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Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania

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ClinicalTrials.gov Identifier: NCT03858998
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults.

Condition or disease Intervention/treatment Phase
HIV Infections Other: Case Management Intervention Other: Control Phase 3

Detailed Description:
This research is being done to assess the efficacy of a case management intervention to improve the one year mortality rate of hospitalized, HIV-infected, Tanzanian adults. The study is being conducted at hospitals in Mwanza, Tanzania. 500 participants will be enrolled: 250 will be randomized to the case management intervention and 250 will randomized to routine clinical care. The case management intervention consists of 5 sessions over 90 days, and is designed to link hospitalized, HIV-infected patients to long term care at an HIV clinic. Participants will be followed for two years in order to evaluate primary and secondary study objectives.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Case Management Intervention
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
Other: Case Management Intervention
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.

Other: Control
Current routine HIV care in Tanzania.

Control
Current routine HIV care in Tanzania.
Other: Control
Current routine HIV care in Tanzania.




Primary Outcome Measures :
  1. Number of participant deaths in the first 12 months post-hospitalization [ Time Frame: 12 months ]
    The number of participants who die in the first 12 months post-hospitalization will be recorded. Death will be determined by phone calls to relatives and will be confirmed by verbal autopsies, obituaries, hospital records, or death certificates.


Secondary Outcome Measures :
  1. Number of participants who attended HIV clinic [ Time Frame: 3, 6, 9, and 12 months ]
    HIV clinic attendance will be monitored by review of HIV clinic records. HIV clinic attendance is defined as alive and attended clinic within a window of 90 days (+/- 45 days) around the time points.

  2. ART adherence [ Time Frame: 3, 6, 9, and 12 months ]
    ART adherence will be assessed using the ACTG 4-Day ART Recall Questionnaire. Adherence will be calculated as a percentage, using 1 - (number of missed doses/number of prescribed doses).

  3. Viral suppression [ Time Frame: 12 months ]
    Suppressed viral load will be defined as a binary outcome based upon the WHO definition of viral suppression as a plasma HIV-1 RNA level <1000 copies/µl.

  4. Traditional Health Beliefs [ Time Frame: Baseline and 12 months ]
    Traditional health beliefs will be assessed at baseline and after 12 months using the HIV Insights and Beliefs Scale, scored from 0 to 6, where higher scores indicate more traditional health beliefs.

  5. Self-Efficacy [ Time Frame: Baseline and 12 months ]
    Self-efficacy will be assessed at baseline and after 12 months using the HIV Adherence Self-Efficacy Scale, scored from 0 to 25, where higher scores indicate a higher level of self-efficacy.

  6. Stigma [ Time Frame: Baseline and 12 months ]
    Stigma will be assessed at baseline and after 12 months using questions based off the AIDS-Related Stigma Scale, scored from 0 to 8, where higher scores indicate a higher level of perceived stigma.

  7. Social Support [ Time Frame: Baseline and 12 months ]
    Social support will be assessed at baseline and after 12 months using the SPS-10 Scale, scored from 0 to 40, where higher scores indicate a higher level of social support.

  8. Perceived Need for HIV Services [ Time Frame: Baseline and 12 months ]
    Perceived need for HIV services will be assessed at baseline and after 12 months using the ART Medications Attitude Scale, scored from 0 to 4, where higher scores indicate a lower perceived need for HIV services.

  9. Physical Weakness [ Time Frame: Baseline and 12 months ]
    Physical weakness will be assessed at baseline and after 12 months using the SF-12 Health Survey. The SF-12 measures physical health, scored from 0 to 100, with higher scores indicating greater physical health.

  10. Acceptability [ Time Frame: 12 months ]
    Qualitative interviews will be conducted with a sub-set of participants to evaluate the acceptability of the intervention. The sub-set will be comprised of 20 intervention participants, 20 routine care control participants, and 20 healthcare workers (nurses and physicians). The interviews will be conducted by trained qualitative research assistants and will focus on the issues central to the intervention including traditional health beliefs, self-efficacy, stigma, social support, and perceived need for HIV services.

  11. Incremental cost of the intervention [ Time Frame: 12 months ]
    Healthcare service utilization will be summarized for each arm as descriptive counts such as number of HIV care visits, home visits, laboratory tests, medications, and hospitalizations. Unit costs will be determined for each type of service unit by applying labor rates and materials costs available from the study hospital, and other expense costs available from previous studies. Unit costs will be multiplied by service utilization to calculate healthcare costs. Resources spent on research activities will be excluded. Costs will be reported from the healthcare sector perspective. All data will be analyzed under an intent-to-treat principle.

  12. Cost per life saved [ Time Frame: 12 months ]
    The difference in costs between the arms from the healthcare perspective will be compared to the observed difference in survival between the arms to calculate incremental cost per life saved. Parametric methods based on parameters obtained from bootstrapping will be used to estimate an acceptability curves, which will illustrate the probability that the intervention is a good value for different willingness-to-pay thresholds



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • HIV-infected
  • ART (anti-retroviral therapy) naïve or have been on ART but have not used ART for > 7 days
  • Lives in the region of Mwanza
  • Able to be referred to an HIV clinic inside the region of Mwanza
  • Has mobile phone or access to mobile phone
  • Planning to stay in the region of Mwanza for the next 24 months
  • Able to speak Kiswahili or English
  • Capable and willing to provide informed consent
  • Willing to provide locator information and two designated contact persons
  • Willing to have a home visits from a study team member

Exclusion Criteria

  • Pregnant
  • On anti-retrovirals at hospital admission and already linked to an HIV clinic
  • Medical, psychiatric or psychological condition that, in the opinion of the site investigator, would interfere with completion of study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858998


Contacts
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Contact: Lindsey Reif, MPH 646-962-8140 lir2020@med.cornell.edu

Locations
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Tanzania
Bugando Medical Center Recruiting
Mwanza, Tanzania
Contact: Bernard Desderius, MD         
Buzuruga Health Center Recruiting
Mwanza, Tanzania
Contact: Florian Tinuga, MD    +255282981196    md@ilemelamc.go.tz   
Nyamagana District Hospital Recruiting
Mwanza, Tanzania
Contact: Juma Mfanga, MD    +255282501375    cd@mwanzacc.go.tz   
Sekou Toure Hospital Recruiting
Mwanza, Tanzania
Contact: Bahati Msaki, MD    +255282502171    sekoutourerrh@afya.go.tz   
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Robert Peck, MD Weill Cornell Medicine

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03858998     History of Changes
Other Study ID Numbers: 1804019134
R01MH118107-01 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

The final dataset will include de-identified data on demographic characteristics, medical history, psychosocial measures, survival, HIV clinic linkage and retention, ART adherence, HIV viral loads, health economic variables and acceptability. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Therefore, we will make the dataset available to users under a data-sharing agreement that includes the following: a commitment to use the data for research purposes and not participant identification, commitment to securing the data with appropriate password protected IT practices, and a commitment to destroying the data after analyses are completed.

For published data, the de-identified individual participant data that underlie the results reported in the article (text, tables, figured, appendices) will be available.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal to achieve aims in the protocol. Proposals should be directed to the Principal Investigator (rnp2002@med.cornell.edu).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases