Background
South African guidelines on TB-HIV integration
▪ Testing and counseling for HIV in all patients with TB. ▪ Intensified case finding for TB in HIV-infected patients. ▪ Isoniazid preventative therapy (IPT) for HIV-positive patients that screen TB negative. ▪ ART initiation for all TB-HIV co-infected patients. ▪ Cotrimoxazole therapy for TB-HIV co-infected patients. ▪ Enhanced retention in care strategies including the post-test counseling and use of community-based outreach workers. ▪ Enhanced ART and TB treatment adherence strategies including the use of community care workers for adherence support and community-based management of selected patients. ▪ A fully integrated data management system—adopting the approach of one patient, one appointment, one file, and one data management system. |
Clinical benefit of known TB-HIV integration interventions
Rationale of the study
Theoretical framework
Methods
Aims and objectives
Study setting and design
Study population
Randomization and study groups
The quality improvement intervention
Training, coaching, and mentorship for HCWs implementing QI in clinics randomized to the intervention arm
Implementation of the intervention
Standard of care in the control clinics: description of TB, HIV, and integration services
Data collection
Data to be collected | Data source | Outcomes measure |
---|---|---|
TB-HIV integration indicators | Clinical outcomes | |
TIER.Net, community care givers, autopsy reports | - Mortality rates—number of deaths among TB and HIV patients accessing care in study clinics from date clinic enrolled to 18 months post enrolment. | |
TIER.Net | - Proportion of patients retained in care—proportion of HIV-infected patients enrolled in care at clinics and alive 12 months. | |
TIER.Net | - Viral load testing coverage—proportion of patients on ART with viral loads test done among those eligible for viral load test at requested time points. | |
TIER.Net | - Viral load suppression—proportion of patients with undetectable viral load tests among those receiving 12 monthly viral load test. | |
TIER.Net and clinic TB registers | - TB treatment outcomes at end of study period— - Cure rates: proportion of new smear-positive patients that are smear-negative in the last month of treatment and on at least one other occasion at least 30 days prior. - Loss to follow-up rates: proportion of new smear-positive patients that interrupted TB treatment for 2 consecutive months or more. - Treatment failure rates: Proportion of new smear-positive patients that are smear-positive at the end of TB treatment period. - Death rate: proportion of new smear-positive patients that died during TB treatment. - Transfer-out rate: proportion of new smear-positive pulmonary TB patients registered that were transferred to another district and for whom the TB treatment outcome is unknown. | |
Process outcome
- HCT Coverage—proportion of patients with unknown HIV status tested for HIV | ||
TIER.Net, DHIS and clinic-based registers | ||
TIER.Net, DHIS and clinic-based registers | - Co-infection—proportion of TB patients co-infected with HIV | |
TIER.Net, DHIS and clinic-based registers | - Time to ART initiation (in days)—time in days between diagnosis of HIV infection diagnosis and ART initiation. | |
TIER.Net, DHIS and clinic-based registers | - TB screening coverage among HIV-infected patients— a) Proportion of HIV-infected patients receiving TB screening and b) Frequency of TB screening during follow-up | |
TIER.Net, DHIS and clinic-based registers | - IPT initiation— a) Proportion of HIV-infected TB negative patients initiated on IPT and b) Proportion of patients completing IPT course. | |
TIER.Net, DHIS and clinic-based registers | - CPT uptake among co-infected patients—proportion of eligible HIV-positive patients initiated on CPT | |
TB-HIV service integration in the facility macro-environment | Survey instrument developed by Uyei et al. 2014 [7] | Measured TB-HIV integration in terms of: ➢ Organization—such as co-location of services, combined patient records, information management, and joint training ➢ Structure—existent practice of joint service delivery, ➢ Process—behavior and practice of delivering services ➢ Culture—work place culture and personal identification with integrated service delivery |
Clinic profile tool aimed at assessing clinics’ infrastructure, capacity, and systems in place to implement TB-HIV integration services | A CAPRISA designed tool | - Resources inventory and needs for implementation of TB-HIV integration services, e.g., available guidelines, protocols, policies, trained staff. - Existing quality improvement interventions, processes and measurements - District level leadership and support |
Clinic culture, leadership, resources, etc. | The COACH tool designed by Bergstrom et al. 2015 [56] | - Clinic leadership and support - Staff knowledge and skills - Perceptions of work culture at PHC |
Staff Work-related Quality of Life | WHO Work-related Quality of Life Scale | Work-related quality of life for staff at PHC |
Study activity | Study time points | |||
---|---|---|---|---|
Baseline (0–1 month) | 6–7th month | 12–13th month | Monthly (1st–18th month) | |
Retrospective collection of 12 months data on TB-HIV indicators from TIER.Net*, DHIS** and clinic-based registers | X | |||
***QI Learning Collaborative (Intervention Clinics Only) | X | X | X | |
Monthly downloads of data on TB-HIV indicators from TIER.Net*, DHIS** and clinic-based registers | X | |||
Clinic Profile Survey | X | X | X | |
TB/HIV Service Integration Survey | X | X | X | |
Work-related Quality of Life Survey | X | X | X | |
Context Assessment Survey | X | X | X | |
Quality Improvement Survey (Intervention Clinics Only) | X | X | X |
Study outcome measures
Sample size estimation
Reduction in mortality (%) | Power to detect an effect (%) |
---|---|
10 | 13 |
20 | 42 |
30 | 80 |
40 | 98 |