N/A
Completed N=150,395
Sustainable East Africa Research in Community Health
Source: ClinicalTrials.gov NCT01864603 ↗Enrolled (actual)
150,395
Serious AEs
2.0%
Results posted
Mar 2022
Primary outcomePrimary: Cumulative HIV Incidence — 0.77; 0.81 cumulative events per 100 persons
Summary
The SEARCH study aims to test evidenced-based innovative community based interventions that lead to the elimination of HIV in rural communities in East Africa using a multi-disease approach. The first phase of the study will quantify the impact of early HIV diagnosis using a streamlined and immediate ART (antiretroviral therapy). The second phase of the study, will quantify the impact of targeted Pre-Exposure Prophylaxis (PrEP) in the context of universal treatment and streamlined care. The study intervention is designed to improve the entire continuum of care, to reduce structural barriers for all populations including those most "at risk".
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cumulative HIV Incidence |
0.77; 0.81 | — |
| PRIMARY HIV Incidence |
0.35; 0.92 | — |
| SECONDARY Incident TB Associated With HIV |
3.7; 4.6 | — |
| SECONDARY Overall Mortality |
3.0; 3.9 | — |
| SECONDARY HIV-free Infant Survival |
96.7; 93.6 | — |
| SECONDARY Percent of HIV+ Adults With HIV RNA <=500 c/mL |
79; 68 | — |
| SECONDARY Time in Care for HIV+ Adults With Baseline Viremia |
81; 73 | — |
| SECONDARY Cumulative Incidence of ART-initiation |
83; 50 | — |
| SECONDARY Hypertension Control |
47; 37 | — |
| SECONDARY Adherence to PrEP Treatment |
3282 | — |
| SECONDARY Average Adults' on- and Off-farm Employment |
85.5; 82.4 | — |
| SECONDARY Year 3 Viremia Among ART-experienced Persons With Baseline Viremia |
67; 47 | — |
| SECONDARY Linkage to Care |
41; 24 | — |
| SECONDARY HIV Incidence Rate |
0.43; 0.31 | — |
| SECONDARY Prevalence of Transmitted HIV Drug-resistance Mutations |
8; 11 | — |
| SECONDARY Prevalence of Chronic Kidney Disease (CKD) |
361; 248 | — |
| SECONDARY Total Costs of Programming (ART) |
291; 221 | — |
Eligibility Criteria
Community Level Inclusion Criteria:
- Non-adjacent geopolitical units in south-western and eastern Uganda and western Kenya.
- Most recent census population between 9, 000 and 11,000 individuals.
- Served by an ART providing health center.
- Community leader commitment for study participation and implementation.
- Accessibility to health center via a maintained transportation route.
- Community location with sufficient distance from other potential study communities to limit contamination of intervention or control conditions (buffer zone)
Individual Level Inclusion Criteria:
- Residency of individual in community, defined as present in household for at least 6 months of the calendar year.
Community Level Exclusion Criteria:
- Presence of ongoing community-based ART intervention strategies that provide treatment outside of the current in-country treatment guidelines.
- An urban setting defined as a city with a population of 100,000 or more inhabitants.
- Absence of a health center able to provide ART.
Data sourced from ClinicalTrials.gov (NCT01864603). 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. Informational only — not medical advice.