HIVNCT02946762
TasP in Correctional Facilities
A study testing Test and treat in people with HIV and Tuberculosis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- Test and treat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419 participants
- Where
- 1 siteZambia
- Study dates
- 1 Feb 2016to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa
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:
- Universal HIV testing within 2 months of facility entry and annually for all current inmates
- Clear integration of TB screening and treatment within HIV care services
- Scaling-up inmate peer supporters and support groups to promote ART adherence
- Strengthened systems for providing integrated TB/HIV care in correctional settings
- 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.
- Conditions
- HIV, Tuberculosis
- Being tested
- Test and treat
- Keywords
- HIV, TB, Antiretroviral Treatment, Anti-tuberculosis Treatment, HIV Counselling and Testing, Treatment as Prevention
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Universal Test and Treat | Other | All incarcerated individuals with HIV infection will receive antiretroviral therapy (ART) by test and treat. Receives: Other: Test and treat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
Measured: 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
Measured: 2 years
Proportion of inmates on ART with an HIV RNA <40 c/mL at 6 months of ART
Measured: 6 months
Proportion of HIV-infected inmates with TB diagnosis who initiate anti-TB therapy under TasP/UTT
Measured: 2 years
Proportion of inmates on ART with an HIV RNA <40 c/mL at 12 months of ART
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start1 Feb 2016
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Department for International Development, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Michael Herce, MD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946762
- Sponsor's protocol ID
- 15-1473
- Status last verified
- Mar 2019
- First submitted
- 14 Sep 2016
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa
- ClinicalTrials.gov ID
- NCT02946762
- Acronym / sponsor ID
- 15-1473
- Conditions
- HIV, Tuberculosis
- Keywords
- HIV, TB, Antiretroviral Treatment, Anti-tuberculosis Treatment, HIV Counselling and Testing, Treatment as Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Department for International Development, United Kingdom
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Universal HIV testing within 2 months of facility entry and annually for all current inmates
- Clear integration of TB screening and treatment within HIV care services
- Scaling-up inmate peer supporters and support groups to promote ART adherence
- Strengthened systems for providing integrated TB/HIV care in correctional settings
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Universal Test and Treat | Other | Other: Test and treatAll incarcerated individuals with HIV infection will receive antiretroviral therapy (ART) by test and treat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test and treatAll 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. | Other | Universal Test and Treat |
Primary outcome
Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT
Time frame: 2 years
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Derived from this study: PubMed 32763152Herce 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.
- Individual participant dataSharing planned: No
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
RecruitingObservational study
Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, Including Long-term Non-progressors
HIV
RecruitingPhase 1
Dasatinib for HIV-1 Reservoir Reduction
HIV Infections
RecruitingObservational study
Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants
HIV
RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Human Immunodeficiency Virus (HIV) Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Herce, MD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test and treat in people with HIV and Tuberculosis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946762, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.