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临床试验/NCT05124665
NCT05124665已完成不适用

Interrupting HIV and TB Stigma in the Household During TB Contact Investigation in Uganda

Yale University1 个研究点 分布在 1 个国家目标入组 612 人开始时间: 2021年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
612
试验地点
1
主要终点
Proportion of Contacts Accepting HIV Testing

研究概览

简要总结

The investigators will carry out a prospective, household cluster-randomized, implementation trial evaluating a complex, multi-component, social and behavioral intervention designed to normalize the acceptance of HIV testing in the household and increase diagnosis of HIV.

详细描述

An estimated 39 million people worldwide are living with HIV, but nearly half do not know their status because they are unaware that they are at risk, unable to access counseling and testing, or unwilling to accept testing because of stigma and fear. Layered on to the stigma of HIV is the risk of tuberculosis (TB), the leading cause of death among persons living with HIV (PLWH). Home testing is a promising approach to increase testing and linkage to care for HIV because it can reach individuals outside the health system, eliminate the costs of traveling for testing, offer testing in a familiar environment, and increase engagement with care among those found to be living with HIV. Nevertheless, many individuals offered home HIV testing in sub-Saharan Africa decline to test.

The investigators developed a complex intervention to increase uptake of testing for HIV among household members by reducing perceptions of stigma associated with HIV and testing for HIV. The intervention involves lay health workers (LHWs) delivering a novel invitation strategy for HIV testing in households that includes 1) acceptance-optimized sequencing, 2) prosocial messaging, and 3) salivary HIV testing. The investigators will administer HIV and TB stigma scales before and after the invitation. The investigators will conduct a household randomized controlled trial to test the intervention's impact on household HIV stigma and uptake of testing among household members undergoing TB contact investigation. The investigators will measure our co-primary outcomes of HIV and TB stigma using standardized instruments before invitation and after completion of post-test counseling. The investigators will measure the proportion consenting to HIV testing, yield of HIV diagnoses, and the proportion of new PLWH linked to HIV care at 1 month and reassess household HIV and TB stigma at 3 months.

This study will be conducted in Kampala, Uganda, and will involve TB index patients and their household contacts. Households will be recruited and enrolled through index patients initiating treatment for pulmonary tuberculosis (PTB) at Kampala Capital City Authority health facilities. The investigators will enroll index patients and their households from Kiswa, Kawaala, and Kisenyi Health Centers, each a public-sector, primary care facility.

This study will enroll households (index patients + their household contacts). Only household contacts are eligible for participation; close contacts are not eligible. For the purposes of this study, household contacts are defined as those individuals "sleeping under the same roof" as the index patient for one or more nights within the past three months.

Upon encountering a patient initiating treatment for TB or returning for 2-week follow-up, study CHWs will assess index patients for household-level eligibility for the study. All index patients whose households meet these criteria will be asked to provide verbal consent after reviewing an information sheet. If the index patient is a minor (age < 18 years), the guardian of the index patient will be asked to provide verbal consent.

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 (Participant, Investigator)

盲法说明

There are 3 teams of community health workers (CHWs) in total: one intervention, one standard of care, and one clinic-based that will always carry out initial enrollment and record clinic follow-up for both arms. Blinding of the CHWs is not feasible because it is a behavioral intervention that is easily recognized and CHWs must be trained to deliver either the standard of care or the intervention strategy. CHWs will collect data for the outcomes. CHWs will be separated into two teams and will only have electronic permissions to access training, procedures, forms, and contact information related to their assigned allocation within the electronic case record forms. They will be blinded to randomization procedures and outcomes. Participants will be blinded to their randomization assignment. Investigators and study staff will be blinded to study outcomes until the database is locked at the end of the trial. The onsite study coordinator who manages randomization will not be blinded.

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
是

入选标准

  • •Index Patient and Household Eligibility:
  • •Index patient is eligible for contact investigation (TB patient of any age identified in the facility's National TB and Leprosy Programme (NTLP) TB Treatment Register as initiating treatment or returning for 2-week follow-up)
  • •Index patient or legal guardian agrees to study procedures in addition to routine contact investigation
  • •Index patient has at least 2 self-reported household contacts age 15 or above
  • •Household is within the boundaries of the Kampala Capital City Authority, Uganda
  • •Does not have multi-drug resistant (MDR) TB
  • •Contact Participant Eligibility:
  • •Household contact age ≥15 years
  • •Agrees to study procedures in addition to routine contact investigation

排除标准

  • 未提供

研究组 & 干预措施

Social Support

Experimental

CHWs will offer HIV testing to the individual nominated by the index patient as most likely to test. If this person is not present, CHWs will decide which contact should be offered testing first. CHWs will use a prosocial script for HIV testing: "Knowing your status sets a good example for your household." CHWs will follow an "opt-out" strategy: "This test kit is approved by the Ministry of Health and used in KCCA health facilities. I am going to offer you a free HIV test now, is that okay?". If the initial household contact who is offered HIV testing agrees to test, the CHW will ask if he/she is willing to share his/her decision to test with other members of the household: "Would you like to share your decision to test with the others? Sharing is completely optional. However, learning that someone else in their household decided to test sometimes gives people the strength to test themselves. Sharing your decision might help another person find the strength to test."

干预措施: Social Support (Behavioral)

Standard of Care

No Intervention

As a control for the socio-behavioral intervention, the control arm will lack the socio-behavioral intervention components. The order of testing invitation will be decided by the CHW; and CHWs will be trained at baseline to provide standard, opt-in framing of test offers, without any mention of asking contacts to share their testing decision with other household contacts. Oral HIV kits will also be used in control households.

结局指标

主要结局

Proportion of Contacts Accepting HIV Testing

时间窗: up to 8 weeks

To test the hypothesis that a norming intervention can increase test uptake, the investigators will compare testing uptake among the intervention households and control households using cluster-adjusted chi-squared tests of proportion and by fitting mixed effects logistic regression models with two levels (household, contact). The effect of the intervention will then be evaluated by comparing adjusted slope differences in the primary outcomes (test uptake) between the intervention and the control arms, using random intercept mixed logit models to account for clustering by household.

次要结局

  • Number of Social Support Household Contacts Deciding to Test for HIV(up to 8 weeks)
  • Change in Effects of Perceived TB Stigma on HIV Test Uptake(Baseline to End of Interview (Up to 8 hours))
  • Change in Score of Perceived TB Stigma(Baseline to End of Interview (Up to 8 hours))
  • Change in Effects of Perceived HIV Stigma on HIV Test Uptake(Baseline to Immediately post intervention (up to 8 hours))
  • Change in Score of Perceived HIV Stigma(Baseline to End of Interview (Up to 8 hours))
  • Proportion of Index Patient Nominated Household Members Who Accept HIV Test(up to 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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