Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 419
- Locations
- 1
- Primary Endpoint
- Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
Study Overview
Brief Summary
At correctional facilities in Zambia and South Africa, a cross-sectional study design will be used to characterize the full continuum of integrated HIV/TB care under Treatment as Prevention (TasP), and will enrich this approach by: 1) using individual-level cohort data for HIV-infected inmates to assess ART uptake under TasP/Universal Test and Treat (UTT), as well as 6-month virological suppression and retention in care for inmates initiating ART; and 2) mixed methods to identify health-system, corrections-related socio-cultural and individual-inmate barriers to and facilitators of TasP/UTT to refine TasP implementation; and 3) conducting a retrospective chart review using routine data from Ministry of Health registers to reconstruct an approximate HIV and TB cascade for all inmates (HIV-infected and HIV-uninfected) at 3 and 12 months into TasP/UTT implementation.
Detailed Description
Treatment as Prevention (TasP) offers promise to: (1) prevent HIV transmission among incarcerated populations; and (2) improve inmate health and tuberculosis control through provision of immediate ART using a "universal test and treat" (UTT) approach.
Increased uptake of routine HIV counseling and testing (HCT) services will be encouraged and currently available ART care will be augmented by offering immediate ART initiation to all HIV-infected inmates not already on ART (after screening for TB and kidney disease) regardless of CD4 count. In this way, the study will promote universal HCT and ART access.
Existing, routine service delivery platforms operated by the MOH and Zambia
Corrections Service will be strengthened in hopes of achieving the following:
- Universal HIV testing within 2 months of facility entry and annually for all current inmates
- Clear integration of TB screening and treatment within HIV care services
- Scaling-up inmate peer supporters and support groups to promote ART adherence
- Strengthened systems for providing integrated TB/HIV care in correctional settings
- Improved continuity of care for prisoners initiating ART
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Previously known or newly diagnosed HIV-infected inmates
- •Not on ART
- •No documented release date within 30 days of enrollment
- •Incarcerated in an adult correctional ward at one of the three study sites.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
Time Frame: 2 years
Secondary Outcomes
- Proportion of HIV-infected inmates with TB diagnosis who initiate anti-TB therapy under TasP/UTT(2 years)
- Proportion of all HIV-infected inmates starting ART who are retained on ART among those who remain in the study facility(2 years)
- Proportion of inmates on ART with an HIV RNA <40 c/mL at 12 months of ART(12 months)
- Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART(6 months)