HIV/AIDSNCT03154320
A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
A study testing Same-Day Treatment and Standard treatment in people with HIV/AIDS and Tuberculosis, run by Brigham and Women's Hospital at 1 site in Haiti.
Trial summary
This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Tuberculosis
- What is being tested?
- Same-Day Treatment and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteHaiti
- Study dates
- 6 Nov 2017to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women of ≥18 years of age
- Presence of cough, fever, night sweats or weight loss
- Ability and willingness to give written informed consent
- Documentation of positive HIV status (test conducted at GHESKIO)
- Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
Who cannot join
- Any use of ART in the past
- Treatment for TB in the year prior to screening visit
- Pregnancy or breastfeeding at the screening visit
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
- Score of <3 for any of the 7 questions on the ART readiness survey
- Planning to transfer care to another clinic during the study period
- Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive multifocal leukoencephalopathy)
- Severe illness, classified as one of the WHO "danger signs" of temperature >39 degrees Celsius, pulse >120 beats/minutes, respiratory rate >30, or inability to walk unaided.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.
Read the detailed description
This study is a randomized trial that will compare outcomes with standard and same-day treatment among patients with TB symptoms at HIV diagnosis. The standard group will receive same-day chest x-ray as well as Xpert Ultra testing with a spot specimen (with 48-hour turn-around-time). Participants will return for Xpert Ultra results and early morning sputum testing on Day 2. TB treatment will be provided on the day of diagnosis (Day 0 for those with high clinical and radiographic suspicion of TB, and Day 2 for those diagnosed by spot Xpert Ultra). Standard group participants who are not diagnosed with TB will be tested and treated for other opportunistic infections (OIs), as clinically indicated, and will initiate ART on Day 7. The same-day group will receive Xpert Ultra testing (with same-day results) and chest x-ray with same-day ART or TB treatment (on Day 0) based on test results. They will also be tested and treated for other OIs as clinically indicated. They will provide early morning sputum for repeat testing on Day 1. Both groups will receive Xpert Ultra testing on both spot and early morning specimens, with liquid culture on both specimens as the diagnostic gold standard; those with TB will start ART according to WHO guidelines.
Three specific aims are proposed:
Aim 1: To compare the proportion of participants in each group who are alive and in care with undetectable viral load (<200 copies/ml) at 48 weeks after HIV testing. Hypothesis: The proportion of participants retained in care with undetectable viral load will be 51% in the standard and 65% in the same-day group.
Aim 2: To compare mortality in each group at 48 weeks after HIV testing. Hypothesis: Mortality will be 10% in the standard group and 4% in the same-day group.
Aim 3: To conduct a comparison of cost and cost-effectiveness of standard and same-day care, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with plasma HIV-1 RNA level <200 copies/ml at 48 weeks after HIV testing. Hypothesis: Same-day treatment will cost less per patient retained in care with undetectable viral load.
Aim 4: To determine the rates of ART and TB treatment initiation, TB diagnosis after ART initiation, IRIS, adverse events, and adherence in both groups, and to evaluate the sensitivity, specificity, and predictive values of single tests and different testing combinations compared to liquid mycobacterial culture results.
- Conditions
- HIV/AIDS, Tuberculosis
- Being tested
- Same-Day Treatment, Standard treatment
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same-Day TreatmentOther
Treatment with ART or TB medication on day of HIV diagnosis
Standard treatmentOther
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Standard Group | Active comparator | On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and provide a sputum specimen for spot Xpert Ultra testing (48-hour results). Those with high clinical/radiographic suspicion for TB will start same-day TB treatment. On Day 2, participants will return for results of Xpert Ultra testing (spot specimen) and to provide a specimen for early morning Xpert Ultra testing. Those who are Xpert Ultra positive will start TB treatment. Those who are not diagnosed with TB will start ART on Day 7, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens. Receives: Other: Standard treatment |
| Same-Day Treatment Group | Experimental | On Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and Xpert Ultra testing with same-day results. Based on clinical symptoms, Xpert Ultra results, and chest x-ray, physician will determine whether or not the participant has tuberculosis. Those who are diagnosed with TB will start same-day TB treatment. Those who are not diagnosed with TB will start same-day ART. Receives: Other: Same-Day Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in care with viral suppression
Proportion of participants who are in care with HIV-1 RNA <200 copies/ml
Measured: 48 weeks after HIV testing
Secondary outcomes (17)
Mortality
All-cause mortality
Measured: 48 weeks after HIV testing
Mean treatment cost per participant
Mean treatment cost per participant
Measured: 48 weeks after HIV testing
Viral suppression
Proportion of participants with HIV-1 RNA <50 copies/ml and <1000 copies/ml
Measured: 48 weeks after HIV testing
Adherence by medication possession ratio
Proportion of participants with 48-week adherence to ART of at least 90% by pharmacy refill records
Measured: 48 weeks after HIV testing
Adherence by 3-day self-report
Proportion of participants with perfect (100%) adherence as measured by 3-day self-report at 48 weeks after HIV testing
Measured: 48 weeks after HIV testing
Treatment failure
