Acute HIV InfectionNCT02467439
Acute Partner and Social Contact Referral: iKnow
A study testing Notification cards in people with Acute HIV Infection and HIV Seropositive, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute HIV Infection, HIV Seropositive, Sexually Transmitted Infections
- What is being tested?
- Notification cards
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,310 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 2 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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):
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
About this study
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.
Read the 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).
- Being tested
- Notification cards
- Keywords
- unaware intervention;, contract sexual partner referral, peer referral
- Medical subject headings
- HIV Seropositivity, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Notification cardsOther
detection of AHI, contract partner notification, and social contact referral to find persons unaware of their HIV infection.
| Study group | Role | What they receive |
|---|---|---|
| Notification Cards | Active comparator | 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. Receives: Other: Notification cards |
| Base Case Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact
Measured: 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)
Measured: 4 years
Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
Measured: 4 years
Total number of sexual partners referred (sexual partners or social contacts) per index
Measured: 4 years
Total number of persons referred per index.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,310 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Miller, MD, PhD, MPH, Principal investigator, University of North Carolina, Chapel HillKimberly Powers, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467439
- Sponsor's protocol ID
- 14-2869
- Other IDs
- UNCPM 21414, 1R01AI114320-01
- Status last verified
- Nov 2019
- First submitted
- 29 May 2015
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37345996Chen 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.
PubMed 33929094
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Partner and Social Contact Referral: iKnow
- ClinicalTrials.gov ID
- NCT02467439
- Acronym / sponsor ID
- 14-2869
- Keywords
- unaware intervention;, contract sexual partner referral, peer referral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,310 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jun 2015
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 10 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Notification Cards | Active comparator | Other: Notification cardsIncludes 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Active and Base Case Index Participants:
- 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.
Key exclusion criteria (9 listed)
- 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.
- Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Notification cardsdetection of AHI, contract partner notification, and social contact referral to find persons unaware of their HIV infection. | Other | Notification Cards |
Primary outcome
the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact
Time frame: 4 years
4 secondary outcomes
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
Total HIV-infected persons, including all subsequent referrals, referred per first-wave index
Time frame: 4 years
Total number of sexual partners referred (sexual partners or social contacts) per index
Time frame: 4 years
Total number of persons referred per index.
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 37345996Maierhofer 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.
- Derived from this study: PubMed 33929094Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Miller, MD, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
Kimberly Powers principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Notification cards in people with Acute HIV Infection and HIV Seropositive, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. 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 26 Nov 2019. 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 United States. 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?
the proportion of HIV-seropositive index participants with at least one newly diagnosed HIV-infected partner or social contact (time frame: 4 years). 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 NCT02467439, which also lists 2 linked publications.
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 26 Nov 2019.