UNCPM 22325 - Supporting Oral and Long-acting Pre-exposure Prophylaxis Decision Making Among Pregnant Women in Lilongwe, Malawi: a Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Intervention Appropriateness Measure Score
研究概览
简要总结
Purpose: The overall objective of this pilot study is to evaluate the feasibility, acceptability, and appropriateness of a shared decision-making (SDM) intervention to support personally appropriate decision making about Pre-exposure prophylaxis (PrEP) use during pregnancy and breastfeeding.
Participants: The primary population to be recruited for this study is HIV-negative pregnant women. For qualitative data collection only, investigators will also recruit male partners of these participants, and PrEP counselors and health care workers. The rationale behind focusing on pregnant women is because of the elevated HIV risk faced by women in the perinatal period. Investigators will recruit 50 women to participate in the feasibility pilot study. A subset of these participants will participate in qualitative interviews. Up to 10 male partners and up to 15 study staff will be recruited to participate in qualitative in-depth interviews.
Procedures (methods): Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, Long-acting injectable cabotegravir (CAB-LA), and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.
详细描述
Study design:
Investigators propose a pilot feasibility study of a shared decision making (SDM) intervention for pregnant women considering PrEP. 50 women will be randomized to receive either the SDM intervention addressing daily oral PrEP, CAB-LA, and alternative HIV prevention methods (condoms), or standard of care counselling addressing the same prevention methods. In both studies, investigators will evaluate the feasibility, acceptability, and appropriateness of the intervention and associated study procedures. Women expressing interest in either PrEP method will be referred to government PrEP services.
Study intervention:
The study intervention, My Choice for HIV Prevention (MyChoice), is a counselor-delivered shared decision-making approach for pregnant women considering PrEP. The intervention counseling will be delivered by trained study staff with a background in psychosocial counseling. The intervention consists of counseling facilitated by a SDM tool. The woman's partner may be present depending on her preference. It begins with a review of HIV risk in pregnancy/breastfeeding including discussion of population-specific risk factors which may apply to the participant. After understanding participant HIV risk and desire for HIV protection, the counselor presents HIV prevention options including CAB-LA, daily oral PrEP, and internal and external condoms (discussing attributes and potential advantages and disadvantages of each method). This is followed by a values clarification exercise to identify which features of the competing options matter most to the participant (product attributes and personal and interpersonal implications of each method). The counselor reviews information about these valued features for each offered method. This information and checks to understand and address any unmet participant decision support needs serve as the basis for structured deliberation to collaboratively identify participant preferred method(s).
Standard of care (control arm):
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The criteria for pregnant women participants is as follows:
- •Inclusion criteria
- •Age 18 or older
- •Documented pregnancy by urine pregnancy test or physical exam
- •Documented negative HIV status within the past three months
- •Identified factor(s) for elevated risk for HIV acquisition per PrEP national eligibility guidelines
- •Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- •Ability and willingness to provide informed consent
- •Investigators will also conduct interviews with male partners and study staff to assess exploratory qualitative outcomes. All study staff will be eligible to participate in an interview. Male partners will be eligible to participate if they meet the following criteria:
- •Referred by a study participant as her romantic partner
- •Age 18 or older
- •Able and willing to provide informed consent
排除标准
- •Positive HIV test at time of screening
- •No identified HIV risk factors per national PrEP guidelines
- •Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
结局指标
主要结局
Intervention Appropriateness Measure Score
时间窗: enrollment, final follow up visit (Month 2)
Intervention appropriateness will be defined as the perceived relevance and usefulness of the intervention to support decision making about HIV prevention methods. Appropriateness will be assessed through self-report using a validated 4-item scale to measure women's perceptions of its relevance and usefulness (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate a greater appropriateness.
Acceptability of Intervention Measure Score
时间窗: enrollment, final follow up visit (Month 2)
Intervention acceptability will be defined as the extent to which participants perceive the intervention to be agreeable, palatable, or satisfactory. Acceptability will be assessed through participant self-report using a validated 4-item scale. This scale measures how agreeable and satisfactory women find the intervention (responses rated on a 5-point Likert scale ranging from "Completely Disagree" to "Completely Agree"). Range is 1-5 and higher scores indicate a greater acceptability.
次要结局
- Number of Days Taken to Achieve Enrollment Targets from the Date of Enrollment Initiation(At the time of enrollment)
- Proportion of Screened Eligible Women Enrolling in the study(At the time of enrollment)
- Proportion of Enrolled Participants Returning for Follow-Up Visits(1-month follow-up, 2-month follow-up)
- Mean Number of Women Screened Weekly(At screening)
- Number of Days Taken to Achieve Retention Targets from the Date of the First Scheduled Follow-up Visit(At the time of enrollment, 2-month follow-up)