Trials / Completed
CompletedNCT02905162
Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
Z 31601 - Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Transitional HIV care for prison releasees | Transitional HIV care program for releasees |
Timeline
- Start date
- 2017-03-16
- Primary completion
- 2019-08-16
- Completion
- 2019-08-16
- First posted
- 2016-09-19
- Last updated
- 2019-11-20
Locations
1 site across 1 country: Zambia
Source: ClinicalTrials.gov record NCT02905162. Inclusion in this directory is not an endorsement.