Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia

HIV Clinical Trial

Official title:

Z 31601 - Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02905162
• Other study ID #: 16-0276
• Secondary ID: 1K01TW010272-01
• Status: Completed
• Start date: March 16, 2017
• Est. completion date: August 16, 2019

Study information

• Verified date: November 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To inform the design of a future transitional HIV care intervention for releasees, the study proposes to prospectively assess clinical outcomes for HIV-infected prisoners after release; explore factors from health behavior theory that are associated with post-release retention in care, with a special focus on Alcohol Use Disorders (AUDs); and conduct formative research to determine releasee and stakeholder knowledge, attitudes, and preferences surrounding transitional care interventions.

Description:

The study will enrol approximately 552 releasees from Lusaka Central Facility, Mwembeshi Correctional Facility, Kamwala Remand Centre, and Chainama Correctional Facility and Kabwe Correctional Complex. HIV care retention, mortality and changes in CD4 count and HIV-1 viral load at 6 month post-release information will be obtained from the SmartCare database.

Validated psychometric instruments will be used to assess AUD prevalence and alcohol use severity pre-incarceration, at release and about 3 to 6 months post-release. Using mixed-methods, effects of AUDs on retention in care at 3 and/or 6 months post-release will be estimated.

Sub-group analyses among HIV-infected individuals on ART and those enrolled in care but not yet on ART (i.e. pre-ART) will enable assessment of AUD effects on biological markers of HIV disease control and progression.

The Behavioural Model for Vulnerable Populations, and validated psychometric instruments, questionnaires, and in-depth interviews, factors beyond AUDs that may influence post-release retention in HIV care will be evaluated. Finally, preferred and relevant program elements for a future prisoner transitional HIV care pilot will be examined by conducting in-depth interviews with a purposive sample of approximately 26 HIV-infected releasees and leaders from the Zambian government and prominent implementing partner organizations, as well as focus group discussions with frontline prison officers, health workers, and representatives of leading civil society organizations in Zambia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 16, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Participant inclusion criteria

• Currently incarcerated a

• Release scheduled or otherwise anticipated within 30 days

• Has documented HIV infection

• Enrolled in the national HIV programme while in prison (i.e. receiving ART, receiving pre- ART care, or otherwise followed by the national HIV programme)

• If on treatment, has been receiving ART for approximately =3 months

• Plan to live in Lusaka Urban district after release

• Willing and able to provide locator information, including a reachable telephone number

• Willing and able to provide informed consent in Nyanja, Bemba, or English, including agreeing to be contacted by study staff after release and be followed for 6 mo. after discharge.

Participant exclusion criteria

• < 18 years of age

• Residing outside Lusaka district before incarceration

• Remandees awaiting trial who have been detained for less than 180 days

• Offenders being held at Lusaka Central Prison while awaiting appeal of a capital offence (e.g.murder or rape) or who have had their current sentence extended for violent behaviour during their period of incarceration.

Focus Group Discussion Participant Eligibility:

• Must be 18 years of age or older

• Working in Corrections or health as a corrections health manager, facility manager, or other corrections officers OR MOH clinician, nurse, physician or peer health educator OR member of a civil society or implementing partner organization working on corrections health.

• Able to provide verbal informed consent in English

Key Stakeholder in-depth Interview Participant eligibility criteria:

• Must be 18 years of age or older

• Involved in corrections and/or health policy making in Zambia

• Able to provide verbal informed consent in English

Related Conditions & MeSH terms

• Alcohol Use Disorders
• Alcoholism
• HIV

Intervention

Other:
• Transitional HIV care for prison releasees
Transitional HIV care program for releasees

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	John E. Fogarty International Center (FIC), National Institutes of Health (NIH)

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of prison releasees retained in care	number of participants known to be alive with at least one clinical encounter in the national HIV program documented	6 months post release
Secondary	Number virologically suppressed		6 months post release (release for ART-treated releasees)
Secondary	Change in CD4 count	for HIV-infected releasees not yet on ART	6 months post-release