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Acute Partner and Social Contact Referral: iKnow

Primary Purpose

Acute HIV Infection, HIV Seropositive, Sexually Transmitted Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Notification cards
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute HIV Infection focused on measuring unaware intervention;, contract sexual partner referral, peer referral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Active and Base Case Index Participants:

    • Acute HIV-1 infection documented by a negative or discordant rapid HIV test results and detectable HIV RNA OR established HIV infection based on two positive HIV antibody rapid tests at the time of screening.
    • Men and women age >/= 18 years.
    • Current resident in the Lilongwe area.
    • Ability and willingness of participant to provide informed consent.
    • Willingness to provide contact/locator information to be contacted for AHI results if rapid test is negative or discordant.

Partners and Social Contacts (referred by active arm):

  • Referred by active arm participant and presenting to STI clinics with a referral card.
  • Men and women age >/= 18 years.
  • Intention to remain in the Lilongwe area for the duration of the study.
  • Ability and willingness of participant to provide informed consent.
  • Willingness to provide contact/locator information to be contacted for AHI results if rapid test is negative or discordant.

Partners (referred by base case arm):

  • Referred by base case arm participant and presenting to STI clinics with a referral card.
  • Men and women age >/= 18 years.
  • Ability and willingness of participant to provide informed consent.

Exclusion Criteria:

Active and Base Case Index Participants:

  • HIV-negative based on one or more antibody rapid test and an HIV RNA PCR test.
  • Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study.

Partner and Social Contacts (referred by active or base case arm):

  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization.
  • Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study.

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Notification Cards

Base Case Arm

Arm Description

Includes two groups of newly diagnosed HIV-infected participants (ppt): Seropositive and Acutely Infected. After consent and a full survey, blood and urine sample are collected for viral genetic testing and future STI testing. Ppts will be given notification cards for their sexual partners, social contacts. Ppts will receive contract partner notification: if the named sexual partners do not present for testing within 7-14 days, community outreach workers will contact and counsel the partners to visit the clinic. Any returning sexual partner or social contact presenting to the clinic with the notification card linking to the original index ppt will be consented (HIV testing, blood and urine specimen collected for viral genetic testing and future STI testing if HIV positive). If HIV-infected, they will be in the active arm, and will receive partner notification and social contact referral cards. If they are HIV-seronegative they will be screened for acute HIV infection.

consist of HIV seropositive and seronegative STI clinic patrons . After a brief survey to obtain demographics and sexual behavior, seronegative ppts will have blood collected for screening for acute HIV infection. If a person has acute HIV infection, they will be contacted by a community outreach worker and brought back in for counseling, and, if consenting, enrolled in the active arm. STI clinic patrons who are seropositive at screening will be given cards and asked to refer their sexual partners for evaluation using passive referral. Sexual partners presenting to the clinic with the notification card linking to the original index ppt in the base case arm will be consented to be in study (HIV testing, blood and urine specimen collected for viral genetic testing and future STI testing if HIV positive). If they are seropositive, these participants will be in the base case arm, and will receive partner notification cards for passive referral.

Outcomes

Primary Outcome Measures

the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact

Secondary Outcome Measures

The proportion of HIV-seropositive index participants with at least one HIV-infected person referred who is not in care (newly diagnosed plus known diagnoses not in care)
Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
Total number of sexual partners referred (sexual partners or social contacts) per index
Total number of persons referred per index.

Full Information

First Posted
May 29, 2015
Last Updated
November 22, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT02467439
Brief Title
Acute Partner and Social Contact Referral: iKnow
Official Title
Acute Partner and Social Contact Referral: iKnow
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this research is to assess the benefit of an "unaware intervention package" for identifying high risk persons who are unaware of their HIV infection status. This intervention package includes screening for acute HIV infection, contract sexual partner referral, and peer referral.
Detailed Description
This two-arm randomized study will evaluate an "unaware intervention package" among HIV-infected persons attending Sexually Transmitted Infection (STI) clinics in Lilongwe, Malawi. The package includes detection of Acute HIV Infection (AHI), contract partner notification, and social contact referral to find persons unaware of their HIV infection. The package will be compared to the current standard of care, passive partner notification, as the base case. Participants will be randomized to receive the intervention package - classified as the "active arm" of the study. The study will characterize the HIV stage (acute, recent, chronic) of the index participants and their sexual partners and social contacts, and use the HIV staging combined with sexual behavior data, phylogenetic analyses, and egocentric sexual/social network assessments to assess the potential impact of the intervention on ongoing transmission. We will obtain the distributions of numerous transmission-related attributes among the recruited contacts/partners of STI clinic patients, including contacts' and partners' HIV infection status and stage, HIV diagnosis/care/treatment status, STI status, and sexual behaviors. This information will allow us to model testing, linkage, and treatment interventions targeted to the traced partners and/or social contacts of acute, recent, and/or chronic index cases identified in STI clinics. We can then assess and compare the predicted effects on population-level HIV incidence of interventions attached to each recruitment method (tracing partners, social contacts, or both) and index case and contact disease stage (acute, recent, and/or chronic).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute HIV Infection, HIV Seropositive, Sexually Transmitted Infections
Keywords
unaware intervention;, contract sexual partner referral, peer referral

