Impart: Provider-Assisted HIV Partner Notification

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04155320
• Other study ID #: 2018-0754
• Secondary ID: R34MH115779
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: November 12, 2021

Study information

• Verified date: May 2022
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 12, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Partner Communication

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Rutan Cipinang	Jakarta Pusat	Jawa Barat

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Indonesia University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Notified	Number of partners who are notified of shared HIV exposure	6 weeks from index patient enrollment
Primary	Tested	Number of partners who receive HIV testing subsequent to notification	6 weeks from index patient enrollment
Primary	Diagnosed	Number of partners who are HIV diagnosed subsequent to testing	6 weeks from index patient enrollment
Secondary	Linked to Care	Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis	6 weeks from index patient enrollment
Secondary	Initiated ART	Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care	6 weeks from index patient enrollment