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HIV/AIDSSHARPNCT03447210

Study of HIV, HCV, APS and Phylogenetics for PWID

A study testing Assisted Partner Services in people with HIV/AIDS and Hepatitis C, run by University of Washington at 3 sites in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will determine whether assisted partner notification services (APS) can identify and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C (HCV) co-infected persons who inject drugs (PWID). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV/AIDS, Hepatitis C
What is being tested?
Assisted Partner Services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,301 participants
Where
3 sitesKenya
Study dates
26 Feb 2018to 28 Feb 2022
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > or = 18 years of age
  • Active intravenous drug use (IDU) as defined by injecting at least twice in the past month
  • Willing and able to provide informed consent
  • HIV infected (either new diagnosis or known diagnosis)
  • Willing and able to provide locator information for sexual and/or injecting partners

Who cannot join

  • Classified as at high risk for IPV*
  • Participants will be classified as at moderate risk for IPV if they report 1) history of IPV during their lifetime either from a current or past partner; and/or 2) fear of IPV if they participate in the study.

Trial locations and contacts

3 sites in 1 country.

Kenya3 sites

  • Githurai Drop-in Centre

    Nairobi

  • Ngara Health Centre

    Nairobi

  • Pangani Drop-in Centre

    Nairobi

Other trials in Kenya

About this study

Official title: Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention

This study will determine whether assisted partner notification services (APS) can identify and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C (HCV) co-infected persons who inject drugs (PWID). It will also define the risk factors for onward HIV and HCV transmission among PWID using viral phylogenetics.

Read the detailed description

Overview: This NIH-funded study uses assisted partner services (APS) to identify HIV-infected and HCV-infected persons who inject drugs (PWID) in Kenya and link them to care. In addition to determining the role of APS in HIV and HCV case-finding for this hard-to-reach key population, we leverage our experience with HIV and HCV phylogenetics in the US and South Africa to define modes and risk factors for onward viral transmission. The specific aims of the proposal are as follows:

AIM 1. To determine whether contact tracing and partner notification practices, known in Kenya as assisted partner services (APS), can identify and link to care, the sexual and injection partners of HIV-infected and HIV/ hepatitis C (HCV) co-infected persons who inject drugs (PWID).

AIM 2. To define the risk factors for HIV transmission among PWID, and to elucidate the role of PWID in the overall Kenyan HIV epidemic, using viral genetic sequencing techniques.

AIM 3. To characterize the modes and risk factors for onward HCV transmission among PWID using viral genetic sequencing.

Design: We will enroll 1000 HIV-infected PWID through a needle and syringe exchange program (NSP) in Nairobi, Kenya. Each index participant will undergo a structured questionnaire, a rapid HCV test, a blood draw, and will provide locator information regarding their sexual and injection partners from the past 3 years. Study staff will then attempt to locate all partners. Once located, partner participants will undergo rapid HIV and HCV testing, a structured questionnaire, and a blood draw. All blood samples will be sent to a central laboratory in Nairobi for processing. Dried blood spot samples will be created in Nairobi and will later be sent to the University of KwaZulu-Natal for quantitative viral loads for both HIV and hepatitis C, and follow-up phylogenetic testing. All participants who test positive for HIV or hepatitis C will be referred for counseling and treatment. HIV care and treatment will take place at multiple local centers offering these services.

Being tested
Assisted Partner Services
Keywords
Persons who inject drugs (PWID), Phylogenetics, HIV testing, HCV testing, HIV care cascade, Assisted partner services
Medical subject headings
Acquired Immunodeficiency Syndrome, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assisted Partner ServicesBehavioural

    Contact tracing for sexual and drug-sharing partners to notify about exposure to HIV and offer HIV and hepatitis C testing with linkage to care and partner services for those who test positive.

Study groups in NCT03447210
Study groupRoleWhat they receive
Assisted Partner ServicesExperimentalAll participants in this arm will be offered assisted partner services (APS) which involves outreach to sexual partners and to individuals with whom they use injection drugs. When partners are contacted they are offered HIV and HCV testing. There is no comparison arm.
Receives: Behavioral: Assisted Partner Services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sexual partners tested

    Numbers of sexual partners tested for HIV and HCV per index participant

    Measured: 4 years

  2. Injecting partners tested

    Numbers of injecting partners tested for HIV and HCV per index participant

    Measured: 4 years

  3. Partners diagnosed with HIV and HCV

    Number of partners newly diagnosed with HIV and HCV infection per index case

    Measured: 4 years

  4. HIV-infected partners linked to HIV care

    Percentage of HIV-infected partners linked to HIV care

    Measured: 4 years

  5. HCV-infected partners linked to HCV care

    Percentage of HCV-infected partners linked to HCV care

    Measured: 4 years

  6. Index participants linked to HIV and HCV care

    Percentage of index participants linked to HIV and HCV care

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start26 Feb 2018
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 2022

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective cohort study with nested cross-sectional studies
Masking
None (open label)
Enrolment
4,301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03447210
Sponsor's protocol ID
STUDY00001536
Other IDs
R01DA043409
Acronym
SHARP
Status last verified
Nov 2022
First submitted
21 Feb 2018
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The proposed studies will include the following data: self-reported demographic and behavioral data, medical/sexual histories, HIV/HCV test results, and HIV/HCV genetic sequences. To facilitate the data sharing process, we will consider the need for data sharing in the study design, creation of informed consent documents, and the structure of data collection. Release of completed viral gene sequences (on NCBI Genbank) shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices.

Publications

  • Monroe-Wise A, Mbogo L, Guthrie B, Bukusi D, Sambai B, Chohan B, Scott J, Cherutich P, Musyoki H, Bosire R, Dunbar M, Macharia P, Masyuko S, Wilkinson E, De Oliveira T, Ludwig-Barron N, Sinkele B, Herbeck J, Farquhar C. Peer-mediated HIV assisted partner services to identify and link to care HIV-positive and HCV-positive people who inject drugs: a cohort study protocol. BMJ Open. 2021 Apr 24;11(4):e041083. doi: 10.1136/bmjopen-2020-041083.

    PubMed 33895711

Questions about this trial

What is this clinical trial studying?

A study testing Assisted Partner Services in people with HIV/AIDS and Hepatitis C, run by University of Washington at 3 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 5 inclusion and 2 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 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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?

Sexual partners tested (time frame: 4 years). The study lists 6 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 NCT03447210, which also lists 1 linked publication.

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 21 Nov 2022.

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