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HIVSHAMANCT02448394

Assessment of a Community Support Worker Intervention for Persons Living With HIV (PLWH) in Rural Ethiopia

A study testing Community Support Worker in people with HIV, run by University of Minnesota at 5 sites in Ethiopia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Community Support Worker
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,799 participants
Where
5 sitesEthiopia
Study dates
Oct 2015to 1 May 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • inability to give consent because of physical or mental incapacity

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Ethiopia5 sites
  • National Alliance of State and Territorial AIDS Directors

    Addis Ababa

  • Arba Minch Hospital

    Arba Minch, Snnpr

  • Butajira Hospital

    Butajīra, Snnpr

  • 29 Other Hospitals and Health Centers

    Multiple Towns, Snnpr

  • Sodo Hospital

    Sodo, Snnpr

Other trials in Ethiopia

About this study

Official title: Assessment of a Community Support Worker Intervention for PLWH in Rural Ethiopia

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.

Read the detailed description

As a critical gap in the HIV cascade of care in sub-Saharan Africa and elsewhere, many patients entering HIV care are lost to follow-up (LTFU), especially within the first 1-2 years. Many such patients die without treatment or return with advanced immune suppression. Our studies in Ethiopia indicate that HIV patients in rural settings (where HIV is increasingly treated) face multiple challenges that may impact retention in care and health status, including lack of knowledge about HIV treatment, internal and perceived stigma, social isolation, and poor access to the medical care system. Although HIV programs have used community support workers (CSWs) to address these and other challenges, evidence for efficacy of CSW programs is largely based on observational and single site studies, and factors associated with positive outcomes are not well understood.

During 2011-2012, we successfully implemented a pilot community intervention to support HIV patients in rural Ethiopia, using CSWs who were themselves HIV positive. Among HIV patients newly enrolled in care, LTFU was minimal, and clients had significant improvement in HIV knowledge, mental and physical quality of life, and perceived social support, with reduction in chronic symptoms and internal stigma.

Using an intervention grounded in the conceptual framework of social support as buffering against the negative effects of stressful events, we propose to rigorously evaluate a CSW intervention in a large multi-site community randomized trial. In Ethiopia's Southern Nations, Nationalities and Peoples' Region, 16 hospitals and 32 health centers will be randomized to intervention or control arms. For each intervention site, CSWs from that local area will be hired, trained, and assigned to HIV positive clients to provide in community settings: informational support (education/counseling); emotional support (to addressed internal and perceived stigma), companionship support (to reduce social isolation), and instrumental support (with increased access to the HIV clinical care system). 2,640 newly diagnosed HIV patients from these sites will receive a baseline assessment and will be followed for 36 months with yearly follow-up assessments with: (a) health surveys that include knowledge about HIV treatment, internal and perceived stigma, feelings of social support, and physical and mental health (quality of life), and (b) data from the clients' HIV Clinic record, including dates of clinic visits (to assess ongoing retention in care) clinical status, cluster of differentiation (CD4+) count and body mass index.

We hypothesize that compared to HIV patients in the control arm, those in the intervention arm will have reduced LTFU from HIV clinical care over 36 months of follow-up (Aim 1), and increased knowledge, feelings of social support, and health status, and decreased feelings of internal/perceived stigma and social isolation (Aim 2). We will also evaluate the extent to which factors in Aim 2 are predictive of retention in care (Aim 3). These results will have strong research implications to improve community programs to strengthen the HIV care continuum and decentralized HIV care not only in Ethiopia, but many other resource-limited settings.

Conditions
HIV
Being tested
Community Support Worker
Keywords
community support workers, retention in care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02448394
Study groupRoleWhat they receive
InterventionExperimentalAt 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.
Receives: Other: Community Support Worker
Standard of CareNo interventionAt 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 3-year follow-up

Secondary outcomes (2)
  1. Change in HIV knowledge

    Knowledge will focus on HIV treatment-related issues

    Measured: 3-year follow-up

  2. Change in HIV-related attitudes

    Questions will be asked about a variety of attitudes, including those related to internalized HIV stigma and perceived social support.

    Measured: 3-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion1 May 2020
  4. Study completion1 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized community trial
Masking
Single blind
Who is masked
Investigator
Enrolment
1,799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02448394
Sponsor's protocol ID
1410S54203
Acronym
SHAMA
Status last verified
Nov 2020
First submitted
14 May 2015
Last updated
10 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29688139

Questions about this trial

What is this clinical trial studying?

A study testing Community Support Worker in people with HIV, run by University of Minnesota at 5 sites in Ethiopia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention in care (time frame: 3-year follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02448394, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.

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