SIMPLIFIED ALGORITHM FOR TREATMENT ELIGIBILITY: THE SLATE STUDY

Not Applicable

• Conditions: HIV/AIDS

• Registration Number: PACTR201609001783150

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-16
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 960

Inclusion Criteria

1. Adult patients (>18 years) (initiating children on ART is likely to require additional information, making the SLATE algorithm less applicable to pediatric populations)

2. Confirmed HIV-positive test result at any time (may have been diagnosed previously)

3. Not currently on ART (three-drug combination) or have started ART initiation process

4. Presented at the study clinic for any HIV-related reason, including an HIV test, pre-ART monitoring, or ART initiation

Exclusion Criteria

1. 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)

2. Not intending to return to this clinic for further HIV care in the coming year (i.e. intends to seek further care somewhere else)

3. Not physically, mentally, or emotionally able to participate in the study, in the opinion of the investigators or study staff

4. Not willing or able to provide written informed consent to participate in the study

5. Previously enrolled in the same study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients initiated on ART within 28 days of study enrollment. While national guidelines recommend ART initiation within two weeks of a patient¿s first clinic visit or HIV diagnosis, recent studies suggest that 28 days is a more realistic deadline for routine care.;The proportion of patients who initiate ART and are alive, in care, and retained on ART eight months after study enrollment. Eight months was selected to allow up to 1 month (28 days) to initiate ART, six months of follow up after treatment initiation, and up to 1 month to return for the six-month routine clinic visit.

Secondary Outcome Measures

Name	Time	Method
The proportion of patients initiated on ART within 14 days of having an HIV test or enrolling in HIV care. ;The proportion of patients who initiate ART and are virally suppressed eight months of having an HIV test or enrolling in HIV care between HIV-infected patients offered immediate ART initiation under the SLATE algorithm and patients offered standard ART initiation.;The proportion of patients who initiate ART and are alive, in care, and retained on ART 14 months after having an HIV test or enrolling in HIV care. Fourteen months extends the primary outcome endpoint, which is at 8 months, by an additional six months.;Reasons for ineligibility for immediate initiation, among those found ineligible in the intervention arm.;Average time to ART initiation (days) for each arm.;Patient preferences on the speed and timing of ART initiation.;Costs to patients of ART initiation under standard and intervention procedures.;Costs to providers of ART initiation under standard and intervention procedures.