Prison-Based HIV Partner Notification

NCT07103928 | Not Yet Recruiting DMC

• 2 other identifiers: 2024-0926R01MH138246
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief Summary

Assisted partner notification (APN) is a voluntary and confidential process that utilizes specially-trained health workers to encourage and assist people diagnosed with HIV to inform their sex and drug use partners about possible shared exposure to HIV. With APN, partners who have come in contact with HIV are notified about exposure and given information to protect themselves from contracting HIV in the future or to begin treatment, if needed. This study compares two types of HIV partner notification. Incarcerated men with HIV will be recruited as "index participants". Participants in both groups will be encouraged to notify sex and needle-sharing partners with whom they may have shared an HIV exposure before incarceration. All participants have the option to self-notify partners during a prison visitation or telephone call. In addition, participants randomized to an APN Choice group also can opt for anonymous notification by specially-trained APN notifiers that includes contact tracing if needed. As outcomes, we will compare the number of partners in each condition who are notified, HIV tested, diagnosed, and linked to HIV treatment. The study will show if prison-based APN is successful in reaching partners for HIV testing.

Conditions

HIV

Keywords

HIV; partner notification; contact tracing; sexually transmitted infections; prisons; Injection drug use

Outcome Measures

Primary Outcomes (1)

• HIV Testing

  Number of partners who complete HIV testing

  6 weeks after randomization

Secondary Outcomes (5)

• HIV Notification

  6 weeks post-randomization

• First HIV Test

  6 weeks post-randomization

• HIV Diagnosis

  6 weeks post-randomization

• ART Linkage

  6 weeks post-randomization

• ART Initiation

  6 weeks post-randomization

Study Arms (2)

Impart Choice of APN or Self-Tell Per Partner

EXPERIMENTAL

Participants are assisted to identify partners whom they wish to notify and coached in how to tell their at-risk partners by the end of 6 weeks. Participants may choose per partner between sell-tell notification or having an Impart HIV-trained nurse and community outreach healthcare provider work as a team to locate, notify, and offer HIV testing to their partners.

Behavioral: Impart Assisted Partner Notification; Behavioral: Self-Tell Notification

Self-Tell Notification Only Standard of Care Condition

ACTIVE COMPARATOR

Participants are assisted to identify partners whom they wish to notify and coached in how to tell their at-risk partners by the end of 6 weeks. Participants may choose to tell their partner(s) by telephone, mail, or in-person during visitation at the jail/prison facility. They also may elect to have an Impart counselor present during in-person telling or by telephone to answer any clinical questions that the partner might have.

Behavioral: Self-Tell Notification

Interventions

Impart Assisted Partner Notification BEHAVIORAL

Participants randomized to the Impart arm may choose per partner either a) sell-tell notification or b) having an Impart-trained APN notifier team locate, notify, and offer HIV testing to their partners without revealing the identity of who had named them. Impart notifiers initially contact named partners by telephone and identify themselves as health service providers with important information about the partner's health that needs to be shared in person. Partners who agree to meet are asked to choose a location. Notification by telephone is only delivered as a last resort when circumstances prevent in-person notification or a partner insists on learning the reason for the telephone call. Once contact is made at a private location, partners will be advised of their possible shared exposure to HIV. APN notifiers never reveal participant names or identifying information during this meeting. All notified partners are offered immediate HIV testing and treatment referral, if HIV-positive.

Also known as: HIV partner notification, Provider-assisted partner notification

Impart Choice of APN or Self-Tell Per Partner

Self-Tell Notification BEHAVIORAL

Participants who wish to self-notify one or more partners are coached to do so either in person or by telephone. APN counselors confirm the names of partners for whom participants provide contact information before giving the phone to the participant to explain the reason for the call: "I want to speak with you because I was diagnosed with HIV and I believe we shared an exposure." Alternately, participants who wish to notify partners in person are coached to inform partners that they have a serious health matter that they wish to discuss, and ask the partner to visit them in jail/prison. Either way, the APN counselor is present to record the names of partners whom participants self-notify, and offers to speak with the partner immediately afterwards to answer their questions about HIV and to provide information about HIV testing and contact information should the partner wish to contact an HIV provider on their own to learn more about HIV testing or to schedule an HIV test.

Impart Choice of APN or Self-Tell Per Partner; Self-Tell Notification Only Standard of Care Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-diagnosed
• Sexually active (penile-vaginal or penile-anal) and/or sharing injection equipment during the year before incarceration

You may not qualify if:

• Incarcerated more than 5 years

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Fakultas Ilmu Keperawatan, Universitas Indonesia

Depok, West Java, 16424, Indonesia

Location

Related Publications (2)

• Culbert GJ, Levy JA, Steffen AD, Waluyo A, Earnshaw VA, Rahadi A. Impart: findings from a prison-based model of HIV assisted partner notification in Indonesia. J Int AIDS Soc. 2023 Jun;26(6):e26132. doi: 10.1002/jia2.26132.

  PMID: 37339342 BACKGROUND

• Culbert GJ, Waluyo A, Levy JA, Steffen AD, Earnshaw VA, Rahadi A. Prison-based HIV partner notification in Indonesia: rationale and design of a hybrid type 1 effectiveness-implementation study. BMC Public Health. 2026 Mar 16;26(1):1321. doi: 10.1186/s12889-026-26950-z.

  PMID: 41840552 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Agung Waluyo, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Gabriel Culbert, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriel Culbert, PhD

CONTACT

312-996-1627; gculbert@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 9, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: We will share data with the research community when papers using the data have been accepted for publication or at the end of the award period, whichever occurs sooner.
• Access Criteria: Access to de-identified scientific data will not be restricted. Due to the sensitive nature of the topic, identifiable data will be limited to sharing through data use agreements.

Locations

ID (1)