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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Case Management Intervention; Other: Control

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.

Secondary outcome measures time frames have been updated to add the 24-month time point for consistency with the pre-specified endpoints in the study protocol.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Mwanza, Tanzania
    • Nyamagana District Hospital
  • Mwanza, Tanzania
    • Bugando Medical Center
  • Mwanza, Tanzania
    • Bukumbi Hospital
  • Mwanza, Tanzania
    • Buzuruga Health Center
  • Mwanza, Tanzania
    • Evangelical Lutheran Church in Tanzania (ELCT) Health Centre
  • Mwanza, Tanzania
    • Igoma Health Centre
  • Mwanza, Tanzania
    • Karume Health Centre
  • Mwanza, Tanzania
    • Kwimba District Hospital
  • Mwanza, Tanzania
    • Misungwi District Hospital
  • Mwanza, Tanzania
    • Sekou Toure Hospital
  • Mwanza, Tanzania
    • Sengerema District Hospital
  • Mwanza, Tanzania
    • Seventh Day Adventist (SDA) Health Centre
  • Mwanza
    • Busisi, Mwanza, Tanzania
      • Busisi Health Center
    • Magu, Mwanza, Tanzania
      • Magu District Hospital
    • Nyamilama, Mwanza, Tanzania
      • Nyamilama Health Center
    • Sengerema, Mwanza, Tanzania
      • Sengerema Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: Control; Current routine HIV care in Tanzania.	Other: Control; Current routine HIV care in Tanzania.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participant Deaths in the First 12 Months Post-hospitalization	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Attended HIV Clinic	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.	3, 6, 9,12, and 24 months
ART Adherence	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, 6, 9, 12, and 24 months
Viral Suppression	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.	12 and 24 months
Traditional Health Beliefs	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.	Baseline,12, and 24 months
Self-Efficacy	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.	Baseline, 12, and 24 months
Stigma	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.	Baseline, 12, and 24 months
Social Support	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.	Baseline, 12, and 24 months
Perceived Need for HIV Services	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.	Baseline, 12, and 24 months
Physical Weakness	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.	Baseline, 12, and 24 months
Acceptability	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.	12 and 24 months
Incremental Cost of the Intervention	A microcosting analysis was conducted to identify the resources needed to implement and sustain the Daraja intervention and estimate the associated costs. Resource identification was accomplished primarily through in-person site visits and semi-structured interviews with relevant personnel. Nationally representative unit costs were assigned to the relevant resources. Resources were categorized as fixed start-up, time-dependent, or variable, and contextualized as being required for implementation or sustainment. The intervention implementation period was defined as the first 12 months following start-up, and consisted of the resources in all 3 of the aforementioned categories, and the sustainment period is intended to reflect a typical year following the implementation period, and consists of time-dependent and variable resources, given that the costs associated with fixed start-up resources become negligible over time. Incremental cost was reported as a number in 2023 USD.	12 months
Cost Per Life Saved	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	12 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Robert Peck, MD, Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Kisigo GA, Issarow B, Abel K, Hashim R, Okello ES, Ayieko P, Lee MH, Grosskurth H, Fitzgerald D, Peck RN, Kapiga S. A social worker intervention to reduce post-hospital mortality in HIV-infected adults in Tanzania (Daraja): Study protocol for a randomized controlled trial. Contemp Clin Trials. 2022 Feb;113:106680. doi: 10.1016/j.cct.2022.106680. Epub 2022 Jan 13.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Urogenital Diseases; Genital Diseases; HIV Infections
• Other Study ID Numbers: 1804019134; R01MH118107-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No