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

July 15, 2020 updated by: The HIV Netherlands Australia Thailand Research Collaboration

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

Study Overview

Status

Completed

Conditions

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:

  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 Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • HIV-NAT, Thai Red Cross AIDS Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators

Kirby Institute

Investigators

  • Principal Investigator: Kiat Ruxrungtham, M.D., M.Sc., HIVNAT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Honeybrook AL. Adherence and Risk Behaviour in Patients With HIV Recieving antiretroviral therapy. XVII International AIDS Conference 2008. Mexico City, Mexico.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 2, 2007

First Submitted That Met QC Criteria

August 2, 2007

First Posted (Estimate)

August 3, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIV-NAT Amendment II to 006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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