Co-Developing a Women-Centered HIV Prevention Intervention to Reduce Stigma, Increase HIV Self-Testing, and Improve PrEP Awareness and Uptake in Ghana
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Feasibility as Measured by FIM Score
研究概览
简要总结
The WISE Woman Study is a research project in Ghana focused on improving HIV prevention among young women aged 18 to 35. In Ghana, young women are at higher risk of HIV but often lack access to the right information and services. This study will first work with young women and community partners to co-develop a youth-friendly and women-centered HIV prevention program. The program will focus on two proven strategies: HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), a medicine that helps prevent HIV.
After the program is created, researchers will test it with 50 young women in Greater Accra and the Eastern Region to see if it's acceptable, easy to use, and if it helps increase knowledge and use of HIVST and PrEP. The intervention will be delivered through WhatsApp and community-based workshops to ensure privacy and reach. Participants will complete surveys and take part in discussions and interviews to share their feedback. This research will help build better HIV prevention strategies tailored to the needs of young women in Ghana.
详细描述
Young women in Ghana face some of the highest risks of HIV infection in the country, yet they often lack access to HIV prevention tools and supportive services that are tailored to their needs. Many of the barriers they face-including stigma, low awareness, and limited youth-friendly options-can prevent them from accessing HIV self-testing (HIVST) or pre-exposure prophylaxis (PrEP), which are proven prevention methods.
The WISE Woman Study seeks to address these barriers by engaging young women as equal partners in the design and implementation of an HIV prevention intervention. The study is based on the idea that solutions are more effective when they are created with the community, not for it. It uses participatory methods to involve young women in shaping the intervention and includes two main phases:
Phase 1 - Co-Development Workshop:
Fifteen participants-including ten young women and five community stakeholders (such as healthcare workers or peer educators)-will take part in a full-day participatory workshop. During this workshop, they will identify key barriers to HIV prevention, co-create solutions, and help design the structure of the intervention. Structured methods such as the Nominal Group Technique (NGT) and Human-Centered Design (HCD) will be used to ensure that all voices are heard and that the final program reflects the participants' preferences and lived experiences.
Phase 2 - Pilot Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
No masking is used in this study. All participants and study staff are aware of the intervention.
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Identify as female and be between 18-35 years of age
- •Reside in Greater Accra or the Eastern Region of Ghana
- •Be sexually active (defined as having engaged in vaginal, anal, or oral sex in the past 6 months)
- •Have access to a mobile phone with WhatsApp
- •Be willing to provide informed consent
- •Be interested in participating in HIV prevention activities
- •Be comfortable discussing sexual and reproductive health in a group setting (for the workshop)
- •For pilot phase only: must not have participated in the co-development workshop
排除标准
- •Do not reside in the two specified regions of Ghana
- •Unable to provide informed consent
- •Have cognitive impairments or severe mental health conditions limiting participation
- •Community partners with commercial conflicts of interest (for workshop only)
研究组 & 干预措施
Women-Centered HIV Prevention Group
Participants will take part in a co-developed HIV prevention intervention created through participatory workshops. The intervention will be delivered via WhatsApp over 4 weeks and will include HIV prevention messaging, discussion prompts, and peer support to improve awareness and uptake of HIV self-testing (HIVST) and pre-exposure prophylaxis (PrEP), and reduce stigma.
干预措施: Women-Centered HIV Prevention Program (Behavioral)
结局指标
主要结局
Feasibility as Measured by FIM Score
时间窗: Week 5 (end of intervention)
Feasibility of the intervention will be measured using the Feasibility of Intervention Measure (FIM), a validated 4-item scale. Each item is rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Scores will be summarized using means and standard deviations. Higher scores indicate greater feasibility. Unit of Measure: Mean FIM score (1-5 scale)
Acceptability as Measured by AIM Score
时间窗: Week 5 (post-intervention)
Acceptability of the intervention will be measured using the Acceptability of Intervention Measure (AIM), a validated 4-item scale with 5-point Likert responses. Scores range from 1 (completely disagree) to 5 (completely agree). Higher scores indicate greater acceptability. Results will be reported as mean and standard deviation. Unit of Measure: Mean AIM score (1-5 scale)
Uptake of HIV self-testing (HIVST)
时间窗: Baseline to Week 8
Defined as the number of participants who report completing an HIV self-test during the study period, verified via WhatsApp photo confirmation or verbal report. Unit of Measure: Number of participants (count)
Willingness to Use PrEP (Survey-Based Behavioral Intention)
时间窗: Baseline to Week 8
Willingness will be measured using a validated PrEP intention scale in pre- and post-surveys (e.g., "I am likely to take PrEP in the next 3 months"). Items are scored on a 1 to 5 Likert scale, with higher scores indicating greater willingness to use PrEP. Change in mean intention scores will be reported. Unit of Measure: Mean change in score (1-5 scale)
Intervention Completion Rate
时间窗: Week 5
Defined as the percentage of participants who complete all required activities during the 4-week WhatsApp-based intervention, including pre- and post-surveys. Unit of Measure: Percentage of participants (%)
次要结局
- Reduction in HIV-Related Stigma (Survey Score Change)(Baseline to Week 8)
- Number of Participants Reporting the WhatsApp-Based Intervention is Sustainable and Scalable(Week 6-8 (exit interviews))
- Perceived Appropriateness of the Intervention (IAM Score)(Week 5)
研究者
Gloria Aidoo-Frimpong
Principal Investigator
State University of New York at Buffalo