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

April 6, 2017 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

2424

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Delayed aPS
Experimental: Immediate aPS
Other: 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.
Other Names:
  • Partner notification services
  • Assisted partner services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of partners testing for HIV
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

University of Nairobi
Kenya Ministry of Health

Investigators

  • Principal Investigator: Carey Farquhar, MD, MPH, University of Washington
  • Study Chair: Peter Cherutich, MBChB, MPH, Kenya Ministry of Health
  • Study Chair: Matthew Golden, MD, MPH, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 7, 2012

First Submitted That Met QC Criteria

June 8, 2012

First Posted (Estimate)

June 11, 2012

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 43628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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