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

NCT02905162 | Completed

• 2 other identifiers: 16-02761K01TW010272-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Alcohol Use Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number virologically suppressed

  6 months post release (release for ART-treated releasees)

• Change in CD4 count

  6 months post-release

Study Arms (1)

HIV positive individuals incarcerated at Lusaka Central Prison

Cohort of individuals scheduled for release within 30 days will be followed for 6 months post release

Other: Transitional HIV care for prison releasees

Interventions

Transitional HIV care for prison releasees OTHER

Transitional HIV care program for releasees

HIV positive individuals incarcerated at Lusaka Central Prison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-infected inmates who are scheduled for release, including those not yet qualifying for ART (pre-ART), those on ART based on Zambian Treatment Guidelines, and those who qualify for ART but who have refused to start treatment

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institutes of Health (NIH): collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Herce, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: March 16, 2017
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

ZA (1)