HIV/AIDS Clinical Trial
— SLATEIIOfficial title:
Randomized Evaluation of a Revised, Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV (SLATEII)
Verified date | January 2021 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In its 2017 revision of the global guidelines for HIV care and treatment, the World Health Organization called for rapid or same-day initiation of antiretroviral treatment (ART) for eligible patients testing positive for HIV. In sub-Saharan Africa, where most HIV patients are located, studies continue to document high losses of treatment-eligible patients from care before they receive their first dose of antiretroviral medications (ARVs). Among facility-level reasons for these losses are treatment initiation protocols that require multiple clinic visits and long waiting times before a patient who tests positive for HIV is dispensed an initial supply of medications. Simpler, more efficient, accelerated algorithms for ART initiation are needed, including strategies for rapid initiation in patients with symptoms of tuberculosis, most of whom do not have active TB. In July 2017, the original SLATE study (SLATE I) completed enrollment in South Africa. One of the most striking findings of the study so far is the large proportion of patients who "screened out" of the SLATE algorithm and were referred for additional services rather than started on ART immediately. Among 298 patients assigned to the intervention arm and evaluated for immediate treatment eligibility under the SLATE algorithm, 149 (50%) screened out, two thirds of these (100/149) due to symptoms of TB. The vast majority of the TB suspects (93/100, 93%) tested negative for active TB. The SLATE II study will revise the original SLATE algorithm to provide a pathway for immediate ART initiation for some patients with TB symptoms. Under SLATE II, patients with TB symptoms will be clinically evaluated by the study nurse and will receive a urine point of care LAM (lipoarabinomannan antigen of mycobacteria) test. Those with milder symptoms and a negative LAM test will be offered immediate ART. Those with more serious symptoms and/or a positive LAM test will be asked to return the next day to receive TB test results and either immediate ART or TB treatment. All intervention arm patients (symptomatic and asymptomatic) will be asked for a sputum sample for Xpert testing, and positives will be contacted on the next day. The SLATE II algorithm will also incorporate other improvements identified from SLATE I.
Status | Completed |
Enrollment | 600 |
Est. completion date | December 31, 2020 |
Est. primary completion date | August 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (>18 years) (initiating children and adolescents on ART is likely to require additional information and adherence support, making the SLATE algorithm less applicable to pediatric populations) - Confirmed HIV-positive test result at any time (may have been diagnosed previously) - Self-report that patient is not currently on ART and has not been prescribed ART in the past three months - Presented at the study clinic for any HIV-related reason or other reason that led to referral for HIV testing or care Exclusion Criteria: - Pregnant (pregnancy is an exclusion criterion because treatment guidelines for pregnant women differ from those for non-pregnant adults; most pregnant women are diagnosed with HIV and initiated on ART in antenatal clinics, not general adult HIV clinics) - Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else) - Not willing to be traced by phone or in person for follow-up care if test results received after the enrollment visit indicate that further care is needed - Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff - Not willing or able to provide written informed consent to participate in the study - Previously enrolled in the same study or the SLATE I study |
Country | Name | City | State |
---|---|---|---|
South Africa | Health Economics and Epidemiology Research Office | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
Boston University | Bill and Melinda Gates Foundation, University of Witwatersrand, South Africa |
South Africa,
Brennan A, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox M, Venter WDF, Ehrenkranz PD, Rosen S. Prevalence of TB symptoms, diagnosis and treatment among people living with HIV (PLHIV) not on ART presenting at outpatient clinics in South Africa and Kenya: baseline results from a clinical trial. BMJ Open. 2020 Sep 6;10(9):e035794. doi: 10.1136/bmjopen-2019-035794. — View Citation
