Lusaka Central Corrections ART Clinic
Lusaka, Zambia
NCT Number: NCT02946762
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lusaka, Zambia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Time frame: 2 years
Time frame: 2 years
Time frame: 6 months
Time frame: 2 years
Time frame: 12 months
University of North Carolina, Chapel Hill
Other
Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02906007
Actinomycetales Infections, Bacterial Infections
Port-au-Prince, Haiti
View Trial DetailsNCT04926922
Actinomycetales Infections, Bacterial Infections
Bethesda, Maryland, United States
View Trial DetailsNCT05868005
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Almería, Andalusia, Spain
View Trial DetailsNCT04520113
Acquired Immunodeficiency Syndrome, Actinomycetales Infections
Johannesburg, South Africa
View Trial Details