HIV
Conditions
Keywords
HIV, Treatment as Prevention, Seek, Test, Treat, Retain Strategies
Brief summary
This study will recruit men and transgender women with acute or recent HIV infection. It wil look at how HIV medicines (ART) when given very early after HIV infection affect the amount of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using modeling studies to look at whether or not this kind of HIV treatment can decrease the risk that a man will infect a person he has sex with and to find out how failure to take medications will impact spreading the virus to other people. In this study, one group will be randomized (like a coin toss) to start ART immediately (just at the time of the enrollment visit) and the other group will wait until week 24 of the study to start ART. Both groups will be followed for a total of 48 weeks and will continue to receive ART from local sources after the study is over.
Detailed description
This is three-step study. Step 1 will screen men who have sex with men (MSM) and transgender women who are unaware of their HIV status and 1) report high risk behaviors for acquiring HIV-1 infection or 2) who have symptoms of acute retroviral syndrome or 3) who have a sexual partner with newly-diagnosed acute or recent HIV infection. HIV testing will be conducted for several thousand MSM and transgender women from study opening until July 2015. In Step 2, high risk HIV-1 uninfected MSM and transgender women with high risk for acquiring HIV will be tested at regular intervals for incident HIV-1 (using tests for HIV p24 and/or HIV RNA). (During this period, men will receive standard HIV prevention interventions.) In Step 3, individuals with acute or recent HIV-1 infection will be enrolled in a 48-week randomized, open-label study of the effects of immediate vs. deferred ART on the decay dynamics of HIV viral load in plasma, semen and rectal secretions. (ART will be provided prior to 24 weeks for any participant in the deferred ART arm who meets initiation criteria.) All participants will be followed for 48 weeks after which they will continue ART from other sources.
Interventions
DRUGAtripla or Stribild
Antiretroviral therapy
Sponsors
Asociación Civil Impacta Salud y Educación, Peru
Asociación Civil Via Libre, Peru
Epicentro, Peru
National Institute on Drug Abuse (NIDA)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult men who have sex with men, and transgender women * Unaware of HIV status at enrollment in follow-up cohort * High risk for HIV infection * Willing to test for HIV * No prior ART, including prior administration of pre- and post-exposure prophylaxis in the last 30 days * Willing to provide informed consent
Exclusion criteria
* Prior receipt of investigational anti-HIV vaccine * Ongoing therapy with any of the following: 1. Systemic corticosteroids. Short course less than or equal to 21 days of corticosteroids is allowed 2. Systemic chemotherapeutic agents 3. Nephrotoxic systemic agents, including aminoglycosides, amphotericin B, cidofovir, cisplatin, foscarnet, pentamidine 4. Immunomodulatory treatments including Interleukin-2 5. Investigational agents * Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART) or their formulations * Active drug or alcohol use or dependence that would interfere with adherence to study requirements * Serious medical or psychiatric illness that would interfere with the ability to adhere to study requirements * Chronic or acute hepatitis B infection * Use of female hormonal products based on estrogen or derivatives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HIV Viral Load Suppression in Plasma | Baseline, Week 12, Week 24, Week 36, and Week 48 | To quantify HIV viral load suppression (\<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was \<1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was \<1000 copies/mL etc. |
| Number of Participants With HIV Viral Load Suppression in Semen | Baseline, Week 12, and Week 24 | To quantify HIV viral load suppression (\<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care | within 3 months of diagnosis of acute HIV infection | To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care. |
| Partner Tracing | within 3 months of diagnosis | Partner tracing and notification |
| Number of Participants Retained in Care | Baseline, Week 12, Week 24, Week 36, and Week 48 | To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48 |
| Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | HIV diagnosis visit | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. |
| Adherence to Viral Load (VL) Procedure | Baseline, Week 12, Week 24, Week 36, and Week 48 | To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48 |
| Adherence to CD4 Procedure | Baseline, Week 12, Week 24, Week 36, and Week 48 | To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48 |
| Adherence to Questionnaires | Baseline, Week 12, Week 24, Week 36, and Week 48 | To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48 |
| Adherence to ART Regimen (Percentage of Pills Taken) | 48 weeks | To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation. |
| Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters | HIV diagnosis visit | HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two. |
Countries
Peru
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate ART (Atripla or Stribild) Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at enrollment.
Atripla or Stribild: Antiretroviral therapy | 105 |
| Deferred ART (Atripla or Stribild) Daily Atripla or Stribild will be provided to these patients for the duration of the study beginning at 24 weeks.
Atripla or Stribild: Antiretroviral therapy | 111 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Excluded from analysis | 5 | 4 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Immediate ART (Atripla or Stribild) | Deferred ART (Atripla or Stribild) | Total |
|---|---|---|---|
| Age, Continuous | 27.9 Years STANDARD_DEVIATION 7.3 | 26.6 Years STANDARD_DEVIATION 6.7 | 27.2 Years STANDARD_DEVIATION 7 |
| Baseline CD4 | 430.1 CD4 T Cell count/mm^3 STANDARD_DEVIATION 207.6 | 432.3 CD4 T Cell count/mm^3 STANDARD_DEVIATION 212.3 | 431.2 CD4 T Cell count/mm^3 STANDARD_DEVIATION 209.6 |
| Baseline Viral Load | 5.84 Log10(copies/mL) STANDARD_DEVIATION 1.16 | 5.78 Log10(copies/mL) STANDARD_DEVIATION 0.96 | 5.81 Log10(copies/mL) STANDARD_DEVIATION 1.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 105 Participants | 111 Participants | 216 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Peru | 105 participants | 111 participants | 216 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 105 Participants | 111 Participants | 216 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 105 | 0 / 111 |
| other Total, other adverse events | 26 / 105 | 28 / 111 |
| serious Total, serious adverse events | 2 / 105 | 1 / 111 |
Outcome results
Primary
Number of Participants With HIV Viral Load Suppression in Plasma
To quantify HIV viral load suppression (\<1000 copies/mL) in plasma at Baseline and weeks 12, 24, 36, and 48 weeks Suppressed at Baseline = HIV Viral load measured at the time of enrollment was \<1000 copies/mL Suppressed at Week 12 = HIV Viral load measured 12 weeks after enrollment was \<1000 copies/mL etc.
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Population: Not all participants had their viral load measured at all time points due to a missed visit or being lost to follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 12 | 84 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 36 | 91 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 24 | 93 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 48 | 94 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at Baseline | 2 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 48 | 92 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at Baseline | 1 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 12 | 8 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 24 | 18 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Plasma | Suppressed at week 36 | 89 Participants |
Primary
Number of Participants With HIV Viral Load Suppression in Semen
To quantify HIV viral load suppression (\<1000 copies/mL) in semen at Baseline and weeks 12, and, 24 weeks
Time frame: Baseline, Week 12, and Week 24
Population: Analysis population is limited to study participants who gave both semen and plasma specimens. This was a planned subset of all participants. Not all participants had their semen viral load measured at all time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed Baseline | 4 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed week 12 | 21 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed week 24 | 19 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed Baseline | 7 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed week 12 | 17 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants With HIV Viral Load Suppression in Semen | Suppressed week 24 | 9 Participants |
Secondary
Adherence to ART Regimen (Percentage of Pills Taken)
To determine percentage of ART pills taken by participants randomized to immediate and deferred ART initiation.
