Study of HIV, HCV, APS and Phylogenetics for PWID (SHARP)
Integrating Assisted Partner Services and Phylogenetics for HIV and HCV Prevention
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
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Nairobi, Kenya
- Githurai Drop-in Centre
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Nairobi, Kenya
- Ngara Health Centre
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Nairobi, Kenya
- Pangani Drop-in Centre
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Assisted Partner Services
All 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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Sexual partners tested
Délai: 4 years
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Numbers of sexual partners tested for HIV and HCV per index participant
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4 years
|
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Injecting partners tested
Délai: 4 years
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Numbers of injecting partners tested for HIV and HCV per index participant
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4 years
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Partners diagnosed with HIV and HCV
Délai: 4 years
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Number of partners newly diagnosed with HIV and HCV infection per index case
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4 years
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HIV-infected partners linked to HIV care
Délai: 4 years
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Percentage of HIV-infected partners linked to HIV care
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4 years
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HCV-infected partners linked to HCV care
Délai: 4 years
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Percentage of HCV-infected partners linked to HCV care
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4 years
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Index participants linked to HIV and HCV care
Délai: 4 years
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Percentage of index participants linked to HIV and HCV care
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4 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Carey Farquhar, MD, MPH, University of Washington
- Chercheur principal: Joshua Herbeck, PhD, University of Washington
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- STUDY00001536
- R01DA043409 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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