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CompletedNCT02946762Updated Mar 13, 2019

TasP in Correctional Facilities

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

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Feb 2016, registered Sep 2016).
Phase
Not applicable
Study type
Interventional
Enrollment
419
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV
  • Tuberculosis

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Keywords

  • HIV
  • TB
  • Antiretroviral Treatment
  • Anti-tuberculosis Treatment
  • HIV Counselling and Testing
  • Treatment as Prevention
03

In context

Tuberculosis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
419 participants (actual)

Study arms

  • Other
    Universal Test and Treat

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

    Other: Test and treat

Interventions

  • OtherTest 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.

06

What researchers measure

Primary outcomes

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

    Time frame: 2 years

Secondary outcomes

  1. 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

  2. Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART

    Time frame: 6 months

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

    Time frame: 2 years

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

    Time frame: 12 months

07

Study locations

1 site
  • Lusaka Central Corrections ART Clinic
    Lusaka, Zambia
08

References and documents

Publications

  • 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. PubMed 32763152 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02946762
Lead sponsor
University of North Carolina, Chapel Hill
Collaborators
Department for International Development, United Kingdom
Responsible party
Sponsor
First posted
Oct 27, 2016
Start date
Feb 1, 2016
Primary completion
Mar 31, 2018
Completion
Mar 31, 2018
Last update
Mar 13, 2019

Study contacts

Michael Herce, MD, MPH
principal investigator · University of North Carolina, Chapel Hill

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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