Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01926379
Status:
COMPLETED
Last Update Posted:
2021-07-13
First Post:
2013-08-05
Brief Title:
ENhance Initiation and Retention in Isoniazid Preventive Therapy IPT Care for HIV Study ENRICH Study
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
A Combination Intervention Package for Isoniazid Preventive Therapy in Ethiopia
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENRICH
Brief Summary:
The purpose of the ENRICH study is to evaluate a combination intervention package CIP designed to improve implementation of Isoniazid Preventive Therapy IPT among people living with HIV PLWH in Ethiopia The study is a two-arm cluster randomized trial randomized at the HIV clinic level which includes 10 HIV clinics in Dire Dawa and Harari Ethiopia Clinics are randomized to deliver the combination intervention package CIP or standard of care SOC with stratification by facility size 80 or 80 patients enrolled in HIV care per year The experimental intervention will be delivered to all patients in HIV clinics randomly assigned to CIP who initiated HIV care at the CIP site on or after January 1 2013 and initiated IPT on or after date of study initiation July 1 2013 In HIV clinics assigned to SOC usual care procedures for provision of IPT will be delivered
Study Aims and Hypotheses
Aim 1 Characterize and compare the effectiveness of a combination intervention package with standard of care for IPT provision in Ethiopia
Hypothesis 11 IPT initiation for new patients enrolling in HIV care at CIP clinics will be higher than that for newly enrolled patients at SOC clinics
Hypothesis 12 Adherence to and completion of IPT for participants initiating IPT at CIP clinics will be higher than that for those initiating IPT at SOC clinics
Aim 1a Assess acceptability of CIP among participants enrolled in HIV care and healthcare providers at CIP clinics Acceptability will include 1 perceived barriers and facilitators of uptake and delivery of the intervention package among healthcare providers and 2 acceptability and utilization of intervention components as well as the overall intervention package among IPT initiators and non-initiators
Aim 2 Assess the impact of CIP compared with SOC on HIV-related outcomes
Hypothesis 2 HIV-related outcomes for participants receiving IPT at CIP clinics will be superior to outcomes in participants receiving care at SOC clinics HIV-related outcomes to be assessed include retention in care and among those participants receiving antiretroviral therapy ART adherence to ART and CD4 count
Aim 3 Assess the safety and tolerability of IPT among HIV-infected individuals under routine program conditions in Ethiopia
Aim 4 Identify patient and program characteristics associated with IPT adherence and completion at SOC sites
Hypothesis 41 IPT adherence and completion will be associated with modifiable patient characteristics including ART status knowledge and attitudes about IPT and social support
Hypothesis 42 IPT adherence and completion will be associated with modifiable program characteristics including providerpatient ratio patient tracking and patient support groups
Study Aims and Hypotheses
Aim 1 Characterize and compare the effectiveness of a combination intervention package with standard of care for IPT provision in Ethiopia
Hypothesis 11 IPT initiation for new patients enrolling in HIV care at CIP clinics will be higher than that for newly enrolled patients at SOC clinics
Hypothesis 12 Adherence to and completion of IPT for participants initiating IPT at CIP clinics will be higher than that for those initiating IPT at SOC clinics
Aim 1a Assess acceptability of CIP among participants enrolled in HIV care and healthcare providers at CIP clinics Acceptability will include 1 perceived barriers and facilitators of uptake and delivery of the intervention package among healthcare providers and 2 acceptability and utilization of intervention components as well as the overall intervention package among IPT initiators and non-initiators
Aim 2 Assess the impact of CIP compared with SOC on HIV-related outcomes
Hypothesis 2 HIV-related outcomes for participants receiving IPT at CIP clinics will be superior to outcomes in participants receiving care at SOC clinics HIV-related outcomes to be assessed include retention in care and among those participants receiving antiretroviral therapy ART adherence to ART and CD4 count
Aim 3 Assess the safety and tolerability of IPT among HIV-infected individuals under routine program conditions in Ethiopia
Aim 4 Identify patient and program characteristics associated with IPT adherence and completion at SOC sites
Hypothesis 41 IPT adherence and completion will be associated with modifiable patient characteristics including ART status knowledge and attitudes about IPT and social support
Hypothesis 42 IPT adherence and completion will be associated with modifiable program characteristics including providerpatient ratio patient tracking and patient support groups
Detailed Description:
