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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of Washington
Sponsor:
Collaborators:
Kenya Ministry of Health
University of Nairobi
Information provided by (Responsible Party):
Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier:
NCT01616420
First received: June 7, 2012
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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 diagnosed 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 individuals with newly diagnosed HIV infection 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.


Condition Intervention
Assisted-partner Notification Services
Other: Assisted-partner notification services

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Rate of HIV testing of partners [ Time Frame: 6 week period following index case enrollment ] [ Designated as safety issue: No ]
    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).

  • Newly identified HIV-infected partners [ Time Frame: 6 week period following index case enrollment ] [ Designated as safety issue: No ]
    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).

  • Rate of linkage to HIV care [ Time Frame: 6 week period following index case enrollment ] [ Designated as safety issue: No ]
    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.)


Secondary Outcome Measures:
  • Incremental cost-effectiveness from payer and societal perspectives [ Time Frame: 6 week period following index case enrollment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Costs of identifying >1 partner per index case [ Time Frame: 6 week period after index case enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 3240
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 learning their status for the first time, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01616420

Contacts
Contact: Carey Farquhar, MD, MPH 206-543-4278 cfarq@u.washington.edu
Contact: Beatrice Wamuti, MBChB +254721778488 bwamuti@gmail.com

Locations
Kenya
Kiambu Hospital VCT Recruiting
Kiambu, Kenya
Kirwara VCT Not yet recruiting
Kiambu, Kenya
Karuri VCT Not yet recruiting
Kiambu, Kenya
Kisumu East District Hospital Recruiting
Kisumu, Kenya
Joo Trh Vct Completed
Kisumu, Kenya
Chulaimbo Health Centre Not yet recruiting
Kisumu, Kenya
Kombewa VCT Recruiting
Kisumu, Kenya
Maseno Mission Recruiting
Maseno, Kenya
Baba Dogo VCT Recruiting
Nairobi, Kenya
Kenyatta National Hospital (KNH) VCT Completed
Nairobi, Kenya
Huruma Lions Not yet recruiting
Nairobi, Kenya
Mama Lucy Kibaki VCT Not yet recruiting
Nairobi, Kenya
Casino VCT Not yet recruiting
Nairobi, Kenya
Mbagathi VCT Recruiting
Nairobi, Kenya
Pumwani VCT Not yet recruiting
Nairobi, Kenya
Kariobangi VCT Recruiting
Nairobi, Kenya
Ongielo Health Centre Not yet recruiting
Siaya, Kenya
Abidha Health Centre Recruiting
Siaya, Kenya
Sponsors and Collaborators
University of Washington
Kenya Ministry of Health
University of Nairobi
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
  More Information

No publications provided

Responsible Party: Carey Farquhar, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01616420     History of Changes
Other Study ID Numbers: 1R01AI099974-01
Study First Received: June 7, 2012
Last Updated: April 28, 2014
Health Authority: Kenya: Ministry of Health

Keywords provided by University of Washington:
HIV
prevention
treatment
cost-effectiveness
assisted partner notification services
Kenya
linkage to HIV care
case-finding

ClinicalTrials.gov processed this record on September 14, 2014