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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Change in HIV knowledge
Knowledge will focus on HIV treatment-related issues
Measured: 3-year follow-up
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.
- First posted19 May 2015 (estimated)
- Study startOct 2015
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan Lifson, MD, Principal investigator, University of Minnesota
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of a Community Support Worker Intervention for PLWH in Rural Ethiopia
- ClinicalTrials.gov ID
- NCT02448394
- Acronym / sponsor ID
- SHAMA / 1410S54203
- Conditions
- HIV
- Keywords
- community support workers, retention in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,799 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized community trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Community Support WorkerAt 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- new enrollment in HIV care at hospital or health clinic in the target region within the previous 3 months, and
- age >18 years
Key exclusion criteria (1 listed)
- inability to give consent because of physical or mental incapacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Support WorkerAt 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. | Other | Intervention |
Primary outcome
Retention in care
Time frame: 3-year follow-up
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).
2 secondary outcomes
Change in HIV knowledge
Time frame: 3-year follow-up
Change in HIV-related attitudes
Time frame: 3-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Derived from this study: PubMed 29688139Lifson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Lifson, MD principal investigator
University of Minnesota
5 sites in 1 country: see every site and its status.
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.