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Table 3 Data collection, measures, data sources

From: Efficacy of an enhanced linkage to HIV care intervention at improving linkage to HIV care and achieving viral suppression following home-based HIV testing in rural Uganda: study protocol for the Ekkubo/PATH cluster randomized controlled trial

Data element

Timeframe

Data source/ instrument

Data collected

Collected from

Brief demographic assessment

Baseline

Self-report

Sociodemographics (gender, age, education, economic and marital status, religion, etc.); prior access to health services (e.g., HIV testing, circumcision among men); HIV stigma; fertility desires and contraception (pregnancy status, number of living children, number of additional children wanted, contraceptive use)

• All individuals consenting to HBHCT and baseline questionnaire interview

Follow-up assessments

6 months, 12 months

Self-report

Clinic recordsa

Linkage and time to HIV carea; co-trimoxazole and ART initiation & time to initiationa; short-term retention in carea; tuberculosisa; ARV adherencea; HIV disclosure; receipt of instrumental and emotional social support; HIV stigma (anticipated, enacted, internalized; subjective health status; perceived need for treatment; barriers to accessing care; health care system literacy; beliefs about traditional and western medicine; patient-provider relationship and clinic wait time; acceptance of HIV diagnosis; alcohol use; depression; positive and negative life events following HIV testing; intimate partner violence

• Intervention trial participants (intervention and control group)

Brief follow-up assessment

12 months

Self-report

Clinic attendance; CD4 results, taking co-trimoxazole and ART

• Viral load and CD4 only group

Biological measures

Baseline, 12 months

Laboratory report

• HIV status (baseline)

• Viral load (baseline, 12 months)

• CD4 cell count (baseline,12 months)

• Intervention trial participants (intervention and control group)

• VL and CD4 only group

Clinic-level data

Twice monthly

Checklist

Drug stock-out: Availability of all ARVs and cotrimoxazole

• All participating HIV clinics

Costing data – service utilization

Ongoing (collected in program records and clinical data)

Program records

Clinic records

Log-book

• Receipt of HBHCT home visits, counseling visits, follow-up contacts

• HIV care services (clinic visits, lab tests, ARVs)

• Intervention trial participants (intervention and control group)

Costing data – service unit costs

Year three of trial

Program accounts, micro-costing at HIV clinics

Intervention related costs – personnel time, consumables, infrastructure, overheads

• Study administration, participant HIV clinics

Costing data – patient costs

12 months

Self-report

Costs incurred by participants related to intervention and/or HIV care

• Intervention trial participants (intervention and control group)

Intervention fidelity

Daily

Electronic protocol checklist

Percentage of intervention sessions steps completed

• Intervention counselors

  1. Note: a indicates follow-up assessment items measured through both participant self-report and clinic records. ARV: antiretroviral; HBHCT Home-based HIV counseling and testing; VL: viral load