Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT05514418
Status:
UNKNOWN
Last Update Posted:
2023-01-31
First Post:
2022-08-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS With Low-level Viraemia in Uganda.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-04-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-27', 'studyFirstSubmitDate': '2022-08-22', 'studyFirstSubmitQcDate': '2022-08-22', 'lastUpdatePostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportions of people living with HIV (PLHIV) with a non-detectable viral load (below 50 copies/ml) in both the intervention and control arms of the study', 'timeFrame': '3 completed months of IAC', 'description': 'Number of people living with HIV (PLHIV) with a non-detectable viral load (below 50 copies/ml) in both the intervention and control arms of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV/AIDS']}, 'referencesModule': {'references': [{'pmid': '37853605', 'type': 'DERIVED', 'citation': 'Nanyeenya N, Nakanjako D, Makumbi F, Nakigozi G, Nalugoda F, Kigozi G, Nasuuna E, Kibira SPS, Nabadda S, Kiyaga C, Huzaifah M, Kiwanuka N. Effectiveness of intensive adherence counselling in achieving an undetectable viral load among people on antiretroviral therapy with low-level viraemia in Uganda. HIV Med. 2024 Feb;25(2):245-253. doi: 10.1111/hiv.13568. Epub 2023 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'Uganda uses a threshold of 1,000 copies/ml to determine HIV viral non-suppression among people living with HIV/AIDS (PLHIV) on treatment, which is indicative of either poor adherence or HIV virologic treatment failure; as per the recent WHO recommendations. The use of this high threshold of 1,000 copies/ml has resulted into an increase in the number of PLHIV having low-level viraemia (≥50 to \\<1,000 copies/ml) from 11.0% in 2017 to 35.0% in 2020 in Uganda. Different studies in developed countries have shown that low-level viraemia is associated with HIV drug resistance, and despite this, there is no intervention to manage and control low-level viraemia (LLV), as per the recent Uganda national HIV guidelines. With this increasing and unmanaged low-level viraemia (LLV), Uganda might never achieve the global targets of ending AIDS as epidemic by 2030, as stipulated by target 3.3 of SDG 3.\n\nThis study will therefore determine the effectiveness of intensive adherence counselling on achieving a non-detectable viral load (below 50 copies/ml) in the management of LLV among PLHIV on ART in Uganda. This study will generate useful information that might guide the review of the national HIV guidelines, to control and manage LLV among PLHIV on ART; and thereby enable Uganda to achieve the global goals of SDG 3, Target 3.3 and the national targets of Vision 2040.', 'detailedDescription': "Study design This study will be a cluster randomized clinical trial, which will determine the effectiveness of IAC in achieving a non-detectable viral load among PLHIV on ART with LLV from selected health facilities from all the four regions of Uganda. The outcome of the study will be the proportions of PLHIV with a non-detectable viral load in both the intervention and control arms of the study.\n\nStudy setting The study will be conducted in selected health facilities from each of the four regions in Uganda (Central, Eastern, Northern and Western).\n\nStudy population The study will comprise of PLHIV on ART who have had recent VL result with LLV.\n\nSample size A sample size of 79 participants per arm will be estimated from; n = \\[(Zα/2 + Zβ)2 × {(p1 (1-p1) + (p2 (1-p2))}\\]/(p1 - p2)2 (Sakpal, 2010; Sullivan, 2020); with a power of 90% and a 5% level of significance to detect a 15% difference in PLHIV on ART who get a non-detectable viral load between those offered IAC and those who are not. IAC is an intervention used to manage PLHIV with a non-suppressed VL and 70% of these PLHIV attain viral suppression (WHO, 2016); and therefore, we assume that p2 is 0.7. PLHIV with LLV have suppressed VL and we assume IAC to even be more effective at about 90% in creating a non-detectable VL in these PLHIV, hence we assume p1 to be 0.9.\n\nAn equal sample size of 12 participants for each of the 8 clusters will be estimated from (Hemming et al., 2011) where nI is the number of participants required for each arm, k is the number of clusters, and p is the intra-cluster correlation estimate, which is 0.0180 (Barnhart et al., 2016), thus a total of 96 participants is required. Considering a design effect of 1.126 and an attrition rate of 20%, the resultant total sample size of 136 participants per study arm will be used, hence a total 17 participants will be recruited per cluster.\n\nSampling procedure The clusters will be grouped into pairs based on the geographical location (Lorenz et al., 2018). In each cluster pair, one cluster will be randomly assigned to the intervention arm, which will receive intensive adherence counselling (IAC) as an intervention to manage LLV. Hence both the intervention and control arms will be balanced.\n\nData collection The study will take place at the HIV clinics of the selected health facilities (clusters), and the selected research assistants who will either be ART counsellors or clinicians or nurses will be oriented and trained about the study and also re-mentored in how to offer IAC sessions.\n\nPLHIV on ART with recent VL results having LLV who will have consented to take part in the study will sequentially be recruited into the clusters, and the demographic data will be collected.\n\nControl Arm (Standard of Care): This arm will comprise of clusters which will receive the routine standard of care. These participants in these clusters will receive the normal patient education and encouragement to continue with their ART at the start of the study. They will not be reviewed monthly or offered any counselling for the entire three months. These participants will be given an appointment after three months for repeat VL testing.