Time frame: 48 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Adherence to ART Regimen (Percentage of Pills Taken) | 93.6 Percent of dispensed pills taken | Standard Deviation 4.7 |
| Deferred ART (Atripla or Stribild) | Adherence to ART Regimen (Percentage of Pills Taken) | 91.5 Percent of dispensed pills taken | Standard Deviation 13.4 |
p-value: 0.14t-test, 2 sided
Secondary
Adherence to CD4 Procedure
To determine the number of participants who had a CD4 test at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Population: Participants still in follow up at each time point who provided a CD4 measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 24 | 97 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 12 | 99 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 36 | 97 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 48 | 96 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Baseline | 103 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 48 | 98 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Baseline | 110 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 12 | 104 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 24 | 104 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to CD4 Procedure | CD4 at Week 36 | 100 Participants |
p-value: >0.12Chi-squared
Secondary
Adherence to Questionnaires
To determine the number of participants who completed the Computer Assisted Self interviews (CASI) at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Population: Participants still in follow up at each time point who completed the study questionnaires
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 12 | 96 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 36 | 92 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 24 | 95 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 48 | 90 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Baseline | 100 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 48 | 92 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Baseline | 109 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 12 | 102 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 24 | 100 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Questionnaires | CASI at Week 36 | 99 Participants |
p-value: >0.22Chi-squared
Secondary
Adherence to Viral Load (VL) Procedure
To determine the number of participants who had a viral load test at Baseline and weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
Population: Participants still in follow up at each time point who provided viral load measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 12 | 98 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at week 36 | 96 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 24 | 95 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 48 | 95 Participants |
| Immediate ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Baseline | 105 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 48 | 98 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Baseline | 111 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 12 | 104 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at Week 24 | 104 Participants |
| Deferred ART (Atripla or Stribild) | Adherence to Viral Load (VL) Procedure | VL at week 36 | 99 Participants |
p-value: >0.3Chi-squared
Secondary
Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care
To determine the proportion of individuals with evidence of acute infection (HIV-1 RNA-positive) who are successfully contacted for confirmatory HIV testing and are then linked to care.
Time frame: within 3 months of diagnosis of acute HIV infection
Population: Analysis population includes only those participants whose HIV infection was diagnosed during the acute phase, that is prior to HIV seroconversion.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate ART (Atripla or Stribild) | Number of Participants Diagnosed With Acute HIV Infection Who Were Linked to Care | 71 Participants |
Secondary
Number of Participants Retained in Care
To determine the number of participants who were retained in care at weeks 12, 24, 36, and 48
Time frame: Baseline, Week 12, Week 24, Week 36, and Week 48
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 12 | 102 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 24 | 101 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 36 | 98 Participants |
| Immediate ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 48 | 96 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 48 | 101 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 12 | 106 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 36 | 103 Participants |
| Deferred ART (Atripla or Stribild) | Number of Participants Retained in Care | Retained at Week 24 | 105 Participants |
p-value: >0.75Chi-squared
Secondary
Partner Tracing
Partner tracing and notification
Time frame: within 3 months of diagnosis
Population: We were unable to trace potential partners because participants were unwilling or unable to identify recent partners
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Immediate ART (Atripla or Stribild) | Partner Tracing | 0 Participants |
Secondary
Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Time frame: HIV diagnosis visit
Population: Analysis population is limited to HIV-infected participants for whom HIV sequence data are available. Per initial protocol design, this analysis was conducted on all HIV sequences without dividing by randomization arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Immediate ART (Atripla or Stribild) | Percent of Participants Whose HIV Sequences Appear in Phylogenetically Defined Clusters | 27 percentage of participants |
Secondary
Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection
HIV present in blood samples from recently infected study participants was sequenced. Sequences that were similar to each other were grouped together in clusters. For this analysis, clusters were defined using a patristic distance threshold of 0.01, and a minimum cluster size of two.
Time frame: HIV diagnosis visit
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | Yes | 16 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | Missing data | 0 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | Yes | 30 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | Yes | 16 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | Missing data | 6 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | No | 123 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | Missing data | 52 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | Missing data | 0 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | Yes | 13 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | Yes | 62 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | No | 57 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | No | 77 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | No | 126 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | Missing data | 0 Participants |
| Immediate ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | No | 117 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | Missing data | 0 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | No | 49 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | Yes | 14 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | No | 26 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Heavy drinker | Missing data | 22 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | Yes | 4 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Audit Score >=20 | Missing data | 9 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | Yes | 4 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | No | 58 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Any illicit drug use | Missing data | 0 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | Yes | 5 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | No | 56 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Sex Work | Missing data | 1 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | Yes | 37 Participants |
| Deferred ART (Atripla or Stribild) | Sequence Clusters Identified Using Phylogenetic Analysis Among Participants With Early HIV Infection | Met a sex partner at any venue | No | 25 Participants |