Enhanced care package to improve survival in advanced HIV disease
A Community-based Phase III, Cluster Randomized Trial of Point-of-care CD4 Testing and Enhanced Screening and Prophylaxis in Advanced HIV Disease
This study is testing if a better care package can help people with advanced HIV in Uganda live longer compared to the usual care they receive.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Makerere University Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT05085171 on ClinicalTrials.gov |
What this trial studies
This Phase III, cluster randomized trial aims to evaluate the survival benefit of an enhanced package of care for patients with advanced HIV disease in Uganda. The study will involve HIV-infected adults with CD4 counts below 200 cells/µL and will compare an enhanced care package, including point-of-care CD4 testing and opportunistic infection prophylaxis, against standard care. Over a duration of 5 years, the trial will assess 24-week survival rates and retention in care among participants. The enhanced package includes innovative screening and treatment options for opportunistic infections.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with advanced HIV disease characterized by a CD4 count of less than 200 cells/µL.
Not a fit: Patients who are virologically suppressed or unable to attend regular clinic visits may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of care for patients with advanced HIV disease.
How similar studies have performed: Other studies have shown success with enhanced care packages in HIV management, suggesting potential for positive outcomes in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * CD4\<200 cells/µL * Ability and willingness to give informed consent for the enhanced package of care arm. Exclusion Criteria: * Known virologic suppression (viral load \<1000 copies/mL) within prior 3 months * Cannot or unlikely to attend regular clinic visits
Where this trial is running
Kampala
- kisugu health center IV — Kampala, Uganda (Recruiting)
Study contacts
- Study coordinator: Radha Rajasingham, MD
- Email: radha@umn.edu
- Phone: 612 626-8171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.