\n\nIntervention Arm (IAC arm): The participants of clusters in this arm will receive three monthly sessions of intensive adherence counselling and psychosocial support, using the 5 A's principles for chronic care (which include; Assess, Advise, Agree, Assist and Arrange). Each monthly IAC session will be offered by the research assistants for about one hour, and adherence will also be assessed by pill counts. Colour-coded IAC forms will be developed and used to differentiate the study from routine IAC services for the non-suppressed patients; and the study will be conducted on different days, from those on which the routine clinic occurs.\n\nFollowing the three months of the study, all the study participants in all the clusters both in the control and intervention arms will be reviewed at the health facility and a repeat VL done for each of the participants, to determine whether they have achieved a non-detectable VL or not.\n\nStatistical Analysis EpiData version 3.02 will be used for data entry, and analysis will be done using Stata version 14. Descriptive statistics will be used to describe the sample size. The proportions of PLHIV attaining a non-detectable VL in the intervention arm will be compared with those PLHIV attaining a non-detectable VL in the control arm. The effectiveness of intensive adherence counselling will be estimated using Cox regression models, adjusted for sociodemographic factors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People living with HIV (PLHIV) on antiretroviral therapy (ART) with recent viral load (VL) results having low-level viraemia (≥50 to \\<1,000 copies/ml)\n* PLHIV aged 18 years or above\n\nExclusion Criteria:\n\n* Critically sick PLHIV\n* Non-suppressed PLHIV'}, 'identificationModule': {'nctId': 'NCT05514418', 'briefTitle': 'Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS With Low-level Viraemia in Uganda.', 'organization': {'class': 'OTHER', 'fullName': 'Makerere University'}, 'officialTitle': 'Viral Non-Suppression, Drug Resistance, Perceptions and Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS on Antiretroviral Therapy With Low-Level Viraemia in Uganda.', 'orgStudyIdInfo': {'id': 'SPH-2021-144'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': "This group will receive three monthly sessions of intensive adherence counselling (IAC) and psychosocial support, using the 5 A's principles for chronic care (which include; Assess, Advise, Agree, Assist and Arrange). Each monthly IAC session will be offered by the research assistants for about one hour, and adherence will also be assessed by pill counts. Colour-coded IAC forms will be developed and used to differentiate the study from routine IAC services for the non-suppressed patients; and the study will be conducted on different days, from those on which the routine clinic occurs.\n\nFollowing the three months of the study, all the study participants both in the control and intervention groups will be reviewed at the health facility and a repeat viral load (VL) test done for each of the participants, to determine whether they have achieved a non-detectable VL or not.", 'interventionNames': ['Procedure: Intensive Adherence Counselling (IAC)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'This group will comprise of participants who will receive the routine standard of care. These participants will receive the normal patient education and encouragement to continue with their antiretroviral therapy (ART) at the start of the study. They will not be reviewed monthly or offered any counselling for the entire three months. These participants will be given an appointment after three months for repeat viral load (VL) testing.'}], 'interventions': [{'name': 'Intensive Adherence Counselling (IAC)', 'type': 'PROCEDURE', 'otherNames': ['Targeted Adherence Counselling', 'Enhanced Adherence Counselling'], 'description': 'Intensive adherence counselling is offered to people living with HIV (PLHIV) having a non-suppressed viral load (VL) result ( a VL of 1,000 copies/ml or more) and this is given once every month for three months. In our study, we are going to give IAC to PLHIV with low-level viraemia (having a VL of 50 copies/ml but less than 1,000 copies/ml) and determine its effectiveness in causing a non-detectable VL (less than 50 copies/ml), which is desirable for PLHIV on ART.', 'armGroupLabels': ['Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinja', 'country': 'Uganda', 'facility': 'Kamuli General Hospital', 'geoPoint': {'lat': 0.43902, 'lon': 33.20317}}, {'city': 'Jinja', 'country': 'Uganda', 'facility': 'Kiyunga health centre IV', 'geoPoint': {'lat': 0.43902, 'lon': 33.20317}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Mityana General Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Mpigi Health Centre IV', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lira', 'country': 'Uganda', 'facility': 'Alebtong health centre IV', 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}, {'city': 'Lira', 'country': 'Uganda', 'facility': 'Orum health centre IV', 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}, {'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Rwekubo health centre IV', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}, {'city': 'Mbarara', 'country': 'Uganda', 'facility': 'TASO Mbarara', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'overallOfficials': [{'name': 'Nicholus Nanyeenya, MBChB, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Makerere University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share the IPD yet'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Makerere University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rakai Health Sciences Project', 'class': 'UNKNOWN'}, {'name': 'Ministry of Health, Uganda', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}