Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted W2W, Waitlist Control.
- Who it may be relevant to
- Registry conditions: Health Risk Behaviors. Basic parameters: from 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Adapted W2W
HIV education sessions and questionnaires. - Behavioral Waitlist Control
HIV education sessions and questionnaires given 4 weeks after W2W intervention.
Primary outcome measures
- Recruitment rate [Time frame: Baseline]
- Acceptability [Time frame: Assessed at weeks 1,2,3,4, 8 and 12]
- Retention Rate [Time frame: Baseline (week 1) and Post-Intervention (Week 8)]
- Change in HIV Knowledge [Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)]
- Change in Condom-use self-efficacy (CUSES) [Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)]
- Change in H-AGE scale [Time frame: Baseline (week 1), Post-Intervention (Week 8), and Study completion (Week 12)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Kentucky — Lexington
Identifiers
NCT: NCT07181616 · 78084 · K01AG092253-01A1