An interventional study of Test and treat in HIV and Tuberculosis, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Health services research
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.
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:
The following study-specific procedures will be carried out:
Study data collection will augment existing routine data collection mechanisms and allow individual-level outcome ascertainment regarding uptake of ART under TasP, as well as 6-month retention in care and virological suppression.
Standardized questionnaires and in-depth interviews will be conducted with inmate participants enrolled under Objective 1. To assess systems-level issues, in-depth interviews will also be conducted with a purposive sample of correctional staff and health care workers.
1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.
This study's enrollment of 419 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
All incarcerated individuals with HIV infection will receive antiretroviral therapy (ART) by test and treat.
Other: Test and treat
All incarcerated individuals found to have HIV infection will be offered universal voluntary HIV counseling and testing (HCV) through routine care provided at the correctional facility followed by referral to the study for immediate (routine, non-study prescribed) ART, regardless of CD4 cell count. The ART regimen prescribed will be the standard first-line, fixed-dose combination efavirenz plus lamivudine/emtricitabine and tenofovir per Zambian national guidelines.
Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
Time frame: 2 years
Proportion of all HIV-infected inmates starting ART who are retained on ART among those who remain in the study facility
Time frame: 2 years
Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART
Time frame: 6 months
Proportion of HIV-infected inmates with TB diagnosis who initiate anti-TB therapy under TasP/UTT
Time frame: 2 years
Proportion of inmates on ART with an HIV RNA <40 c/mL at 12 months of ART
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill