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临床试验/NCT03167879
NCT03167879已完成不适用

Integrating Counseling to Transform HIV Family Planning Services

RAND1 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2017年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
389
试验地点
1
主要终点
Number of Participants Who Used Dual Contraception or Safer Conception Method

研究概览

简要总结

This 3-arm cluster randomized controlled trial (RCT) will compare (1) a comprehensive family planning (FP) program that incorporates a structured, multi-component safer conception counseling (SCC) intervention (SCC1) versus (2) a SCC training workshop for FP nurses (SCC2; less intensive and mimics approach used by Ugandan Ministry of Health (MoH) to integrate new services), and (3) existing FP services (usual care) at 9 HIV clinics (3 per arm) operated by The AIDS Support Organization (TASO) Uganda.

详细描述

Family planning (FP) services for people living HIV/AIDS (PLHA) focus on preventing unplanned pregnancies and mother-to-child-transmission (PMTCT), and currently provide no services to support safer conception, despite ~40% of HIV+ women in sub-Saharan Africa (SSA) becoming pregnant post HIV diagnosis. Antiretroviral therapy (ART) greatly reduces the transmission risks associated with childbearing, but many PLHA are either not on ART or not adequately adherent; hence the need for using safer conception methods (SCM) such as manual self-insemination and timed unprotected intercourse. This cluster RCT will compare (1) a comprehensive FP program that incorporates a structured, multi-component SCC intervention (SCC1) versus (2) an SCC training workshop for FP nurses (SCC2; mimics approach used by Ugandan MoH to integrate new services), and (3) existing FP services (usual care) at 6 HIV clinics operated by TASO Uganda. The 3-arm design, together with the planned cost-effectiveness analysis, allows us to examine two models for integrating SCC into FP services that differ on level of intensity, thereby informing MoH policy and resource allocation. Sixty clients in HIV serodiscordant relationships who express childbearing desires at recruitment will be enrolled at each site (n=360) and followed for 12 months or completion of pregnancy (if applicable). The primary outcome is use of either SCM (for those trying to conceive) or dual contraception (those who decide against pregnancy).

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
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HIV+ client of TASO
  • Client if of reproductive age (males age 15-60; females age 15-45).
  • Has a partner with whom the client is considering having a child.
  • If client or their partner is age 15-17, the couple must be "married", defined as cohabitating and the parents of the minor(s) are reported to be aware of the relationship.
  • Partner with whom the client is considering having a child is HIV-negative.
  • Client reports that their partner is aware of the client being HIV-positive.

排除标准

  • Female client (or partner of male client) is pregnant

结局指标

主要结局

Number of Participants Who Used Dual Contraception or Safer Conception Method

时间窗: Month 12

Number of participants who used either of these methods based on the choice of the client to seek childbearing or pregnancy prevention following intervention

次要结局

  • Number Who Achieved Desired Pregnancy Status(Month 12)
  • Partner HIV Status(study end point (Month 12 or when learning of pregnancy))

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (1)

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