TasP in Correctional Facilities
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|ClinicalTrials.gov Identifier: NCT02946762|
Recruitment Status : Completed
First Posted : October 27, 2016
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Tuberculosis||Other: Test and treat||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Z 31501 - Treatment as Prevention (TasP) in Correctional Facilities in Zambia and South Africa|
|Actual Study Start Date :||February 1, 2016|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||March 31, 2018|
Universal Test and Treat
All incarcerated individuals with HIV infection will receive antiretroviral therapy (ART) by test and treat.
Other: Test 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.
- Proportion of inmates with HIV-infection who were assessed for and offered ART initiation under TasP/UTT [ Time Frame: 2 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02946762
|Lusaka Central Corrections ART Clinic|
|Principal Investigator:||Michael Herce, MD, MPH||University of North Carolina, Chapel Hill|