Trial Outcomes & Findings for The "START" (a Streamlined ART Initiation Strategy) Study (NCT NCT01810289)

NCT ID: NCT01810289

Last Updated: 2018-11-07

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12024 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2018-11-07

Participant Flow

Participant milestones

Measure	Pre-intervention This study is stepped-wedge in design, therefore each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. In the pre-intervention condition the clinic is using the standard of care.	Post-intervention This study is stepped-wedge in design, therefore each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. In the intervention condition ("post-intervention") the clinics have received the intervention - training, ongoing feedback, as well as the point of care CD4 (PIMA) machine.
Overall Study STARTED	7277	4747
Overall Study COMPLETED	7277	4747
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Pre-intervention n=7277 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.	Post-intervention n=4747 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.	Total n=12024 Participants Total of all reporting groups
Age, Continuous	31 years n=5 Participants	30 years n=7 Participants	31 years n=5 Participants
Sex: Female, Male Female	4715 Participants n=5 Participants	2830 Participants n=7 Participants	7545 Participants n=5 Participants
Sex: Female, Male Male	2562 Participants n=5 Participants	1917 Participants n=7 Participants	4479 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Persons who did have the opportunity for 14 days of follow up were excluded from these analyses.

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.

Outcome measures

Measure	Pre-intervention n=7066 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the pre-intervention condition are giving the standard of care.	Post-intervention n=4747 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the intervention ("post-intervention") have experienced training, ongoing feedback and have the PIMA machine.
Cumulative Incidence of ART Initiation 14 Days After Clinical Eligibility in Treatment Eligible HIV-infected Patients	2585 participants	3753 participants

SECONDARY outcome

Timeframe: 1 years

Population: Mortality information is not systematically measured in the program data. We assessed this outcome in the subgroup selected for HIV RNA.

We ascertained mortality in the subgroup of those selected for HIV RNA assessment. Vital status is not reliably reported in program data. Assessment was 1 year after ART eligibility.

Outcome measures

Measure	Pre-intervention n=199 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the pre-intervention condition are giving the standard of care.	Post-intervention n=208 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the intervention ("post-intervention") have experienced training, ongoing feedback and have the PIMA machine.
Incidence of Mortality in Treatment-eligible, HIV-infected Patients.	3 percentage of reported deaths	2 percentage of reported deaths

SECONDARY outcome

Timeframe: 1 years

Population: Retention was assess among all in the study

Retention was operationalized as the proportion of appointments made within 7 days within one year after ART eligibility.

Outcome measures

Measure	Pre-intervention n=25920 Appointments This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the pre-intervention condition are giving the standard of care.	Post-intervention n=15241 Appointments This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the intervention ("post-intervention") have experienced training, ongoing feedback and have the PIMA machine.
Retention in HIV Care Among Treatment-eligible, HIV-infected Patients.	84 percentage of appointments made	84 percentage of appointments made

SECONDARY outcome

Timeframe: 1 year

Population: A total of 437 (217 in control + 220 in intervention) patients were selected for blood samples. We did two analyses, one treating missing as failure and another using inverse probability weighting to address missing outcomes. The primary reported here is missing as failure.

Due to financial constraints, HIV RNA was measured in a random sample of patients to asses virologic suppression.

Outcome measures

Measure	Pre-intervention n=217 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the pre-intervention condition are giving the standard of care.	Post-intervention n=220 Participants This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions. Clinics in the intervention ("post-intervention") have experienced training, ongoing feedback and have the PIMA machine.
HIV RNA Levels Among Treatment-eligible, HIV-infected Patients One Year Following ART Eligibility	58 percentage of participants	66 percentage of participants

SECONDARY outcome

Timeframe: 3 years

Population: Linking children to mothers in a systematic way was unattainable in these program data. We were unable to ascertain this outcome.

Outcome measures

Outcome data not reported

Adverse Events

Pre-intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Elvin Geng

University of California at San Francisco

Phone: 415-476-4082

Email: elvin.geng@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place