HIV InfectionsARBNCT00511056
Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- How many people
- 700 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2007to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- HIV seropositive.
- On continuous HAART for at least 6 months
- Signed written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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 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:
- Demographics
- Medication adherence
- 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
- Conditions
- HIV Infections
- Keywords
- HIV, Adherence, Compliance, Highly Active Antiretroviral Therapy (HAART), ARV, ART, Sexual Risk Behavior, Unsafe, Transmission
- Medical subject headings
- HIV Infections, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The relationship between sexual risk behavior and adherence to HIV medications and how do these behaviors relate to patient beliefs about HIV transmission.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Kirby Institute
- Responsible party
- Sponsor
- Investigators
- Kiat Ruxrungtham, M.D., M.Sc., Principal investigator, HIVNAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511056
- Sponsor's protocol ID
- HIV-NAT Amendment II to 006
- Acronym
- ARB
- Status last verified
- Jul 2020
- First submitted
- 2 Aug 2007
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Honeybrook AL. Adherence and Risk Behaviour in Patients With HIV Recieving antiretroviral therapy. XVII International AIDS Conference 2008. Mexico City, Mexico.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence and Risk Behaviour in Patients With HIV Infection Receiving Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00511056
- Acronym / sponsor ID
- ARB / HIV-NAT Amendment II to 006
- Conditions
- HIV Infections
- Keywords
- HIV, Adherence, Compliance, Highly Active Antiretroviral Therapy (HAART), ARV, ART, Sexual Risk Behavior, Unsafe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Kirby Institute
- Study start
- Sep 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 3 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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:
- Demographics
- Medication adherence
- 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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- HIV seropositive.
- On continuous HAART for at least 6 months
- Signed written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2020.
- Results publicationHoneybrook AL. Adherence and Risk Behaviour in Patients With HIV Recieving antiretroviral therapy. XVII International AIDS Conference 2008. Mexico City, Mexico.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiat Ruxrungtham, M.D., M.Sc. principal investigator
HIVNAT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by The HIV Netherlands Australia Thailand Research Collaboration at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00511056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2020.