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HIV InfectionsNCT04155320

Impart: Provider-Assisted HIV Partner Notification

A study testing IMPART in people with HIV Infections and Partner Communication, run by University of Illinois at Chicago at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infections, Partner Communication
What is being tested?
IMPART
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteIndonesia
Study dates
27 Jan 2020to 12 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rutan Cipinang

    Jakarta Pusat, West Java

Other trials in Indonesia

About this study

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

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.

Read the 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.
Being tested
IMPART, Standard Care
Keywords
contact tracing, HIV prevention, partner notification
Medical subject headings
HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMPARTBehavioural

    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 CareBehavioural

    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.

Study groups in NCT04155320
Study groupRoleWhat they receive
Group AActive comparatorSubjects are encouraged to disclose their HIV status to their partner(s) with or without a counselor present (Options 1 \& 2).
Receives: Behavioral: Standard Care
Group BExperimentalSubjects 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).
Receives: Behavioral: IMPART

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Notified

    Number of partners who are notified of shared HIV exposure

    Measured: 6 weeks from index patient enrollment

  2. Tested

    Number of partners who receive HIV testing subsequent to notification

    Measured: 6 weeks from index patient enrollment

  3. Diagnosed

    Number of partners who are HIV diagnosed subsequent to testing

    Measured: 6 weeks from index patient enrollment

Secondary outcomes (2)

  1. Linked to Care

    Number of partners who have been evaluated for treatment by a physician subsequent to diagnosis

    Measured: 6 weeks from index patient enrollment

  2. Initiated ART

    Number of partners who have initiated antiretroviral therapy (ART) subsequent to linkage to care

    Measured: 6 weeks from index patient enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2019
  2. Study start27 Jan 2020
  3. Primary completion26 Mar 2021
  4. Study completion12 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04155320
Sponsor's protocol ID
2018-0754
Other IDs
R34MH115779
Status last verified
May 2022
First submitted
5 Nov 2019
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 37339342

Questions about this trial

What is this clinical trial studying?

A study testing IMPART in people with HIV Infections and Partner Communication, run by University of Illinois at Chicago at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Notified (time frame: 6 weeks from index patient enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04155320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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Impart: Provider-Assisted HIV Partner Notification | AzTrials