The study intervention combination intervention package CIP will contain programmatic structural and psychosocial components including 1 health care provider training and mentorship in IPT provision using a clinical algorithm 2 identification of HIV-infected family members eligible for IPT using a family care enrollment form 3 review of monitoring data on IPT initiation and adherence during monthly multidisciplinary team meetings 4 reimbursement of transportation costs to patients for monthly clinic visits and 5 real-time adherence support using interactive voice response IVR via mobile phones and trained peer educators
Data will be collected from all HIV-infected patients enrolled in HIV care at study sites on or after January 1 2013 from a subset of patients who initiate IPT and enroll into a measurement cohort MC and from program characteristics surveys conducted at the study sites Routine clinic data from all HIV-infected patients enrolled in HIV care at the 10 participating clinics on or after January 1 2013 will be used to measure the following outcomes IPT initiation completion of IPT and retention in HIV care These data will be collected by Research Assistants RA by abstracting the following information from the clinic Pre-ART ART antiretroviral therapy and IPT registers during the period of observation on all HIV patients who enrolled in care at a study site on or after January 1 2013 date of enrollment in HIV care IPT initiation yesno date of ART initiation if applicable IPT outcomes completion default death stopped transferred out TB tuberculosis screening results TB treatment yesno TB treatment outcomes if applicable and retention in HIV care
A measurement cohort of 500 HIV-infected patients initiating IPT on or after July 1 2013 will be recruited from the 10 clinics n250 per study arm MC participants will be assessed at baseline enrollment and monthly intervals for six to nine months depending on the duration of IPT Outcomes to be measured among MC participants include adherence to IPT adherence to ART if applicable change in CD4 count and side effectsadverse events MC participants at both SOC and CIP sites will receive the same assessments RAs will administer assessments on the day of regularly scheduled clinic visits including a Baseline interview administered on the day of enrollment which coincides with the day the participant initiates IPT monthly follow-up interviews completed throughout IPT and an end of treatment interview that is completed on the day the participant ends IPT Participants who miss a study visit will be contacted by study staff and administered the questionnaire over the phone within a 1-week window period of the scheduled clinic visit RAs will also call the MC participants between clinic visits to conduct unannounced pill counts to assess medication adherence In addition 30 MC participants from CIP sites will participate in a qualitative interview to assess feasibility and acceptability of the Interactive Voice Response IVR system one of the interventions in place at CIP sites Also three groups will be recruited from CIP clinics to participate in in-depth interviews IPT initiators from among participants in the Measurement Cohort n 15 IPT non-initiators n15 and healthcare providers nurses and peer educators n13 In-depth interviews will assess acceptability and preferences of intervention components as well as reasons for IPT non-initiation
RAs will conduct an assessment of programmatic activities at each HIV clinic prior to study implementation and on a monthly basis thereafter throughout the study period Clinics in both conditions will receive the same assessments The RA will administer a brief semi-structured Program Characteristics survey to the ART nurse who will be most familiar with the day-to-day operations of the HIV clinic The survey will assess nurse training and mentorship in IPT initiation and HIV treatment availability and use of an IPT clinical algorithm IPT and ART adherence training for peer educators PEs IPT health education for patients availability and use of an IPT treatment literacy curriculum including a flip chart used by PEs reimbursement for transportation costs for patients provision of mobile phones subscriber identification module SIM cards and airtime vouchers for HIV patients on IPT use of IVR messages for medication and appointment reminders and assessment of medication adherence and side effects and provision of community-based adherence and side effect monitoring by PEs These data will be used to assess fidelity with the intervention at CIP sites as well as to measure any potential contamination at SOC sites
All clinical care will be performed by the clinic staff nurses and PEs All study procedures including participant interviews pill counts medical record abstraction and program characteristics surveys will be performed by study staff research assistants Following routine clinic visits clinic staff will refer patients initiating IPT to study staff who will screen for eligibility obtain informed consent and enroll consenting eligible patients into the MC In addition RAs at CIP sites will provide parts of the intervention including disbursement of mobile phones SIM cards airtime vouchers and cash for transportation reimbursement to eligible patients
