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

Completed

• Conditions: Alcohol Use Disorders; HIV
• Interventions: Other: Transitional HIV care for prison releasees

• Registration Number: NCT02905162
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-19
• Study Start: 2017-03-16
• Primary Completion: 2019-08-16
• Study Completion: 2019-08-16
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV positive individuals incarcerated at Lusaka Central Prison	Transitional HIV care for prison releasees	Cohort of individuals scheduled for release within 30 days will be followed for 6 months post release

Primary Outcome Measures

Name	Time	Method
Number of prison releasees retained in care	6 months post release	number of participants known to be alive with at least one clinical encounter in the national HIV program documented

Secondary Outcome Measures

Name	Time	Method
Change in CD4 count	6 months post-release	for HIV-infected releasees not yet on ART
Number virologically suppressed	6 months post release (release for ART-treated releasees)

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia