Clinical trial NCT02467439: Acute Partner and Social Contact Referral: iKnow
Official title: Acute Partner and Social Contact Referral: iKnow
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute HIV Infection
HIV Seropositive
Sexually Transmitted Infections
Keywords: unaware intervention;
contract sexual partner referral
peer referral
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2015-06-10
Enrollment: 15310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact
timeFrame: 4 years
Secondary outcomes:
measure: 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)
timeFrame: 4 years
measure: Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
timeFrame: 4 years
measure: Total number of sexual partners referred (sexual partners or social contacts) per index
timeFrame: 4 years
measure: Total number of persons referred per index.
timeFrame: 4 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: William Miller, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Kimberly Powers
role: PRINCIPAL_INVESTIGATOR
References:
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.