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| ID | Type | Description | Link |
|---|---|---|---|
| CID 1002 | Other Identifier | UNC Chapel Hill |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard HIV prevention messages | Behavioral | A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Unprotected Sex Acts in Previous One Week - 12 Weeks | The mean number of unprotected sex acts in previous one week, assessed at 12 weeks | 12 weeks |
| Unprotected Sex Acts in Previous One Week - 26 Weeks |
Not provided
Inclusion Criteria:
Primary participants:
Partner Participants:
Exclusion Criteria:
Primary Participants:
Partner Participants:
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| William C Miller, MD, PhD, MPH | University of North Carolina, Chapel Hill | Study Chair |
| Audrey Pettifor, PhD, MPH | University of North Carolina, Chapel Hill | Study Chair |
| Sam Phiri, PhD, MSc | Kamuzu Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lighthouse Trust, Kamuzu Central Hospital | Lilongwe | Malawi | ||||
| UNC Project |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35044991 | Derived | 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. | |
| 30476007 |
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Participants were evaluated in two stages: screening for acute HIV infection (AHI) and enrollment of persons with AHI for follow-up. As this is a pilot study, some outcomes refer to screening only. The original protocol called for 115 persons with AHI; only 46 persons were enrolled as the study period ended and funding expired.
Participants were recruited through screening in two sexually transmitted disease clinics and two HIV testing sites in Lilongwe, Malawi.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Counseling Arm | 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. Standard HIV prevention messages: The standard counseling (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. |
| FG001 | Behavioral Intervention Arm | The BI arm 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. 5 counselor-delivered sessions: The behavioral intervention (BI) arm 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. |
| FG002 | Behavioral Intervention Plus Antiretrovirals (BIA) | The BIA arm consists of the same 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. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Counseling Arm | 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. Standard HIV prevention messages: The standard counseling (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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Persons Agreeing to be Screened for Acute HIV Infection Among Those Offered Screening | All persons screened | Posted | Number | 95% Confidence Interval | proportion of participants screened | 1 year |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Counseling Arm | 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. Standard HIV prevention messages: The standard counseling (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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| genital discharge/sores | Reproductive system and breast disorders | Non-systematic Assessment |
Please note that this trial was a pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William C Miller | University of North Carolina at Chapel Hill | 9199669407 | bill_miller@unc.edu |
Not provided
| ID | Term |
|---|---|
| D000068898 | Raltegravir Potassium |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Not provided
| BI: Information-Motivation-Behavioral Skills Model | Behavioral | 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 | Drug | raltegravir (400 mg) administered orally twice daily for 12 weeks |
|
|
| emtricitabine/tenofovir disoproxil fumarate | Drug | emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks |
|
|
The mean number of unprotected sex acts in previous one week, assessed at 26 weeks
| 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 | 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 | 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 | 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 | 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 | 26 weeks |
| Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) | At least one incident infection with either gonorrhea, chlamydia or trichomoniasis | 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. | 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. | 52 weeks |
| Number of Partners Reporting for HIV Testing | Number of partners per index reporting for HIV testing at any time during follow-up | 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 | 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 | 12 weeks |
| Time to HIV RNA Suppression <1000 c/ml | median time to viral load suppression (<1000 c/ml) | From date of randomization until viral load suppression, up to 52 weeks |
| Blood HIV RNA Concentration at Week 12 | 12 weeks |
| Blood HIV RNA Concentration at Week 26 | 26 weeks |
| Blood HIV RNA Concentration at Week 52 | 52 weeks |
| Genital HIV RNA Concentration - Week 12, Women | median HIV RNA concentration in cervical lavage fluid | 12 weeks |
| Genital HIV RNA Concentration - Week 26, Women | median HIV RNA concentration in cervical lavage fluid | 26 weeks |
| Genital HIV RNA Concentration - Week 52, Women | median HIV RNA concentration in cervical lavage fluid | 52 weeks |
| Genital HIV RNA Concentration - Week 12, Men | median HIV RNA concentration as measured in semen | 12 weeks |
| Genital HIV RNA Concentration - Week 26, Men | median HIV RNA concentration as measured in semen | 26 weeks |
| Genital HIV RNA Concentration - Week 52, Men | median HIV RNA concentration as measured in semen | 52 weeks |
| Lilongwe |
| Malawi |
| Derived |
| Dennis 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. |
| 30048496 | Derived | Hino 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. |
| BG001 | Behavioral Intervention Arm | The BI arm 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. 5 counselor-delivered sessions: The behavioral intervention (BI) arm 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. |
| BG002 | Behavioral Intervention Plus Antiretrovirals (BIA) | The BIA arm consists of the same 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. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Prevalence of AHI Among Persons Screened | Prevalence of AHI among all persons screened. This measure is among all persons screened, prior to randomization. | Posted | Number | 95% Confidence Interval | proportion of participants | 1 year |
|
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | Proportion of persons with AHI recruited | 1 year |
|
|
|
| Primary | 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 | Number of persons in BIA arm eligible for study-provided ARVs | Posted | Number | 95% Confidence Interval | proportion of BIA participants | 1 year |
|
|
|
| Primary | 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. | All persons in the two behavioral intervention arms | Posted | Number | 95% Confidence Interval | proportion of participants | 1 year |
|
|
|
