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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03858998
• Other study ID #: 1804019134
• Secondary ID: R01MH118107-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Case Management Intervention
A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
• Control
Current routine HIV care in Tanzania.

Locations

Country	Name	City	State
Tanzania	Busisi Health Center	Busisi	Mwanza
Tanzania	Magu District Hospital	Magu	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	Nyamagana District Hospital	Mwanza
Tanzania	Sekou Toure Hospital	Mwanza
Tanzania	Sengerema District Hospital	Mwanza
Tanzania	Seventh Day Adventist (SDA) Health Centre	Mwanza
Tanzania	Nyamilama Health Center	Nyamilama	Mwanza
Tanzania	Sengerema Health Center	Sengerema	Mwanza

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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