N/A
N=500
Reducing Post-Hospital Mortality in HIV-infected Adults in Tanzania
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03858998 ↗Enrolled (actual)
500
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participant Deaths in the First 12 Months Post-hospitalization — 43; 42 Participants — p=0.91
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Case Management Intervention (Other); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant Deaths in the First 12 Months Post-hospitalization |
43; 42 | 0.91 |
| SECONDARY Number of Participants Who Attended HIV Clinic |
215; 187; 190; 160; 180; 158 | — |
| SECONDARY ART Adherence |
95.1; 94.6; 95.7; 91.6; 90.9; 93.0 | — |
| SECONDARY Viral Suppression |
162; 139; 153; 134 | — |
| SECONDARY Traditional Health Beliefs |
0.53; 0.44; 0.81; 0.89; 1.10; 1.31 | — |
| SECONDARY Self-Efficacy |
22.42; 22.39; 22.65; 21.47; 22.48; 20.50 | — |
| SECONDARY Stigma |
2.32; 2.28; 2.12; 2.24; 2.16; 2.27 | — |
| SECONDARY Social Support |
34.84; 34.74; 33.02; 32.59; 33.16; 31.66 | — |
| SECONDARY Perceived Need for HIV Services |
1.90; 1.94; 1.85; 1.86; 1.90; 1.91 | — |
| SECONDARY SF-12 Health Survey: Physical and Mental Health |
37.52; 37.15; 45.08; 44.76; 50.59; 51.15 | — |
| SECONDARY Acceptability |
20; 20; 20; 20; 20; 20 | — |
| SECONDARY Incremental Cost of the Intervention |
22; 0; 17; 0 | — |
| SECONDARY Cost Per Life Saved |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03858998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.