The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial
Background: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective: The ENRICH Study is a mixed methods clust...
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| Format: | Article |
| Language: | English |
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Elsevier
2017-06-01
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| Series: | Contemporary Clinical Trials Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865416301028 |
| _version_ | 1828287886779219968 |
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| author | Andrea A. Howard Yael Hirsch-Moverman Suzue Saito Tsigereda Gadisa Amrita Daftary Zenebe Melaku |
| author_facet | Andrea A. Howard Yael Hirsch-Moverman Suzue Saito Tsigereda Gadisa Amrita Daftary Zenebe Melaku |
| author_sort | Andrea A. Howard |
| collection | DOAJ |
| description | Background: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap.
Objective: The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia.
Design: Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6–9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete.
Discussion: The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa. |
| first_indexed | 2024-04-13T09:55:34Z |
| format | Article |
| id | doaj.art-6ac5aaf48d13474090faac5dd2eb2ec5 |
| institution | Directory Open Access Journal |
| issn | 2451-8654 |
| language | English |
| last_indexed | 2024-04-13T09:55:34Z |
| publishDate | 2017-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj.art-6ac5aaf48d13474090faac5dd2eb2ec52022-12-22T02:51:26ZengElsevierContemporary Clinical Trials Communications2451-86542017-06-016C465410.1016/j.conctc.2017.03.001The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trialAndrea A. Howard0Yael Hirsch-Moverman1Suzue Saito2Tsigereda Gadisa3Amrita Daftary4Zenebe Melaku5ICAP, Columbia University Mailman School of Public Health, 722 West 168th Street, MSPH Box 18, New York, NY, USAICAP, Columbia University Mailman School of Public Health, 722 West 168th Street, MSPH Box 18, New York, NY, USAICAP, Columbia University Mailman School of Public Health, 722 West 168th Street, MSPH Box 18, New York, NY, USAICAP, Kirkos Kifle-Ketema, Kebel 05/06/07, House #21, P.O. Box 5556, Addis Ababa, EthiopiaICAP, Columbia University Mailman School of Public Health, 722 West 168th Street, MSPH Box 18, New York, NY, USAICAP, Kirkos Kifle-Ketema, Kebel 05/06/07, House #21, P.O. Box 5556, Addis Ababa, EthiopiaBackground: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. Objective: The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. Design: Ten health centers were randomized to receive the CIP or standard of care. The CIP includes: nurse training and mentorship using a clinical algorithm, tool to identify IPT-eligible family members, and data review at multidisciplinary team meetings; patient transport reimbursement; and adherence support using peer educators and interactive voice response messages. Routine data were abstracted for all newly-enrolled IPT-eligible HIV-positive patients; anticipated sample size was 1400 individuals. A measurement cohort of patients initiating IPT was recruited; target enrollment was 500 individuals, to be followed for the duration of IPT (6–9 months). Inclusion criteria were: HIV-positive; initiated IPT; age ≥18; Amharic-, Oromiffa-, Harari-, or Somali-speaking; and capable of informed consent. Three groups were recruited from CIP health centers for in-depth interviews: IPT initiators; IPT non-initiators; and health care providers. Primary outcomes are: IPT initiation; and IPT completion. Secondary outcomes include: retention; adherence; change in CD4+ count; adverse events; and acceptability. Follow-up is complete. Discussion: The ENRICH Study evaluates a CIP targeting barriers to IPT implementation. If the CIP is found effective and acceptable, this study has the potential to inform TB prevention strategies for HIV patients in resource-limited countries in sub-Saharan Africa.http://www.sciencedirect.com/science/article/pii/S2451865416301028Isoniazid preventive therapyHIVTuberculosisAdherenceImplementation scienceMixed methods |
| spellingShingle | Andrea A. Howard Yael Hirsch-Moverman Suzue Saito Tsigereda Gadisa Amrita Daftary Zenebe Melaku The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial Contemporary Clinical Trials Communications Isoniazid preventive therapy HIV Tuberculosis Adherence Implementation science Mixed methods |
| title | The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial |
| title_full | The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial |
| title_fullStr | The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial |
| title_full_unstemmed | The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial |
| title_short | The ENRICH study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation, adherence and completion among people living with HIV in Ethiopia: Rationale and design of a mixed methods cluster randomized trial |
| title_sort | enrich study to evaluate the effectiveness of a combination intervention package to improve isoniazid preventive therapy initiation adherence and completion among people living with hiv in ethiopia rationale and design of a mixed methods cluster randomized trial |
| topic | Isoniazid preventive therapy HIV Tuberculosis Adherence Implementation science Mixed methods |
| url | http://www.sciencedirect.com/science/article/pii/S2451865416301028 |
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