Effect of Medication Diaries on Adherence to Highly Active Antiretroviral Drugs Among HIV-1 Infected Kenyan Children

NCT00194545 | Completed Phase 2

• 1 other identifier: 04-1519-D 02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Following significant reduction in antiretroviral drug prices over the past two years, more HIV-1 infected African adults and children are gaining access to treatment. However, due to complex drug regimens that have to be taken continuously, suboptimal adherence is likely to be a formidable challenge. As programs providing antiretroviral drugs in Africa scale up, achievement of excellent adherence is a high priority as this will result in maximum benefits from the drugs and forestall development of resistant virus. A better understanding of predictors of pediatric HAART adherence in African children is essential in order to formulate feasible, culturally appropriate, strategies to monitor and enhance adherence. There is also urgent need to evaluate simple, inexpensive interventions that are widely applicable in the African setting. The medication diary has been used empirically among HIV infected adults and children in Western countries, mainly as a tool for monitoring and to a lesser extent improving HAART adherence. Literacy levels have risen significantly in most African regions over the past few years, and the diary can also be further modified using pictures to suit parents of different literacy levels. We propose to conduct a randomized control trial to determine the effect of medication diaries and counseling versus counseling alone on HAART-adherence in HIV-1 infected children and their parents/caregivers in Nairobi Kenya.

Conditions

HIV Infections

Keywords

HIV-1; pediatric adherence; medication diaries; HAART; Treatment Naive

Outcome Measures

Primary Outcomes (1)

• HIV-1 RNA

  9 months

Secondary Outcomes (1)

• Follow-up CD4% and adherence

  6 months, 15 months

Study Arms (2)

1

EXPERIMENTAL

Medication diary

Behavioral: Medication diaries

2

NO INTERVENTION

Caregivers only receive counseling which is the standard of care

Interventions

Medication diaries BEHAVIORAL

Caregivers expected to complete medication diaries daily

1

Eligibility Criteria

• Age: 18 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• parents/caregivers planning to reside in Nairobi for at least one year after initiation of antiretroviral therapy
• HIV-1 infected children between ages 18 months to 12 years with symptomatic disease (WHO stage II or III) and/or CD4 \<20% \[where CD4 counts available\]

You may not qualify if:

• previous use of antiretroviral drugs by the child apart from drugs taken as part of prevention of mother to child transmission of HIV
• children with end-stage AIDS including widespread disseminated malignancy, and generalized severe encephalopathy

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Nairobi

Nairobi, Kenya

Location

Related Publications (5)

• Farquhar C, Wamalwa D, Selig S, John-Stewart G, Mabuka J, Majiwa M, Sutton W, Haigwood N, Wariua G, Lohman-Payne B. Immune responses to measles and tetanus vaccines among Kenyan human immunodeficiency virus type 1 (HIV-1)-infected children pre- and post-highly active antiretroviral therapy and revaccination. Pediatr Infect Dis J. 2009 Apr;28(4):295-9. doi: 10.1097/INF.0b013e3181903ed3.

  PMID: 19258919 RESULT

• Wamalwa DC, Farquhar C, Obimbo EM, Selig S, Mbori-Ngacha DA, Richardson BA, Overbaugh J, Egondi T, Inwani I, John-Stewart G. Medication diaries do not improve outcomes with highly active antiretroviral therapy in Kenyan children: a randomized clinical trial. J Int AIDS Soc. 2009 Jun 24;12:8. doi: 10.1186/1758-2652-12-8.

  PMID: 19549342 RESULT

• Wamalwa DC, Farquhar C, Obimbo EM, Selig S, Mbori-Ngacha DA, Richardson BA, Overbaugh J, Emery S, Wariua G, Gichuhi C, Bosire R, John-Stewart G. Early response to highly active antiretroviral therapy in HIV-1-infected Kenyan children. J Acquir Immune Defic Syndr. 2007 Jul 1;45(3):311-7. doi: 10.1097/QAI.0b013e318042d613.

  PMID: 17356470 RESULT

• Wamalwa DC, Obimbo EM, Farquhar C, Richardson BA, Mbori-Ngacha DA, Inwani I, Benki-Nugent S, John-Stewart G. Predictors of mortality in HIV-1 infected children on antiretroviral therapy in Kenya: a prospective cohort. BMC Pediatr. 2010 May 18;10:33. doi: 10.1186/1471-2431-10-33.

  PMID: 20482796 RESULT

• Yucha R, Litchford ML, Fish CS, Yaffe ZA, Richardson BA, Maleche-Obimbo E, John-Stewart G, Wamalwa D, Overbaugh J, Lehman DA. Higher HIV-1 Env gp120-Specific Antibody-Dependent Cellular Cytotoxicity (ADCC) Activity Is Associated with Lower Levels of Defective HIV-1 Provirus. Viruses. 2023 Oct 6;15(10):2055. doi: 10.3390/v15102055.

  PMID: 37896832 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Carey Farquhar, MD, MPH

  University of Washington

  STUDY DIRECTOR

• Dalton Wamalwa, MBChB, MPH

  University of Nairobi

  PRINCIPAL INVESTIGATOR

• Grace John-Stewart, MD, PhD

  University of Washington

  STUDY DIRECTOR

• Dorothy Mbori-Ngacha, MBChB, MPH

  University of Nairobi

  STUDY DIRECTOR

• Barbra Richardson, PhD

  University of Washington

  STUDY DIRECTOR

• Grace Wariua, MBChB, MPH

  University of Nairobi

  STUDY DIRECTOR

• Julie Overbaugh, PhD

  Fred Hutchinson Cancer Center

  STUDY DIRECTOR

• Elizabeth Obimbo, MBChB,MPH

  University of Nairobi

  STUDY DIRECTOR

• Christine Gichuhi, MBChB,MMed

  University of Nairobi

  STUDY DIRECTOR

• Ruth Nduati, MBChB,MPH

  University of Nairobi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: July 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

KE (1)