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临床试验/NCT03547739
NCT03547739已完成不适用

Testing Strategies for Couple Engagement in PMTCT and Family Health in Kenya

University of Alabama at Birmingham1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2019年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,600
试验地点
1
主要终点
Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum

研究概览

简要总结

This study will test the efficacy and cost-effectiveness of an interdependence theory-based couples intervention in Kenya that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services.

详细描述

Despite the potential for antiretroviral therapy to improve maternal health and reduce mother-to-child transmission of HIV to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. This is particularly true in Kenya, where crucial drop-offs occur in the cascade of prevention of mother-to-child transmission (PMTCT) services. Weak health systems contribute to insufficient service coverage, but many barriers lie beyond the clinic-in the partner, family, and community factors that shape women's health decisions. The investigators' research in a high HIV prevalence area of southwestern Kenya has shown that many women avoid couples HIV testing and do not adhere to PMTCT regimens because they fear negative consequences from a male partner. Men can play a crucial supportive role for family health, but male partners in Kenya are poorly engaged in antenatal care and uptake of couples HIV testing during pregnancy is low. Pregnant women desire to be tested for HIV together with their partner and need the support for mutual disclosure involved in couples HIV testing and counseling (CHTC), regardless of whether they know their own HIV status. In this context, the investigators will test the efficacy of an interdependence theory-based couples intervention that reaches pregnant women and male partners through home visits by male-female pairs of lay health workers, and includes offer of home-based CHTC services. The randomized pilot study of this intervention with 96 pregnant couples (R34MH102103) demonstrated significant increases in uptake of couples testing (64% in intervention vs. 23% in control, p<0.001) and significant improvements in health behaviors such as exclusive breastfeeding and postpartum care. The investigators will now conduct a more robust investigation to determine whether this intervention improves uptake of couples HIV testing and health outcomes over and above less intensive male engagement strategies being used in the region. This theory-based couples intervention has strong potential to increase couple HIV testing and collaboration for family health. The study will inform decision-makers about cost-effective strategies to engage pregnant couples in PMTCT and family health, with important downstream benefits for maternal, paternal, and infant health.

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
None

入排标准

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

入选标准

  • Women at 36 weeks of pregnancy or less
  • 15 years of age or older
  • Has been offered HIV testing at ANC
  • Is currently in a stable relationship with a male partner and living with that male partner - Has not yet participated in couple HIV testing during this pregnancy.
  • Male partner is the person identified by the pregnant woman as her primary male partner and should also be 15 years of age or older.
  • Not in an HIV-positive concordant relationship.

排除标准

  • Greater than 36 weeks of pregnancy
  • Less than 15 years of age
  • Not currently in a stable relationship with a male partner
  • Does not currently live with male partner
  • Has not been offered HIV testing at ANC

结局指标

主要结局

Number of Couples Who Tested for HIV as a Couple After Study Enrollment up to 12 Months Postpartum

时间窗: up to 12 months postpartum

Number of couples with couple HIV testing uptake during observation period (from baseline to 12 months postpartum), coded as Y=if the couple tested together for HIV up to 12 months postpartum and N=if the couple has not tested together for HIV up to 12 months postpartum. At 3 and 12 months postpartum, each couple member was asked to report whether they had tested together for HIV as a couple at home with HIV self-test kits or at the clinic.

次要结局

  • Mean Man's Adherence to HIV Treatment (ART) (HIV-positive Men Retained up to 12 Months Postpartum)(Up to 12 months postpartum)
  • Mean Number of HIV Care Visits (HIV-positive Men Retained up to 12 Months Postpartum)(Up to 12 months postpartum)
  • Number of New Discordant Couples (Intervention Arms Only)(Up to 12 months postpartum)
  • HIV+ Women Who Utilized All 3 PMTCT Interventions up to 18 Months Postpartum(Up to 18 months postpartum)
  • HIV Re-testing(Up to 12 months postpartum)
  • Number of New Male HIV-positive Diagnoses From Baseline up to 12 Months Postpartum (Intervention Arms Only)(Up to 12 months postpartum)
  • Women Who Utilized All 4 MCH Services up to 3 Months Postpartum(Up to 3 months postpartum)
  • Pre-Exposure Prophylaxis (PrEP) Uptake (HIV Negative at Baseline)(Up to 18 months postpartum)
  • Number of HIV-positive Women Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum(Up to 12 months postpartum)
  • Number of HIV-positive Women at Baseline Retained in HIV Care up to 12 Months Follow-up(Up to 12 months postpartum)
  • Mean Woman's Adherence to HIV Treatment (ART) (HIV-positive Women Retained up to 12-months Follow-up)(Up to 12 months postpartum)
  • Mean Number of HIV Care Visits (HIV-positive Women Retained up to 12-months Follow-up)(Up to 12 months postpartum)
  • Number of HIV-positive Men Not Linked to HIV Care at Baseline Reported Being Linked to HIV Care at 12 Months Postpartum(Up to 12 months postpartum)
  • Number of HIV-positive Men at Baseline Retained in HIV Care up to 12 Months Follow-up(Up to 12 months postpartum)
  • Maternal HIV Viral Suppression (HIV-positive Women Retained up to 18-months Follow-up)(Up to 18 months postpartum)
  • Time to First Infant HIV Test (Infants of HIV-positive Women Retained up to 18-months Follow-up)(Up to 18 months after birth)
  • HIV-free Child Survival(18 months after the birth)
  • Number of Infants of HIV-positive Mothers Who Tested HIV+ up to 18 Months Postpartum(Up to 18 months after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Janet M. Turan, PhD

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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