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Table 1 Bridge study outcomes and assessments

From: Improving HIV service delivery for people who inject drugs in Kazakhstan: study protocol for the Bridge stepped-wedge trial

Outcome Description Assessment tool Timing of assessment
Study Aim 1: To evaluate, at both client and NSP levels, the effectiveness of Bridge on (1) increasing the number of PWID clients who attend NSPs, (2) on increasing the number of PWID clients who receive a rapid test for HIV at the NSP, and (3) in linking HIV-positive PWID at NSPs (including both new cases and those who have not attended HIV care in the past 6 months) to HIV care at the AIDS Center.
 Linkage to care The number and percent of HIV-positive clients who visit HIV clinic at least once in the past 6 months Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review Ongoing during both pre-implementation and program implementation periods
 HIV testing The number and percent of NSP clients who have received an HIV test in the past 3 months at the NSP Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review Ongoing during both pre-implementation and program implementation periods
 NSP visits The number of total clients per NSP, number of new NSP clients enrolled in the past 6 months Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review Ongoing during both pre-implementation and program implementation periods
Study Aim 2: To assess how the Bridge intervention’s package of implementation strategies (including training, supervision, a community of practice and technical assistance) impacts intervention uptake and fidelity and the intervention effectiveness outcomes.
 Uptake The number of NSPs, NSP staff, and NSP clients implementing, conducting, and receiving each component of the Bridge program Bridge program documentation completed by NSP staff (program activity checklists and reports; Google-based data collection tool) completed by NSP and AIDS Center nurses Ongoing during program implementation period
 Fidelity The number and percent of Bridge program activities conducted in accordance with the protocols Bridge program documentation completed by NSP staff (supervision checklists and reports); Community of Practice (CoP) meeting minutes Ongoing during program implementation period
 Dosage and content of training on Bridge components Amount and quality of training (per Bridge program component) that program staff were exposed to and received Training attendance records; number of audio recordings and feedback sessions conducted; pre and post training evaluations Ongoing during program implementation period
 Dosage and content of supervision Amount and quality of supervision that was provided by program supervisors and received by program staff. Number, frequency, and modality (in-person, by phone, etc.) of supervision sessions held between program supervisor and NSP staff
Staff perceptions of supervision
Ongoing during program implementation period
 Dosage and content of technical assistance (TA) Amount and categories of technical assistance provided by GHRCCA staff to study team Number, frequency and content of technical assistance requests Ongoing during program implementation period
 Dosage and content of Bridge Community of Practice (CoP) Amount and quality of CoP sessions Number and content of CoP meetings, participation in CoP, surveys on perceived usefulness of CoP Ongoing during program implementation period
Study Aim 3: To evaluate the effectiveness of Bridge on (1) increasing retention in HIV care, (2) increasing retention in NSPs, (3) initiating ART, and (4) increasing adherence to HIV treatment regimens and viral suppression.
 Retention in HIV care The number and percent of HIV-positive PWID who have visited the AIDS Center at least once in the past 6 months Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review Ongoing during both pre-implementation and program implementation periods
 Retention in NSPs The number and percent of NSP clients who have visited the NSP at least once in the past 3 months Google-based data collection tool completed by NSP and AIDS Center nurses Ongoing during both pre-implementation and program implementation periods
 Enrollment in ART The number and percent of HIV + PWID (new cases and those who have fallen out of care) who have initiated ART in the past 6 months Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review Ongoing during both pre-implementation and program implementation periods
 Adherence to ART The number and percent of HIV-positive PWID who have taken ART medication as prescribed in the past 6 months Google-based data collection tool completed by NSP and AIDS Center nurses; AC chart review, Ongoing during both pre-implementation and program implementation periods
 Viral suppression The number of HIV + PWID with undetectable viral load Laboratory assay Ongoing during both pre-implementation and program implementation periods
Study Aim 4: To assess how multi-level theory-driven factors (individual, staff, agency, community, structural) influence the implementation and effectiveness of Bridge on primary and secondary effectiveness aims using mixed methods.
 Multi-level theory-driven factors (client, staff, agency, community, structural) Knowledge, attitudes, beliefs and experiences of clients, program staff and leadership Surveys including TCU-ORC, ORCA, PCIS, and other standardized and innovative assessments based on the CFIR model Once every 6 months (January and July) during both pre-implementation and program implementation periods
 Policy and environment monitoring External events that may influence Bridge program implementation Record of ongoing policy initiatives and external factors Ongoing during both pre-implementation and program implementation periods
Study Aim 5: To evaluate the cost-effectiveness of the Bridge intervention, including implications for feasibility of program expansion and sustainability.
 Cost-effectiveness Costs of implementing individual program elements of Bridge Records of time spent on program activities and salary of relevant staff 1 month during program implementation period