Clinical trial NCT03447210: Study of HIV, HCV, APS and Phylogenetics for PWID
Official title: Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Hepatitis C
Keywords: Persons who inject drugs (PWID)
Phylogenetics
HIV testing
HCV testing
HIV care cascade
Assisted partner services
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Kenyatta National Hospital
name: Kenya Ministry of Health
name: University of KwaZulu
First posted: 2018-02-27
Enrollment: 4301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort study with nested cross-sectional studies
Primary purpose: DIAGNOSTIC

Brief 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). It will also define the risk factors for onward HIV and HCV transmission among PWID using viral phylogenetics.

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.

Eligibility criteria: Inclusion Criteria:

* \> 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

Exclusion Criteria:

• 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.

Primary outcomes:
measure: Sexual partners tested
timeFrame: 4 years
measure: Injecting partners tested
timeFrame: 4 years
measure: Partners diagnosed with HIV and HCV
timeFrame: 4 years
measure: HIV-infected partners linked to HIV care
timeFrame: 4 years
measure: HCV-infected partners linked to HCV care
timeFrame: 4 years
measure: Index participants linked to HIV and HCV care
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Githurai Drop-in Centre
city: Nairobi
country: Kenya
facility: Ngara Health Centre
city: Nairobi
country: Kenya
facility: Pangani Drop-in Centre
Study officials:
affiliation: University of Washington
name: Joshua Herbeck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Carey Farquhar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.