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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07181616
Enrollment
60
Registered
2025-09-18
Start date
2026-11-30
Completion date
2030-07-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Risk Behaviors

Keywords

HIV, Health Education, Health Equity

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.

Interventions

BEHAVIORALAdapted W2W

HIV education sessions and questionnaires.

BEHAVIORALWaitlist Control

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

Sponsors

Laneshia Conner
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rateBaselineFeasibility will be measured by recruitment rate (number of participants who sign the informed consent divided by those participants who meet the eligibility criteria)
AcceptabilityAssessed at weeks 1,2,3,4, 8 and 12Acceptability will be measured by program satisfaction evaluations. Participants rate statements (1-5) with higher scores equating to greater satisfaction.
Retention RateBaseline (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)
Change in HIV KnowledgeBaseline (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.
Change in Condom-use self-efficacy (CUSES)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).
Change in H-AGE scaleBaseline (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)

Countries

United States

Contacts

CONTACTLaneshia Conner, PhD
laneshia.conner@uky.edu859-562-3355
PRINCIPAL_INVESTIGATORLaneshia Conner, PhD

University of Kentucky

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026