A Pilot Study of Vaginal Progesterone to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Adequate Adherence to Study Product
研究概览
简要总结
More than 1.5 million HIV-infected women become pregnant each year. Approximately half have access to antiretroviral therapy (ART), but all are at increased risk of preterm birth (PTB). Vaginal progesterone (VP) is a promising and cost-effective intervention to prevent PTB that should be studied in this high-risk population. This pilot study will provide critical insight into the feasibility of a phase III trial by determining whether women are willing to participate, to adhere to study drug, and to complete follow-up.
详细描述
This will be a mixed method study to evaluate the feasibility and acceptability of a trial of VP to prevent PTB among HIV-infected Zambian women. To assess the feasibility of a full-scale clinical trial, the investigators will implement a pilot two-arm, double-masked, placebo-controlled trial of VP among HIV-infected women in antenatal care in Lusaka, Zambia. Participants will be randomly assigned to either daily self-administered VP or indistinguishable placebo prior to 24 weeks gestational age. In this pilot study, the investigators will be able to estimate study uptake, adherence to study product and protocol, and study retention. To assess the acceptability of a trial to test VP among HIV-infected women in Zambia, the investigators will employ a qualitative approach of longitudinal semi-structured interviews among women agreeing to trial participation and one-time semi-structured interviews (SSIs) among those who decline to participate.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •viable intrauterine pregnancy confirmed by ultrasound
- •presentation to antenatal care prior to 24 weeks gestation
- •antibody-confirmed HIV-1 infection
- •initiating or continuing ART treatment in pregnancy
- •ability and willingness to provide written informed consent
- •willing to adhere to study visit schedule
排除标准
- •multiple gestation
- •non-research indication for antenatal progesterone (i.e. prior spontaneous PTB and/or cervical length <20mm on screening ultrasound)
- •planned or in situ cervical cerclage
- •evidence of threatened abortion, preterm labor, or ruptured membranes
- •major fetal anomaly detected on screening ultrasound
- •known uterine anomaly
- •known or suspected allergy or contraindication to VP or placebo components
研究组 & 干预措施
Vaginal Progesterone
Daily self-administered vaginal progesterone
干预措施: Vaginal Progesterone (Drug)
Placebo
Daily self-administered indistinguishable placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Adequate Adherence to Study Product
时间窗: Enrollment through 36th gestational week, an overall total of up to 17 weeks
Number of participants who achieved adequate adherence to study product, defined as proper self-administration of at least 80% of prescribed study product doses, as measured by a dye stain assay of returned applicators
次要结局
- Acceptability of Use of Vaginal Progesterone (VP)(At enrollment (20-24 weeks gestation), at 28 weeks gestation, and at 36 weeks gestation)
- Reported Barriers and Facilitators to Adherence to Study Product, Returning Used Applicators, and Retention in the Study(Late in pregnancy or postpartum)
- Summary of Reported Knowledge, Attitudes, and Practices Related to HIV, Antiretroviral Therapy (ART), Risk of Preterm Birth, and Participation in Placebo Controlled Randomized Clinical Trials (RCTs)(Late in pregnancy or postpartum)
- Acceptability of a Vaginal Medication to Prevent Preterm Birth(Visit 9.0 (36 weeks of gestation))
- Reported Barriers to Adherence to Study Product(Visit 9.0 (36 weeks of gestation))
- Sensitivity, Specificity, and Predictive Value of Dose Diaries(Enrollment through 36th gestational week, an overall total of up to 17 weeks)
- Enrollment of Eligible Participants(Screening through Enrollment)
- Ascertainment of Date of Delivery and Infant Vital Status(Visit 10.0 (Delivery))
- Preliminary Efficacy(Visit 10.0 (Delivery))
- Birth Weight(Visit 10.0 (Delivery))
- Stillbirth(Visit 10.0 (Delivery))
- Adverse Events(Enrollment through Visit 10.0 (Delivery))