HIVMP3NCT01450189
A Key Link for Transmission Prevention
A study testing Standard HIV prevention messages, BI: Information-Motivation-Behavioral Skills Model and Raltegravir in people with HIV, run by University of North Carolina, Chapel Hill at 2 sites in Malawi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV
- What is being tested?
- Standard HIV prevention messages, BI: Information-Motivation-Behavioral Skills Model and Raltegravir
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesMalawi
- Study dates
- Oct 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
- Exclusion for Receipt of Antiretroviral Drugs in the BIA Arm
- 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
- Platelet count <40,000/mm3
- Aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase > 5 x upper limit of normal (ULN)
- Total bilirubin >2.5 x ULN
- Creatinine Clearance (CrCl) <60 mL/min
- Hepatitis B surface antigen positivity
- Positive serum or urine pregnancy test at Day 0.
- Breastfeeding
- Refusal to use at least one method of contraception, if a woman is of reproductive potential.
- Acceptable forms of contraception include: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, intrauterine device (IUD), or a hormonal-based contraceptive.
- Women not meeting the reproductive potential criteria above may receive the study drugs without using contraception.
- Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or their formulation.
- Requirement for any current medications that are prohibited with any study drugs.
Trial locations and contacts
2 sites in 1 country.
Malawi2 sites
Lighthouse Trust, Kamuzu Central Hospital
Lilongwe
UNC Project
Lilongwe
About this study
Official title: Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study
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.
Read the detailed description
The HIV epidemic in sub-Saharan Africa is severe and continues to grow. In urban areas of Malawi, 19% of pregnant women seeking antenatal care and 15.6% of Malawians aged 15-49 years were infected with HIV in 2007. Prevention interventions that prevent onward transmission of HIV are urgently needed.
Persons with acute HIV infection (AHI) may be responsible for a substantial proportion of onward transmission of HIV infection. AHI is characterized by unfettered replication of HIV in a "ramp up viremia". The high concentration of HIV in blood and genital secretions remains elevated for up to 10-12 weeks before it declines to the levels observed in established infection. These high levels of HIV shedding in the genital tract are likely to produce very efficient sexual transmission and the proportion of virions that are infectious may be substantially higher during acute compared to chronic infection. Consequently, the probability of transmission during unprotected intercourse for those with AHI is very high. Identifying persons with AHI and intervening to reduce onward transmission represents a tantalizing, but unproven, opportunity for HIV prevention.
To have maximal impact, a prevention program targeting AHI must identify a substantial number of acutely infected persons and intervene quickly to minimize onward transmission. An effective immediate intervention would require behavioral modification to limit sexual partners and unprotected sex acts, and a biological intervention to reduce infectious viral burden in genital secretions. This is the first study to pilot a combined behavioral and biomedical intervention in individuals with AHI to reduce onward transmission of HIV.
- Conditions
- HIV
- Being tested
- Standard HIV prevention messages, BI: Information-Motivation-Behavioral Skills Model, Raltegravir, emtricitabine/tenofovir disoproxil fumarate
- Keywords
- Acute HIV, Transmission Prevention, Randomized Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HIV prevention messagesBehavioural
A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
BI: Information-Motivation-Behavioral Skills ModelBehavioural
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.
RaltegravirDrug
Also called Isentress, RAL
raltegravir (400 mg) administered orally twice daily for 12 weeks
emtricitabine/tenofovir disoproxil fumarateDrug
Also called Truvada, FTC/TDF
emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Counseling Arm | Active comparator | The 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. Receives: Behavioral: Standard HIV prevention messages |
| Behavioral Intervention Arm only | Active comparator | Behavior- 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. Receives: Behavioral: Standard HIV prevention messages; Behavioral: BI: Information-Motivation-Behavioral Skills Model |
| Behavioral Intervention plus ARV | Active comparator | The 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. Receives: Behavioral: Standard HIV prevention messages; Behavioral: BI: Information-Motivation-Behavioral Skills Model; Drug: Raltegravir; Drug: emtricitabine/tenofovir disoproxil fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 year
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
Measured: 1 year
Number of Adverse Events
Mean number of adverse events per group
Measured: one year
Secondary outcomes (23)
Unprotected Sex Acts in Previous One Week - 12 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 12 weeks
Measured: 12 weeks
Unprotected Sex Acts in Previous One Week - 26 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 26 weeks
Measured: 26 weeks
Unprotected Sex Acts in Previous One Week - 52 Weeks
The mean number of unprotected sex acts in previous one week, assessed at 52 weeks
Measured: 52 weeks
Unprotected Sex Acts in Previous One Month - 12 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 12 weeks
Measured: 12 weeks
Unprotected Sex Acts in Previous One Month - 26 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 26 weeks
Measured: 26 weeks
Unprotected Sex Acts in Previous One Month - 52 Weeks
The mean number of unprotected sex acts in previous one month, assessed at 52 weeks
Measured: 52 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Measured: 26 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
At least one incident infection with either gonorrhea, chlamydia or trichomoniasis
Measured: 52 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 26 weeks. Persons with baseline positivity were excluded.
