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临床试验/NCT05285670
NCT05285670进行中(未招募)不适用

Mobile Solutions to Empower Reproductive Life Planning for Women Living With HIV

University of Washington10 个研究点 分布在 1 个国家目标入组 3,310 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,310
试验地点
10
主要终点
Contraceptive discontinuation

研究概览

简要总结

Use of a mobile health (mHealth) intervention to provide reproductive life counseling to women living with HIV may improve delivery of integrated reproductive health/HIV services and prevent adverse reproductive health outcomes. The proposed study will evaluate SMS platform and reproductive health counseling intervention in a cluster randomized controlled trial among women receiving routine HIV care, and plan for future implementation with qualitative and health economic analyses.

详细描述

Meeting reproductive health needs of women living with HIV (WLWH) is essential to help women prevent unintended pregnancies, safely conceive, and eliminate mother-to-child HIV transmission (MTCT). Reproductive life planning is complex for WLWH, who are faced with making decisions about antiretroviral treatment selections and potential for drug interactions with contraceptive methods, planning for safe conception, and planning to prevent sexually transmitted infections. While family planning (FP) use is high among WLWH, discontinuation of FP is common among women who desire pregnancy prevention, and is an important driver of unmet need for FP and subsequent risk of unintended pregnancy and adverse maternal and child health outcomes. Many programs in sub-Saharan Africa integrate FP service delivery into routine HIV care, but HIV care providers face challenges with implementing these models of care. HIV care providers may be ill equipped to ensure WLWH receive high-quality, rights' based reproductive health counseling and services due to lack time, training, resources, and skills. Prior studies on integrating FP services into HIV care consistently cite implementation challenges. Mobile health technology may provide a low cost solution to augment counseling services, strengthen health care systems, and alleviate demands on HIV providers. The investigators hypothesize that providing comprehensive counseling and two-way SMS communication, will 1) improve delivery of integrated HIV and reproductive health care services, 2) reduce contraceptive discontinuation rates, 3) be acceptable and feasible to implement, and 4) be cost-effective and contribute to prevention MTCT efforts. The investigators will adapt a unique two-way SMS platform (Mobile WACh) that combines automated bulk SMS messaging and dialogue with a health care provider for a new population, new environment, and new outcomes for long-term impact. The Mobile WACh platform will be customized to provide continuous reproductive life planning counseling for WLWH. The investigators will test the combined intervention in a cluster randomized controlled trial among women receiving HIV care at 10 facilities in Kenya (330 per facility). The investigators propose to evaluate the effect of the counseling and SMS communication intervention, Mobile WACh Empower, on reproductive health outcomes. In Aim 1, the investigators will determine the effect of the Mobile WACh Empower intervention on FP discontinuation, dual method use, and unmet need for FP over 2 years. In Aim 2, the investigators will evaluate acceptability, feasibility, and scalability of implementing Mobile WACh Empower under real-world settings, from both WLWH and provider perspectives in focus group discussions. In Aim 3, the investigators will construct a mathematical model to measure health and economic impacts of Mobile WACh Empower, including cost-effectiveness of the intervention per pregnancy and MTCT averted. This trial will evaluate a novel intervention to address a crucial gap in provision of integrated reproductive health and HIV care, and has the potential to make a significant contribution to global goals of universal access to FP and elimination of MTCT.

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
14 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • HIV-infected
  • Receiving HIV care at study site
  • Reproductive age (18-45; 14-17 if emancipated minors)
  • Daily access to mobile phone (own phone or shared)
  • Plan to receive HIV care at enrollment facility for 2 years
  • Speak English, Kiswahili, or Luo
  • Literate or comfortable with someone reading study SMS

排除标准

  • Currently pregnant

研究组 & 干预措施

Digital counseling plus interactive two-way SMS dialogue

Experimental

Participants will receive initial counseling on a tablet followed by automated SMS messages with prompts to reply. They will have the ability to both respond to and initiate SMS dialogue. Trained Study Nurses will monitor and respond to participant messages.

干预措施: Digital counseling plus interactive two-way SMS dialogue (Behavioral)

Control

No Intervention

Control receiving standard of care.

结局指标

主要结局

Contraceptive discontinuation

时间窗: 2 years

Proportion not using contraception among women who initiated or continued contraception to prevent pregnancy

次要结局

  • Uptake of dual methods of contraception(2 years)
  • Unmet need for contraception(2 years)

研究者

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

Alison Drake

Associate Professor, SPH: Global Health

University of Washington

研究点 (10)

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