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Clinical Trials/NCT04155320
NCT04155320CompletedNot Applicable

Provider-Assisted HIV Partner Notification & Testing With Prisoners in Indonesia: A Randomized Controlled Trial

University of Illinois at Chicago1 site in 1 country55 target enrollmentStarted: January 27, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
1
Primary Endpoint
Notified

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Masking Description

Outcomes assessor is blinded as to treatment allocation during analyses.

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Exclusion Criteria

  • Not provided

Arms & Interventions

Group A

Active Comparator

Subjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 & 2).

Intervention: Standard Care (Behavioral)

Group B

Experimental

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: IMPART (Behavioral)

Outcomes

Primary Outcomes

Notified

Time Frame: 6 weeks from index patient enrollment

Number of partners who are notified of shared HIV exposure

Tested

Time Frame: 6 weeks from index patient enrollment

Number of partners who receive HIV testing subsequent to notification

Diagnosed

Time Frame: 6 weeks from index patient enrollment

Number of partners who are HIV diagnosed subsequent to testing

Secondary Outcomes

  • Linked to Care(6 weeks from index patient enrollment)
  • Initiated ART(6 weeks from index patient enrollment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gabriel John Culbert

Assistant Professor

University of Illinois at Chicago

Study Sites (1)

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