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临床试验/NCT04131465
NCT04131465Unknown不适用

Home HIV Testing for Older Adults and Their Family and Community Members: a Three-arm Randomized Controlled Trial in Rural South Africa

Harvard School of Public Health (HSPH)1 个研究点 分布在 1 个国家目标入组 3,578 人开始时间: 2019年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
3,578
试验地点
1
主要终点
Recent HIV testing

研究概览

简要总结

Many older adults in rural South Africa still lack knowledge of their HIV status despite a high probability of infection. Older adults tend to test less for HIV because most HIV testing and prevention programs have been targeted at younger age groups. Other reasons for failure to test for HIV include frailty and lack of financial resources to travel to HIV testing centers. Home-based testing is a powerful approach to bring HIV testing services -- and HIV status knowledge -- to older adults. In real-life health systems, community health workers, such as the South African community care givers, could potentially provide home-based HIV testing on a routine basis. In this study, the investigators are trying to establish the best 'form' for the 'function' home-based HIV testing.

Specifically, the investigators aim to

  1. Establish the comparative effectiveness of three home-based HIV testing options among older adults in rural South Africa
  2. Identify spill-over effects of the different home-based HIV testing options to other adults in the households and communities of the older adults receiving the testing options
  3. Determine the comparative cost-effectiveness of the three home-based HIV testing options among older adults.

详细描述

Background In the first wave of a large population-representative study of older adults in rural South Africa, the 'Health and Aging in Africa: A Longitudinal Study of an INDEPTH Community in South Africa (HAALSI)' study, large gaps in knowledge of HIV status were found among participants, coupled with low rates of recent HIV testing and high rates of sexual behaviour that can lead to acquisition and transmission of HIV. In general, older adults should test for HIV at least once per year (HIVAge.org), but few do so, in part because current HIV testing programmes have traditionally focused on young and middle-age adults and HIV testing facilities are often difficult to access for older populations. Only 17% of older adults in the HAALSI community reported having tested for HIV in the past 6 months.

Home testing can provide a powerful approach to bring the health systems 'function' of HIV testing to older adults in rural Africa. In the routine health system, community health workers, such as the South African community care givers, could provide this 'function' on a regular basis. Home rapid HIV testing and HIV self-test kits have been intensively studied in many populations. HIV self-test kits have recently become available as over the- counter products in South Africa, after the South African Pharmacy Council (SAPC) lifted a ban on their sale in pharmacies in December 2016.

To date, however, no study has compared head-to-head different 'forms' of home testing for HIV. In this study, the investigators aim to establish the comparative effectiveness and cost-effectiveness of three different options of home HIV testing among older adults in rural South Africa: (1) home delivery of HIV self-test kits, (2) home HIV rapid testing, and (3) both home delivery of HIV self-test kits and home HIV rapid testing.

Overall, home HIV testing is likely attractive for older adults because it allows testing without having to visit a health care facility. Home delivery of HIV self-testing kits has the additional advantage that it allows HIV testing in a place and at a time of one's own choosing. Home approaches to HIV testing are particularly policy-relevant at this time, because South Africa and many other countries in sub-Saharan Africa are currently expanding in re-designing their community health worker programs, through which home HIV testing could be provided on a routine basis.

Preliminary evidence in this and in other populations have suggested that HIV testing and linkage to HIV treatment and care improve health care utilization for other non-HIV chronic care and reduce risky sexual behavior. The investigators will thus not only assess the effects of the different home HIV testing offers on HIV testing but also assess comparative effects on healthcare utilization, noncommunicable disease endpoints, and sexual behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

The outcomes assessors will not know the arm assignment when they assess the outcomes. The investigators analyzing the data for the initial effect size estimations will be blinded to the arm assignment. Care providers (i.e., the fieldworkers providing the home-based HIV testing) and participants cannot be blinded to the assignment to the trial arms.

入排标准

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

入选标准

  • •Participants need to be part of the second wave of a population-representative longitudinal study in rural South Africa: "Health and Aging in Africa: A Longitudinal Study of an INDEPTH community in South Africa" (HAALSI)
  • •Mental capacity to consent to participation in this study

排除标准

  • •Participants who meet the inclusion criteria but do not wish to participate in this study

研究组 & 干预措施

Home HIV self-testing

Experimental

Fieldworkers will visit potential participants in their homes and offer 3 oral HIV self-testing kits with a short introduction to HIV self-testing.

干预措施: Home HIV self-testing (Diagnostic Test)

Home HIV rapid testing

Experimental

Fieldworkers will visit potential participants in their homes and offer home-based HIV rapid testing and counselling.

干预措施: Home HIV rapid testing (Diagnostic Test)

Home HIV self-testing and rapid testing

Experimental

Fieldworkers will visit participants in their homes and offer 3 oral HIV self-testing kits with a short introduction to HIV self-testing as well as home-based HIV rapid testing and counselling.

干预措施: Home HIV self-testing and rapid testing (Diagnostic Test)

结局指标

主要结局

Recent HIV testing

时间窗: 9 months

Binary endpoint: participant has tested since enrollment in the HIV trial vs. participant has not tested since enrollment in the HIV trial

Ever tested for HIV

时间窗: 9 months

Binary endpoint: participant has ever tested for HIV vs. has never tested for HIV

次要结局

  • Use of HIV self-test(9 months)
  • Correct report of HIV status(9 months)
  • Use of home rapid HIV test(9 months)
  • Recent linkage to HIV treatment and care(9 months)
  • Number of recent sex partners(9 months)
  • HIV testing at healthcare facility(9 months)
  • Linkage to HIV treatment and care(9 months)
  • Satisfaction with the fieldworker visit(9 months)
  • Depressive Symptoms(9 months)
  • Most recent sex partner was casual or anonymous(9 months)
  • HIV treatment uptake(9 months)
  • Diabetes treatment(9 months)
  • Blood pressure(18-24 months)
  • Repeated HIV testing(9 months)
  • HIV status knowledge(9 months)
  • Trust in other people and healthcare providers(9 months)
  • Recent condom use(9 months)
  • Rapid HIV testing during HAALSI(9 months)
  • Antihypertensive treatment(9 months)
  • Satisfaction with the South African government and healthcare system(9 months)
  • Viral load(18-24 months)
  • Biological Antiretroviral Screening(18-24 months)
  • Blood sugar(18-24 months)

研究者

发起方
Harvard School of Public Health (HSPH)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Till Barnighausen

Adjunct Professor of Global Health

Harvard School of Public Health (HSPH)

研究点 (1)

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