Brennan AT, Maskew M, Larson BA, Tsikhutsu I, Bii M, Vezi L, Fox MP, Venter WD, Ehrenkranz P, Rosen S. Who is seeking antiretroviral treatment for HIV now? Characteristics of patients presenting in Kenya and South Africa in 2017-2018. J Int AIDS Soc. 2019 Sep;22(9):e25358. doi: 10.1002/jia2.25358. — View Citation
Maskew M, Brennan AT, Fox MP, Vezi L, Venter WDF, Ehrenkranz P, Rosen S. A clinical algorithm for same-day HIV treatment initiation in settings with high TB symptom prevalence in South Africa: The SLATE II individually randomized clinical trial. PLoS Med. — View Citation
Rosen S, Maskew M, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, Venter WDF. Improved simplified clinical algorithm for identifying patients eligible for immediate initiation of antiretroviral therapy for HIV (SLATE II): protocol for a randomized evaluation. Trials. 2018 Oct 11;19(1):548. doi: 10.1186/s13063-018-2928-5. — View Citation
Scott NA, Maskew M, Fong RM, Olson IE, Brennan AT, Fox MP, Vezi L, Ehrenkranz PD, Rosen S. Patient Perspectives of Quality of the Same-Day Antiretroviral Therapy Initiation Process in Gauteng Province, South Africa: Qualitative Dominant Mixed-Methods Analysis of the SLATE II Trial. Patient. 2020 Sep 10. doi: 10.1007/s40271-020-00437-4. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients initiated on ART | % of enrolled patients initiated onto ART within one week of study enrollment, which may occur at HIV diagnosis or at a pre-ART follow-up visit | 7 days after study enrollment | |
Primary | Proportion of patients initiated on ART and alive, in care, and retained | Proportion of enrolled patients initiated on ART within 28 days of study enrollment and retained in care 8 months after study enrollment, as indicated by a clinic visit no more than 7 months after ART initiation | 8 months after study enrollment | |
Secondary | Proportion of TB suspects initiated on ART within 14 days of study enrollment | Proportion of TB suspects initiated on ART within 14 days of study enrollment | 14 days after study enrollment | |
Secondary | Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment | Proportions of patients initiated on ART within 1, 14, and 28 days of study enrollment | 28 days after study enrollment | |
Secondary | Proportions of all patients and of TB suspects who initiate ART and are virally suppressed eight months after having an HIV test or enrolling in HIV care | Viral suppression stratified by TB symptom status at baseline | 8 months after study enrollment | |
Secondary | Proportions of all patients and of TB suspects who initiate ART and are alive, in care, and retained on ART 14 months after having an HIV test or enrolling in HIV care | Retention 12 months after enrollment, allowing 1 month for initiation and 1 month for making and recording data from 12-month visit. | 14 months after study enrollment | |
Secondary | Proportions of HIV-positive patients presenting at study clinics and not yet on ART who are eligible and ineligible for immediate initiation using SLATE algorithm criteria | Patients who screen in and screen out of algorithm in intervention arm | 1 day after study enrollment | |
Secondary | Reasons for ineligibility for immediate initiation | Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm | 1 day after study enrollment | |
Secondary | Median time to ART initiation (days) for each arm | Median and IQR time to ART initiation (days) for each arm | 28 days after study enrollment | |
Secondary | Adverse events | Frequency and types of adverse events reported in medical records after ART initiation for each follow up period | 1, 7, 14, and 28 days after enrollment; 8 and 14 months after enrollment | |
Secondary | Patient preferences | Patient self-reported preferences on the speed and timing of ART initiation, from questionnaires | 1 day after enrollment | |
Secondary | LAM test results | Proportion of symptomatic patients who test positive for TB using the LAM test | 1 day after enrollment | |
Secondary | Xpert test results | Proportions of symptomatic and asymptomatic patients who test positive for TB using Xpert MTB/RIF, among those able to produce a sputum sample | 1 week after enrollment | |
Secondary | Costs to patients | Costs to patients of ART initiation under standard and intervention procedures | 14 months after study enrollment (end of followup) | |
Secondary | Costs to providers | Costs to providers of ART initiation under standard and intervention procedures | 14 months after study enrollment (end of followup) | |
Secondary | Differences from SLATE I | Comparison of results of SLATE II study to SLATE I study | 14 months after study enrollment (end of followup) |
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