NCT04155320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable hiv-infections

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 27, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

1.2 years

First QC Date

November 5, 2019

Last Update Submit

May 17, 2022

Conditions

HIV InfectionsPartner Communication

Keywords

contact tracingHIV preventionpartner notification

Outcome Measures

Primary Outcomes (3)

  • Notified

    Number of partners who are notified of shared HIV exposure

    6 weeks from index patient enrollment

  • Tested

    Number of partners who receive HIV testing subsequent to notification

    6 weeks from index patient enrollment

  • Diagnosed

    Number of partners who are HIV diagnosed subsequent to testing

    6 weeks from index patient enrollment

Secondary Outcomes (2)

  • Linked to Care

    6 weeks from index patient enrollment

  • Initiated ART

    6 weeks from index patient enrollment

Study Arms (2)

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).

Behavioral: Standard Care

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).

Behavioral: IMPART

Interventions

IMPARTBEHAVIORAL

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.

Group B
Standard CareBEHAVIORAL

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.

Group A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutan Cipinang

Jakarta Pusat, West Java, Indonesia

Location

Related Publications (1)

  • 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: 37339342DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor is blinded as to treatment allocation during analyses.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

January 27, 2020

Primary Completion

March 26, 2021

Study Completion

November 12, 2021

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

ID(1)