Short Adherence Intervention for Viral Re-suppression

NCT03242980 | Completed

• 1 other identifier: SAVIR
• Study Type: interventional
• Target: 928
• Locations: 1 country
• Sites: 12

Brief Summary

In the era of test-and-treat, with anticipated high numbers of patients who will have unsuppressed viral load (VL) due to poor adherence, simple, short and standardized adherence interventions with documented efficacy will be needed. Achieving re-suppression in patients with unsuppressed VL is beneficial for the health of the individual, important to reduce the risk of transmission and has a direct cost implication because patients with sustained unsuppressed VL will ultimately be switched to more expensive 2nd-line regimens. Information is still largely lacking on how to best address adherence problems among patients with unsuppressed VL. VL monitoring is recognized as a useful tool to reinforce adherence in patients with unsuppressed VL. The Lesotho Guidelines recommend redoing a VL 8-12 weeks after the first enhanced adherence counselling. To date no study has been published clearly demonstrating higher re-suppression rates after enhanced adherence counselling for patients with unsuppressed VL. This project aims to test an adherence intervention for HIV-positive individuals on first-line ART who have an unsuppressed viral load. A step wedged study will be used to compare the effectiveness of a short, standardized adherence counselling followed by an SMS reminder to the standard of care (≥ 2 unstructured adherence counselling sessions) in terms of viral re-suppression rates and switches to 2nd line ART.

Conditions

Adherence, Medication; HIV/AIDS

Keywords

HIV; Adherence; Viral re-suppression; Step-wedgged randomized trial

Outcome Measures

Primary Outcomes (1)

• Re-suppression rates after one elevated viral load

  HIV viral load \<1000 copies/ml

  Up to 16 weeks

Secondary Outcomes (4)

• Rates of switch to second-line ART

  Up to 6 months

• Major drug resistance mutations

  3 months after 1st elevated VL

• Rates of attrition from care

  6 months

• Rates of viral re-suppression

  6 months after switch

Study Arms (2)

Enhanced adherence counseling

NO INTERVENTION

Individuals with elevated VL are required to attend a minimum of 2 session of enhanced adherence counselling performed at monthly intervals. A follow-up VL is done at 8 to 12 weeks after the first counselling session.

Structured EAC plus SMS

EXPERIMENTAL

The behavioral intervention will consist of structured adherence counseling and a short text message (SMS). A culturally adapted graphical brochure was specifically developed to guide adherence-counselling for individuals with unsuppressed VL.

Behavioral: Structured adherence counseling

Interventions

Structured adherence counseling BEHAVIORAL

Patients will undergo one standardized enhanced adherence counselling session. Counselling guidelines and a brochure were specifically developed to guide the adherence counselling for individuals with unsuppressed VL. All nurses at the health centres will be trained on the counselling prior to the cross-over to the intervention. The brochure was developed by culturally adapted by social scientists and contains only 3 key messages. The brochure will be given to the patient to take home. Four weeks after the adherence counselling session, a SMS will be sent to the patient reminding them to take their ART. The content of the text message will be anonymous to protect disclosure and discussed/agreed upon with the patient during the adherence counselling.

Structured EAC plus SMS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving VL monitoring at one of the 2 hospitals and 10 health centres in Butha-Buthe district
• Patients on first-line ART
• Patients with a VL≥ 1000 copies/mL after a minimum of 6 months on first-line ART

You may not qualify if:

• Patients receiving VL monitoring at a non-participating center in Butha-Buthe

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• SolidarMed: collaborator
• Ministry of Health, Lesotho: collaborator
• University of Basel: collaborator

Study Sites (12)

Boiketsiso Health Center

Butha-Buthe, Lesotho

Location

Linakeng Health Center

Butha-Buthe, Lesotho

Location

Makhunoane Health Center

Butha-Buthe, Lesotho

Location

Motete Health Center

Butha-Buthe, Lesotho

Location

Muela Health Center

Butha-Buthe, Lesotho

Location

Ngoajane Health Center

Butha-Buthe, Lesotho

Location

Paballong

Butha-Buthe, Lesotho

Location

Rampai Health Center

Butha-Buthe, Lesotho

Location

Seboche

Butha-Buthe, Lesotho

Location

St Paul Health Center

Butha-Buthe, Lesotho

Location

St Peters Health Center

Butha-Buthe, Lesotho

Location

Tsime Health Center

Butha-Buthe, Lesotho

Location

Related Publications (5)

• Government of Lesotho: NATIONAL GUIDELINES ON THE USE OF ANTIRETROVIRAL THERAPY FOR HIV PREVENTION AND TREATMENT. Fifth Edition 2016.

  BACKGROUND

• Conway B. The role of adherence to antiretroviral therapy in the management of HIV infection. J Acquir Immune Defic Syndr. 2007 Jun 1;45 Suppl 1:S14-8. doi: 10.1097/QAI.0b013e3180600766.

  PMID: 17525686 BACKGROUND

• Bonner K, Mezochow A, Roberts T, Ford N, Cohn J. Viral load monitoring as a tool to reinforce adherence: a systematic review. J Acquir Immune Defic Syndr. 2013 Sep 1;64(1):74-8. doi: 10.1097/QAI.0b013e31829f05ac.

  PMID: 23774877 BACKGROUND

• Jobanputra K, Parker LA, Azih C, Okello V, Maphalala G, Kershberger B, Khogali M, Lujan J, Antierens A, Teck R, Ellman T, Kosgei R, Reid T. Factors associated with virological failure and suppression after enhanced adherence counselling, in children, adolescents and adults on antiretroviral therapy for HIV in Swaziland. PLoS One. 2015 Feb 19;10(2):e0116144. doi: 10.1371/journal.pone.0116144. eCollection 2015.

  PMID: 25695494 BACKGROUND

• Ministry of Health and Social Welfare Lesotho: National Guidelines For HIV Testing And Counselling. National Guidelines For HIV Testing And Counselling 2009.

  BACKGROUND

MeSH Terms

Conditions

Medication Adherence; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; 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

• Tracy R Glass, PhD

  Swiss TPH

  PRINCIPAL INVESTIGATOR

• Niklaus Labhardt, MD

  Swiss TPH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Leader

Model Details: To ensure that the effect of this intervention is measured and to avoid a long delay in adopting the intervention, a stepped wedge design was chosen. In addition the study would thus not disrupt the on-going staggered roll-out of routine viral load provision to patients on ART at the 12 health facilities. Stepped wedge designs are a form of clustered study in which the intervention is delivered to groups rather than individuals.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 8, 2017
• Study Start: May 18, 2017
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

LE (12)