Measured: 26 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
cumulative incidence of herpes simplex virus type 2, assessed at 52 weeks. Persons with baseline positivity were excluded.
Measured: 52 weeks
Number of Partners Reporting for HIV Testing
Number of partners per index reporting for HIV testing at any time during follow-up
Measured: 52 weeks
Proportion of Partners Reporting for HIV Testing
Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants
Measured: 52 weeks
Suppression of HIV RNA to <1000c/ml at 12 Weeks
Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks
Measured: 12 weeks
Time to HIV RNA Suppression <1000 c/ml
median time to viral load suppression (<1000 c/ml)
Measured: From date of randomization until viral load suppression, up to 52 weeks
Blood HIV RNA Concentration at Week 12
Measured: 12 weeks
Blood HIV RNA Concentration at Week 26
Measured: 26 weeks
Blood HIV RNA Concentration at Week 52
Measured: 52 weeks
Genital HIV RNA Concentration - Week 12, Women
median HIV RNA concentration in cervical lavage fluid
Measured: 12 weeks
Genital HIV RNA Concentration - Week 26, Women
median HIV RNA concentration in cervical lavage fluid
Measured: 26 weeks
Genital HIV RNA Concentration - Week 52, Women
median HIV RNA concentration in cervical lavage fluid
Measured: 52 weeks
Genital HIV RNA Concentration - Week 12, Men
median HIV RNA concentration as measured in semen
Measured: 12 weeks
Genital HIV RNA Concentration - Week 26, Men
median HIV RNA concentration as measured in semen
Measured: 26 weeks
Genital HIV RNA Concentration - Week 52, Men
median HIV RNA concentration as measured in semen
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William C Miller, MD, PhD, MPH, Study chair, University of North Carolina, Chapel HillAudrey Pettifor, PhD, MPH, Study chair, University of North Carolina, Chapel HillSam Phiri, PhD, MSc, Principal investigator, Kamuzu Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01450189
- Sponsor's protocol ID
- 11-0815
- Other IDs
- CID 1002
- Acronym
- MP3
- Status last verified
- Nov 2016
- First submitted
- 18 Sep 2011
- Last updated
- 19 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 35044991Dennis 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.
PubMed 30476007Hino 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.
PubMed 30048496
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute HIV Infection - A Key Link for Transmission Prevention: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01450189
- Acronym / sponsor ID
- MP3 / 11-0815
- Conditions
- HIV
- Keywords
- Acute HIV, Transmission Prevention, Randomized Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Oct 2011 (estimated)
- Results
- Posted 12 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The HIV epidemic in sub-Saharan Africa is severe and continues to grow. In urban areas of Malawi, 19% of pregnant women seeking antenatal care and 15.6% of Malawians aged 15-49 years were infected with HIV in 2007. Prevention interventions that prevent onward transmission of HIV are urgently needed.
Persons with acute HIV infection (AHI) may be responsible for a substantial proportion of onward transmission of HIV infection. AHI is characterized by unfettered replication of HIV in a "ramp up viremia". The high concentration of HIV in blood and genital secretions remains elevated for up to 10-12 weeks before it declines to the levels observed in established infection. These high levels of HIV shedding in the genital tract are likely to produce very efficient sexual transmission and the proportion of virions that are infectious may be substantially higher during acute compared to chronic infection. Consequently, the probability of transmission during unprotected intercourse for those with AHI is very high. Identifying persons with AHI and intervening to reduce onward transmission represents a tantalizing, but unproven, opportunity for HIV prevention.
