Acute Partner and Social Contact Referral: iKnow

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).

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.