Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya (APS)

6. april 2017 opdateret af: Carey Farquhar, University of Washington

The main purpose of this implementation science study is to find out if providing aPS at 18 different Ministry of Health (MOH) VCT clinics in Kenya works and is cost-effective. This would enable co-investigators in the Kenyan MOH to justify funding to scale-up these services.

The primary aim of the study is to find out whether providing aPS to sexual partners of newly tested HIV-infected individuals can result in more sexual partners getting counseled and HIV tested and linked to HIV care programs for initiation of ART if appropriate. The investigators hypothesize that aPS will increase rates of case-finding, linkages to care, and ART initiation and will not result in social harm.

The second aim is whether aPS is cost-effective in the Kenyan setting. The investigators will estimate how much it costs (when compared to standard methods) to identify and link HIV-infected persons into care. The investigators will also determine how successful aPS is at preventing future HIV transmission events and other outcomes associated with untreated HIV infection. The investigators hypothesize that HIV prevalence among partners in the immediate aPS arm will be high enough to make this approach cost-effective from the payer and societal perspective.

Finally, with the Kenya MOH, the investigators want to establish a nationwide monitoring system to evaluate why Kenyans are testing for HIV. In the future, when aPS is rolled out nationally, this will help Kenyan public health officials define the contribution of aPS to HIV case-finding. The investigators hypothesize that the proportion of newly tested HIV-infected individuals who report testing because of known exposure to a person with HIV will represent a significant proportion of new cases and the investigators will be able to identify places in Kenya where aPS will have the greatest impact on HIV treatment and prevention.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Diagnosing HIV soon after infection can benefit individuals and also has important public health benefits. It has been shown that starting antiretroviral therapy (ART) before HIV has progressed results in a better response to treatment and gives the person a better chance of long-term survival with HIV. Treating HIV can also reduce the risk that someone will transmit HIV to his or her sexual partners. The first step in achieving these individual and population level benefits is testing people for HIV. Unfortunately, in many parts of the world, including Kenya where we plan to conduct this study, many people are not tested regularly and do not know that they are infected. This study involves providing a public health service, notification of an exposure to a communicable disease and HIV testing, to sexual partners of those who test HIV-positive at voluntary counseling and testing (VCT) clinics in Kenya. Sexual partners are identified voluntarily by the person who tests at the VCT. A public health provider then goes to the home of the sexual partners to offer them HIV counseling and testing. This process is called provision of assisted partner services (aPS).

We propose a cluster randomized clinical trial which will be conducted in collaboration with the Kenya Ministry of Health (MOH) at 18 rural and urban voluntary counseling and testing (VCT) facilities across Kenya. Proposed activities will assess the effectiveness and cost-effectiveness of providing aPS, improve capacity for program implementation in Kenya, and lay the foundation for evaluating the program's impact at the national level.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

2424

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kenya
      • Kiambu, Kenya
        • Karuri VCT
      • Kiambu, Kenya
        • Kiambu Hospital VCT
      • Kiambu, Kenya
        • Kirwara VCT
      • Kisumu, Kenya
        • Chulaimbo Health Centre
      • Kisumu, Kenya
        • Joo Trh Vct
      • Kisumu, Kenya
        • Kisumu East District Hospital
      • Kisumu, Kenya
        • Kombewa VCT
      • Maseno, Kenya
        • Maseno Mission
      • Nairobi, Kenya
        • Baba Dogo VCT
      • Nairobi, Kenya
        • Casino VCT
      • Nairobi, Kenya
        • Huruma Lions
      • Nairobi, Kenya
        • Kariobangi VCT
      • Nairobi, Kenya
        • Kenyatta National Hospital (KNH) VCT
      • Nairobi, Kenya
        • Mama Lucy Kibaki VCT
      • Nairobi, Kenya
        • Mbagathi VCT
      • Nairobi, Kenya
        • Pumwani VCT
      • Siaya, Kenya
        • Abidha Health Centre
      • Siaya, Kenya
        • Ongielo Health Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Written informed consent is required of all participants. All participants must be 18 years or older.
  • Index case participants must be HIV-seropositive, and willing and able to provide locator information for sexual partners in the past three years.

Exclusion Criteria:

  • Index cases will be excluded from participation if they are pregnant, or have reported intimate partner violence during the last month. There is no exclusion criteria for partner participants.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Delayed aPS
Eksperimentel: Immediate aPS
Andet: Assisted-partner notification services
Assisted-partner notification services (aPS) is a public health service which notifies the partners of those who test positive for a communicable disease of their exposure.
Andre navne:
  • Partner notification services
  • Assisted partner services

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of partners testing for HIV
Tidsramme: 6 week period following index case enrollment
The number of partners of an index participant that were tested for HIV (offset will be the number of partners with locator information provided by the index participant).
6 week period following index case enrollment
Newly tested HIV-infected partners
Tidsramme: 6 week period following index case enrollment
The number of partners of an index participant identified as HIV-infected (offset will be the number of partners of that index participant who were HIV tested).
6 week period following index case enrollment
Number of partners linking to HIV care
Tidsramme: 6 week period following index case enrollment
The number of partners of an index participant who were linked to HIV care (offset will be the number of partners of an index participant identified as HIV-infected and analysis will be limited to index participants with at least one HIV-infected partner.)
6 week period following index case enrollment

Sekundære resultatmål

Resultatmål
Tidsramme
Incremental cost-effectiveness from payer and societal perspectives
Tidsramme: 6 week period following index case enrollment
6 week period following index case enrollment
Proportion of individuals with newly diagnosed HIV infection who report testing because of known exposure to a person with HIV
Tidsramme: 6 week period after index case enrollment
6 week period after index case enrollment
Costs of identifying >1 partner per index case
Tidsramme: 6 week period after index case enrollment
6 week period after index case enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Samarbejdspartnere

University of Nairobi
Kenya Ministry of Health

Efterforskere

  • Ledende efterforsker: Carey Farquhar, MD, MPH, University of Washington
  • Studiestol: Peter Cherutich, MBChB, MPH, Kenya Ministry of Health
  • Studiestol: Matthew Golden, MD, MPH, University of Washington

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. august 2015

Studieafslutning (Faktiske)

1. august 2015

Datoer for studieregistrering

Først indsendt

7. juni 2012

Først indsendt, der opfyldte QC-kriterier

8. juni 2012

Først opslået (Skøn)

11. juni 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 43628

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV

Kliniske forsøg med Assisted-partner notification services

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Estonia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner