Back to resultsImpart: Provider-Assisted HIV Partner Notification
Primary Purpose
HIV Infections, Partner Communication
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
IMPART
Standard Care
Sponsored by
About this trial
This is an interventional diagnostic trial for HIV Infections focused on measuring contact tracing, HIV prevention, partner notification
Eligibility 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.
Sites / Locations
- Rutan Cipinang
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).
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).
Outcomes
Primary Outcome Measures
Notified
Number of partners who are notified of shared HIV exposure
Tested
Number of partners who receive HIV testing subsequent to notification
Diagnosed
Number of partners who are HIV diagnosed subsequent to testing
Secondary Outcome Measures
Linked to Care
Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis
Initiated ART
Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care
Full Information
NCT ID
NCT04155320
First Posted
November 5, 2019
Last Updated
May 17, 2022
Sponsor
University of Illinois at Chicago
Collaborators
Indonesia University, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04155320
Brief Title
Impart: Provider-Assisted HIV Partner Notification
Official Title
Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 27, 2020 (Actual)
Primary Completion Date
March 26, 2021 (Actual)
Study Completion Date
November 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Indonesia University, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Partner Communication
Keywords
contact tracing, HIV prevention, partner notification
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcomes assessor is blinded as to treatment allocation during analyses.
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).
Arm Title
Group B
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
IMPART
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Notified
Description
Number of partners who are notified of shared HIV exposure
Time Frame
6 weeks from index patient enrollment
Title
Tested
Description
Number of partners who receive HIV testing subsequent to notification
Time Frame
6 weeks from index patient enrollment
Title
Diagnosed
Description
Number of partners who are HIV diagnosed subsequent to testing
Time Frame
6 weeks from index patient enrollment
Secondary Outcome Measure Information:
Title
Linked to Care
Description
Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis
Time Frame
6 weeks from index patient enrollment
Title
Initiated ART
Description
Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care
Time Frame
6 weeks from index patient enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Rutan Cipinang
City
Jakarta Pusat
State/Province
Jawa Barat
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Impart: Provider-Assisted HIV Partner Notification
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