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

NCT ID: NCT07181616

Last Updated: 2025-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2030-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Health Risk Behaviors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Adapted W2W

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.

Group Type EXPERIMENTAL

Adapted W2W

Intervention Type BEHAVIORAL

HIV education sessions and questionnaires.

Waitlist Control

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

Group Type ACTIVE_COMPARATOR

Waitlist Control

Intervention Type BEHAVIORAL

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

Interventions

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Adapted W2W

HIV education sessions and questionnaires.

Intervention Type BEHAVIORAL

Waitlist Control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Pre-menopausal
* Cognitive impairment
Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Laneshia Conner

OTHER

Sponsor Role lead

Responsible Party

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Laneshia Conner

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Laneshia Conner, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status

Countries

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United States

Central Contacts

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Laneshia Conner, PhD

Role: CONTACT

859-562-3355

Other Identifiers

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K01AG092253-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

78084

Identifier Type: -

Identifier Source: org_study_id

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