NCT01616420

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,424

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable hiv

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 11, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3.2 years

First QC Date

June 7, 2012

Last Update Submit

April 6, 2017

Conditions

HIV

Keywords

preventiontreatmentcost-effectivenessassisted partner notification servicesKenyalinkage to HIV carecase-finding

Outcome Measures

Primary Outcomes (3)

  • Number of partners testing for HIV

    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

    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

    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 Outcomes (3)

  • Incremental cost-effectiveness from payer and societal perspectives

    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

    6 week period after index case enrollment

  • Costs of identifying >1 partner per index case

    6 week period after index case enrollment

Study Arms (2)

Delayed aPS

NO INTERVENTION

Immediate aPS

EXPERIMENTAL
Other: Assisted-partner notification services

Interventions

Assisted-partner notification servicesOTHER

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.

Also known as: Partner notification services, Assisted partner services
Immediate aPS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Karuri VCT

Kiambu, Kenya

Location

Kiambu Hospital VCT

Kiambu, Kenya

Location

Kirwara VCT

Kiambu, Kenya

Location

Chulaimbo Health Centre

Kisumu, Kenya

Location

Joo Trh Vct

Kisumu, Kenya

Location

Kisumu East District Hospital

Kisumu, Kenya

Location

Kombewa VCT

Kisumu, Kenya

Location

Maseno Mission

Maseno, Kenya

Location

Baba Dogo VCT

Nairobi, Kenya

Location

Casino VCT

Nairobi, Kenya

Location

Huruma Lions

Nairobi, Kenya

Location

Kariobangi VCT

Nairobi, Kenya

Location

Kenyatta National Hospital (KNH) VCT

Nairobi, Kenya

Location

Mama Lucy Kibaki VCT

Nairobi, Kenya

Location

Mbagathi VCT

Nairobi, Kenya

Location

Pumwani VCT

Nairobi, Kenya

Location

Abidha Health Centre

Siaya, Kenya

Location

Ongielo Health Centre

Siaya, Kenya

Location

Related Publications (2)

  • Cherutich P, Golden MR, Wamuti B, Richardson BA, Asbjornsdottir KH, Otieno FA, Ng'ang'a A, Mutiti PM, Macharia P, Sambai B, Dunbar M, Bukusi D, Farquhar C; aPS Study Group. Assisted partner services for HIV in Kenya: a cluster randomised controlled trial. Lancet HIV. 2017 Feb;4(2):e74-e82. doi: 10.1016/S2352-3018(16)30214-4. Epub 2016 Nov 30.

    PMID: 27913227DERIVED

  • Wamuti BM, Erdman LK, Cherutich P, Golden M, Dunbar M, Bukusi D, Richardson B, Ng'ang'a A, Barnabas R, Mutiti PM, Macharia P, Jerop M, Otieno FA, Poole D, Farquhar C. Assisted partner notification services to augment HIV testing and linkage to care in Kenya: study protocol for a cluster randomized trial. Implement Sci. 2015 Feb 13;10:23. doi: 10.1186/s13012-015-0212-6.

    PMID: 25884936DERIVED

Study Officials

  • Carey Farquhar, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Peter Cherutich, MBChB, MPH

    Kenya Ministry of Health

    STUDY CHAIR

  • Matthew Golden, MD, MPH

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2012

First Posted

June 11, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

April 10, 2017

Record last verified: 2017-04

Locations

KE(18)