Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy (ARB)

This study has been completed.
Sponsor:
Collaborator:
Kirby Institute
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00511056
First received: August 2, 2007
Last updated: July 7, 2011
Last verified: July 2011

August 2, 2007
July 7, 2011
September 2007
January 2009   (final data collection date for primary outcome measure)
The relationship between sexual risk behavior and adherence to HIV medications and how do these behaviors relate to patient beliefs about HIV transmission. [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00511056 on ClinicalTrials.gov Archive Site
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Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy
Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy

Study Hypothesis: Do certain risk behaviours impact/predict levels of HIV antiretroviral adherence?

Objectives:

  • To assess risk behavior in HIV-positive individuals receiving highly active antiretroviral therapy.(HAART)
  • To assess levels of adherence in the same subjects at the same time point
  • To determine if there is a correlation between HAART adherence and risk behaviour

Background and Rationale:

Adherence to an effective antiretroviral (ARV) regimen is the most important determinant of treatment success in patients receiving ARV. It is now well established that virological suppression on highly active antiretroviral therapy (HAART) requires strict adherence to prescribed dosing schedules. It is essential to reach and maintain therapeutic levels of these drugs, and strict adherence is particularly crucial for preventing the development of drug-resistant viral strains. If therapeutic drugs levels are suboptimal and the virus is able to replicate, this has important individual and public health implications.

Indirect evidence also suggests that the use of HAART by HIV-infected individuals decreases sexual transmission of HIV. Specifically, ARV treatment decreases serum and genital fluid HIV viral load. It has become evident that the availability of HAART may paradoxically increase sexual practices that lead to HIV transmission. This has been seen in several developed countries where the introduction of HAART coincided with increasing sexual risk behaviour and sexually transmitted infections. Thus far there has been very little evidence showing these trends in developing countries.

Despite the high burden on HIV in developing countries compared with developed countries, considerably more evidence is available in the latter regarding adherence and risk behaviour. Studies to ascertain the correlation between these two factors are important as new interventions may be established to ensure that improved health and economic outcomes will follow. Understanding which patients have increased risk behaviours, or are at risk for non-adherence enables identification of patients who are important targets for interventional strategies to optimise HIV treatment programmes.

Adherence and risk behaviour:

Apart from the beneficial clinical effects of HAART, treatment advances may have unintended effects on sexual behaviour. Evidence suggests that since HAART became available, the prevalence of unprotected sex and the incidence of sexually transmitted infections including HIV have increased, mostly among men who have sex with men (MSM). Some HIV positive persons receiving HAART, especially those with a undetectable viral load, may feel protected from transmitting HIV sexually. Recent evidence does suggest that an undetectable viral load may reduce the level of infectiousness of HIV positive persons receiving HAART.

As this information moves into the public domain it may influence peoples beliefs about HIV transmission and lessen concern about engaging in unsafe sex. People who hold these beliefs are more likely than their counterparts to engage in unprotected sex.

HIV positive patients who engage in high-risk behaviours linked to HIV spread are as likely to be receiving HAART as those at low risk for disease transmission, but those who engage in high-risk behaviours have much lower rates of medication adherence and thus much higher viral loads. This suggests a strong behavioural basis for transmission of drug resistant HIV, and parallels recent increases in all sexually transmitted infections. Given that taking HAART and having an undetectable viral load do not eliminate the possibility of transmitting HIV, it is important to examine whether the use of HAART and beliefs about HAART are associated with sexual risk taking.

Definitions:

Risk behavior is defined as behavior which may result in transmission of HIV

Study subjects:

Subjects will be asked to complete a questionnaire which will contain questions on adherence and risk behaviour.At the completion of data collection an analysis will be made accordingly. Approximately 700 patients in HIV-NAT 006 who provide consent will be enrolled.

Inclusion criteria are:

  • Age ≥ 18 years
  • HIV seropositive.
  • On continuous HAART for at least 6 months
  • Signed written informed consent

Methods:

Cross sectional survey of adherence and behavior in subjects enrolled in the HIVNAT 006 long term follow up cohort.

Patients enrolled in HIVNAT 006 are normally required to attend regular 6 monthly follow up appointments. Over the coming months 700 subjects who give consent will be asked to complete an anonymous self-administered questionnaire at their next clinic visit. Completion of the questionnaire will be facilitated by people living with HIV/AIDS (PLHA) who will be trained by HIVNAT.

The questionnaire will comprise the following categories:

  1. Demographics
  2. Medication adherence
  3. Factors affecting adherence (risk behaviour)

Furthermore the following will be extracted from the HIVNAT database:

  • CDC disease stage over the previous 12 months and at current consult
  • CD4 over the previous 12 months and at current consult
  • VL over the previous 12 months and at current consult
  • ARV regimen and changes in regimen
  • Opportunistic infections
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood samples required to provide Viral Load data and CD4 cell count

Non-Probability Sample

Approximately 500 subjects were surveyed from the HIVNAT 006 long term follow up cohort. A sample size as large as this is likely to yield accurate results as to the true relationship between sexual risk behavior and adherence to HIV medications.

HIV Infections
Not Provided
HIVNAT 006
HIVNAT 006 is a long term follow up cohort. The primary objective of this study is to collect and evaluate the long-term clinical outcomes of HIV infected patients have participated in HIV-NAT studies. These subjects will be used to test our hypothesis.
Honeybrook AL. Adherence and Risk Behaviour in Patients With HIV Recieving antiretroviral therapy. XVII International AIDS Conference 2008. Mexico City, Mexico.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
December 2009
January 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years
  • HIV seropositive.
  • On continuous HAART for at least 6 months
  • Signed written informed consent
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00511056
HIV-NAT Amendment II to 006
No
Dr Kiat Ruxrungtham, The HIV Netherlands Australia Thailand Research Collaboration
The HIV Netherlands Australia Thailand Research Collaboration
Kirby Institute
Principal Investigator: Kiat Ruxrungtham, M.D., M.Sc. HIVNAT
The HIV Netherlands Australia Thailand Research Collaboration
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP