A Key Link for Transmission Prevention
MP3
Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study
2 other identifiers
interventional
46
1 country
2
Brief Summary
This pilot study will assess the feasibility for the potential public health benefit of behavioral and antiretroviral interventions during acute HIV infection. Central Hypothesis The investigators hypothesize that delivering behavioral and antiretroviral interventions to acutely infected persons will reduce onward transmission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv
Started Oct 2011
Typical duration for not_applicable hiv
2 active sites
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
September 18, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
May 12, 2016
CompletedApril 19, 2018
November 1, 2016
2.8 years
September 18, 2011
January 13, 2016
April 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
1 year
Prevalence of AHI Among Persons Screened
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.
1 year
Proportion of Persons With AHI Successfully Recruited Into the Study
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.
1 year
Proportion of Participants Completing Full Course of ARVs in Arm BIA
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that
1 year
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
In this pilot study, we addressed our ability to complete the behavioral intervention quickly. As two arms received the behavioral intervention, this outcome is combined across those two arms.
1 year
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
1 year
Number of Adverse Events
Mean number of adverse events per group
one year
Secondary Outcomes (23)
Unprotected Sex Acts in Previous One Week - 12 Weeks
12 weeks
Unprotected Sex Acts in Previous One Week - 26 Weeks
26 weeks
Unprotected Sex Acts in Previous One Week - 52 Weeks
52 weeks
Unprotected Sex Acts in Previous One Month - 12 Weeks
12 weeks
Unprotected Sex Acts in Previous One Month - 26 Weeks
26 weeks
- +18 more secondary outcomes
Study Arms (3)
Standard Counseling Arm
ACTIVE COMPARATORThe SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.
Behavioral Intervention Arm only
ACTIVE COMPARATORBehavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
Behavioral Intervention plus ARV
ACTIVE COMPARATORThe BIA arm consists of the behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.
Interventions
A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks
Eligibility Criteria
You may qualify if:
- Primary participants:
- Acute HIV-1 infection
- Men and women age greater than/= 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, be contacted, and asked to return for AHI results.
- Partner Participants:
- Referred by a primary participant and present with a referral card.
- Had vaginal or anal sex with a primary participant within 12 weeks prior to that primary participant's enrolling
- Men and women age greater than/=18 years.
- remain in the Lilongwe area for the duration of the study.
- Ability and willingness of participant to provide informed consent.
You may not qualify if:
- Primary Participants:
- HIV infection based on two positive HIV antibody rapid tests at the time of screening.
- 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.
- Current imprisonment or involuntary incarceration.
- 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 Participants:
- Active drug or alcohol use or dependence.
- Current imprisonment or involuntary incarceration in a medical facility for psychiatric or physical illness.
- Note:A key component of this pilot study is to estimate the potential effect of ARVs during acute infection when applied on a large population scale.In effect, this pilot study should be viewed as a pilot for an effectiveness trial. Consequently, we will randomize all eligible participants to one of the three arms. If, however, persons should not receive ARVs for a variety of medically-related reasons, these persons will remain in the BIA arm, but will not receive ARVs. Women who are of reproductive potential but who refuse to use at least one form of contraception (see below), will remain in the BIA arm but will not receive ARVs. Similarly, persons randomized to the BI arm who do not attend all sessions will remain in the BI arm.
- Persons randomized to BIA with any of the following conditions will be excluded from receiving ARVs, but will remain in the BIA group for purposes of analysis.
- Laboratory values obtained at Day 0 prior to initiating ARVs at a subsequent visit
- Absolute neutrophil count \<300/mm3
- Hemoglobin \<8.0 g/dL
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Lighthouse Trust, Kamuzu Central Hospital
Lilongwe, Malawi
UNC Project
Lilongwe, Malawi
Related Publications (3)
Chen JS, Pettifor AE, Nelson JAE, Phiri S, Pasquale DK, Kumwenda W, Kamanga G, Cottrell ML, Sykes C, Kashuba ADM, Tegha G, Krysiak R, Thengolose I, Cohen MS, Hoffman IF, Miller WC, Rutstein SE. Brief Report: Blood and Genital Fluid Viral Load Trajectories Among Treated and Untreated Persons With Acute HIV Infection in Malawi. J Acquir Immune Defic Syndr. 2022 May 1;90(1):56-61. doi: 10.1097/QAI.0000000000002917.
PMID: 35044991DERIVEDDennis AM, Cohen MS, Rucinski KB, Rutstein SE, Powers KA, Pasquale DK, Phiri S, Hosseinipour MC, Kamanga G, Nsona D, Massa C, Hoffman IF, Pettifor AE, Miller WC. Human Immunodeficiency Virus (HIV)-1 Transmission Among Persons With Acute HIV-1 Infection in Malawi: Demographic, Behavioral, and Phylogenetic Relationships. Clin Infect Dis. 2019 Aug 16;69(5):853-860. doi: 10.1093/cid/ciy1006.
PMID: 30476007DERIVEDHino S, Grodensky C, Rutstein SE, Golin C, Smith MK, Christmas L, Miller W, Phiri S, Massa C, Kamanga G, Pettifor A. HIV status disclosure during acute HIV infection in Malawi. PLoS One. 2018 Jul 26;13(7):e0201265. doi: 10.1371/journal.pone.0201265. eCollection 2018.
PMID: 30048496DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Please note that this trial was a pilot study.
Results Point of Contact
- Title
- William C Miller
- Organization
- University of North Carolina at Chapel Hill
Study Officials
- STUDY CHAIR
William C Miller, MD, PhD, MPH
University of North Carolina, Chapel Hill
- STUDY CHAIR
Audrey Pettifor, PhD, MPH
University of North Carolina, Chapel Hill
- PRINCIPAL INVESTIGATOR
Sam Phiri, PhD, MSc
Kamuzu Central Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
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
September 18, 2011
First Posted
October 12, 2011
Study Start
October 1, 2011
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
April 19, 2018
Results First Posted
May 12, 2016
Record last verified: 2016-11