An interventional study of Same-Day Treatment and Standard treatment in HIV/AIDS and Tuberculosis, sponsored by Brigham and Women's Hospital. Completed at 1 site in Haiti. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-09.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Other: Standard treatment
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
Standard treatment
Retention in care with viral suppression
Proportion of participants who are in care with HIV-1 RNA \<200 copies/ml
Time frame: 48 weeks after HIV testing
Mortality
All-cause mortality
Time frame: 48 weeks after HIV testing
Mean treatment cost per participant
Mean treatment cost per participant
Time frame: 48 weeks after HIV testing
Viral suppression
Proportion of participants with HIV-1 RNA \<50 copies/ml and \<1000 copies/ml
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First study day and first study month
Coping with HIV diagnosis
Scores on the COPE survey
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Connectedness to Treatment Setting
Scores on the Connectedness to Treatment Setting Scale
Time frame: 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)
Time frame: 48-week study period
Incidence of immune reconstitution inflammatory syndrome (IRIS)
Incidence of paradoxical or unmasking IRIS
Time frame: 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
Time frame: 48-week study period
Measure of hope and optimism
Scores on the State Hope Scale
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Patient satisfaction
Scores on the HRSA Patient Satisfaction Survey
Time frame: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing
Time to death
Days to death
Time frame: 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
Time frame: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Plan to share: 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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Brigham and Women's Hospital