Proportion of participants meeting WHO criteria for ART failure and proportion initiating second-line ART during the study period
Measured: 48 weeks
TB testing characteristics
Sensitivity, specificity, predictive values, and likelihood ratios of spot and early morning Xpert Ultra results and chest x-ray, as single and as combined tests, with liquid culture as gold standard
Measured: These diagnostic tests will be conducted during the first week of study enrollment
Time in clinic
Median time spent in clinic during first day and month of the study
Measured: First study day and first study month
Coping with HIV diagnosis
Scores on the COPE survey
Measured: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Connectedness to Treatment Setting
Scores on the Connectedness to Treatment Setting Scale
Measured: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
TB diagnosis after ART initiation
Diagnosis of culture-positive TB after ART initiation (BACTEC MGIT 960, Becton Dickinson)
Measured: 48-week study period
Incidence of immune reconstitution inflammatory syndrome (IRIS)
Incidence of paradoxical or unmasking IRIS
Measured: 48-week study period
Adverse events
New Division of AIDS Grade 3 or Grade 4 signs, symptoms, or laboratory abnormalities that are at least a one-grade increase from baseline
Measured: 48-week study period
Measure of hope and optimism
Scores on the State Hope Scale
Measured: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Patient satisfaction
Scores on the HRSA Patient Satisfaction Survey
Measured: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Time to death
Days to death
Measured: 48-week study period
Last missed dose of medication
Proportion of participants who report last missed dose of ART was at least 2 weeks ago
Measured: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start6 Nov 2017
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio to standard or same-day treatment
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, Florida International University, University of California, Davis, Analysis Group, Inc.
- Responsible party
- Principal investigator, Serena Patricia Koenig, Brigham and Women's Hospital
- Investigators
- Serena P Koenig, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154320
- Sponsor's protocol ID
- AI131998
- Status last verified
- Sep 2022
- First submitted
- 24 Mar 2017
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study has been completed, anonymized data will be made publicly available, which will permit replication of reported outcomes.
Publications
Dorvil N, Rivera VR, Riviere C, Berman R, Severe P, Bang H, Lavoile K, Devieux JG, Faustin M, Saintyl G, Mendicuti MD, Pierre S, Apollon A, Dumond E, Forestal GPL, Rouzier V, Marcelin A, McNairy ML, Walsh KF, Dupnik K, Reif LK, Byrne AL, Bousleiman S, Orvis E, Joseph P, Cremieux PY, Pape JW, Koenig SP. Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti. PLoS Med. 2023 Jun 9;20(6):e1004246. doi: 10.1371/journal.pmed.1004246. eCollection 2023 Jun.
PubMed 37294843Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
PubMed 33616229
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
- ClinicalTrials.gov ID
- NCT03154320
- Acronym / sponsor ID
- AI131998
- Conditions
- HIV/AIDS, Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Weill Medical College of Cornell University, Florida International University, University of California, Davis, Analysis Group, Inc.
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, unblinded study comparing standard vs. same-day treatment for patients with TB symptoms (cough, fever, night sweats, or weight loss) at HIV diagnosis. Six hundred patients will be randomized in a 1:1 ratio to the standard group or the same-day treatment group. All study activities will take place at the GHESKIO Centers in Port-au-Prince, Haiti. The study population includes HIV-infected men and women ≥18 years of age who are ART-naïve, and who present with symptoms of TB (cough, fever, nights sweats, or weight loss) at HIV diagnosis.
Detailed description
This study is a randomized trial that will compare outcomes with standard and same-day treatment among patients with TB symptoms at HIV diagnosis. The standard group will receive same-day chest x-ray as well as Xpert Ultra testing with a spot specimen (with 48-hour turn-around-time). Participants will return for Xpert Ultra results and early morning sputum testing on Day 2. TB treatment will be provided on the day of diagnosis (Day 0 for those with high clinical and radiographic suspicion of TB, and Day 2 for those diagnosed by spot Xpert Ultra). Standard group participants who are not diagnosed with TB will be tested and treated for other opportunistic infections (OIs), as clinically indicated, and will initiate ART on Day 7. The same-day group will receive Xpert Ultra testing (with same-day results) and chest x-ray with same-day ART or TB treatment (on Day 0) based on test results. They will also be tested and treated for other OIs as clinically indicated. They will provide early morning sputum for repeat testing on Day 1. Both groups will receive Xpert Ultra testing on both spot and early morning specimens, with liquid culture on both specimens as the diagnostic gold standard; those with TB will start ART according to WHO guidelines.
Three specific aims are proposed:
Aim 1: To compare the proportion of participants in each group who are alive and in care with undetectable viral load (<200 copies/ml) at 48 weeks after HIV testing. Hypothesis: The proportion of participants retained in care with undetectable viral load will be 51% in the standard and 65% in the same-day group.
Aim 2: To compare mortality in each group at 48 weeks after HIV testing. Hypothesis: Mortality will be 10% in the standard group and 4% in the same-day group.
Aim 3: To conduct a comparison of cost and cost-effectiveness of standard and same-day care, where cost is measured by the mean treatment cost and effectiveness is measured by being alive and in care with plasma HIV-1 RNA level <200 copies/ml at 48 weeks after HIV testing. Hypothesis: Same-day treatment will cost less per patient retained in care with undetectable viral load.
