HIVNCT02905162
Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
An observational study of HIV and Alcohol Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Alcohol Use Disorders
- What is being tested?
- Transitional HIV care for prison releasees
- How many people
- 300 participants
- Where
- 1 siteZambia
- Study dates
- 16 Mar 2017to 16 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Z 31601 - Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
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.
Read the 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
- HIV, Alcohol Use Disorders
- Being tested
- Transitional HIV care for prison releasees
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional HIV care for prison releaseesOther
Transitional HIV care program for releasees
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Transitional HIV care for prison releasees |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months post release
Secondary outcomes (2)
Number virologically suppressed
Measured: 6 months post release (release for ART-treated releasees)
Change in CD4 count
for HIV-infected releasees not yet on ART
Measured: 6 months post-release
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start16 Mar 2017
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor
- Investigators
- Michael Herce, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905162
- Sponsor's protocol ID
- 16-0276
- Other IDs
- 1K01TW010272-01
- Status last verified
- Nov 2019
- First submitted
- 14 Sep 2016
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z 31601 - Understanding Longitudinal Clinical Outcomes and Post-release Retention in Care Among HIV-infected Prisoners in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT02905162
- Acronym / sponsor ID
- 16-0276
- Conditions
- HIV, Alcohol Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Fogarty International Center of the National Institute of Health
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive individuals incarcerated at Lusaka Central Prison | – | Other: Transitional HIV care for prison releaseesCohort of individuals scheduled for release within 30 days will be followed for 6 months post release |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transitional HIV care for prison releaseesTransitional HIV care program for releasees | Other | HIV positive individuals incarcerated at Lusaka Central Prison |
Primary outcome
Number of prison releasees retained in care
Time frame: 6 months post release
number of participants known to be alive with at least one clinical encounter in the national HIV program documented
2 secondary outcomes
Number virologically suppressed
Time frame: 6 months post release (release for ART-treated releasees)
Change in CD4 count
Time frame: 6 months post-release
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Herce, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Alcohol Use Disorders, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of prison releasees retained in care (time frame: 6 months post release). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.