To have maximal impact, a prevention program targeting AHI must identify a substantial number of acutely infected persons and intervene quickly to minimize onward transmission. An effective immediate intervention would require behavioral modification to limit sexual partners and unprotected sex acts, and a biological intervention to reduce infectious viral burden in genital secretions. This is the first study to pilot a combined behavioral and biomedical intervention in individuals with AHI to reduce onward transmission of HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Counseling Arm | Active comparator | Behavioral: Standard HIV prevention messagesThe 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 comparator | Behavioral: Standard HIV prevention messages, Behavioral: BI: Information-Motivation-Behavioral Skills ModelBehavior- 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 comparator | Behavioral: Standard HIV prevention messages, Behavioral: BI: Information-Motivation-Behavioral Skills Model, Drug: Raltegravir, Drug: emtricitabine/tenofovir disoproxil fumarateThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
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 |
|---|---|---|
| Standard HIV prevention messagesA single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection. | Behavioural | Behavioral Intervention Arm only, Behavioral Intervention plus ARV, Standard Counseling Arm |
| BI: Information-Motivation-Behavioral Skills ModelThe 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. | Behavioural | Behavioral Intervention Arm only, Behavioral Intervention plus ARV |
| RaltegravirAlso: Isentress, RALraltegravir (400 mg) administered orally twice daily for 12 weeks | Drug | Behavioral Intervention plus ARV |
| emtricitabine/tenofovir disoproxil fumarateAlso: Truvada, FTC/TDFemtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks | Drug | Behavioral Intervention plus ARV |
Primary outcome
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening
Time frame: 1 year
Prevalence of AHI Among Persons Screened
Time frame: 1 year
Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization.
Proportion of Persons With AHI Successfully Recruited Into the Study
Time frame: 1 year
This outcome reflects the ability to recruit persons with AHI into a study. The outcome is based on the population prior to randomization.
Proportion of Participants Completing Full Course of ARVs in Arm BIA
Time frame: 1 year
Proportion of participants in the BIA arm receiving full course of ARVs. This outcome is calculated among the BIA arm only, as that
Proportion of Participants in Arm BI and BIA (Combined) Who Complete the 4 Behavioral Sessions Within 3 Weeks of Enrollment.
Time frame: 1 year
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.
Proportion of Persons Completing All Scheduled Visits in Each Study Arm
Time frame: 1 year
Number of Adverse Events
Time frame: one year
Mean number of adverse events per group
23 secondary outcomes
Unprotected Sex Acts in Previous One Week - 12 Weeks
Time frame: 12 weeks
Unprotected Sex Acts in Previous One Week - 26 Weeks
Time frame: 26 weeks
Unprotected Sex Acts in Previous One Week - 52 Weeks
Time frame: 52 weeks
Unprotected Sex Acts in Previous One Month - 12 Weeks
Time frame: 12 weeks
Unprotected Sex Acts in Previous One Month - 26 Weeks
Time frame: 26 weeks
Unprotected Sex Acts in Previous One Month - 52 Weeks
Time frame: 52 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Time frame: 26 weeks
Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite)
Time frame: 52 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
Time frame: 26 weeks
Cumulative Incidence Herpes Simplex Virus Type 2
Time frame: 52 weeks
Number of Partners Reporting for HIV Testing
Time frame: 52 weeks
Proportion of Partners Reporting for HIV Testing
Time frame: 52 weeks
Suppression of HIV RNA to <1000c/ml at 12 Weeks
Time frame: 12 weeks
Time to HIV RNA Suppression <1000 c/ml
Time frame: From date of randomization until viral load suppression, up to 52 weeks
Blood HIV RNA Concentration at Week 12
Time frame: 12 weeks
Blood HIV RNA Concentration at Week 26
Time frame: 26 weeks
Blood HIV RNA Concentration at Week 52
Time frame: 52 weeks
Genital HIV RNA Concentration - Week 12, Women
Time frame: 12 weeks
Genital HIV RNA Concentration - Week 26, Women
Time frame: 26 weeks
Genital HIV RNA Concentration - Week 52, Women
Time frame: 52 weeks
Genital HIV RNA Concentration - Week 12, Men
Time frame: 12 weeks
Genital HIV RNA Concentration - Week 26, Men
Time frame: 26 weeks
Genital HIV RNA Concentration - Week 52, Men
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35044991Chen 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.
- Derived from this study: PubMed 30476007Dennis 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.
- Derived from this study: PubMed 30048496Hino 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.
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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 C Miller, MD, PhD, MPH study chair
University of North Carolina, Chapel Hill
Audrey Pettifor, PhD, MPH study chair
University of North Carolina, Chapel Hill
Sam Phiri, PhD, MSc principal investigator
Kamuzu Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard HIV prevention messages, BI: Information-Motivation-Behavioral Skills Model and Raltegravir in people with HIV, run by University of North Carolina, Chapel Hill at 2 sites in Malawi.
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 12 inclusion and 28 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 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malawi. 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?
Yes. Results are posted in the registry (first posted 12 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening (time frame: 1 year). The study lists 7 primary outcomes in all. 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 NCT01450189, which also lists 3 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 19 Apr 2018.