Simplified Algorithm for Treatment Eligibility

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT02891135
• Date of registration: 01/09/2016
• Prospective Registration: Yes
• Primary sponsor: Boston University
• Public title: Simplified Algorithm for Treatment Eligibility SLATE
• Scientific title: Randomized Evaluation of a Simplified Clinical Algorithm for Identifying Patients Eligible for Immediate Initiation of Antiretroviral Therapy for HIV
• Date of first enrolment: March 6, 2017
• Target sample size: 1077
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02891135
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Kenya, South Africa

Contacts

• Name: Sydney Rosen
• Affiliation: Boston University

Key inclusion & exclusion criteria

Inclusion Criteria:

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

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

- Not currently on ART (three-drug combination)

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

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 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Other: SLATE

Primary Outcome(s)

Treatment initiation [Time Frame: 28 days after study enrollment]

Treatment initiation and retention [Time Frame: 8 months after study enrollment]

Secondary Outcome(s)

Time to initiation [Time Frame: 8 months]

SLATE eligibility [Time Frame: Study enrollment]

SLATE ineligibility reasons [Time Frame: Study enrollment]

Viral suppression [Time Frame: 8 months after study enrollment]

One-year retention in care [Time Frame: 14 months after study enrollment]

Initiation within 14 days [Time Frame: 14 days after study enrollment]

One-year retention in care [Time Frame: 16 months after study enrollment]

Secondary ID(s)

H-35634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Witwatersrand, South Africa

Kenya Medical Research Institute