The "START" (a Streamlined ART Initiation Strategy) Study

NCT01810289 | Completed Results

• 1 other identifier: START-ART
• Study Type: interventional
• Target: 12,024
• Locations: 0 countries
• Sites: N/A

Brief Summary

START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level \< 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2) targeted knowledge transfer (i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3) feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.

Conditions

HIV

Keywords

HIV, ART, CD4

Outcome Measures

Primary Outcomes (1)

• Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients

  Patients may be ART eligible at the start of the study or become ART eligible for the first time in the 3 year time frame.

  14 days

Secondary Outcomes (4)

• Incidence of Mortality in Treatment-eligible, HIV-infected Patients.

  1 years

• Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.

  1 years

• HIV RNA Levels Among Treatment-eligible, HIV-infected Patients One Year Following ART Eligibility

  1 year

• Incidence of Vertical Transmission in All HIV-infected Women Who Are Treatment-eligible During the Study Period.

  3 years

Study Arms (2)

MJAP Clinics Intervention

EXPERIMENTAL

START intervention. This is a stepped wedge design so each clinic will experience both conditions.

Behavioral: START

MJAP Clinics Pre-Intervention

NO INTERVENTION

Standard of care. This is a stepped wedge design so each clinic will experience both conditions.

Interventions

START BEHAVIORAL

INTERVENTION: START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level \< 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2)targeted knowledge transfer(i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3)feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model. This intervention will be implemented at all Makerere Joint AIDS Program (MJAP) clinics in Kampala and Mbarara districts in a step-wedge design.

MJAP Clinics Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All MJAP-supported clinics in Kampala and Mbarara Districts

You may not qualify if:

• None.

Sponsors & Collaborators

• University of California, San Francisco: lead

Related Publications (2)

• Amanyire G, Semitala FC, Namusobya J, Katuramu R, Kampiire L, Wallenta J, Charlebois E, Camlin C, Kahn J, Chang W, Glidden D, Kamya M, Havlir D, Geng E. Effects of a multicomponent intervention to streamline initiation of antiretroviral therapy in Africa: a stepped-wedge cluster-randomised trial. Lancet HIV. 2016 Nov;3(11):e539-e548. doi: 10.1016/S2352-3018(16)30090-X. Epub 2016 Aug 27.

  PMID: 27658873 RESULT

• Hodgson S, Griffin TJ, Reilly C, Harvey S, Witthuhn BA, Sandri BJ, Kunisaki KM, Wendt CH. Plasma sphingolipids in HIV-associated chronic obstructive pulmonary disease. BMJ Open Respir Res. 2017 Apr 3;4(1):e000180. doi: 10.1136/bmjresp-2017-000180. eCollection 2017.

  PMID: 28409005 DERIVED

Results Point of Contact

• Title: Dr. Elvin Geng
• Organization: University of California at San Francisco

elvin.geng@ucsf.edu

415-476-4082

Study Officials

• Diane V Havlir, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Moses Kamya, MB.Ch.B

  Makerere University

  PRINCIPAL INVESTIGATOR

• Elvin Geng, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Clinic level stepped wedge design where each clinic has an amount of time in the pre-intervention or standard of care condition and then crosses over in the intervention condition

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: April 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: November 7, 2018
• Results First Posted: February 27, 2017

Record last verified: 2018-11