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临床试验/NCT00405990
NCT00405990已完成4 期

Optimizing the Impact of Prevention of Mother to Child Transmission of HIV in South Africa: the Forgotten Half of the Equation.

Imperial College London2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2006年11月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
1,000
试验地点
2
主要终点
Percentage of partners agreeing to attend VCT.

研究概览

简要总结

The study aims to invite male sexual partners to attend antenatal clinic with their pregnant partners to either acquire pregnancy information or undergo voluntary counselling and testing for HIV. To see if male sexual partner involvement will decrease sexual risk behaviour.

详细描述

We will enrol 1000 pregnant women; recruited from antenatal clinic at Khayelitsha Midwive and Obstetric Unit (MOU). Community sensitization activities will be implemented in the catchment community to encourage male partner participation.

At the booking visit all women will be offered antenatal care, HIV group education and VCT as usual. Thereafter women will be recruited to enrol into the study, after signing the consent form half of the cohort members will be randomly assigned to partner VCT (Group A) and half to partner pregnancy information (Group B). Men in group B will be offered VCT at the second interview late in pregnancy. However, VCT will be provided if requested by study participants at any stage of the study or if the female partner is HIV positive. Women in group A will be given a written invitation to hand to their partners to encourage them to invite their partners to come to the antenatal clinic for VCT. In group B, women will be given a written invitation to give to their partners to encourage their partners to attend a pregnancy information session at the antenatal clinic.

VCT will be offered again close to delivery for all women and men who were previously uninfected or of unknown status. For those found to be HIV-infected at a prior visit, CD4 and CD8 T-cell counts, viral load, and full blood count tests will be conducted. Both women and men will be referred to the Antiretroviral clinic where ARV will be offered if appropriate and formula feeding (or exclusive breastfeeding) will be recommended. Reasons for declining VCT and data on sexual behaviour and violence will be sought at each visit.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • To be eligible for participation, a woman must be less than 30 weeks pregnant at enrolment.

排除标准

  • Women who are more than 30 weeks pregnant will be excluded.

结局指标

主要结局

Percentage of partners agreeing to attend VCT.

时间窗: 12 weeks

次要结局

  • Percentage of partners and pregnant women abstaining, faithful to one partner and using condoms consistently.(12 weeks)

研究者

申办方类型
Other

研究点 (2)

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