NCT02448394

Brief Summary

This study, to be conducted in southern Ethiopia, is a randomized community trial, evaluating the use of local community support workers who provide for HIV patients education, counseling/social support, and linkage to the HIV Clinic. Patients will be followed for at least three years, with a primary goal of improving retention in HIV care, and secondary goals of improving client knowledge, attitudes about being HIV-positive, feelings of social support and clinical health status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,799

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable hiv

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4.6 years

First QC Date

May 14, 2015

Last Update Submit

November 9, 2020

Conditions

HIV

Keywords

community support workersretention in care

Outcome Measures

Primary Outcomes (1)

  • Retention in care

    Retention in HIV care will be defined as the fraction of all patients initiating care who continue to be alive and access HIV care (i.e., minus those who die, transfer to another care facility, or are lost to follow-up).

    3-year follow-up

Secondary Outcomes (2)

  • Change in HIV knowledge

    3-year follow-up

  • Change in HIV-related attitudes

    3-year follow-up

Study Arms (2)

Intervention

EXPERIMENTAL

At each of the intervention sites, all newly enrolled participants will have an HIV community support worker (CSW) assigned them. Strong preference will be given to matching CSWs and clients from the same kebele (village or neighborhood of residence). CSW responsibilities include: education on HIV treatment and health promoting behaviors, social support/counseling, facilitated communication with the HIV clinic, referrals as needed for other support needs.

Other: Community Support Worker

Standard of Care

NO INTERVENTION

At control sites, patients will receive standard of care facility-based medical care and counseling, consistent with general standards of care offered to HIV patients throughout the country as determined by the Ethiopian Ministry of Health.

Interventions

Community Support WorkerOTHER

At each of the intervention sites, all newly enrolled participants will have an HIV community support worker (CSW) assigned them. CSW responsibilities include: education on HIV treatment and health promoting behaviors, social support/counseling, facilitated communication with the HIV clinic, referrals as needed for other support needs.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • new enrollment in HIV care at hospital or health clinic in the target region within the previous 3 months, and
  • age \>18 years

You may not qualify if:

  • inability to give consent because of physical or mental incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arba Minch Hospital

Arba Minch, Snnpr, Ethiopia

Location

Butajira Hospital

Butajīra, Snnpr, Ethiopia

Location

29 Other Hospitals and Health Centers

Multiple Towns, Snnpr, Ethiopia

Location

Sodo Hospital

Sodo, Snnpr, Ethiopia

Location

National Alliance of State and Territorial AIDS Directors

Addis Ababa, Ethiopia

Location

Related Publications (1)

  • Lifson AR, Workneh S, Hailemichael A, MacLehose RF, Horvath KJ, Hilk R, Fabian L, Sites A, Shenie T. A multi-site community randomized trial of community health workers to provide counseling and support for patients newly entering HIV care in rural Ethiopia: study design and baseline implementation. HIV Clin Trials. 2018 Jun;19(3):112-119. doi: 10.1080/15284336.2018.1461999. Epub 2018 Apr 24.

    PMID: 29688139DERIVED

Study Officials

  • Alan Lifson, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Study investigators (except statistician and data manager) blinded to interim outcome results by study arm.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized community trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 19, 2015

Study Start

October 1, 2015

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

ET(5)