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Table 1 Measures, data sources, and data collection schedules for protocol exposures and outcomes

From: Evaluation of short message service and peer navigation to improve engagement in HIV care in South Africa: study protocol for a three-arm cluster randomized controlled trial

Domain

Instrument/measure

Data source

Data collection schedule

PRIMARY EXPOSURE

   

Clinic randomization assignment

Clinic where participant receives care

Intake form

Baseline

SECONDARY EXPOSURE

   

Intervention Dosage

Minutes of intervention received

PN participant contact forms and CommConnect system records

Ongoing capture

PRIMARY OUTCOMES

   

Retention in HIV care

Patients on or initiating ART who remain on treatment 6 and 12 months later (with documented receipt of treatment)

Intake and Record extraction

Weekly (ART)

Survey data (self-report)

0, 6, and 12 months

Patients not ART eligible who have a repeat CD4 test at 6 months and 12 months after initial CD4

Intake and Record extraction

Bi-weekly (pre-ART)

Survey data (self-report)

0, 6, and 12 months

SECONDARY OUTCOMES

   

Linkage to HIV care

CD4 drawn and results available at clinic within 3 months of testing HIV positive

Intake and Record extraction

Weekly (ART) bi-weekly (pre-ART)

CD4 result received within 3 months of testing HIV positive

Survey data (self-report)

0 and 6 months

Patients eligible for ART who initiate treatment within 3 months of CD4 staging

Intake and Record extraction

Weekly (ART)

Survey data (self-report)

0, 6, and 12 months

Adherence to ART

Proportion taking 90 % and 100 % of pills in the past 30 days

Survey data (self-report)

0, 6, and 12 months

Breaks in treatment during the previous six months (at least 4 days in a row)

Intake and Record extraction

Weekly (ART)

Survey data (self-report)

0, 6, and 12 months

Proportion of days covered (# of dispensed days of medication/# of days between refills)

Intake and Record extraction

Weekly (ART)

Prevention (transmission risk)

Number of unprotected sex acts by partner HIV status

Survey data (self-report)

0, 6, and 12 months