Safer Conception for HIV-infected Men Choosing to Conceive With At-risk Partners: Sinikithemba Kwabesilisa (Helping Men Have Healthy Babies)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- HIV RNA Suppression
研究概览
简要总结
Many men living with HIV (MLWH) want to have children. HIV-RNA suppression can minimize sexual HIV transmission risks while allowing for conception. The study will evaluate a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on the investigators' Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.
详细描述
The study will evaluate and test a safer conception intervention that leverages men's motivations to have healthy babies in order to promote serostatus disclosure and early ART initiation. The intervention is based on a Safer Conception Conceptual Framework, which considers individual, dyadic, and structural factors that affect periconception risk behavior.
The researchers will conduct an open pilot to refine the intervention. The study will enroll men who want to have children with uninfected or unknown status female partners. Men will participate in three study sessions offering motivational interviewing and problem solving to help men develop a plan to have a healthy baby. The counseling will explore safer conception options including safe disclosure, delaying conception attempts until on ART with viral suppression, STI testing and treatment, timing condomless sex to peak fertility. The primary outcome is HIV RNA suppression at 12 weeks. Secondary outcomes include acceptability, feasibility, early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.
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
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Identifies as male
- •Not on ART, or initiated ART within the past 3 months
- •HIV-positive and status known for at least 1 (one) month,
- •in care/patient at iThembalabantu clinic
- •want to have a child in the next year,
- •with a stable sexual pregnancy partner for at least 6 months,
- •their pregnancy partner should be HIV-uninfected or HIV-status unknown,
- •their pregnancy partner should not be known to be currently pregnant,
- •have their own/ a mobile phone
- •be fluent in either English or isiZulu and,
- •able to participate in informed consent process
- •not sterilized or known to be infertile
排除标准
- 未提供
结局指标
主要结局
HIV RNA Suppression
时间窗: 12 weeks
Proportion of men achieving HIV-RNA suppression
次要结局
- Uptake of ART(12 weeks)
- Uptake of HIV-serostatus disclosure(12 weeks)
- Use of timing condomless sex to peak fertility(12 weeks)
研究者
Lynn T Matthews
Principal Investigator
University of Alabama at Birmingham