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

6 april 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

2424

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Delayed aPS
Experimenteel: Immediate aPS
Ander: 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.
Andere namen:
  • Partner notification services
  • Assisted partner services

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of partners testing for HIV
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Incremental cost-effectiveness from payer and societal perspectives
Tijdsspanne: 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
Tijdsspanne: 6 week period after index case enrollment
6 week period after index case enrollment
Costs of identifying >1 partner per index case
Tijdsspanne: 6 week period after index case enrollment
6 week period after index case enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Washington

Medewerkers

University of Nairobi
Kenya Ministry of Health

Onderzoekers

  • Hoofdonderzoeker: Carey Farquhar, MD, MPH, University of Washington
  • Studie stoel: Peter Cherutich, MBChB, MPH, Kenya Ministry of Health
  • Studie stoel: Matthew Golden, MD, MPH, University of Washington

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2012

Primaire voltooiing (Werkelijk)

1 augustus 2015

Studie voltooiing (Werkelijk)

1 augustus 2015

Studieregistratiedata

Eerst ingediend

7 juni 2012

Eerst ingediend dat voldeed aan de QC-criteria

8 juni 2012

Eerst geplaatst (Schatting)

11 juni 2012

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 april 2017

Laatste update ingediend die voldeed aan QC-criteria

6 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 43628

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