| Primary | Proportion of Persons Completing All Scheduled Visits in Each Study Arm | Posted | Number | 95% Confidence Interval | Proportion of participants | 1 year |
|
|
|
| Primary | Number of Adverse Events | Mean number of adverse events per group | Posted | Mean | 95% Confidence Interval | number of events | one year |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Week - 12 Weeks | The mean number of unprotected sex acts in previous one week, assessed at 12 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/week | 12 weeks |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Week - 26 Weeks | The mean number of unprotected sex acts in previous one week, assessed at 26 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/week | 26 weeks |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Week - 52 Weeks | The mean number of unprotected sex acts in previous one week, assessed at 52 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/week | 52 weeks |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Month - 12 Weeks | The mean number of unprotected sex acts in previous one month, assessed at 12 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/month | 12 weeks |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Month - 26 Weeks | The mean number of unprotected sex acts in previous one month, assessed at 26 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/month | 26 weeks |
|
|
|
| Secondary | Unprotected Sex Acts in Previous One Month - 52 Weeks | The mean number of unprotected sex acts in previous one month, assessed at 52 weeks | Number includes enrolled persons who completed the ACASI interview within the window for this visit | Posted | Mean | 95% Confidence Interval | unprotected sex acts/month | 52 weeks |
|
|
|
| Secondary | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) | Cumulative incidence, definied as at least one incident infection with either gonorrhea, chlamydia or trichomoniasis | Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results who had not withdrawn from the study by the first scheduled STI tests | Posted | Number | 95% Confidence Interval | proportion of participants | 26 weeks |
|
|
|
| Secondary | Cumulative Incidence of Gonorrhea, Chlamydial Infection and Trichomoniasis (Composite) | At least one incident infection with either gonorrhea, chlamydia or trichomoniasis | Number includes all persons with gonorrhea, chlamydia, and trichomoniasis results and who had at least one visit after Week 26 | Posted | Number | 95% Confidence Interval | proportion of participants | 52 weeks |
|
|
|
| Secondary | 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. | Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 26 | Posted | Number | 95% Confidence Interval | Proportion of participants | 26 weeks |
|
|
|
| Secondary | 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. | Number includes all persons who were confirmed HSV-2 negative at baseline and who had an informative test on or before Week 52 | Posted | Number | 95% Confidence Interval | Proportion of participants | 52 weeks |
|
|
|
| Secondary | Number of Partners Reporting for HIV Testing | Number of partners per index reporting for HIV testing at any time during follow-up | Posted | Mean | 95% Confidence Interval | partners per index participant | 52 weeks |
|
|
|
| Secondary | Proportion of Partners Reporting for HIV Testing | Proportion of sexual partners reporting for HIV testing among all sexual partners named by the index participants | The number of sexual partners named by the index participants is the denominator. For example, the 9 index participants in the standard arm named 35 partners. 4 partners presented, giving a proportion of 0.1 (4/35) | Posted | Number | 95% Confidence Interval | proportion of sex partners | 52 weeks | sexual partners | sexual partners |
|
|
|
| Secondary | Suppression of HIV RNA to <1000c/ml at 12 Weeks | Proportion of persons in each arm with viral load <1000copies/ml at 12 weeks | Posted | Number | 95% Confidence Interval | Proportion of participants | 12 weeks |
|
|
|
| Secondary | Time to HIV RNA Suppression <1000 c/ml | median time to viral load suppression (<1000 c/ml) | Posted | Median | 95% Confidence Interval | weeks | From date of randomization until viral load suppression, up to 52 weeks |
|
|
|
| Secondary | Blood HIV RNA Concentration at Week 12 | Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit. | Posted | Median | Full Range | copies/ml | 12 weeks |
|
|
|
| Secondary | Blood HIV RNA Concentration at Week 26 | Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit. | Posted | Median | Full Range | copies/ml | 26 weeks |
|
|
|
| Secondary | Blood HIV RNA Concentration at Week 52 | Number includes enrolled persons who had an HIV RNA (blood) specimen available the window for this visit. | Posted | Median | Full Range | copies/ml | 52 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 12, Women | median HIV RNA concentration in cervical lavage fluid | Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 12 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 26, Women | median HIV RNA concentration in cervical lavage fluid | Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 26 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 52, Women | median HIV RNA concentration in cervical lavage fluid | Number includes enrolled women who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 52 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 12, Men | median HIV RNA concentration as measured in semen | Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 12 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 26, Men | median HIV RNA concentration as measured in semen | Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 26 weeks |
|
|
|
| Secondary | Genital HIV RNA Concentration - Week 52, Men | median HIV RNA concentration as measured in semen | Number includes enrolled men who had a genital HIV RNA sample obtained during the window for this visit. | Posted | Median | Full Range | copies/ml | 52 weeks |
|
|
|
| 0 |
| 9 |
| 4 |
| 9 |
| EG001 | Behavioral Intervention Arm | The BI arm 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. 5 counselor-delivered sessions: The behavioral intervention (BI) arm 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. | 0 | 18 | 11 | 18 |
| EG002 | Behavioral Intervention Plus Antiretrovirals (BIA) | The BIA arm consists of the same 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. ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks. | 0 | 19 | 13 | 19 |
| fever/chills | General disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Numbness (feet) | Nervous system disorders | Non-systematic Assessment |
|
| finger nail changes | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| headache | General disorders | Non-systematic Assessment |
|
| nausea/vomiting/diarrhea/abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Skin rash/skin sores/itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| weakness | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
| D000068698 |
| Tenofovir |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000068679 | Emtricitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |