Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511056
Status:
COMPLETED
Last Update Posted:
2020-07-17
First Post:
2007-08-02
Brief Title:
Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy
Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Organization:
The HIV Netherlands Australia Thailand Research Collaboration
Study Overview
Official Title:
Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARB
Brief Summary:
Study Hypothesis Do certain risk behaviours impactpredict levels of HIV antiretroviral adherence
Objectives
To assess risk behavior in HIV-positive individuals receiving highly active antiretroviral therapyHAART
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
Objectives
To assess risk behavior in HIV-positive individuals receiving highly active antiretroviral therapyHAART
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
Detailed Description:
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 behaviourAt 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 HIVAIDS 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
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 behaviourAt 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 HIVAIDS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None