Data will be collected from all HIV-infected patients enrolled in HIV care at study sites on or after January 1 2013 from a subset of patients who initiate IPT and enroll into a measurement cohort MC and from program characteristics surveys conducted at the study sites Routine clinic data from all HIV-infected patients enrolled in HIV care at the 10 participating clinics on or after January 1 2013 will be used to measure the following outcomes IPT initiation completion of IPT and retention in HIV care These data will be collected by Research Assistants RA by abstracting the following information from the clinic Pre-ART ART antiretroviral therapy and IPT registers during the period of observation on all HIV patients who enrolled in care at a study site on or after January 1 2013 date of enrollment in HIV care IPT initiation yesno date of ART initiation if applicable IPT outcomes completion default death stopped transferred out TB tuberculosis screening results TB treatment yesno TB treatment outcomes if applicable and retention in HIV care
A measurement cohort of 500 HIV-infected patients initiating IPT on or after July 1 2013 will be recruited from the 10 clinics n250 per study arm MC participants will be assessed at baseline enrollment and monthly intervals for six to nine months depending on the duration of IPT Outcomes to be measured among MC participants include adherence to IPT adherence to ART if applicable change in CD4 count and side effectsadverse events MC participants at both SOC and CIP sites will receive the same assessments RAs will administer assessments on the day of regularly scheduled clinic visits including a Baseline interview administered on the day of enrollment which coincides with the day the participant initiates IPT monthly follow-up interviews completed throughout IPT and an end of treatment interview that is completed on the day the participant ends IPT Participants who miss a study visit will be contacted by study staff and administered the questionnaire over the phone within a 1-week window period of the scheduled clinic visit RAs will also call the MC participants between clinic visits to conduct unannounced pill counts to assess medication adherence In addition 30 MC participants from CIP sites will participate in a qualitative interview to assess feasibility and acceptability of the Interactive Voice Response IVR system one of the interventions in place at CIP sites Also three groups will be recruited from CIP clinics to participate in in-depth interviews IPT initiators from among participants in the Measurement Cohort n 15 IPT non-initiators n15 and healthcare providers nurses and peer educators n13 In-depth interviews will assess acceptability and preferences of intervention components as well as reasons for IPT non-initiation
RAs will conduct an assessment of programmatic activities at each HIV clinic prior to study implementation and on a monthly basis thereafter throughout the study period Clinics in both conditions will receive the same assessments The RA will administer a brief semi-structured Program Characteristics survey to the ART nurse who will be most familiar with the day-to-day operations of the HIV clinic The survey will assess nurse training and mentorship in IPT initiation and HIV treatment availability and use of an IPT clinical algorithm IPT and ART adherence training for peer educators PEs IPT health education for patients availability and use of an IPT treatment literacy curriculum including a flip chart used by PEs reimbursement for transportation costs for patients provision of mobile phones subscriber identification module SIM cards and airtime vouchers for HIV patients on IPT use of IVR messages for medication and appointment reminders and assessment of medication adherence and side effects and provision of community-based adherence and side effect monitoring by PEs These data will be used to assess fidelity with the intervention at CIP sites as well as to measure any potential contamination at SOC sites
All clinical care will be performed by the clinic staff nurses and PEs All study procedures including participant interviews pill counts medical record abstraction and program characteristics surveys will be performed by study staff research assistants Following routine clinic visits clinic staff will refer patients initiating IPT to study staff who will screen for eligibility obtain informed consent and enroll consenting eligible patients into the MC In addition RAs at CIP sites will provide parts of the intervention including disbursement of mobile phones SIM cards airtime vouchers and cash for transportation reimbursement to eligible patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AI100044-01 | NIH | None | httpsreporternihgovquickSearch1R01AI100044-01 |