Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS With Low-level Viraemia in Uganda.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study design This study will be a single blinded (participant-blinded) 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 groups of the study.
Study population The study will comprise of PLHIV on ART who have had recent VL result with LLV. Sample size A sample size of 157 participants per group 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 85% in creating a non-detectable VL in these PLHIV, hence we assume p1 to be 0.85.
Considering an attrition rate of 25%, and a design effect of 2, the resultant total sample size of 392 participants per study group will be used.
Sampling procedure The participants will be grouped into different strata based on level of viraemia and region, using proportionate stratified random sampling, in both the intervention group which will receive intensive adherence counselling (IAC) as an intervention to manage LLV, and the control group (the standard of care group) which will receive no intervention, other than the routine services.
Data collection The study will take place at the HIV clinics of the selected health facilities, 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 be grouped into different strata based on the levels of viraemia, that is 50 to 199, 200 to 399, 400 to 599, and 600 to 999 copies/ml. The participants will then randomly be allocated to the two groups, either the intervention group or the control group and concealment of the patient allocation to these groups will be done to avoid both conscious and unconscious selection of patients into the study.
Control Group (Standard of Care): 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 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 Group (IAC group): This group 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 both in the control and intervention groups 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 15. Descriptive statistics will be used to describe the sample size. The proportions of PLHIV attaining a non-detectable VL in the intervention group will be compared with those PLHIV attaining a non-detectable VL in the control group. The effectiveness of intensive adherence counselling will be estimated using Cox regression models, adjusted for sociodemographic factors.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Arm 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)
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.
Other Names:
|
| No Intervention: Control Arm 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. |
Outcome Measures
Primary Outcome Measures
- 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 [3 completed months of IAC]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
-
PLHIV aged 18 years or above
Exclusion Criteria:
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Critically sick PLHIV
-
Non-suppressed PLHIV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kalisizo Hospital | Masaka | Uganda |
Sponsors and Collaborators
- Makerere University
- Rakai Health Sciences Project
- Ministry of Health, Uganda
Investigators
- Principal Investigator: Nicholus Nanyeenya, MBChB, MPH, Makerere University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPH-2021-144