Clinical trial NCT02946762: TasP in Correctional Facilities
Official title: Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Tuberculosis
Keywords: HIV
TB
Antiretroviral Treatment
Anti-tuberculosis Treatment
HIV Counselling and Testing
Treatment as Prevention
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Department for International Development, United Kingdom
First posted: 2016-10-27
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

1. Universal HIV testing within 2 months of facility entry and annually for all current inmates
2. Clear integration of TB screening and treatment within HIV care services
3. Scaling-up inmate peer supporters and support groups to promote ART adherence
4. Strengthened systems for providing integrated TB/HIV care in correctional settings
5. Improved continuity of care for prisoners initiating ART

The following study-specific procedures will be carried out:

* ART will be initiated following clinical and laboratory assessment according to local guidelines.
* All inmates with newly diagnosed or previously documented HIV infection will be offered immediate ART regardless of CD4+ count or WHO clinical stage. A clinical assessment, including TB screening, and testing of serum creatinine will be completed, per Zambian national guidelines, prior to starting a standard ART regimen, which in Zambia is efavirenz plus lamivudine/ emtricitabine and tenofovir.
* A study specific follow-up visit, aligned with the routine HIV care schedule, for all inmates identified as HIV-infected will occur:
* Study nurses will support blood sample collection for HIV-1 viral load monitoring at the single study follow-up visit for all participants initiating ART under TasP. The planned follow-up visit will be scheduled to occur at 6 months following ART initiation. However, if a high recidivism rate and loss to follow-up prior to 6 months on treatment is observed, the study follow-up visit may be moved up to 3 months.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of all HIV-infected inmates starting ART who are retained on ART among those who remain in the study facility
timeFrame: 2 years
measure: Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART
timeFrame: 6 months
measure: Proportion of HIV-infected inmates with TB diagnosis who initiate anti-TB therapy under TasP/UTT
timeFrame: 2 years
measure: Proportion of inmates on ART with an HIV RNA <40 c/mL at 12 months of ART
timeFrame: 12 months
Other outcomes:
Locations:
city: Lusaka
country: Zambia
facility: Lusaka Central Corrections ART Clinic
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael Herce, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herce ME, Hoffmann CJ, Fielding K, Topp SM, Hausler H, Chimoyi L, Smith HJ, Chetty-Makkan CM, Mukora R, Tlali M, Olivier AJ, Muyoyeta M, Reid SE, Charalambous S. Universal test-and-treat in Zambian and South African correctional facilities: a multisite prospective cohort study. Lancet HIV. 2020 Dec;7(12):e807-e816. doi: 10.1016/S2352-3018(20)30188-0. Epub 2020 Aug 4.