A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
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|ClinicalTrials.gov Identifier: NCT03154320|
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : August 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV/AIDS Tuberculosis||Other: Same-Day Treatment Other: Standard treatment||Not Applicable|
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 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will be randomized in a 1:1 ratio to standard or same-day treatment|
|Masking:||None (Open Label)|
|Official Title:||A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV|
|Actual Study Start Date :||November 6, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||November 2019|
Active Comparator: Standard Group
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 9, after testing and treatment for other opportunistic infections. A liquid TB culture will be performed on both the spot and early morning specimens.
Other: Standard treatment
Experimental: Same-Day Treatment Group
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.
Other: Same-Day Treatment
Treatment with ART or TB medication on day of HIV diagnosis
- 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
- Mortality [ Time Frame: 48 weeks after HIV testing ]All-cause mortality
- Mean treatment cost per participant [ Time Frame: 48 weeks after HIV testing ]Mean treatment cost per participant
- Viral suppression [ Time Frame: 48 weeks after HIV testing ]Proportion of participants with HIV-1 RNA <50 copies/ml and <1000 copies/ml
- Adherence by medication possession ratio [ Time Frame: 48 weeks after HIV testing ]Proportion of participants with 48-week adherence to ART of at least 90% by pharmacy refill records
- Adherence by 3-day self-report [ Time Frame: 48 weeks after HIV testing ]Proportion of participants with perfect (100%) adherence as measured by 3-day self-report at 48 weeks after HIV testing
- Treatment failure [ Time Frame: 48 weeks ]Proportion of participants meeting WHO criteria for ART failure and proportion initiating second-line ART during the study period
- TB testing characteristics [ Time Frame: These diagnostic tests will be conducted during the first week of study enrollment ]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
- Time in clinic [ Time Frame: First study day and first study month ]Median time spent in clinic during first day and month of the study
- Coping with HIV diagnosis [ Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing ]Scores on the COPE survey
- Connectedness to Treatment Setting [ Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing ]Scores on the Connectedness to Treatment Setting Scale
- TB diagnosis after ART initiation [ Time Frame: 48-week study period ]Diagnosis of culture-positive TB after ART initiation (BACTEC MGIT 960, Becton Dickinson)
- Incidence of immune reconstitution inflammatory syndrome (IRIS) [ Time Frame: 48-week study period ]Incidence of paradoxical or unmasking IRIS
- Adverse events [ Time Frame: 48-week study period ]New Division of AIDS Grade 3 or Grade 4 signs, symptoms, or laboratory abnormalities that are at least a one-grade increase from baseline
- Measure of hope and optimism [ Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing ]Scores on the State Hope Scale
- Patient satisfaction [ Time Frame: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing ]Scores on the HRSA Patient Satisfaction Survey
- Time to death [ Time Frame: 48-week study period ]Days to death
- Last missed dose of medication [ Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks ]Proportion of participants who report last missed dose of ART was at least 2 weeks ago
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154320
|Contact: Serena P Koenig, MDfirstname.lastname@example.org|
|Contact: Patrice Severe, MDemail@example.com|
|Contact: Jean W Pape, MD 01150929401430 firstname.lastname@example.org|
|Contact: Patrice Severe, MD 01150929401430 email@example.com|
|Principal Investigator:||Serena P Koenig, MD||Brigham and Women's Hospital|