University of Miami Developmental Center for AIDs Research Promoting Male Involvement to Improve PMTCT Uptake and Reduce Antenatal Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 1
- 主要终点
- Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
研究概览
简要总结
This study will evaluate the impact of combining two evidence-based interventions: a couples risk reduction intervention with an evidence based medication adherence intervention designed to enhance male participation in combination with improving medication and prevention of mother to child transmission (PMTCT) adherence in antenatal clinics (ANCs). Clinics will be randomly assigned to experimental and control conditions and effectiveness of the combined intervention to enhance PMTCT as well as reduce antenatal seroconversion by both individuals and clinics will be examined. It is hypothesized that community clinics implementing PartnerPlus will have more effective PMTCT program adherence, as measured by total participant 1) maternal and paternal ANC and PartnerPlus visits, 2) maternal and paternal human immunodeficiency virus (HIV) Counseling & Testing (HCT) uptake, 3) maternal and infant antiretroviral (ARV) prophylaxis uptake, 4) maternal highly active antiretroviral therapy (HAART) uptake, 5) infant polymerase chain reaction (PCR) for HIV, and 5) maternal and infant HIV serostatus and that community clinics implementing PartnerPlus will have reduced sexual risk behavior, as measured by participant sexual barrier use.
详细描述
This study is a group-randomized controlled trial using a 2 x 6 comparison (Clinic, Experimental, Control x Time, Baseline, Post-Intervention, Pre-delivery 32 weeks, Pre-delivery day, Delivery, Post Partum). Twelve community health centers (CHCs) in communities within the Gert Sibande and Nkangala Districts in Mpumalanga, South Africa (SA) will be randomly assigned to condition in a 1:1 ratio. Six usual care condition clinics will provide the standard of care, PMTCT; six experimental condition clinics will offer PartnerPlus to mothers completing HIV testing, regardless of serostatus, who are willing to enroll with their male partners and participate in the integrated PartnerPlus intervention. This study will recruit 240 couples (n = 480 individuals); community clinics will recruit 2 cohort per clinic over 3 months (10 couples per cohort, n = 40, 120 individuals per condition).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •pregnant women age 18 and older who have received HCT (HIC Counseling & Testing) at the antenatal clinic (ANC),
- •willing to attend PartnerPlus or prevention of mother to child transmission (PMTCT) visits with their male partners,
- •male partners must also be available to participate and
- •both partners must be willing to participate in the study.
- •All participants will be current adult residents of Mpumalanga Province and agree to be attend four group sessions, 2 psychosocial assessments and 1 three day post-delivery assessment (maternal and infant blood sample).
排除标准
- •Single mothers not being tested for HIV at the ANC
结局指标
主要结局
Change in number of ANC visits by mother and father from baseline to one month post intervention to 32 weeks to 3 days post partum
时间窗: Baseline, one month, 32 weeks, 3 days post partum
次要结局
- Change in Mother, father, infant HIV VCT from baseline to one month to 3 days post partum(Baseline, one month, 3 days post partum)
- Mother and infant ARV prophylaxis(3 days post partum)
- Change in Maternal PMTCT ARV uptake from baseline to 32 weeks to 3 days post partum(Baseline, 32 weeks, 3 days post partum)
- Infant PCR(6 weeks)
- Change in rate of condom use from baseline to one month to 3 days post partum(Baseline, one month, 3 days post partum)
研究者
Deborah Jones
Research Associate Professor
University of Miami