An interventional study of Intensive Adherence Counselling (IAC) in HIV/AIDS, sponsored by Makerere University. Status unknown at 8 sites in Uganda. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by Makerere University · Not applicable, Interventional, and Health services research
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Among 10 studies in Acquired Immunodeficiency Syndrome by Makerere University — 1 open to participants now, 1 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · Makerere University.
Among the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University, this one is the only one that started in 2022, is one of 5 with no phase, and was the 9th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →1 of the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University is open now, in 1 country. Recruiting first, the newest first:
Makerere University · Sites in Uganda
Ages 18+
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 136 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 124 across the 9 interventional studies, 200 across the 1 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
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Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
1 of the studies in Acquired Immunodeficiency Syndrome by Makerere University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07840651Makerere UniversityIntegrating Tuberculosis Treatment Into Community Pharmacies to Improve TB/HIV Outcomes in Uganda | 2027-09 |
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Among the 10 studies in Acquired Immunodeficiency Syndrome by Makerere University, from their registry updates:
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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.
This 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.
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.
Study setting The study will be conducted in selected health facilities from each of the four regions in Uganda (Central, Eastern, Northern and Western).
Study population The study will comprise of PLHIV on ART who have had recent VL result with LLV.
Sample 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.
An 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.
Sampling 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.
Data 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.
PLHIV 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.
Control 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.
Intervention 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.
Following 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.
Statistical 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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Following 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.
Procedure: Intensive Adherence Counselling (IAC)
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.
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.
Also known as: Targeted Adherence Counselling, Enhanced Adherence Counselling
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
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
Time frame: 3 completed months of IAC
Plan to share: No — No plan to share the IPD yet
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Feb 2023, 5 months after the start.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's planned 5 months is below that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →