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NCT Number: NCT07181616

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

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.

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Key information

Conditions

Health Risk Behaviors Adherence Interventions Behavior Health Behavior Health Education Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adapted W2W

Behavioral

HIV education sessions and questionnaires.

Waitlist Control

Behavioral

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

Primary outcomes

  1. Recruitment rate

    Time frame: Baseline

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

  2. Acceptability

    Time frame: Assessed at weeks 1,2,3,4, 8 and 12

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

  3. Retention Rate

    Time frame: Baseline (week 1) and Post-Intervention (Week 8)

    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)

  4. Change in HIV Knowledge

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

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

  5. Change in Condom-use self-efficacy (CUSES)

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

    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).

  6. Change in H-AGE scale

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Laneshia Conner, PhD

CONTACT

[email protected]

859-562-3355

Sponsors and collaborators

Lead sponsor

Laneshia Conner

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 18, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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