Aim 4: To determine the rates of ART and TB treatment initiation, TB diagnosis after ART initiation, IRIS, adverse events, and adherence in both groups, and to evaluate the sensitivity, specificity, and predictive values of single tests and different testing combinations compared to liquid mycobacterial culture results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio to standard or same-day treatment
| Arm | Type | Receives |
|---|---|---|
| Standard Group | Active comparator | Other: Standard treatmentOn Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and provide a sputum specimen for spot Xpert Ultra testing (48-hour results). Those with high clinical/radiographic suspicion for TB will start same-day TB treatment. On Day 2, participants will return for results of Xpert Ultra testing (spot specimen) and to provide a specimen for early morning Xpert Ultra testing. Those who are Xpert Ultra positive will start TB treatment. Those who are not diagnosed with TB will start ART on Day 7, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens. |
| Same-Day Treatment Group | Experimental | Other: Same-Day TreatmentOn Day 0 (day of HIV diagnosis and study enrollment) participants will receive a chest x-ray and Xpert Ultra testing with same-day results. Based on clinical symptoms, Xpert Ultra results, and chest x-ray, physician will determine whether or not the participant has tuberculosis. Those who are diagnosed with TB will start same-day TB treatment. Those who are not diagnosed with TB will start same-day ART. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women of ≥18 years of age
- Presence of cough, fever, night sweats or weight loss
- Ability and willingness to give written informed consent
- Documentation of positive HIV status (test conducted at GHESKIO)
- Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I believe that HIV and AIDS exist" and "I believe that the results of my HIV test show that I am infected".
Key exclusion criteria (8 listed)
- Any use of ART in the past
- Treatment for TB in the year prior to screening visit
- Pregnancy or breastfeeding at the screening visit
- Active drug, alcohol use, or mental condition that would interfere with the ability to adhere to study requirements, in the opinion of the study physician
- Score of <3 for any of the 7 questions on the ART readiness survey
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 |
|---|---|---|
| Same-Day TreatmentTreatment with ART or TB medication on day of HIV diagnosis | Other | Same-Day Treatment Group |
| Standard treatmentStandard treatment | Other | Standard Group |
Primary outcome
Retention in care with viral suppression
Time frame: 48 weeks after HIV testing
Proportion of participants who are in care with HIV-1 RNA <200 copies/ml
17 secondary outcomes
Mortality
Time frame: 48 weeks after HIV testing
Mean treatment cost per participant
Time frame: 48 weeks after HIV testing
Viral suppression
Time frame: 48 weeks after HIV testing
Adherence by medication possession ratio
Time frame: 48 weeks after HIV testing
Adherence by 3-day self-report
Time frame: 48 weeks after HIV testing
Treatment failure
Time frame: 48 weeks
TB testing characteristics
Time frame: These diagnostic tests will be conducted during the first week of study enrollment
Time in clinic
Time frame: First study day and first study month
Coping with HIV diagnosis
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Connectedness to Treatment Setting
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
TB diagnosis after ART initiation
Time frame: 48-week study period
Incidence of immune reconstitution inflammatory syndrome (IRIS)
Time frame: 48-week study period
Adverse events
Time frame: 48-week study period
Measure of hope and optimism
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Patient satisfaction
Time frame: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Time to death
Time frame: 48-week study period
Last missed dose of medication
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Derived from this study: PubMed 37294843Dorvil N, Rivera VR, Riviere C, Berman R, Severe P, Bang H, Lavoile K, Devieux JG, Faustin M, Saintyl G, Mendicuti MD, Pierre S, Apollon A, Dumond E, Forestal GPL, Rouzier V, Marcelin A, McNairy ML, Walsh KF, Dupnik K, Reif LK, Byrne AL, Bousleiman S, Orvis E, Joseph P, Cremieux PY, Pape JW, Koenig SP. Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti. PLoS Med. 2023 Jun 9;20(6):e1004246. doi: 10.1371/journal.pmed.1004246. eCollection 2023 Jun.
- Derived from this study: PubMed 33616229Zifodya JS, Kreniske JS, Schiller I, Kohli M, Dendukuri N, Schumacher SG, Ochodo EA, Haraka F, Zwerling AA, Pai M, Steingart KR, Horne DJ. Xpert Ultra versus Xpert MTB/RIF for pulmonary tuberculosis and rifampicin resistance in adults with presumptive pulmonary tuberculosis. Cochrane Database Syst Rev. 2021 Feb 22;2(2):CD009593. doi: 10.1002/14651858.CD009593.pub5.
- Individual participant dataSharing planned: Yes. When the study has been completed, anonymized data will be made publicly available, which will permit replication of reported outcomes.
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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.
Serena P Koenig, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same-Day Treatment and Standard treatment in people with HIV/AIDS and Tuberculosis, run by Brigham and Women's Hospital at 1 site in Haiti.
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 5 inclusion and 8 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 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Haiti. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in care with viral suppression (time frame: 48 weeks after HIV testing). 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 NCT03154320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.