HIVAPSNCT01616420
Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya
A study testing Assisted-partner notification services in people with HIV, run by University of Washington at 18 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Assisted-partner notification services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,424 participants
- Where
- 18 sitesKenya
- Study dates
- Jun 2012to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Kenya18 sites
Karuri VCT
Kiambu
Kiambu Hospital VCT
Kiambu
Kirwara VCT
Kiambu
Chulaimbo Health Centre
Kisumu
Joo Trh Vct
Kisumu
Kisumu East District Hospital
Kisumu
Kombewa VCT
Kisumu
Maseno Mission
Maseno
Baba Dogo VCT
Nairobi
Casino VCT
Nairobi
Huruma Lions
Nairobi
Kariobangi VCT
Nairobi
Kenyatta National Hospital (KNH) VCT
Nairobi
Mama Lucy Kibaki VCT
Nairobi
Mbagathi VCT
Nairobi
Pumwani VCT
Nairobi
Abidha Health Centre
Siaya
Ongielo Health Centre
Siaya
About this study
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.
Read more
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.
Read the 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.
- Conditions
- HIV
- Being tested
- Assisted-partner notification services
- Keywords
- prevention, treatment, cost-effectiveness, assisted partner notification services, Kenya, linkage to HIV care, case-finding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted-partner notification servicesOther
Also called Partner notification services, Assisted partner 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.
| Study group | Role | What they receive |
|---|---|---|
| Delayed aPS | No intervention | Not described |
| Immediate aPS | Experimental | Not described Receives: Other: Assisted-partner notification services |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.)
Measured: 6 week period following index case enrollment
Secondary outcomes (3)
Incremental cost-effectiveness from payer and societal perspectives
Measured: 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
Measured: 6 week period after index case enrollment
Costs of identifying >1 partner per index case
Measured: 6 week period after index case enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,424 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Ministry of Health, University of Nairobi
- Responsible party
- Principal investigator, Carey Farquhar, University of Washington
- Investigators
- Carey Farquhar, MD, MPH, Principal investigator, University of WashingtonPeter Cherutich, MBChB, MPH, Study chair, Kenya Ministry of HealthMatthew Golden, MD, MPH, Study chair, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01616420
- Sponsor's protocol ID
- 43628
- Acronym
- APS
- Status last verified
- Apr 2017
- First submitted
- 7 Jun 2012
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27913227Wamuti 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.
PubMed 25884936
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assisted Partner Notification to Augment HIV Treatment and Prevention in Kenya
- ClinicalTrials.gov ID
- NCT01616420
- Acronym / sponsor ID
- APS / 43628
- Conditions
- HIV
- Keywords
- prevention, treatment, cost-effectiveness, assisted partner notification services, Kenya, linkage to HIV care, case-finding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,424 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kenya Ministry of Health, University of Nairobi
- Study start
- Jun 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed aPS | No intervention | – |
| Immediate aPS | Experimental | Other: Assisted-partner notification services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted-partner notification servicesAlso: Partner notification services, Assisted partner servicesAssisted-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 | Immediate aPS |
Primary outcome
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).
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).
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.)
3 secondary outcomes
Incremental cost-effectiveness from payer and societal perspectives
Time frame: 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
Costs of identifying >1 partner per index case
Time frame: 6 week period after index case enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Derived from this study: PubMed 27913227Cherutich 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.
- Derived from this study: PubMed 25884936Wamuti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carey Farquhar, MD, MPH principal investigator
University of Washington
Peter Cherutich, MBChB, MPH study chair
Kenya Ministry of Health
Matthew Golden, MD, MPH study chair
University of Washington
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted-partner notification services in people with HIV, run by University of Washington at 18 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of partners testing for HIV (time frame: 6 week period following index case enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616420, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.