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Notification Cards
Arm Type
Active Comparator
Arm Description
Includes two groups of newly diagnosed HIV-infected participants (ppt): Seropositive and Acutely Infected. After consent and a full survey, blood and urine sample are collected for viral genetic testing and future STI testing. Ppts will be given notification cards for their sexual partners, social contacts. Ppts will receive contract partner notification: if the named sexual partners do not present for testing within 7-14 days, community outreach workers will contact and counsel the partners to visit the clinic. Any returning sexual partner or social contact presenting to the clinic with the notification card linking to the original index ppt will be consented (HIV testing, blood and urine specimen collected for viral genetic testing and future STI testing if HIV positive). If HIV-infected, they will be in the active arm, and will receive partner notification and social contact referral cards. If they are HIV-seronegative they will be screened for acute HIV infection.
Arm Title
Base Case Arm
Arm Type
No Intervention
Arm Description
consist of HIV seropositive and seronegative STI clinic patrons . After a brief survey to obtain demographics and sexual behavior, seronegative ppts will have blood collected for screening for acute HIV infection. If a person has acute HIV infection, they will be contacted by a community outreach worker and brought back in for counseling, and, if consenting, enrolled in the active arm. STI clinic patrons who are seropositive at screening will be given cards and asked to refer their sexual partners for evaluation using passive referral. Sexual partners presenting to the clinic with the notification card linking to the original index ppt in the base case arm will be consented to be in study (HIV testing, blood and urine specimen collected for viral genetic testing and future STI testing if HIV positive). If they are seropositive, these participants will be in the base case arm, and will receive partner notification cards for passive referral.
Intervention Type
Other
Intervention Name(s)
Notification cards
Intervention Description
detection of AHI, contract partner notification, and social contact referral to find persons unaware of their HIV infection.
Primary Outcome Measure Information:
Title
the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact
Time Frame
4 years
Secondary Outcome Measure Information:
Title
The proportion of HIV-seropositive index participants with at least one HIV-infected person referred who is not in care (newly diagnosed plus known diagnoses not in care)
Time Frame
4 years
Title
Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
Time Frame
4 years
Title
Total number of sexual partners referred (sexual partners or social contacts) per index
Time Frame
4 years
Title
Total number of persons referred per index.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Active and Base Case Index Participants: Acute HIV-1 infection documented by a negative or discordant rapid HIV test results and detectable HIV RNA OR established HIV infection based on two positive HIV antibody rapid tests at the time of screening. Men and women age >/= 18 years. Current resident in the Lilongwe area. Ability and willingness of participant to provide informed consent. Willingness to provide contact/locator information to be contacted for AHI results if rapid test is negative or discordant. Partners and Social Contacts (referred by active arm): Referred by active arm participant and presenting to STI clinics with a referral card. Men and women age >/= 18 years. Intention to remain in the Lilongwe area for the duration of the study. Ability and willingness of participant to provide informed consent. Willingness to provide contact/locator information to be contacted for AHI results if rapid test is negative or discordant. Partners (referred by base case arm): Referred by base case arm participant and presenting to STI clinics with a referral card. Men and women age >/= 18 years. Ability and willingness of participant to provide informed consent. Exclusion Criteria: Active and Base Case Index Participants: HIV-negative based on one or more antibody rapid test and an HIV RNA PCR test. Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study. Partner and Social Contacts (referred by active or base case arm): Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. Serious illness, including tuberculosis or opportunistic infection, requiring systemic treatment and/or hospitalization. Any other condition that in the opinion of the study investigator would compromise the safety of the study participant or study staff, or would prevent proper conduct of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Miller, MD, PhD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kimberly Powers
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33929094
Citation
Chen JS, Matoga M, Pence BW, Powers KA, Maierhofer CN, Jere E, Massa C, Khan S, Rutstein SE, Phiri S, Hosseinipour MC, Cohen MS, Hoffman IF, Miller WC, Lancaster KE. A randomized controlled trial evaluating combination detection of HIV in Malawian sexually transmitted infections clinics. J Int AIDS Soc. 2021 Apr;24(4):e25701. doi: 10.1002/jia2.25701.
Results Reference
derived

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Acute Partner and Social Contact Referral: iKnow

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