Acute Partner and Social Contact Referral: iKnow
3 other identifiers
interventional
15,310
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedNovember 26, 2019
November 1, 2019
3.9 years
May 29, 2015
November 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact
4 years
Secondary Outcomes (4)
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)
4 years
Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
4 years
Total number of sexual partners referred (sexual partners or social contacts) per index
4 years
Total number of persons referred per index.
4 years
Study Arms (2)
Notification Cards
ACTIVE COMPARATORIncludes 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.
Base Case Arm
NO INTERVENTIONconsist 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.
Interventions
detection of AHI, contract partner notification, and social contact referral to find persons unaware of their HIV infection.
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514, United States
Related Publications (2)
Maierhofer CN, Powers KA, Matoga MM, Chen JS, Jere E, Massa C, Mmodzi P, Bhushan NL, Phiri S, Hoffman IF, Lancaster KE, Miller WC, Rutstein SE. Characterizing Network-Based HIV Testing Interventions to Guide HIV Testing and Contact Tracing at STI Clinics in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2023 Oct 1;94(2):151-159. doi: 10.1097/QAI.0000000000003240.
PMID: 37345996DERIVEDChen 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.
PMID: 33929094DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Miller, MD, PhD, MPH
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Kimberly Powers
University of North Carolina, Chapel Hill
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2015
First Posted
June 10, 2015
Study Start
June 1, 2015
Primary Completion
May 2, 2019
Study Completion
May 2, 2019
Last Updated
November 26, 2019
Record last verified: 2019-11