Feasibility, Acceptability, and Preliminary Efficacy of an HIV Prevention Intervention for Older Black Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pre-menopausal
- •Cognitive impairment
研究组 & 干预措施
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.
干预措施: Adapted W2W (Behavioral)
Waitlist Control
This group will receive the intervention 8 weeks after the W2W intervention group completes their follow-up and in the same pattern.
干预措施: Waitlist Control (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: 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)
Acceptability
时间窗: 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.
Retention Rate
时间窗: 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)
Change in HIV Knowledge
时间窗: 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.
Recruitment rate
时间窗: 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)
Acceptability
时间窗: 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.
Retention Rate
时间窗: 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)
Change in HIV Knowledge
时间窗: 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.
Change in Condom-use self-efficacy (CUSES)
时间窗: 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 scale
时间窗: 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)
次要结局
未报告次要终点
研究者
Laneshia Conner
Assistant Professor
University of Kentucky