Clinical trial NCT01616420: Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya
Official title: Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: prevention
treatment
cost-effectiveness
assisted partner notification services
Kenya
linkage to HIV care
case-finding
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenya Ministry of Health
name: University of Nairobi
First posted: 2012-06-11
Enrollment: 2424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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 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 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.

Primary outcomes:
measure: Number of partners testing for HIV
timeFrame: 6 week period following index case enrollment
measure: Newly tested HIV-infected partners
timeFrame: 6 week period following index case enrollment
measure: Number of partners linking to HIV care
timeFrame: 6 week period following index case enrollment
Secondary outcomes:
measure: Incremental cost-effectiveness from payer and societal perspectives
timeFrame: 6 week period following index case enrollment
measure: Proportion of individuals with newly diagnosed HIV infection who report testing because of known exposure to a person with HIV
timeFrame: 6 week period after index case enrollment
measure: Costs of identifying >1 partner per index case
timeFrame: 6 week period after index case enrollment
Other outcomes:
Locations:
city: Kiambu
country: Kenya
facility: Karuri VCT
city: Kiambu
country: Kenya
facility: Kiambu Hospital VCT
city: Kiambu
country: Kenya
facility: Kirwara VCT
city: Kisumu
country: Kenya
facility: Chulaimbo Health Centre
city: Kisumu
country: Kenya
facility: Joo Trh Vct
city: Kisumu
country: Kenya
facility: Kisumu East District Hospital
city: Kisumu
country: Kenya
facility: Kombewa VCT
city: Maseno
country: Kenya
facility: Maseno Mission
city: Nairobi
country: Kenya
facility: Baba Dogo VCT
city: Nairobi
country: Kenya
facility: Casino VCT
city: Nairobi
country: Kenya
facility: Huruma Lions
city: Nairobi
country: Kenya
facility: Kariobangi VCT
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital (KNH) VCT
city: Nairobi
country: Kenya
facility: Mama Lucy Kibaki VCT
city: Nairobi
country: Kenya
facility: Mbagathi VCT
city: Nairobi
country: Kenya
facility: Pumwani VCT
city: Siaya
country: Kenya
facility: Abidha Health Centre
city: Siaya
country: Kenya
facility: Ongielo Health Centre
Study officials:
affiliation: University of Washington
name: Carey Farquhar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Ministry of Health
name: Peter Cherutich, MBChB, MPH
role: STUDY_CHAIR
affiliation: University of Washington
name: Matthew Golden, MD, MPH
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.