HIViSTARNCT03018002
Intervention for Sustained Testing and Retention Among HIV-infected Patients
A study testing iSTAR in people with HIV, run by University of Nevada, Las Vegas at 1 site in Nigeria.
Trial summary
The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- iSTAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteNigeria
- Study dates
- Jul 2016to Mar 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HIV-infected pregnant women identified during baby showers programs at participating worship centers.
Who cannot join
- HIV-infected women already on treatment
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Catholic Caritas Foundation
Makurdi, Benue State
John Olawepo, MD, MSc, +234-805 564 8788, jolawepo@ccfng.org
Echezona Ezeanolue, MD, MPH
About this study
The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.
Read the detailed description
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.
- Conditions
- HIV
- Being tested
- iSTAR
- Keywords
- HIV, PMTCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iSTAROther
Each component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up.
CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection. |
| iSTAR | Experimental | HIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team. Receives: Other: iSTAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage in care
Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.
Measured: 1 month
Retention in care
Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.
Measured: 12 months
Secondary outcomes (2)
ART Initiation
The secondary outcome is engagement in care defined as the percentage of participants initiated on ART at 1 month following enrollment.
Measured: 1 month
Viral Suppression
Viral suppression is defined as the percentage of participants whose most recent two viral load are <20 copies/mL.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Echezona Ezeanolue, University of Nevada, Las Vegas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018002
- Sponsor's protocol ID
- 845695-4
- Other IDs
- R01HD087994-01
- Acronym
- iSTAR
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
PubMed 23758933
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Sustained Testing and Retention Among HIV-infected Patients
- ClinicalTrials.gov ID
- NCT03018002
- Acronym / sponsor ID
- iSTAR / 845695-4
- Conditions
- HIV
- Keywords
- HIV, PMTCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jul 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 11 Jan 2017 (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.
The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.
Detailed description
Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –HIV-infected participants identified from the churches randomized to CG will be referred to PEPFAR-supported HIV clinics that provide comprehensive care including counseling, laboratory testing, ART and ongoing support during treatment as the standard of care. The study team will not be involved in their care beyond data collection. |
| iSTAR | Experimental | Other: iSTARHIV-infected participants identified from the churches clustered within the randomized health facilities will receive interventions from the study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-infected pregnant women identified during baby showers programs at participating worship centers.
Key exclusion criteria (1 listed)
- HIV-infected women already on treatment
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 |
|---|---|---|
| iSTAREach component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up. CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results. | Other | iSTAR |
Primary outcome
Linkage in care
Time frame: 1 month
Linkage in care is defined as the percentage of participants with at least one HIV medical care visit following HIV diagnosis.
Retention in care
Time frame: 12 months
Retention is defined as the percentages of participants with two or more documented viral load measurement during the 12 months following enrollment.
2 secondary outcomes
ART Initiation
Time frame: 1 month
Viral Suppression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Background: PubMed 23758933Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iSTAR in people with HIV, run by University of Nevada, Las Vegas at 1 site in Nigeria.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Echezona Ezeanolue, MD, MPH (7028952687, echezona.ezeanolue@unlv.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage in care (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT03018002, 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 11 Jan 2017.