items, scores range from 0-112 (with higher scores indicating more self-efficacy).

  Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

• Change in H-AGE scale

  The H-AGE scale is a gender and aging specific HIV knowledge scale with 6 items that assess participants knowledge of gender and age related issues regarding HIV. Q1 is a true/false question; Q2 \& 3 are multiple choice questions; Q4 is rating of strongly disagree (1) to strongly agree (5); Q5 is rating very comfortable (1)to very uncomfortable (5); Q6 they select one from the following (positive, negative, mixed, neutral)

  Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)

Study Arms (2)

Adapted W2W

EXPERIMENTAL

HIV intervention focused on aging-related HIV knowledge, identifying HIV prevention practices, and reducing HIV transmission. Intervention given in four, 2 hour educational sessions with a fifth booster session and a final follow up session.

Behavioral: Adapted W2W

Waitlist Control

ACTIVE COMPARATOR

This group will receive the intervention 8 weeks after the W2W intervention group completes their follow-up and in the same pattern.

Behavioral: Waitlist Control

Interventions

Adapted W2W BEHAVIORAL

HIV education sessions and questionnaires.

Adapted W2W

Waitlist Control BEHAVIORAL

HIV education sessions and questionnaires given 4 weeks after W2W intervention.

Waitlist Control

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 50 years of age
• A resident of Selected sites
• A MOCA score of less than 24
• Self-identifying as an African American woman
• English speaking

You may not qualify if:

• Pre-menopausal
• Cognitive impairment

Sponsors & Collaborators

• Laneshia Conner: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Health Risk Behaviors; Health Education

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Laneshia Conner, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laneshia Conner, PhD

CONTACT

859-562-3355; laneshia.conner@uky.edu

Study Design

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

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)