NCT02946762

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

September 14, 2016

Last Update Submit

March 11, 2019

Conditions

HIVTuberculosis

Keywords

HIVTBAntiretroviral TreatmentAnti-tuberculosis TreatmentHIV Counselling and TestingTreatment as Prevention

Outcome Measures

Primary Outcomes (1)

  • Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT

    2 years

Secondary Outcomes (4)

  • 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 6 months of ART

    6 months

  • Proportion of HIV-infected inmates with TB diagnosis who initiate anti-TB therapy under TasP/UTT

    2 years

  • Proportion of inmates on ART with an HIV RNA <40 c/mL at 12 months of ART

    12 months

Study Arms (1)

Universal Test and Treat

OTHER

All incarcerated individuals with HIV infection will receive antiretroviral therapy (ART) by test and treat.

Other: Test and treat

Interventions

Test and treatOTHER

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.

Universal Test and Treat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lusaka Central Corrections ART Clinic

Lusaka, Zambia

Location

Related Publications (1)

  • 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.

    PMID: 32763152DERIVED

MeSH Terms

Conditions

Tuberculosis

Interventions

Coal Tar

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TarsComplex Mixtures

Study Officials

  • Michael Herce, MD, MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

October 27, 2016

Study Start

February 1, 2016

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

ZA(1)