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Impart: Provider-Assisted HIV Partner Notification

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155320
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : January 31, 2020
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Gabriel John Culbert, University of Illinois at Chicago

Brief Summary:
Researchers will conduct a 2-arm pilot randomized controlled trial with HIV-infected index patients recruited from two all-male prisons in Indonesia to assess the acceptability and feasibility of provider-assisted HIV partner notification (provider referral) and examine its potential to increase the number of partners who are tested for HIV and subsequently linked to prevention and treatment services.

Condition or disease Intervention/treatment Phase
HIV Infections Partner Communication Behavioral: IMPART Behavioral: Standard Care Not Applicable

Detailed Description:

This study compares three options for partner notification:

  • Option 1 (Self-tell): Participant is encouraged to disclose his HIV+ status to his partner(s) and given information about sites where his partner(s) can receive free HIV testing.
  • Option 2 (Tell together): Participant discloses his HIV+ status to his partners with a counselor (project staff) present. Counselor refers the partner to HIV testing, including a study-affiliated HIV testing site.
  • Option 3 (Provider referral): Project staff (nurse or peer educator) will notify the partner anonymously - without identifying the participant (index patient). Partners are offered immediate HIV testing in their home or at a study-affiliated HIV testing site.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 347 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor is blinded as to treatment allocation during analyses.
Primary Purpose: Diagnostic
Official Title: Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Group A
Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).
Behavioral: Standard Care
Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects are responsible for contacting and notifying their partner(s) on their own. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell) or 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together). Subjects may decide which partners to notify and may choose the same or a different method for each partner.

Experimental: Group B
Subjects may choose to notify their partners themselves, with or without a counselor present (Options 1 & 2), or choose to have one or more partners notified anonymously by project staff (Option 3).
Behavioral: IMPART
Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell), 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together), or 3) have their partner(s) notified confidentially by a disease notifier (anonymous provider referral), who will locate partners, notify them of potential HIV exposure, and offer them HIV testing. Partners with an initial reactive HIV screening test will be referred to care and treatment services.




Primary Outcome Measures :
  1. Notified [ Time Frame: 6 weeks from index patient enrollment ]
    Number of partners who are notified of shared HIV exposure

  2. Tested [ Time Frame: 6 weeks from index patient enrollment ]
    Number of partners who receive HIV testing subsequent to notification

  3. Diagnosed [ Time Frame: 6 weeks from index patient enrollment ]
    Number of partners who are HIV diagnosed subsequent to testing


Secondary Outcome Measures :
  1. Linked to Care [ Time Frame: 6 weeks from index patient enrollment ]
    Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis

  2. Initiated ART [ Time Frame: 6 weeks from index patient enrollment ]
    Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for HIV-positive Prisoners (N=65): Index patients must beat least 18 years of age, HIV-seropositive and aware of their HIV+ status; (HIV-infection documented by a rapid HIV test); sexually active and/or sharing needles in the 12 months before incarceration; incarcerated within the past 3 years and ≥6 months of their prison sentence remaining. We will limit enrollment to index patients who are willing to notify partners and have 1 or more partner(s) who have not yet been notified.

Inclusion Criteria for Partners: Eligible partners will be persons who participants (index patients) are able to identify by first and/or last name, residential address and/or mobile phone number, and physical descriptors (e.g., approximate height) and have given nurses permission to contact. No named partner will be excluded on the basis of religion, ethnicity, age, sex, or gender identity.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155320


Contacts
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Contact: Gabriel Culbert, PhD, RN 13129961627 gculbert@uic.edu

Locations
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Indonesia
Rutan Cipinang Recruiting
Jakarta Pusat, Jawa Barat, Indonesia
Contact: Arie Rahadi, PhD    628112202240    arie.rahadi@impart-trial.org   
Principal Investigator: Agung Waluyo, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Indonesia University
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Responsible Party: Gabriel John Culbert, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04155320    
Other Study ID Numbers: 2018-0754
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gabriel John Culbert, University of Illinois at Chicago:
contact tracing
HIV prevention
partner notification
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases