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 : May 18, 2020
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Condition or disease | Intervention/treatment | Phase |
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HIV Infections | Other: Case Management Intervention Other: Control | Phase 3 |
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 |

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

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

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
Contact: Lindsey Reif, MPH | 646-962-8140 | lir2020@med.cornell.edu |
Tanzania | |
Bugando Medical Center | Recruiting |
Mwanza, Tanzania | |
Contact: Bernard Desderius, MD | |
Bukumbi Hospital | Recruiting |
Mwanza, Tanzania | |
Contact: Phinias Makubi, MD +255 786 072 071 | |
Buzuruga Health Center | Recruiting |
Mwanza, Tanzania | |
Contact: Florian Tinuga, MD +255282981196 md@ilemelamc.go.tz | |
Evangelical Lutheran Church in Tanzania (ELCT) Health Centre | Recruiting |
Mwanza, Tanzania | |
Contact: Richard Mbwambo, MD +255 75444379 | |
Igoma Health Centre | Recruiting |
Mwanza, Tanzania | |
Contact: Illuminata Kafumu, MD +255 712447655 | |
Karume Health Centre | Recruiting |
Mwanza, Tanzania | |
Contact: Samia Nuru, MD +255 756 388 999 | |
Kwimba District Hospital | Recruiting |
Mwanza, Tanzania | |
Contact: Tumaini Ringo, MD +255 752 127 351 | |
Misungwi District Hospital | Recruiting |
Mwanza, Tanzania | |
Contact: Judith Kiwango, MD +255 765 057 142 | |
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 | |
Sengerema District Hospital | Recruiting |
Mwanza, Tanzania | |
Contact: Marie-Jose Voeten, MD +255 755 643 680 srmariejosecb@gmail.com | |
Seventh Day Adventist (SDA) Health Centre | Recruiting |
Mwanza, Tanzania | |
Contact: Godfrey Mabuba, MD +255 756 141 593 |
Principal Investigator: | Robert Peck, MD | Weill Cornell Medicine |
Responsible Party: | Weill Medical College of Cornell University |
ClinicalTrials.gov Identifier: | NCT03858998 |
Other Study ID Numbers: |
1804019134 R01MH118107-01 ( U.S. NIH Grant/Contract ) |
First Posted: | March 1, 2019 Key Record Dates |
Last Update Posted: | May 18, 2020 |
Last Verified: | May 2020 |
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). |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |