Sustainable East Africa Research in Community Health (SEARCH)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Hypertension; Diabetes; Tuberculosis; HIV; Maternal Child Health; Cost Effectiveness

Treatments: Other: Targeted PrEP and Targeted testing interventions; Other: Universal ART in a streamlined care model; Other: Baseline community-based HIV and multi-disease testing; Other: Annual Community Health Campaigns

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry; NIH

Identifiers

NCT01864603

SEARCH

Details and patient eligibility

About

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".

Full description

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".

Enrollment: 150,395 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150,395 participants in 2 patient groups

1st: universal test and treat; 2nd: targeted PrEP and cascade

Experimental group

Description:

Intervention arm first phase: annual universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery Intervention arm second phase: baseline universal community-based HIV and multi-disease testing; ART for all HIV+ using streamlined care delivery + targeted PrEP, and targeted HIV testing interventions

Treatment:

Other: Universal ART in a streamlined care model

Other: Annual Community Health Campaigns

Other: Targeted PrEP and Targeted testing interventions

1st: baseline community testing; 2nd: None

Active Comparator group

Description:

Comparator arm first phase: baseline community-based HIV and multi-disease testing; ART by country standard of care

Treatment:

Other: Universal ART in a streamlined care model

Other: Baseline community-based HIV and multi-disease testing