Effectiveness of Intensive Adherence Counselling Among People Living With HIV/AIDS With Low-level Viraemia in Uganda.

NCT05514418 | Unknown

• 1 other identifier: SPH-2021-144
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 8

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.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• 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

  3 completed months of IAC

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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)

Control Arm

NO INTERVENTION

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

Intensive Adherence Counselling (IAC) PROCEDURE

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

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Critically sick PLHIV
• Non-suppressed PLHIV

Sponsors & Collaborators

• Makerere University: lead
• Rakai Health Sciences Project: collaborator
• Ministry of Health, Uganda: collaborator

Study Sites (8)

Kamuli General Hospital

Jinja, Uganda

Location

Kiyunga health centre IV

Jinja, Uganda

Location

Mityana General Hospital

Kampala, Uganda

Location

Mpigi Health Centre IV

Kampala, Uganda

Location

Alebtong health centre IV

Lira, Uganda

Location

Orum health centre IV

Lira, Uganda

Location

Rwekubo health centre IV

Mbarara, Uganda

Location

TASO Mbarara

Mbarara, Uganda

Location

Related Publications (1)

• 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.

  PMID: 37853605 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Nicholus Nanyeenya, MBChB, MPH

  Makerere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 24, 2022
• Study Start: September 12, 2022
• Primary Completion: February 12, 2023
• Study Completion: April 12, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

UG (8)